Ignite Creation Date:
2025-12-24 @ 6:41 PM
Ignite Modification Date:
2025-12-24 @ 6:41 PM
Study NCT ID:
NCT03843957
Status:
COMPLETED
Last Update Posted:
2024-01-31
First Post:
2019-02-14
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Effectiveness and Implementation of mPATH-CRC
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D012004', 'term': 'Rectal Neoplasms'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dmiller@wakehealth.edu', 'phone': '336-713-5218', 'title': 'Dr. David P. Miller, Jr', 'organization': 'Wake Forest University School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '2 years', 'eventGroups': [{'id': 'EG000', 'title': 'Clinic Patients Eligible for CRC Screening on "High Touch" Strategy (Post-Implementation)', 'description': 'English or Spanish-speaking patients aged 50-74 who are eligible for CRC screening who are seen in the study clinics randomized to mPATH utilizing the "high touch" implementation strategy in the 12 months after implementation.\n\nmPATH-CRC: mPATH-CRC is a self-administered iPad program that patients eligible for CRC screening use in primary care clinics to help them receive CRC screening.\n\nmPATH-Checkin: The mPATH-CheckIn program includes health questions to assist clinics with patient check-in, thereby incentivizing its use for all patients.\n\n"high touch" Implementation strategy: The "high touch" strategy consists of pre-implementation activities, training, and ongoing support.\n\nPre-Implementation Activities\n\n* Clinic champion identified.\n* Study team meeting with clinic champion\n* Implementation adaptations as needed for clinic flow\n\nImplementation Kick-Off (Day 1)\n\n• On-site training with key clinic personnel\n\nMonths 1 - 6\n\n* Phone/email technical support, as needed.\n* Access to web-based QA dashboard\n* Monthly program usage report sent to clinic champions\n* Scheduled phone-calls with clinic champion to review QA data and explore potential barriers.\n* Implementation adaptations as needed for clinic flow\n* Goal-triggered follow-up on-site trainings\n* Additional on-site trainings as requested.\n\nMonths 7 - 12\n\n* Phone/email technical support, as needed\n* Access to web-based QA dashboard', 'otherNumAtRisk': 7933, 'deathsNumAtRisk': 7933, 'otherNumAffected': 0, 'seriousNumAtRisk': 7933, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Clinic Patients Eligible for CRC Screening on "Low Touch" Strategy (Post-Implementation)', 'description': 'English or Spanish-speaking patients aged 50-74 who are eligible for CRC screening who are seen in the study clinics randomized to mPATH utilizing the "low touch" implementation strategy in the 12 months after implementation.\n\nmPATH-CRC: mPATH-CRC is a self-administered iPad program that patients eligible for CRC screening use in primary care clinics to help them receive CRC screening.\n\nmPATH-Checkin: The mPATH-CheckIn program includes health questions to assist clinics with patient check-in, thereby incentivizing its use for all patients.\n\n"low touch" Implementation Strategy: Clinics randomized to receive the low touch implementation strategy will receive: Pre-Implementation Activities\n\n• N/A\n\nImplementation Kick-Off (Day 1)\n\n• On-site training with key clinic personnel\n\nMonths 1 - 6\n\n* Phone/email technical support, as needed.\n* Access to web-based QA dashboard\n\nMonths 7 - 12\n\n* Phone/email technical support, as needed\n* Access to web-based QA dashboard', 'otherNumAtRisk': 5159, 'deathsNumAtRisk': 5159, 'otherNumAffected': 0, 'seriousNumAtRisk': 5159, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'All Adult Clinic Patients on "High Touch" Strategy (Post-Implementation)', 'description': 'English or Spanish-speaking patients aged 18 or older who are seen in the study clinics randomized to mPATH utilizing the "high touch" implementation strategy in the 12 months after implementation.\n\nmPATH-Checkin: The mPATH-CheckIn program includes health questions to assist clinics with patient check-in, thereby incentivizing its use for all patients.\n\n"high touch" Implementation strategy: The "high touch" strategy consists of pre-implementation activities, training, and ongoing support.\n\nPre-Implementation Activities\n\n* Clinic champion identified.\n* Study team meeting with clinic champion\n* Implementation adaptations as needed for clinic flow\n\nImplementation Kick-Off (Day 1)\n\n• On-site training with key clinic personnel\n\nMonths 1 - 6\n\n* Phone/email technical support, as needed.\n* Access to web-based QA dashboard\n* Monthly program usage report sent to clinic champions\n* Scheduled phone-calls with clinic champion to review QA data and explore potential barriers.\n* Implementation adaptations as needed for clinic flow\n* Goal-triggered follow-up on-site trainings\n* Additional on-site trainings as requested.\n\nMonths 7 - 12\n\n* Phone/email technical support, as needed\n* Access to web-based QA dashboard', 'otherNumAtRisk': 43775, 'deathsNumAtRisk': 43775, 'otherNumAffected': 0, 'seriousNumAtRisk': 43775, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'All Adult Clinic Patients on "Low Touch" Strategy (Post-Implementation)', 'description': 'English or Spanish-speaking patients aged 18 or older who are seen in the study clinics randomized to mPATH utilizing the "low touch" implementation strategy in the 12 months after implementation.\n\nmPATH-Checkin: The mPATH-CheckIn program includes health questions to assist clinics with patient check-in, thereby incentivizing its use for all patients.\n\n"low touch" Implementation Strategy: Clinics randomized to receive the low touch implementation strategy will receive: Pre-Implementation Activities\n\n• N/A\n\nImplementation Kick-Off (Day 1)\n\n• On-site training with key clinic personnel\n\nMonths 1 - 6\n\n* Phone/email technical support, as needed.\n* Access to web-based QA dashboard\n\nMonths 7 - 12\n\n* Phone/email technical support, as needed\n* Access to web-based QA dashboard', 'otherNumAtRisk': 23359, 'deathsNumAtRisk': 23359, 'otherNumAffected': 0, 'seriousNumAtRisk': 23359, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Clinic Personnel on "High Touch" Strategy (Post-Implementation)', 'description': 'Clinic personnel (e.g., administrators, nurses, providers) who are involved with the implementation of mPATH-CRC, in the study clinics randomized to mPATH utilizing the "high touch" implementation strategy in the 12 months after implementation.\n\nmPATH-CRC: mPATH-CRC is a self-administered iPad program that patients eligible for CRC screening use in primary care clinics to help them receive CRC screening.\n\nmPATH-Checkin: The mPATH-CheckIn program includes health questions to assist clinics with patient check-in, thereby incentivizing its use for all patients.\n\n"high touch" Implementation strategy: The "high touch" strategy consists of pre-implementation activities, training, and ongoing support.\n\nPre-Implementation Activities\n\n* Clinic champion identified.\n* Study team meeting with clinic champion\n* Implementation adaptations as needed for clinic flow\n\nImplementation Kick-Off (Day 1)\n\n• On-site training with key clinic personnel\n\nMonths 1 - 6\n\n* Phone/email technical support, as needed.\n* Access to web-based QA dashboard\n* Monthly program usage report sent to clinic champions\n* Scheduled phone-calls with clinic champion to review QA data and explore potential barriers.\n* Implementation adaptations as needed for clinic flow\n* Goal-triggered follow-up on-site trainings\n* Additional on-site trainings as requested.\n\nMonths 7 - 12\n\n* Phone/email technical support, as needed\n* Access to web-based QA dashboard', 'otherNumAtRisk': 282, 'deathsNumAtRisk': 282, 'otherNumAffected': 0, 'seriousNumAtRisk': 282, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Clinic Personnel on "Low Touch" Strategy (Post-Implementation)', 'description': 'Clinic personnel (e.g., administrators, nurses, providers) who are involved with the implementation of mPATH-CRC, in the study clinics randomized to mPATH utilizing the "low touch" implementation strategy in the 12 months after implementation.