Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 3:00 AM
Study NCT ID:
NCT04149002
Status:
COMPLETED
Last Update Posted:
2022-11-02
First Post:
2019-10-11
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Improving the Clinical Encounter to Enhance Delivery of an Individualized Prematurity Prevention Plan
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sarahn.wheeler@duke.edu', 'phone': '(919) 684-6327', 'title': 'Sarahn M. Wheeler, MD', 'organization': 'Duke University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Approximately 1 year', 'description': 'Adverse Events are for Mothers only.', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention Arm: Weekly IP3 Text Messages', 'description': '* A narrated powerpoint presentation describing the logistical details and medical rationale for components of the IP3. Participants will view the chapters of the presentation that are relevant to their specific IP3. There are a total of 4 possible chapters (lifestyle modifications, cervix length screening/cerclage, progesterone therapy, low dose aspirin). Each chapter of the presentation is \\~ 10 - 15 min in length. Each chapter also includes a 4- 5 questions pre-test and the same questions are delivered as a post-test after the presentation.\n* Print materials including a letter explaining the importance of prenatal care for preterm birth prevention to employers.\n* Text messages sent weekly to encourage the patient to continue with their IP3 and provide basic pregnancy information\n* Formal letter of encouragement from provider at 28 weeks gestation\n\nIntervention Arm Weekly IP3 text messages: Subjects will be provided with a pre and post intervention survey, in addition to a narrated Powerpoint presentation focusing on the logistics of their IP3. Subjects will also receive weekly automated text messages to encourage adherence to the need for their IP3.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Arm: General Pregnancy Text Messages', 'description': '* a pre-intervention questionnaire\n* a narrated powerpoint with general information about the clinic\n* a post-presentation questionnaire\n* text messages sent approximately weekly with general pregnancy information (e.g. today your baby is about the size of an apple)\n* an exit interview\n\nActive Control Arm General pregnancy text messages: Subjects will be given pre and post pre questionnaires, in addition to a narrated Powerpoint presentation about the Clinic. Subjects will also be sent weekly text messages with general pregnancy information.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Feasibility as Measured by Number of Recruited Eligible Patients Enrolled', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Eligible Patients Recruited', 'description': 'Patients who met all study inclusion criteria.'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'study duration (approximately 14 months)', 'description': 'Enrollment target of 30% of eligible patients recruited.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Acceptability as Measured by Number of Participants Who Completed the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Arm: Weekly IP3 Text Messages', 'description': '* A narrated powerpoint presentation describing the logistical details and medical rationale for components of the IP3. Participants will view the chapters of the presentation that are relevant to their specific IP3. There are a total of 4 possible chapters (lifestyle modifications, cervix length screening/cerclage, progesterone therapy, low dose aspirin). Each chapter of the presentation is \\~ 10 - 15 min in length. Each chapter also includes a 4- 5 questions pre-test and the same questions are delivered as a post-test after the presentation.\n* Print materials including a letter explaining the importance of prenatal care for preterm birth prevention to employers.\n* Text messages sent weekly to encourage the patient to continue with their IP3 and provide basic pregnancy information\n* Formal letter of encouragement from provider at 28 weeks gestation\n\nIntervention Arm Weekly IP3 text messages: Subjects will be provided with a pre and post intervention survey, in addition to a narrated Powerpoint presentation focusing on the logistics of their IP3. Subjects will also receive weekly automated text messages to encourage adherence to the need for their IP3.'}, {'id': 'OG001', 'title': 'Control Arm: General Pregnancy Text Messages', 'description': '* a pre-intervention questionnaire\n* a narrated powerpoint with general information about the clinic\n* a post-presentation questionnaire\n* text messages sent approximately weekly with general pregnancy information (e.g. today your baby is about the size of an apple)\n* an exit interview\n\nActive Control Arm General pregnancy text messages: Subjects will be given pre and post pre questionnaires, in addition to a narrated Powerpoint presentation about the Clinic. Subjects will also be sent weekly text messages with general pregnancy information.'