\n\nmPATH-CRC: mPATH-CRC is a self-administered iPad program that patients eligible for CRC screening use in primary care clinics to help them receive CRC screening.\n\nmPATH-Checkin: The mPATH-CheckIn program includes health questions to assist clinics with patient check-in, thereby incentivizing its use for all patients.\n\n"low touch" Implementation Strategy: Clinics randomized to receive the low touch implementation strategy will receive: Pre-Implementation Activities\n\n• N/A\n\nImplementation Kick-Off (Day 1)\n\n• On-site training with key clinic personnel\n\nMonths 1 - 6\n\n* Phone/email technical support, as needed.\n* Access to web-based QA dashboard\n\nMonths 7 - 12\n\n* Phone/email technical support, as needed\n* Access to web-based QA dashboard', 'otherNumAtRisk': 232, 'deathsNumAtRisk': 232, 'otherNumAffected': 0, 'seriousNumAtRisk': 232, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Clinic Patients Eligible for CRC Screening on "High Touch" Strategy (Pre-Implementation)', 'description': 'English or Spanish-speaking patients aged 50-74 who are eligible for CRC screening who are seen in the study clinics randomized to mPATH utilizing the "high touch" implementation strategy but in 8 months before implementation.\n\n"high touch" Implementation strategy: The "high touch" strategy consists of pre-implementation activities, training, and ongoing support.\n\nPre-Implementation Activities\n\n* Clinic champion identified.\n* Study team meeting with clinic champion\n* Implementation adaptations as needed for clinic flow\n\nImplementation Kick-Off (Day 1)\n\n• On-site training with key clinic personnel\n\nMonths 1 - 6\n\n* Phone/email technical support, as needed.\n* Access to web-based QA dashboard\n* Monthly program usage report sent to clinic champions\n* Scheduled phone-calls with clinic champion to review QA data and explore potential barriers.\n* Implementation adaptations as needed for clinic flow\n* Goal-triggered follow-up on-site trainings\n* Additional on-site trainings as requested.\n\nMonths 7 - 12\n\n* Phone/email technical support, as needed\n* Access to web-based QA dashboard', 'otherNumAtRisk': 5526, 'deathsNumAtRisk': 5526, 'otherNumAffected': 0, 'seriousNumAtRisk': 5526, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Clinic Patients Eligible for CRC Screening on "Low Touch" Strategy (Pre-Implementation)', 'description': 'English or Spanish-speaking patients aged 50-74 who are eligible for CRC screening who are seen in the study clinics randomized to mPATH utilizing the "low touch" implementation strategy but in 8 months before implementation.\n\n"low touch" Implementation Strategy: Clinics randomized to receive the low touch implementation strategy will receive: Pre-Implementation Activities\n\n• N/A\n\nImplementation Kick-Off (Day 1)\n\n• On-site training with key clinic personnel\n\nMonths 1 - 6\n\n* Phone/email technical support, as needed.\n* Access to web-based QA dashboard\n\nMonths 7 - 12\n\n* Phone/email technical support, as needed\n* Access to web-based QA dashboard', 'otherNumAtRisk': 3971, 'deathsNumAtRisk': 3971, 'otherNumAffected': 0, 'seriousNumAtRisk': 3971, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent of Patients Who Complete the mPATH-CRC Program', 'denoms': [{'units': 'Participants', 'counts': [{'value': '558', 'groupId': 'OG000'}, {'value': '397', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clinic Patients Eligible for CRC Screening on "High Touch" Strategy (Post-Implementation)', 'description': 'English or Spanish-speaking patients aged 50-74 who are eligible for CRC screening who are seen in the study clinics randomized to mPATH utilizing the "high touch" implementation strategy in the 12 months after implementation.\n\nmPATH-CRC: mPATH-CRC is a self-administered iPad program that patients eligible for CRC screening use in primary care clinics to help them receive CRC screening.\n\nmPATH-Checkin: The mPATH-CheckIn program includes health questions to assist clinics with patient check-in, thereby incentivizing its use for all patients.\n\n"high touch" Implementation strategy: The "high touch" strategy consists of pre-implementation activities, training, and ongoing support.\n\nPre-Implementation Activities\n\n* Clinic champion identified.\n* Study team meeting with clinic champion\n* Implementation adaptations as needed for clinic flow\n\nImplementation Kick-Off (Day 1)\n\n• On-site training with key clinic personnel\n\nMonths 1 - 6\n\n* Phone/email technical support, as needed.\n* Access to web-based QA dashboard\n* Monthly program usage report sent to clinic champions\n* Scheduled phone-calls with clinic champion to review QA data and explore potential barriers.\n* Implementation adaptations as needed for clinic flow\n* Goal-triggered follow-up on-site trainings\n* Additional on-site trainings as requested.\n\nMonths 7 - 12\n\n* Phone/email technical support, as needed\n* Access to web-based QA dashboard'}, {'id': 'OG001', 'title': 'Clinic Patients Eligible for CRC Screening on "Low Touch" Strategy (Post-Implementation)', 'description': 'English or Spanish-speaking patients aged 50-74 who are eligible for CRC screening who are seen in the study clinics randomized to mPATH utilizing the "low touch" implementation strategy in the 12 months after implementation.\n\nEnglish or Spanish-speaking patients aged 50-74 who are eligible for CRC screening who are seen in the study clinics randomized to mPATH utilizing the "high touch" implementation strategy in the 12 months after implementation.\n\nmPATH-CRC: mPATH-CRC is a self-administered iPad program that patients eligible for CRC screening use in primary care clinics to help them receive CRC screening.\n\nmPATH-Checkin: The mPATH-CheckIn program includes health questions to assist clinics with patient check-in, thereby incentivizing its use for all patients.\n\n"low touch" Implementation Strategy: Clinics randomized to receive the low touch implementation strategy will receive: Pre-Implementation Activities\n\n• N/A\n\nImplementation Kick-Off (Day 1)\n\n• On-site training with key clinic personnel\n\nMonths 1 - 6\n\n* Phone/email technical support, as needed.\n* Access to web-based QA dashboard\n\nMonths 7 - 12\n\n* Phone/email technical support, as needed\n* Access to web-based QA dashboard'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Month 6', 'description': 'mPATH-CRC Implementation: Percent of all eligible patients, ages 50 - 74, who complete the mPATH-CRC program in the 6th month following the implementation date.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population for this outcome is in the sixth month after implementation, so this is a subset of the overall baseline population that includes patients eligible for CRC screening over the full12 months following implementation.'}, {'type': 'SECONDARY', 'title': 'mPATH-CRC Reach (by Socioeconomic Strata)', 'timeFrame': 'up to month 6', 'description': 'mPATH-CRC Reach: The proportion of patients, ages 50 - 74, who are given mPATH-CRC or have risk factors identified by mPATH-CheckIn in months 1-6 by varying socioeconomic strata (Describe strata)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'mPATH-CRC Adoption', 'timeFrame': 'up to month 6', 'description': 'The mean usage of mPATH-CRC among staff and providers over the first 6 months following implementation; usage is calculated for each staff/provider as the proportion of times mPATH-CRC is completed out of the total times mPATH-CRC should have been launched.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'mPATH-CheckIn Reach', 'timeFrame': 'up to month 6', 'description': 'The proportion of patients aged 18 or older who complete mPATH-CheckIn in months 1-6; this outcome will be calculated overall and within socioeconomic strata', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'mPATH-CheckIn Adoption', 'timeFrame': 'up to month 6', 'description': 'The mean usage of mPATH-CheckIn among staff and providers over the first 6 months following implementation; usage is calculated for front desk staff as the proportion of times mPATH-CheckIn is completed out of the total times mPATH-CheckIn should have been handed out; usage is calculated for nurses/providers as the proportion of times mPATH-CheckIn is completed and data is transmitted to the EHR out of the total times mPATH-CheckIn should have been handed out', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'mPATH-CRC Implementation Fidelity', 'timeFrame': 'up to month 6', 'description': 'The proportion of patients who use mPATH-CRC and request a CRC screening test who have a test ordered or have the order dismissed (i.e., "self-order" feature is used as designed) in months 1-6', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'mPATH-CRC Maintenance', 'timeFrame': 'months 7-12', 'description': 'The proportion of patients aged 50-74 who are eligible for CRC screening who complete mPATH-CRC or have risk factors identified by mPATH-CheckIn in months 7-12', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'mPATH-CheckIn Maintenance', 'timeFrame': 'months 7-12', 'description': 'The proportion of patients aged 18 or older who complete mPATH-CheckIn in months 7-12', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'CRC Screening Tests Ordered', 'timeFrame': 'up to 16 weeks from index visit', 'description': 'The outcome is defined as the proportion of patients aged 50-74 who are eligible for CRC screening who have a CRC screening test ordered (colonoscopy, flexible sigmoidoscopy, fecal testing for blood, or fecal DNA testing) within 16 weeks of their index visit to the clinic. This outcome will also be compared between the pre- and post-implementation cohorts.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'mPATH-CRC Effectiveness', 'timeFrame': 'up to 16 weeks from index visit', 'description': 'The proportion of patients aged 50-74 who are eligible for CRC screening who complete CRC screening within 16 weeks of their index visit to the clinic. Effectiveness is determined by comparing the proportion who complete screening in a pre-implementation cohort (months 12 - 4 before implementation) to a post-implementation cohort (months 1 - 8 after implementation).', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Facilitators and Barriers to Maintenance (Sustained Use of mPATH-CRC Over Time)', 'timeFrame': 'Month 12 or month of discontinuation of mPATH use', 'description': "These will be identified through semi-structured interviews. Interviews will explore how mPATH-CRC was incorporated in the clinic's work flow and factors that affected maintenance such as intervention adaptations, organizational characteristics, and the champion's role. Interviews will be conducted with four members of each selected clinic: the clinic champion, one clinician, one front desk team member, and one medical assistant/nursing team member.", 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'mPATH-CRC Reach (by Month)', 'timeFrame': 'Months 1-5', 'description': 'The proportion of patients aged 50-74 who are eligible for CRC screening who complete mPATH-CRC or have risk factors identified by mPATH-CheckIn in months 1-5 following implementation', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'mPATH-CRC Acceptability', 'timeFrame': 'month 6', 'description': 'The Acceptability of Intervention Measure (AIM) is a 4-item measure scored on a 5-point scale and summed. The Range of Scores is from 4 to 20. Higher Scores indicate higher acceptability.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'mPATH-CRC Appropriateness', 'timeFrame': 'month 6', 'description': 'The Intervention Appropriateness Measure (IAM) is a 4-item measure scored on a 5-point scale and summed. The Range of Scores is from 4 to 20. Higher Scores indicate higher appropriateness.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'mPATH-CRC Feasibility', 'timeFrame': 'month 6', 'description': 'The Feasibility of Intervention Measure (FIM) is a 4-item measure scored on a 5-point scale and summed. The Range of Scores is from 4 to 20. Higher Scores indicate higher feasibility.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'mPATH-CheckIn Acceptability', 'timeFrame': 'month 6', 'description': 'The Acceptability of Intervention Measure (AIM) is a 4-item measure scored on a 5-point scale and summed. The Range of Scores is from 4 to 20. Higher Scores indicate higher acceptability.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'mPATH-CheckIn Appropriateness', 'timeFrame': 'month 6', 'description': 'The Intervention Appropriateness Measure (IAM) is a 4-item measure scored on a 5-point scale and summed. The Range of Scores is from 4 to 20. Higher Scores indicate higher appropriateness.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'mPATH-CheckIn Feasibility', 'timeFrame': 'month 6', 'description': 'The Feasibility of Intervention Measure (FIM) is a 4-item measure scored on a 5-point scale and summed. The Range of Scores is from 4 to 20. Higher Scores indicate higher feasibility.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '"High Touch" Strategy', 'description': 'Populations evaluated include: Patients Eligible for CRC Screening (Pre- and Post-Implementation), All Adult Patients (Post-Implementation), and Clinic Personnel (Post-Implementation) at clinics randomized to the "high touch" strategy.\n\nmPATH-CRC: mPATH-CRC is a self-administered iPad program that patients eligible for CRC screening use in primary care clinics to help them receive CRC screening.\n\nmPATH-Checkin: The mPATH-CheckIn program includes health questions to assist clinics with patient check-in, thereby incentivizing its use for all patients.\n\n"high touch" Implementation strategy: The "high touch" strategy consists of pre-implementation activities, training, and ongoing support.\n\nPre-Implementation Activities\n\n* Clinic champion identified.\n* Study team meeting with clinic champion\n* Implementation adaptations as needed for clinic flow\n\nImplementation Kick-Off (Day 1)\n\n• On-site training with key clinic personnel\n\nMonths 1 - 6\n\n* Phone/email technical support, as needed.\n* Access to web-based QA dashboard\n* Monthly program usage report sent to clinic champions\n* Scheduled phone-calls with clinic champion to review QA data and explore potential barriers.\n* Implementation adaptations as needed for clinic flow\n* Goal-triggered follow-up on-site trainings\n* Additional on-site trainings as requested.\n\nMonths 7 - 12\n\n* Phone/email technical support, as needed\n* Access to web-based QA dashboard'}, {'id': 'FG001', 'title': '"Low Touch" Strategy', 'description': 'Populations evaluated include: Patients Eligible for CRC Screening (Pre- and Post-Implementation), All Adult Patients (Post-Implementation), and Clinic Personnel (Post-Implementation) at clinics randomized to the "low touch" strategy.\n\nmPATH-CRC: mPATH-CRC is a self-administered iPad program that patients eligible for CRC screening use in primary care clinics to help them receive CRC screening.\n\nmPATH-Checkin: The mPATH-CheckIn program includes health questions to assist clinics with patient check-in, thereby incentivizing its use for all patients.\n\n"low touch" Implementation Strategy: Clinics randomized to receive the low touch implementation strategy will receive: Pre-Implementation Activities\n\n• N/A\n\nImplementation Kick-Off (Day 1)\n\n• On-site training with key clinic personnel\n\nMonths 1 - 6\n\n* Phone/email technical support, as needed.