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'study duration (approximately 14 months)', 'description': 'Completion target of 80% participants retained in study protocol.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'IP3 Adherence as Measured by Number of Participants With Patient and EMR (Electronic Medical Record) Report of Medication Compliance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Arm: Weekly IP3 Text Messages', 'description': '* A narrated powerpoint presentation describing the logistical details and medical rationale for components of the IP3. Participants will view the chapters of the presentation that are relevant to their specific IP3. There are a total of 4 possible chapters (lifestyle modifications, cervix length screening/cerclage, progesterone therapy, low dose aspirin). Each chapter of the presentation is \\~ 10 - 15 min in length. Each chapter also includes a 4- 5 questions pre-test and the same questions are delivered as a post-test after the presentation.\n* Print materials including a letter explaining the importance of prenatal care for preterm birth prevention to employers.\n* Text messages sent weekly to encourage the patient to continue with their IP3 and provide basic pregnancy information\n* Formal letter of encouragement from provider at 28 weeks gestation\n\nIntervention Arm Weekly IP3 text messages: Subjects will be provided with a pre and post intervention survey, in addition to a narrated Powerpoint presentation focusing on the logistics of their IP3. Subjects will also receive weekly automated text messages to encourage adherence to the need for their IP3.'}, {'id': 'OG001', 'title': 'Control Arm: General Pregnancy Text Messages', 'description': '* a pre-intervention questionnaire\n* a narrated powerpoint with general information about the clinic\n* a post-presentation questionnaire\n* text messages sent approximately weekly with general pregnancy information (e.g. today your baby is about the size of an apple)\n* an exit interview\n\nActive Control Arm General pregnancy text messages: Subjects will be given pre and post pre questionnaires, in addition to a narrated Powerpoint presentation about the Clinic. Subjects will also be sent weekly text messages with general pregnancy information.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'approximately 1 year', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pregnancy Specific Anxiety (PSA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Arm: Weekly IP3 Text Messages', 'description': '* A narrated powerpoint presentation describing the logistical details and medical rationale for components of the IP3. Participants will view the chapters of the presentation that are relevant to their specific IP3. There are a total of 4 possible chapters (lifestyle modifications, cervix length screening/cerclage, progesterone therapy, low dose aspirin). Each chapter of the presentation is \\~ 10 - 15 min in length. Each chapter also includes a 4- 5 questions pre-test and the same questions are delivered as a post-test after the presentation.\n* Print materials including a letter explaining the importance of prenatal care for preterm birth prevention to employers.\n* Text messages sent weekly to encourage the patient to continue with their IP3 and provide basic pregnancy information\n* Formal letter of encouragement from provider at 28 weeks gestation\n\nIntervention Arm Weekly IP3 text messages: Subjects will be provided with a pre and post intervention survey, in addition to a narrated Powerpoint presentation focusing on the logistics of their IP3. Subjects will also receive weekly automated text messages to encourage adherence to the need for their IP3.'}, {'id': 'OG001', 'title': 'Control Arm: General Pregnancy Text Messages', 'description': '* a pre-intervention questionnaire\n* a narrated powerpoint with general information about the clinic\n* a post-presentation questionnaire\n* text messages sent approximately weekly with general pregnancy information (e.g. today your baby is about the size of an apple)\n* an exit interview\n\nActive Control Arm General pregnancy text messages: Subjects will be given pre and post pre questionnaires, in addition to a narrated Powerpoint presentation about the Clinic. Subjects will also be sent weekly text messages with general pregnancy information.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '2.6', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '0.9', 'groupId': 'OG001'}]}]}, {'title': '28 Weeks', 'categories': [{'measurements': [{'value': '2.3', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '0.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 28 weeks', 'description': 'Pregnancy specific anxiety is a 4-question scale. Each question can be answered on a range of 1 to 5. Scores were averaged to produce one mean PSA score ranging from 1-5. Higher scores are negative and denote increased anxiety.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the PSA questionnaire.'