\n* Access to web-based QA dashboard\n\nMonths 7 - 12\n\n* Phone/email technical support, as needed\n* Access to web-based QA dashboard'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '10', 'numSubjects': '49583'}, {'groupId': 'FG001', 'numUnits': '8', 'numSubjects': '27562'}]}, {'type': 'All Adult Clinic Patients Post-Implementation: 18 or Older', 'achievements': [{'groupId': 'FG000', 'numUnits': '10', 'numSubjects': '43775'}, {'groupId': 'FG001', 'numUnits': '8', 'numSubjects': '23359'}]}, {'type': 'Adult Clinic Patients Eligible for CRC Screening Post-Implementation: Aged 50-74', 'achievements': [{'groupId': 'FG000', 'numUnits': '10', 'numSubjects': '7933'}, {'groupId': 'FG001', 'numUnits': '8', 'numSubjects': '5159'}]}, {'type': 'Clinic Personnel Post-Implementation', 'achievements': [{'groupId': 'FG000', 'numUnits': '10', 'numSubjects': '282'}, {'groupId': 'FG001', 'numUnits': '8', 'numSubjects': '232'}]}, {'type': 'Adult Clinic Patients Eligible for CRC Screening Pre-Implementation: Aged 50-74', 'achievements': [{'groupId': 'FG000', 'numUnits': '10', 'numSubjects': '5526'}, {'groupId': 'FG001', 'numUnits': '8', 'numSubjects': '3971'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '10', 'numSubjects': '49583'}, {'groupId': 'FG001', 'numUnits': '8', 'numSubjects': '27562'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'Clinics', 'recruitmentDetails': '18 clinics were enrolled in the study. These clinics were randomized to the "high touch" or "low touch" implementation strategy. From these 18 clinics, 77145 total participants were enrolled. This includes 67134 adult patients (13092 of whom were eligible for CRC screening) seen in the clinics sometime during the 12 months after implementation, 514 clinic personnel involved in the implementation of mPATH, and 9497 patients in the pre-implementation cohort (8 months prior to implementation).', 'preAssignmentDetails': 'This is a pragmatic trial, with data being pulled from the electronic health record, so there is no loss to follow-up. A patient enters the dataset once at the time of their clinic visit; they are not actively followed over time but rather a retrospective data pull was conducted at the end of the study for relevant outcomes. The periods described under the description for "high touch" and "low touch" are at the clinic level, not the patient level.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '43775', 'groupId': 'BG000'}, {'value': '23359', 'groupId': 'BG001'}, {'value': '282', 'groupId': 'BG002'}, {'value': '232', 'groupId': 'BG003'}, {'value': '5526', 'groupId': 'BG004'}, {'value': '3971', 'groupId': 'BG005'}, {'value': '77145', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'All Adult Clinic Patients on "High Touch" Strategy (Post-Implementation)', 'description': 'English or Spanish-speaking patients aged 18 or older who are seen in the study clinics randomized to mPATH utilizing the "high touch" implementation strategy in the 12 months after implementation.\n\nmPATH-Checkin: The mPATH-CheckIn program includes health questions to assist clinics with patient check-in, thereby incentivizing its use for all patients.\n\n"high touch" Implementation strategy: The "high touch" strategy consists of pre-implementation activities, training, and ongoing support.\n\nPre-Implementation Activities\n\n* Clinic champion identified.\n* Study team meeting with clinic champion\n* Implementation adaptations as needed for clinic flow\n\nImplementation Kick-Off (Day 1)\n\n• On-site training with key clinic personnel\n\nMonths 1 - 6\n\n* Phone/email technical support, as needed.\n* Access to web-based QA dashboard\n* Monthly program usage report sent to clinic champions\n* Scheduled phone-calls with clinic champion to review QA data and explore potential barriers.\n* Implementation adaptations as needed for clinic flow\n* Goal-triggered follow-up on-site trainings\n* Additional on-site trainings as requested.\n\nMonths 7 - 12\n\n* Phone/email technical support, as needed\n* Access to web-based QA dashboard'}, {'id': 'BG001', 'title': 'All Adult Clinic Patients on "Low Touch" Strategy (Post-Implementation)', 'description': 'English or Spanish-speaking patients aged 18 or older who are seen in the study clinics randomized to mPATH utilizing the "low touch" implementation strategy in the 12 months after implementation.\n\nmPATH-Checkin: The mPATH-CheckIn program includes health questions to assist clinics with patient check-in, thereby incentivizing its use for all patients.\n\n"low touch" Implementation Strategy: Clinics randomized to receive the low touch implementation strategy will receive: Pre-Implementation Activities\n\n• N/A\n\nImplementation Kick-Off (Day 1)\n\n• On-site training with key clinic personnel\n\nMonths 1 - 6\n\n* Phone/email technical support, as needed.\n* Access to web-based QA dashboard\n\nMonths 7 - 12\n\n* Phone/email technical support, as needed\n* Access to web-based QA dashboard'}, {'id': 'BG002', 'title': 'Clinic Personnel on "High Touch" Strategy (Post-Implementation)', 'description': 'Clinic personnel (e.g., administrators, nurses, providers) who are involved with the implementation of mPATH-CRC, in the study clinics randomized to mPATH utilizing the "high touch" implementation strategy in the 12 months after implementation.\n\nmPATH-CRC: mPATH-CRC is a self-administered iPad program that patients eligible for CRC screening use in primary care clinics to help them receive CRC screening.\n\nmPATH-Checkin: The mPATH-CheckIn program includes health questions to assist clinics with patient check-in, thereby incentivizing its use for all patients.\n\n"high touch" Implementation strategy: The "high touch" strategy consists of pre-implementation activities, training, and ongoing support.\n\nPre-Implementation Activities\n\n* Clinic champion identified.\n* Study team meeting with clinic champion\n* Implementation adaptations as needed for clinic flow\n\nImplementation Kick-Off (Day 1)\n\n• On-site training with key clinic personnel\n\nMonths 1 - 6\n\n* Phone/email technical support, as needed.\n* Access to web-based QA dashboard\n* Monthly program usage report sent to clinic champions\n* Scheduled phone-calls with clinic champion to review QA data and explore potential barriers.\n* Implementation adaptations as needed for clinic flow\n* Goal-triggered follow-up on-site trainings\n* Additional on-site trainings as requested.\n\nMonths 7 - 12\n\n* Phone/email technical support, as needed\n* Access to web-based QA dashboard'}, {'id': 'BG003', 'title': 'Clinic Personnel on "Low Touch" Strategy (Post-Implementation)', 'description': 'Clinic personnel (e.g., administrators, nurses, providers) who are involved with the implementation of mPATH-CRC, in the study clinics randomized to mPATH utilizing the "low touch" implementation strategy in the 12 months after implementation.\n\nmPATH-CRC: mPATH-CRC is a self-administered iPad program that patients eligible for CRC screening use in primary care clinics to help them receive CRC screening.\n\nmPATH-Checkin: The mPATH-CheckIn program includes health questions to assist clinics with patient check-in, thereby incentivizing its use for all patients.\n\n"low touch" Implementation Strategy: Clinics randomized to receive the low touch implementation strategy will receive: Pre-Implementation Activities\n\n• N/A\n\nImplementation Kick-Off (Day 1)\n\n• On-site training with key clinic personnel\n\nMonths 1 - 6\n\n* Phone/email technical support, as needed.\n* Access to web-based QA dashboard\n\nMonths 7 - 12\n\n* Phone/email technical support, as needed\n* Access to web-based QA dashboard'}, {'id': 'BG004', 'title': 'Clinic Patients Eligible for CRC Screening on "High Touch" Strategy (Pre-Implementation)', 'description': 'English or Spanish-speaking patients aged 50-74 who are eligible for CRC screening who are seen in the study clinics randomized to mPATH utilizing the "high touch" implementation strategy but in 8 months before implementation.\n\n"high touch" Implementation strategy: The "high touch" strategy consists of pre-implementation activities, training, and ongoing support.\n\nPre-Implementation Activities\n\n* Clinic champion identified.\n* Study team meeting with clinic champion\n* Implementation adaptations as needed for clinic flow\n\nImplementation Kick-Off (Day 1)\n\n• On-site training with key clinic personnel\n\nMonths 1 - 6\n\n* Phone/email technical support, as needed.\n* Access to web-based QA dashboard\n* Monthly program usage report sent to clinic champions\n* Scheduled phone-calls with clinic champion to review QA data and explore potential barriers.\n* Implementation adaptations as needed for clinic flow\n* Goal-triggered follow-up on-site trainings\n* Additional on-site trainings as requested.\n\nMonths 7 - 12\n\n* Phone/email technical support, as needed\n* Access to web-based QA dashboard'}, {'id': 'BG005', 'title': 'Clinic Patients Eligible for CRC Screening on "Low Touch" Strategy (Pre-Implementation)', 'description': 'English or Spanish-speaking patients aged 50-74 who are eligible for CRC screening who are seen in the study clinics randomized to mPATH utilizing the "low touch" implementation strategy but in 8 months before implementation.\n\n"low touch" Implementation Strategy: Clinics randomized to receive the low touch implementation strategy will receive: Pre-Implementation Activities\n\n• N/A\n\nImplementation Kick-Off (Day 1)\n\n• On-site training with key clinic personnel\n\nMonths 1 - 6\n\n* Phone/email technical support, as needed.\n* Access to web-based QA dashboard\n\nMonths 7 - 12\n\n* Phone/email technical support, as needed\n* Access to web-based QA dashboard'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'All Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43775', 'groupId': 'BG000'}, {'value': '23359', 'groupId': 'BG001'}, {'value': '126', 'groupId': 'BG002'}, {'value': '78', 'groupId': 'BG003'}, {'value': '5526', 'groupId': 'BG004'}, {'value': '3971', 'groupId': 'BG005'}, {'value': '76835', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '55.0', 'spread': '17.7', 'groupId': 'BG000'}, {'value': '52.3', 'spread': '17.8', 'groupId': 'BG001'}, {'value': '37.0', 'spread': '8.8', 'groupId': 'BG002'}, {'value': '37.6', 'spread': '8.4', 'groupId': 'BG003'}, {'value': '59.5', 'spread': '7.1', 'groupId': 'BG004'}, {'value': '59.4', 'spread': '6.9', 'groupId': 'BG005'}, {'value': '54.7', 'spread': '16.9', 'groupId': 'BG006'}]}]}, {'title': 'Adult Clinic Patients Eligible for CRC Screening Post-Implementation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7933', 'groupId': 'BG000'}, {'value': '5159', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '13092', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '59.9', 'spread': '7.2', 'groupId': 'BG000'}, {'value': '59.6', 'spread': '6.9', 'groupId': 'BG001'}, {'value': '59.8', 'spread': '7.1', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Demographics data are only available for clinic personnel who filled out a survey. "Adult Clinic Patients Eligible for CRC Screening Post-Implementation" is a subset of "All Adult Clinic Patients (Post-Implementation)." The subset is included here because the patients eligible for CRC screening is the analysis population for outcomes related to implementation of mPATH-CRC.'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'All Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43775', 'groupId': 'BG000'}, {'value': '23359', 'groupId': 'BG001'}, {'value': '282', 'groupId': 'BG002'}, {'value': '232', 'groupId': 'BG003'}, {'value': '5526', 'groupId': 'BG004'}, {'value': '3971', 'groupId': 'BG005'}, {'value': '77145', 'groupId': 'BG006'}]}], 'categories': [{'title': 'Male', 'measurements': [{'value': '17952', 'groupId': 'BG000'}, {'value': '9828', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '2389', 'groupId': 'BG004'}, {'value': '1783', 'groupId': 'BG005'}, {'value': '31983', 'groupId': 'BG006'}]}, {'title': 'Female', 'measurements': [{'value': '25823', 'groupId': 'BG000'}, {'value': '13530', 'groupId': 'BG001'}, {'value': '162', 'groupId': 'BG002'}, {'value': '108', 'groupId': 'BG003'}, {'value': '3137', 'groupId': 'BG004'}, {'value': '2188', 'groupId': 'BG005'}, {'value': '44948', 'groupId': 'BG006'}]}, {'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}, {'value': '113', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '214', 'groupId': 'BG006'}]}]}, {'title': 'Adult Clinic Patients Eligible for CRC Screening Post-Implementation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7933', 'groupId': 'BG000'}, {'value': '5159', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '13092', 'groupId': 'BG006'}]}], 'categories': [{'title': 'Male', 'measurements': [{'value': '3504', 'groupId': 'BG000'}, {'value': '2376', 'groupId': 'BG001'}, {'value': '5880', 'groupId': 'BG006'}]}, {'title': 'Female', 'measurements': [{'value': '4429', 'groupId': 'BG000'}, {'value': '2782', 'groupId': 'BG001'}, {'value': '7211', 'groupId': 'BG006'}]}, {'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '"Adult Clinic Patients Eligible for CRC Screening Post-Implementation" is a subset of "All Adult Clinic Patients (Post-Implementation)." The subset is included here because the patients eligible for CRC screening is the analysis population for outcomes related to implementation of mPATH-CRC.'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'title': 'All Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43775', 'groupId': 'BG000'}, {'value': '23359', 'groupId': 'BG001'}, {'value': '282', 'groupId': 'BG002'}, {'value': '232', 'groupId': 'BG003'}, {'value': '5526', 'groupId': 'BG004'}, {'value': '3971', 'groupId': 'BG005'}, {'value': '77145', 'groupId': 'BG006'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2412', 'groupId': 'BG000'}, {'value': '955', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '361', 'groupId': 'BG004'}, {'value': '114', 'groupId': 'BG005'}, {'value': '3863', 'groupId': 'BG006'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '41035', 'groupId': 'BG000'}, {'value': '22286', 'groupId': 'BG001'}, {'value': '162', 'groupId': 'BG002'}, {'value': '107', 'groupId': 'BG003'}, {'value': '5112', 'groupId': 'BG004'}, {'value': '3840', 'groupId': 'BG005'}, {'value': '72542', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '328', 'groupId': 'BG000'}, {'value': '118', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}, {'value': '118', 'groupId': 'BG003'}, {'value': '53', 'groupId': 'BG004'}, {'value': '17', 'groupId': 'BG005'}, {'value': '740', 'groupId': 'BG006'}]}]}, {'title': 'Adult Clinic Patients Eligible for CRC Screening Post-Implementation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7933', 'groupId': 'BG000'}, {'value': '5159', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '13092', 'groupId': 'BG006'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '444', 'groupId': 'BG000'}, {'value': '195', 'groupId': 'BG001'}, {'value': '639', 'groupId': 'BG006'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '7419', 'groupId': 'BG000'}, {'value': '4937', 'groupId': 'BG001'}, {'value': '12356', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '"Adult Clinic Patients Eligible for CRC Screening Post-Implementation" is a subset of "All Adult Clinic Patients (Post-Implementation)." The subset is included here because the patients eligible for CRC screening is the analysis population for outcomes related to implementation of mPATH-CRC.'}, {'title': 'Race (NIH/OMB)', 'classes': [{'title': 'All Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43775', 'groupId': 'BG000'}, {'value': '23359', 'groupId': 'BG001'}, {'value': '282', 'groupId': 'BG002'}, {'value': '232', 'groupId': 'BG003'}, {'value': '5526', 'groupId': 'BG004'}, {'value': '3971', 'groupId': 'BG005'}, {'value': '77145', 'groupId': 'BG006'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '319', 'groupId': 'BG000'}, {'value': '128', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '55', 'groupId': 'BG004'}, {'value': '22', 'groupId': 'BG005'}, {'value': '527', 'groupId': 'BG006'}]}, {'title': 'Asian', 'measurements': [{'value': '930', 'groupId': 'BG000'}, {'value': '504', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '115', 'groupId': 'BG004'}, {'value': '86', 'groupId': 'BG005'}, {'value': '1644', 'groupId': 'BG006'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '98', 'groupId': 'BG006'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4490', 'groupId': 'BG000'}, {'value': '3329', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '656', 'groupId': 'BG004'}, {'value': '533', 'groupId': 'BG005'}, {'value': '9058', 'groupId': 'BG006'}]}, {'title': 'White', 'measurements': [{'value': '35542', 'groupId': 'BG000'}, {'value': '18286', 'groupId': 'BG001'}, {'value': '135', 'groupId': 'BG002'}, {'value': '85', 'groupId': 'BG003'}, {'value': '4346', 'groupId': 'BG004'}, {'value': '3181', 'groupId': 'BG005'}, {'value': '61575', 'groupId': 'BG006'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2448', 'groupId': 'BG000'}, {'value': '1077', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}, {'value': '121', 'groupId': 