}, {'type': 'SECONDARY', 'title': 'Interpersonal Process of Care (IPC-18) at Protocol Completion - Communication Domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Arm: Weekly IP3 Text Messages', 'description': '* A narrated powerpoint presentation describing the logistical details and medical rationale for components of the IP3. Participants will view the chapters of the presentation that are relevant to their specific IP3. There are a total of 4 possible chapters (lifestyle modifications, cervix length screening/cerclage, progesterone therapy, low dose aspirin). Each chapter of the presentation is \\~ 10 - 15 min in length. Each chapter also includes a 4- 5 questions pre-test and the same questions are delivered as a post-test after the presentation.\n* Print materials including a letter explaining the importance of prenatal care for preterm birth prevention to employers.\n* Text messages sent weekly to encourage the patient to continue with their IP3 and provide basic pregnancy information\n* Formal letter of encouragement from provider at 28 weeks gestation\n\nIntervention Arm Weekly IP3 text messages: Subjects will be provided with a pre and post intervention survey, in addition to a narrated Powerpoint presentation focusing on the logistics of their IP3. Subjects will also receive weekly automated text messages to encourage adherence to the need for their IP3.'}, {'id': 'OG001', 'title': 'Control Arm: General Pregnancy Text Messages', 'description': '* a pre-intervention questionnaire\n* a narrated powerpoint with general information about the clinic\n* a post-presentation questionnaire\n* text messages sent approximately weekly with general pregnancy information (e.g. today your baby is about the size of an apple)\n* an exit interview\n\nActive Control Arm General pregnancy text messages: Subjects will be given pre and post pre questionnaires, in addition to a narrated Powerpoint presentation about the Clinic. Subjects will also be sent weekly text messages with general pregnancy information.'}], 'classes': [{'title': 'Lack of clarity', 'categories': [{'measurements': [{'value': '1.6', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '1.1', 'groupId': 'OG001'}]}]}, {'title': 'Elicits concern', 'categories': [{'measurements': [{'value': '4.6', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '4.7', 'spread': '0.6', 'groupId': 'OG001'}]}]}, {'title': 'Explain results', 'categories': [{'measurements': [{'value': '4.5', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '0.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'protocol completion (approximately 1 year)', 'description': "The IPC is an 18-question questionnaire that asks participants about their experience with receiving care within a specific clinic (in this case the Duke Perinatal Durham Clinic). All IPC items use an identical set of response options: 1='never'; 2='rarely'; 3='sometimes'; 4='usually'; 5='always.' Item responses are averaged, not summed; thus, scores have a possible range of 1-5. All scales are scored so that higher scores indicate higher frequency of the labeled interpersonal process: Lack of clarity (higher scores are negative), Elicits concern (higher scores are positive), and Explain results (higher scores are positive).", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the IPC-18 questionnaire.'}, {'type': 'SECONDARY', 'title': 'Interpersonal Process of Care (IPC-18) at Protocol Completion - Decision Making Domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Arm: Weekly IP3 Text Messages', 'description': '* A narrated powerpoint presentation describing the logistical details and medical rationale for components of the IP3. Participants will view the chapters of the presentation that are relevant to their specific IP3. There are a total of 4 possible chapters (lifestyle modifications, cervix length screening/cerclage, progesterone therapy, low dose aspirin). Each chapter of the presentation is \\~ 10 - 15 min in length. Each chapter also includes a 4- 5 questions pre-test and the same questions are delivered as a post-test after the presentation.\n* Print materials including a letter explaining the importance of prenatal care for preterm birth prevention to employers.\n* Text messages sent weekly to encourage the patient to continue with their IP3 and provide basic pregnancy information\n* Formal letter of encouragement from provider at 28 weeks gestation\n\nIntervention Arm Weekly IP3 text messages: Subjects will be provided with a pre and post intervention survey, in addition to a narrated Powerpoint presentation focusing on the logistics of their IP3. Subjects will also receive weekly automated text messages to encourage adherence to the need for their IP3.'}, {'id': 'OG001', 'title': 'Control Arm: General Pregnancy Text Messages', 'description': '* a pre-intervention questionnaire\n* a narrated powerpoint with general information about the clinic\n* a post-presentation questionnaire\n* text messages sent approximately weekly with general pregnancy information (e.g. today your baby is about the size of an apple)\n* an exit interview\n\nActive Control Arm General pregnancy text messages: Subjects will be given pre and post pre questionnaires, in addition to a narrated Powerpoint presentation about the Clinic. Subjects will also be sent weekly text messages with general pregnancy information.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.4', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '4.8', 'spread': '0.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'protocol completion (approximately 1 year)', 'description': "The IPC is an 18-question questionnaire that asks participants about their experience with receiving care within a specific clinic (in this case the Duke Perinatal Durham Clinic). All IPC items use an identical set of response options: 1='never'; 2='rarely'; 3='sometimes'; 4='usually'; 5='always.' Item responses are averaged, not summed; thus, scores have a possible range of 1-5. All scales are scored so that higher scores indicate higher frequency of the labeled interpersonal process: Decision Making (higher scores are positive, denoting more collaborative decision making between the clinician and patient).", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the IPC-18 questionnaire.'}, {'type': 'SECONDARY', 'title': 'Interpersonal Process of Care (IPC-18) at Protocol Completion - Interpersonal Style Domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Arm: Weekly IP3 Text Messages', 'description': '* A narrated powerpoint presentation describing the logistical details and medical rationale for components of the IP3. Participants will view the chapters of the presentation that are relevant to their specific IP3. There are a total of 4 possible chapters (lifestyle modifications, cervix length screening/cerclage, progesterone therapy, low dose aspirin). Each chapter of the presentation is \\~ 10 - 15 min in length. Each chapter also includes a 4- 5 questions pre-test and the same questions are delivered as a post-test after the presentation.\n* Print materials including a letter explaining the importance of prenatal care for preterm birth prevention to employers.\n* Text messages sent weekly to encourage the patient to continue with their IP3 and provide basic pregnancy information\n* Formal letter of encouragement from provider at 28 weeks gestation\n\nIntervention Arm Weekly IP3 text messages: Subjects will be provided with a pre and post intervention survey, in addition to a narrated Powerpoint presentation focusing on the logistics of their IP3. Subjects will also receive weekly automated text messages to encourage adherence to the need for their IP3.'}, {'id': 'OG001', 'title': 'Control Arm: General Pregnancy Text Messages', 'description': '* a pre-intervention questionnaire\n* a narrated powerpoint with general information about the clinic\n* a post-presentation questionnaire\n* text messages sent approximately weekly with general pregnancy information (e.g. today your baby is about the size of an apple)\n* an exit interview\n\nActive Control Arm General pregnancy text messages: Subjects will be given pre and post pre questionnaires, in addition to a narrated Powerpoint presentation about the Clinic. Subjects will also be sent weekly text messages with general pregnancy information.'}], 'classes': [{'title': 'Emotional support', 'categories': [{'measurements': [{'value': '4.7', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '4.8', 'spread': '0.4', 'groupId': 'OG001'}]}]}, {'title': 'Discrimination due to race/ethnicity', 'categories': [{'measurements': [{'value': '1.5', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'Disrespectful to office staff', 'categories': [{'measurements': [{'value': '1.2', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '0.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'protocol completion (approximately 1 year)', 'description': "The IPC is an 18-question questionnaire that asks participants about their experience with receiving care within a specific clinic (in this case the Duke Perinatal Durham Clinic). All IPC items use an identical set of response options: 1='never'; 2='rarely'; 3='sometimes'; 4='usually'; 5='always.' Item responses are averaged, not summed; thus, scores have a possible range of 1-5. All scales are scored so that higher scores indicate higher frequency of the labeled interpersonal process: Emotional support (higher scores are positive), Discrimination due to race/ethnicity (higher scores are negative), Disrespectful to office staff (higher scores are negative).", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the IPC-18 questionnaire.'}, {'type': 'SECONDARY', 'title': 'Change in Maternal Social Support Scale (MSSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Arm: Weekly IP3 Text Messages', 'description': '* A narrated powerpoint presentation describing the logistical details and medical rationale for components of the IP3. Participants will view the chapters of the presentation that are relevant to their specific IP3. There are a total of 4 possible chapters (lifestyle modifications, cervix length screening/cerclage, progesterone therapy, low dose aspirin). Each chapter of the presentation is \\~ 10 - 15 min in length. Each chapter also includes a 4- 5 questions pre-test and the same questions are delivered as a post-test after the presentation.