'BG003'}, {'value': '341', 'groupId': 'BG004'}, {'value': '145', 'groupId': 'BG005'}, {'value': '4240', 'groupId': 'BG006'}]}]}, {'title': 'Adult Clinic Patients Eligible for CRC Screening Post-Implementation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7933', 'groupId': 'BG000'}, {'value': '5159', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '13092', 'groupId': 'BG006'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG006'}]}, {'title': 'Asian', 'measurements': [{'value': '154', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '253', 'groupId': 'BG006'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG006'}]}, {'title': 'Black or African American', 'measurements': [{'value': '860', 'groupId': 'BG000'}, {'value': '704', 'groupId': 'BG001'}, {'value': '1564', 'groupId': 'BG006'}]}, {'title': 'White', 'measurements': [{'value': '6387', 'groupId': 'BG000'}, {'value': '4093', 'groupId': 'BG001'}, {'value': '10480', 'groupId': 'BG006'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '457', 'groupId': 'BG000'}, {'value': '213', 'groupId': 'BG001'}, {'value': '670', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '"Adult Clinic Patients Eligible for CRC Screening Post-Implementation" is a subset of "All Adult Clinic Patients (Post-Implementation)." The subset is included here because the patients eligible for CRC screening is the analysis population for outcomes related to implementation of mPATH-CRC.'}, {'title': 'Insurance', 'classes': [{'title': 'All Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43775', 'groupId': 'BG000'}, {'value': '23359', 'groupId': 'BG001'}, {'value': '282', 'groupId': 'BG002'}, {'value': '232', 'groupId': 'BG003'}, {'value': '5526', 'groupId': 'BG004'}, {'value': '3971', 'groupId': 'BG005'}, {'value': '77145', 'groupId': 'BG006'}]}], 'categories': [{'title': 'Commercial', 'measurements': [{'value': '23666', 'groupId': 'BG000'}, {'value': '13028', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2922', 'groupId': 'BG004'}, {'value': '2124', 'groupId': 'BG005'}, {'value': '41740', 'groupId': 'BG006'}]}, {'title': 'Medicare', 'measurements': [{'value': '14644', 'groupId': 'BG000'}, {'value': '6893', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1857', 'groupId': 'BG004'}, {'value': '1293', 'groupId': 'BG005'}, {'value': '24687', 'groupId': 'BG006'}]}, {'title': 'Medicaid', 'measurements': [{'value': '1783', 'groupId': 'BG000'}, {'value': '1587', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '141', 'groupId': 'BG004'}, {'value': '113', 'groupId': 'BG005'}, {'value': '3624', 'groupId': 'BG006'}]}, {'title': 'Other', 'measurements': [{'value': '1374', 'groupId': 'BG000'}, {'value': '722', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '222', 'groupId': 'BG004'}, {'value': '128', 'groupId': 'BG005'}, {'value': '2446', 'groupId': 'BG006'}]}, {'title': 'Uninsured', 'measurements': [{'value': '2308', 'groupId': 'BG000'}, {'value': '1129', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '384', 'groupId': 'BG004'}, {'value': '313', 'groupId': 'BG005'}, {'value': '4134', 'groupId': 'BG006'}]}, {'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '282', 'groupId': 'BG002'}, {'value': '232', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '514', 'groupId': 'BG006'}]}]}, {'title': 'Adult Clinic Patients Eligible for CRC Screening Post-Implementation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7933', 'groupId': 'BG000'}, {'value': '5159', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '13092', 'groupId': 'BG006'}]}], 'categories': [{'title': 'Commercial', 'measurements': [{'value': '4414', 'groupId': 'BG000'}, {'value': '2880', 'groupId': 'BG001'}, {'value': '7294', 'groupId': 'BG006'}]}, {'title': 'Medicare', 'measurements': [{'value': '2627', 'groupId': 'BG000'}, {'value': '1648', 'groupId': 'BG001'}, {'value': '4275', 'groupId': 'BG006'}]}, {'title': 'Medicaid', 'measurements': [{'value': '216', 'groupId': 'BG000'}, {'value': '203', 'groupId': 'BG001'}, {'value': '419', 'groupId': 'BG006'}]}, {'title': 'Other', 'measurements': [{'value': '273', 'groupId': 'BG000'}, {'value': '140', 'groupId': 'BG001'}, {'value': '413', 'groupId': 'BG006'}]}, {'title': 'Uninsured', 'measurements': [{'value': '403', 'groupId': 'BG000'}, {'value': '288', 'groupId': 'BG001'}, {'value': '691', 'groupId': 'BG006'}]}, {'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '"Adult Clinic Patients Eligible for CRC Screening Post-Implementation" is a subset of "All Adult Clinic Patients (Post-Implementation)." The subset is included here because the patients eligible for CRC screening is the analysis population for outcomes related to implementation of mPATH-CRC.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-02-22', 'size': 1849654, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-09-19T11:00', 'hasProtocol': True}, {'date': '2022-11-02', 'size': 68700, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-09-19T10:48', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 77145}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-03-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-08', 'studyFirstSubmitDate': '2019-02-14', 'resultsFirstSubmitDate': '2023-09-19', 'studyFirstSubmitQcDate': '2019-02-14', 'lastUpdatePostDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-01-08', 'studyFirstPostDateStruct': {'date': '2019-02-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent of Patients Who Complete the mPATH-CRC Program', 'timeFrame': 'Month 6', 'description': 'mPATH-CRC Implementation: Percent of all eligible patients, ages 50 - 74, who complete the mPATH-CRC program in the 6th month following the implementation date.'}], 'secondaryOutcomes': [{'measure': 'mPATH-CRC Reach (by Socioeconomic Strata)', 'timeFrame': 'up to month 6', 'description': 'mPATH-CRC Reach: The proportion of patients, ages 50 - 74, who are given mPATH-CRC or have risk factors identified by mPATH-CheckIn in months 1-6 by varying socioeconomic strata (Describe strata)'}, {'measure': 'mPATH-CRC Adoption', 'timeFrame': 'up to month 6', 'description': 'The mean usage of mPATH-CRC among staff and providers over the first 6 months following implementation; usage is calculated for each staff/provider as the proportion of times mPATH-CRC is completed out of the total times mPATH-CRC should have been launched.'}, {'measure': 'mPATH-CheckIn Reach', 'timeFrame': 'up to month 6', 'description': 'The proportion of patients aged 18 or older who complete mPATH-CheckIn in months 1-6; this outcome will be calculated overall and within socioeconomic strata'}, {'measure': 'mPATH-CheckIn Adoption', 'timeFrame': 'up to month 6', 'description': 'The mean usage of mPATH-CheckIn among staff and providers over the first 6 months following implementation; usage is calculated for front desk staff as the proportion of times mPATH-CheckIn is completed out of the total times mPATH-CheckIn should have been handed out; usage is calculated for nurses/providers as the proportion of times mPATH-CheckIn is completed and data is transmitted to the EHR out of the total times mPATH-CheckIn should have been handed out'}, {'measure': 'mPATH-CRC Implementation Fidelity', 'timeFrame': 'up to month 6', 'description': 'The proportion of patients who use mPATH-CRC and request a CRC screening test who have a test ordered or have the order dismissed (i.e., "self-order" feature is used as designed) in months 1-6'}, {'measure': 'mPATH-CRC Maintenance', 'timeFrame': 'months 7-12', 'description': 'The proportion of patients aged 50-74 who are eligible for CRC screening who complete mPATH-CRC or have risk factors identified by mPATH-CheckIn in months 7-12'}, {'measure': 'mPATH-CheckIn Maintenance', 'timeFrame': 'months 7-12', 'description': 'The proportion of patients aged 18 or older who complete mPATH-CheckIn in months 7-12'}, {'measure': 'CRC Screening Tests Ordered', 'timeFrame': 'up to 16 weeks from index visit', 'description': 'The outcome is defined as the proportion of patients aged 50-74 who are eligible for CRC screening who have a CRC screening test ordered (colonoscopy, flexible sigmoidoscopy, fecal testing for blood, or fecal DNA testing) within 16 weeks of their index visit to the clinic. This outcome will also be compared between the pre- and post-implementation cohorts.'