\n* Print materials including a letter explaining the importance of prenatal care for preterm birth prevention to employers.\n* Text messages sent weekly to encourage the patient to continue with their IP3 and provide basic pregnancy information\n* Formal letter of encouragement from provider at 28 weeks gestation\n\nIntervention Arm Weekly IP3 text messages: Subjects will be provided with a pre and post intervention survey, in addition to a narrated Powerpoint presentation focusing on the logistics of their IP3. Subjects will also receive weekly automated text messages to encourage adherence to the need for their IP3.'}, {'id': 'OG001', 'title': 'Control Arm: General Pregnancy Text Messages', 'description': '* a pre-intervention questionnaire\n* a narrated powerpoint with general information about the clinic\n* a post-presentation questionnaire\n* text messages sent approximately weekly with general pregnancy information (e.g. today your baby is about the size of an apple)\n* an exit interview\n\nActive Control Arm General pregnancy text messages: Subjects will be given pre and post pre questionnaires, in addition to a narrated Powerpoint presentation about the Clinic. Subjects will also be sent weekly text messages with general pregnancy information.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '2.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline to protocol completion (approximately 1 year)', 'description': "The MSSS is a six-question scale that quantifies a pregnant woman's social support. Social factors (lack of family support, low friendship network, lack of help from spouse/partner, conflict with spouse/partner, feeling controlled by spouse/partner, and feeling unloved by spouse/partner) are combined in a 6-item self-report 5-point Likert scale. The total possible score for the scale is between 6 and 30, with higher scores indicating increased support.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the MSSS questionnaire.'}, {'type': 'SECONDARY', 'title': 'Gestational Age at Delivery in Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Arm: Weekly IP3 Text Messages', 'description': '* A narrated powerpoint presentation describing the logistical details and medical rationale for components of the IP3. Participants will view the chapters of the presentation that are relevant to their specific IP3. There are a total of 4 possible chapters (lifestyle modifications, cervix length screening/cerclage, progesterone therapy, low dose aspirin). Each chapter of the presentation is \\~ 10 - 15 min in length. Each chapter also includes a 4- 5 questions pre-test and the same questions are delivered as a post-test after the presentation.\n* Print materials including a letter explaining the importance of prenatal care for preterm birth prevention to employers.\n* Text messages sent weekly to encourage the patient to continue with their IP3 and provide basic pregnancy information\n* Formal letter of encouragement from provider at 28 weeks gestation\n\nIntervention Arm Weekly IP3 text messages: Subjects will be provided with a pre and post intervention survey, in addition to a narrated Powerpoint presentation focusing on the logistics of their IP3. Subjects will also receive weekly automated text messages to encourage adherence to the need for their IP3.'}, {'id': 'OG001', 'title': 'Control Arm: General Pregnancy Text Messages', 'description': '* a pre-intervention questionnaire\n* a narrated powerpoint with general information about the clinic\n* a post-presentation questionnaire\n* text messages sent approximately weekly with general pregnancy information (e.g. today your baby is about the size of an apple)\n* an exit interview\n\nActive Control Arm General pregnancy text messages: Subjects will be given pre and post pre questionnaires, in addition to a narrated Powerpoint presentation about the Clinic. Subjects will also be sent weekly text messages with general pregnancy information.'}], 'classes': [{'categories': [{'measurements': [{'value': '34.0', 'spread': '6.1', 'groupId': 'OG000'}, {'value': '35.7', 'spread': '3.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'approximately 40 weeks', 'unitOfMeasure': 'weeks', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Birth Weight in Grams', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Arm: Weekly IP3 Text Messages', 'description': '* A narrated powerpoint presentation describing the logistical details and medical rationale for components of the IP3. Participants will view the chapters of the presentation that are relevant to their specific IP3. There are a total of 4 possible chapters (lifestyle modifications, cervix length screening/cerclage, progesterone therapy, low dose aspirin). Each chapter of the presentation is \\~ 10 - 15 min in length. Each chapter also includes a 4- 5 questions pre-test and the same questions are delivered as a post-test after the presentation.