}, {'measure': 'mPATH-CRC Effectiveness', 'timeFrame': 'up to 16 weeks from index visit', 'description': 'The proportion of patients aged 50-74 who are eligible for CRC screening who complete CRC screening within 16 weeks of their index visit to the clinic. Effectiveness is determined by comparing the proportion who complete screening in a pre-implementation cohort (months 12 - 4 before implementation) to a post-implementation cohort (months 1 - 8 after implementation).'}, {'measure': 'Facilitators and Barriers to Maintenance (Sustained Use of mPATH-CRC Over Time)', 'timeFrame': 'Month 12 or month of discontinuation of mPATH use', 'description': "These will be identified through semi-structured interviews. Interviews will explore how mPATH-CRC was incorporated in the clinic's work flow and factors that affected maintenance such as intervention adaptations, organizational characteristics, and the champion's role. Interviews will be conducted with four members of each selected clinic: the clinic champion, one clinician, one front desk team member, and one medical assistant/nursing team member."}, {'measure': 'mPATH-CRC Reach (by Month)', 'timeFrame': 'Months 1-5', 'description': 'The proportion of patients aged 50-74 who are eligible for CRC screening who complete mPATH-CRC or have risk factors identified by mPATH-CheckIn in months 1-5 following implementation'}, {'measure': 'mPATH-CRC Acceptability', 'timeFrame': 'month 6', 'description': 'The Acceptability of Intervention Measure (AIM) is a 4-item measure scored on a 5-point scale and summed. The Range of Scores is from 4 to 20. Higher Scores indicate higher acceptability.'}, {'measure': 'mPATH-CRC Appropriateness', 'timeFrame': 'month 6', 'description': 'The Intervention Appropriateness Measure (IAM) is a 4-item measure scored on a 5-point scale and summed. The Range of Scores is from 4 to 20. Higher Scores indicate higher appropriateness.'}, {'measure': 'mPATH-CRC Feasibility', 'timeFrame': 'month 6', 'description': 'The Feasibility of Intervention Measure (FIM) is a 4-item measure scored on a 5-point scale and summed. The Range of Scores is from 4 to 20. Higher Scores indicate higher feasibility.'}, {'measure': 'mPATH-CheckIn Acceptability', 'timeFrame': 'month 6', 'description': 'The Acceptability of Intervention Measure (AIM) is a 4-item measure scored on a 5-point scale and summed. The Range of Scores is from 4 to 20. Higher Scores indicate higher acceptability.'}, {'measure': 'mPATH-CheckIn Appropriateness', 'timeFrame': 'month 6', 'description': 'The Intervention Appropriateness Measure (IAM) is a 4-item measure scored on a 5-point scale and summed. The Range of Scores is from 4 to 20. Higher Scores indicate higher appropriateness.'}, {'measure': 'mPATH-CheckIn Feasibility', 'timeFrame': 'month 6', 'description': 'The Feasibility of Intervention Measure (FIM) is a 4-item measure scored on a 5-point scale and summed. The Range of Scores is from 4 to 20. Higher Scores indicate higher feasibility.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mortality', 'Cancer Screening', 'Cancer Intervention', 'Mobile Health', 'Implementation Science'], 'conditions': ['Colorectal Cancer', 'Cancer', 'Rectum Cancer', 'Colon Cancer']}, 'referencesModule': {'references': [{'pmid': '22343624', 'type': 'BACKGROUND', 'citation': "Sharp L, Tilson L, Whyte S, O'Ceilleachair A, Walsh C, Usher C, Tappenden P, Chilcott J, Staines A, Barry M, Comber H. Cost-effectiveness of population-based screening for colorectal cancer: a comparison of guaiac-based faecal occult blood testing, faecal immunochemical testing and flexible sigmoidoscopy. Br J Cancer. 2012 Feb 28;106(5):805-16. doi: 10.1038/bjc.2011.580. Epub 2012 Feb 16."}, {'pmid': '27305422', 'type': 'BACKGROUND', 'citation': "Lin JS, Piper MA, Perdue LA, Rutter CM, Webber EM, O'Connor E, Smith N, Whitlock EP. 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JAMA Intern Med. 2025 Jul 1;185(7):788-795. doi: 10.1001/jamainternmed.2025.0779.'}, {'pmid': '37060023', 'type': 'DERIVED', 'citation': 'Snavely AC, Foley K, Dharod A, Dignan M, Brower H, Wright E, Miller DP Jr. Effectiveness and implementation of mPATH-CRC: a mobile health system for colorectal cancer screening. Trials. 2023 Apr 14;24(1):274. doi: 10.1186/s13063-023-07273-5.'}], 'seeAlsoLinks': [{'url': 'http://eric.ed.gov/?id=ED493284', 'label': "Kutner M, Greenburg E, Jin Y, Paulsen C. The Health Literacy of America's Adults: Results from the 2003 National Assessment of Adult Literacy. NCES 2006-483. Natl Cent Educ Stat \\[Internet\\]. 2006 \\[cited 2015 Sep 23\\];"}, {'url': 'https://ftp.cdc.gov/pub/Health_Statistics/NCHS/NHIS/SHS/2015_SHS_Table_A-18.pdf', 'label': 'U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Health Statistics. 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British National Health Service Modernization Agency; 2004 \\[cited 2017 Jun 9\\].'}, {'url': 'http://www.longwoods.com/content/20979', 'label': 'Soo S, Baker WB and GR. Role of Champions in the Implementation of Patient Safety Practice Change. Healthc Q \\[Internet\\]. 2009 Aug 15 \\[cited 2017 May 8\\];'}, {'url': 'http://www.cdc.gov/brfss/questionnaires/pdf-ques/2015-brfss-questionnaire-12-29-14.pdf', 'label': 'Behavioral Risk Factor Surveillance System, 2015 Questionnaire \\[Internet\\]. Centers for Disease Control and Prevention (US); 2014 \\[cited 2016 Sep 30\\].'}]}, 'descriptionModule': {'briefSummary': 'Study Investigators are conducting this study to learn how to best implement a new iPad program in clinical practice.', 'detailedDescription': 'The study team has developed mPATH-CRC (mobile PAtient Technology for Health-Colorectal Cancer), a patient-friendly iPad program used by individuals immediately before a routine primary care visit. mPATH-CheckIn is a module that is used in conjunction with mPATH-CRC that consists of questions asked of all adult patients at check-in. mPATH-CRC is a module specific for patients due for CRC screening.\n\nTo fully realize mPATH-CRC\'s potential to decrease CRC mortality, the program now must be implemented in primary care practices in a way that encourages routine and sustained use. However, while hundreds of mobile health (mHealth) tools have been developed in recent years, the optimal strategies for implementing and maintaining mHealth interventions in clinical practice are unknown. This study will compare the results of a "high touch" strategy to a "low touch" strategy using a Type III hybrid design and incorporating mixed methods to evaluate implementation, maintenance, and effectiveness of mPATH-CRC in a diverse sample of community-based practices.\n\nThe study will be conducted in three phases: 1) in a cluster-randomized controlled trial of 22 primary care clinics, the study team will compare the implementation outcomes of a "high touch" evidence-based mHealth implementation strategy with a "low touch" implementation strategy; 2) in a nested pragmatic study, the study team will estimate the effect of mPATH-CRC on completion of CRC screening within 16 weeks of a clinic visit; and 3) by surveying and interviewing clinic staff and providers after implementation is complete, the study team will determine the factors that facilitate or impede the maintenance of mHealth interventions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'This study will include three distinct populations of participants: 1) healthcare providers and staff at primary care practices, 2) patients aged 18 and older seen in the participating study sites, and 3) patients aged 50-74 seen in the participating study sites who are eligible for CRC screening\n\nPatient Inclusion Criteria:\n\nDue for routine CRC screening, defined as:\n\n* No colonoscopy within the prior 10 years\n* No flexible sigmoidoscopy within the prior 5 years\n* No CT colonography within the prior 5 years\n* No fecal DNA testing within the prior 3 years\n* No fecal blood testing (guaiac-based test with home kit or fecal immunochemical test) within the prior 12 months\n\nPatient Exclusion Criteria:\n\n* Personal history of CRC\n* First degree relative with CRC\n* Personal history of colorectal polyps'}, 'identificationModule': {'nctId': 'NCT03843957', 'briefTitle': 'Effectiveness and Implementation of mPATH-CRC', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Effectiveness and Implementation of mPATH-CRC: a Mobile Health System for Colorectal Cancer Screening', 'orgStudyIdInfo': {'id': 'IRB00048919'}, 'secondaryIdInfos': [{'id': 'R01CA218416', 'link': 'https://reporter.nih.gov/quickSearch/R01CA218416', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Clinic Patients Eligible for CRC Screening on "high touch" Strategy (Post-Implementation)', 'description': 'English or Spanish-speaking patients aged 50-74 who are eligible for CRC screening who are seen in the study clinics randomized to mPATH utilizing the "high touch" implementation strategy in the 12 months after implementation.', 'interventionNames': ['Other: mPATH-CRC', 'Other: mPATH-Checkin', 'Other: "high touch" Implementation strategy']}, {'type': 'EXPERIMENTAL', 'label': 'Clinic Patients Eligible for CRC Screening on "low touch" Strategy (Post-Implementation)', 'description': 'English or Spanish-speaking patients aged 50-74 who are eligible for CRC screening who are seen in the study clinics randomized to mPATH utilizing the "low touch" implementation strategy in the 12 months after implementation.', 'interventionNames': ['Other: mPATH-CRC', 'Other: mPATH-Checkin', 'Other: "low touch" Implementation Strategy']}, {'type': 'EXPERIMENTAL', 'label': 'Clinic personnel on "high touch" Strategy (Post-Implementation)', 'description': 'Clinic personnel (e.g., administrators, nurses, providers) who are involved with the implementation of mPATH-CRC, in the study clinics randomized to mPATH utilizing the "high touch" implementation strategy in the 12 months after implementation.', 'interventionNames': ['Other: mPATH-CRC', 'Other: mPATH-Checkin', 'Other: "high touch" Implementation strategy']}, {'type': 'EXPERIMENTAL', 'label': 'Clinic personnel on "low touch" Strategy (Post-Implementation)', 'description': 'Clinic personnel (e.g., administrators, nurses, providers) who are involved with the implementation of mPATH-CRC, in the study clinics randomized to mPATH utilizing the "low touch" implementation strategy in the 12 months after implementation.', 'interventionNames': ['Other: mPATH-CRC', 'Other: mPATH-Checkin', 'Other: "low touch" Implementation Strategy']}, {'type': 'EXPERIMENTAL', 'label': 'All Adult Clinic Patients on "high touch" Strategy (Post-Implementation)', 'description': 'English or Spanish-speaking patients aged 18 or older who are seen in the study clinics randomized to mPATH utilizing the "high touch" implementation strategy in the 12 months after implementation.', 'interventionNames': ['Other: mPATH-Checkin', 'Other: "high touch" Implementation strategy']}, {'type': 'EXPERIMENTAL', 'label': 'All Adult Clinic Patients on "low touch" Strategy (Post-Implementation)', 'description': 'English or Spanish-speaking patients aged 18 or older who are seen in the study clinics randomized to mPATH utilizing the "low touch" implementation strategy in the 12 months after implementation.', 'interventionNames': ['Other: mPATH-Checkin', 'Other: "low touch" Implementation Strategy']}, {'type': 'OTHER', 'label': 'Clinic Patients Eligible for CRC Screening on "high touch" Strategy (Pre-Implementation)', 'description': 'English or Spanish-speaking patients aged 50-74 who are eligible for CRC screening who are seen in the study clinics randomized to mPATH utilizing the "high touch" implementation strategy but in 8 months before implementation.', 'interventionNames': ['Other: "high touch" Implementation strategy']}, {'type': 'OTHER', 'label': 'Clinic Patients Eligible for CRC Screening on "low touch" Strategy (Pre-Implementation)', 'description': 'English or Spanish-speaking patients aged 50-74 who are eligible for CRC screening who are seen in the study clinics randomized to mPATH utilizing the "low touch" implementation strategy but in 8 months before implementation.', 'interventionNames': ['Other: "low touch" Implementation Strategy']}], 'interventions': [{'name': 'mPATH-CRC', 'type': 'OTHER', 'description': 'mPATH-CRC is a self-administered iPad program that patients eligible for CRC screening use in primary care clinics to help them receive CRC screening.', 'armGroupLabels': ['Clinic Patients Eligible for CRC Screening on "high touch" Strategy (Post-Implementation)', 'Clinic Patients Eligible for CRC Screening on "low touch" Strategy (Post-Implementation)', 'Clinic personnel on "high touch" Strategy (Post-Implementation)', 'Clinic personnel on "low touch" Strategy (Post-Implementation)']}, {'name': 'mPATH-Checkin', 'type': 'OTHER', 'description': 'The mPATH-CheckIn program includes health questions to assist clinics with patient check-in, thereby incentivizing its use for all patients.', 'armGroupLabels': ['All Adult Clinic Patients on "high touch" Strategy (Post-Implementation)', 'All Adult Clinic Patients on "low touch" Strategy (Post-Implementation)', 'Clinic Patients Eligible for CRC Screening on "high touch" Strategy (Post-Implementation)', 'Clinic Patients Eligible for CRC Screening on "low touch" Strategy (Post-Implementation)', 'Clinic personnel on "high touch" Strategy (Post-Implementation)', 'Clinic personnel on "low touch" Strategy (Post-Implementation)']}, {'name': '"high touch" Implementation strategy', 'type': 'OTHER', 'description': 'The "high touch" strategy consists of pre-implementation activities, training, and ongoing support.\n\nPre-Implementation Activities\n\n* Clinic champion identified.\n* Study team meeting with clinic champion\n* Implementation adaptations as needed for clinic flow\n\nImplementation Kick-Off (Day 1)\n\n• On-site training with key clinic personnel\n\nMonths 1 - 6\n\n* Phone/email technical support, as needed.\n* Access to web-based QA dashboard\n* Monthly program usage report sent to clinic champions\n* Scheduled phone-calls with clinic champion to review QA data and explore potential barriers.\n* Implementation adaptations as needed for clinic flow\n* Goal-triggered follow-up on-site trainings\n* Additional on-site trainings as requested.\n\nMonths 7 - 12\n\n* Phone/email technical support, as needed\n* Access to web-based QA dashboard', 'armGroupLabels': ['All Adult Clinic Patients on "high touch" Strategy (Post-Implementation)', 'Clinic Patients Eligible for CRC Screening on "high touch" Strategy (Post-Implementation)', 'Clinic Patients Eligible for CRC Screening on "high touch" Strategy (Pre-Implementation)', 'Clinic personnel on "high touch" Strategy (Post-Implementation)']}, {'name': '"low touch" Implementation Strategy', 'type': 'OTHER', 'description': 'Clinics randomized to receive the low touch implementation strategy will receive:\n\nPre-Implementation Activities\n\n• N/A\n\nImplementation Kick-Off (Day 1)\n\n• On-site training with key clinic personnel\n\nMonths 1 - 6\n\n* Phone/email technical support, as needed.\n* Access to web-based QA dashboard\n\nMonths 7 - 12\n\n* Phone/email technical support, as needed\n* Access to web-based QA dashboard', 'armGroupLabels': ['All Adult Clinic Patients on "low touch" Strategy (Post-Implementation)', 'Clinic Patients Eligible for CRC Screening on "low touch" Strategy (Post-Implementation)', 'Clinic Patients Eligible for CRC Screening on "low touch" Strategy (Pre-Implementation)', 'Clinic personnel on "low touch" Strategy (Post-Implementation)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University Health Sciences', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'David Miller, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Beginning 6 months and ending 5 years following article publication.', 'ipdSharing': 'YES', 'description': 'We will share de-identified participant data that underlie the results reported in peer-reviewed publications (text, tables, figures, and appendices).', 'accessCriteria': 'Investigators who provide a methodologically sound proposal to use the participant data in a meta-analysis.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}