\n* Print materials including a letter explaining the importance of prenatal care for preterm birth prevention to employers.\n* Text messages sent weekly to encourage the patient to continue with their IP3 and provide basic pregnancy information\n* Formal letter of encouragement from provider at 28 weeks gestation\n\nIntervention Arm Weekly IP3 text messages: Subjects will be provided with a pre and post intervention survey, in addition to a narrated Powerpoint presentation focusing on the logistics of their IP3. Subjects will also receive weekly automated text messages to encourage adherence to the need for their IP3.'}, {'id': 'OG001', 'title': 'Control Arm: General Pregnancy Text Messages', 'description': '* a pre-intervention questionnaire\n* a narrated powerpoint with general information about the clinic\n* a post-presentation questionnaire\n* text messages sent approximately weekly with general pregnancy information (e.g. today your baby is about the size of an apple)\n* an exit interview\n\nActive Control Arm General pregnancy text messages: Subjects will be given pre and post pre questionnaires, in addition to a narrated Powerpoint presentation about the Clinic. Subjects will also be sent weekly text messages with general pregnancy information.'}], 'classes': [{'categories': [{'measurements': [{'value': '2442.5', 'spread': '1255.9', 'groupId': 'OG000'}, {'value': '2607.9', 'spread': '750.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'approximately 40 weeks', 'unitOfMeasure': 'grams', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Neonates Admitted to the Newborn Intensive Care Unit (NICU)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}, {'units': 'Neonates', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Arm: Weekly IP3 Text Messages', 'description': '* A narrated powerpoint presentation describing the logistical details and medical rationale for components of the IP3. Participants will view the chapters of the presentation that are relevant to their specific IP3. There are a total of 4 possible chapters (lifestyle modifications, cervix length screening/cerclage, progesterone therapy, low dose aspirin). Each chapter of the presentation is \\~ 10 - 15 min in length. Each chapter also includes a 4- 5 questions pre-test and the same questions are delivered as a post-test after the presentation.\n* Print materials including a letter explaining the importance of prenatal care for preterm birth prevention to employers.\n* Text messages sent weekly to encourage the patient to continue with their IP3 and provide basic pregnancy information\n* Formal letter of encouragement from provider at 28 weeks gestation\n\nIntervention Arm Weekly IP3 text messages: Subjects will be provided with a pre and post intervention survey, in addition to a narrated Powerpoint presentation focusing on the logistics of their IP3. Subjects will also receive weekly automated text messages to encourage adherence to the need for their IP3.'}, {'id': 'OG001', 'title': 'Control Arm: General Pregnancy Text Messages', 'description': '* a pre-intervention questionnaire\n* a narrated powerpoint with general information about the clinic\n* a post-presentation questionnaire\n* text messages sent approximately weekly with general pregnancy information (e.g. today your baby is about the size of an apple)\n* an exit interview\n\nActive Control Arm General pregnancy text messages: Subjects will be given pre and post pre questionnaires, in addition to a narrated Powerpoint presentation about the Clinic. Subjects will also be sent weekly text messages with general pregnancy information.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'approximately 40 weeks', 'unitOfMeasure': 'Neonates', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Neonates', 'denomUnitsSelected': 'Neonates'}, {'type': 'SECONDARY', 'title': 'Length of Delivery Hospital Admission in Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Arm: Weekly IP3 Text Messages', 'description': '* A narrated powerpoint presentation describing the logistical details and medical rationale for components of the IP3. Participants will view the chapters of the presentation that are relevant to their specific IP3. There are a total of 4 possible chapters (lifestyle modifications, cervix length screening/cerclage, progesterone therapy, low dose aspirin). Each chapter of the presentation is \\~ 10 - 15 min in length. Each chapter also includes a 4- 5 questions pre-test and the same questions are delivered as a post-test after the presentation.\n* Print materials including a letter explaining the importance of prenatal care for preterm birth prevention to employers.\n* Text messages sent weekly to encourage the patient to continue with their IP3 and provide basic pregnancy information\n* Formal letter of encouragement from provider at 28 weeks gestation\n\nIntervention Arm Weekly IP3 text messages: Subjects will be provided with a pre and post intervention survey, in addition to a narrated Powerpoint presentation focusing on the logistics of their IP3. Subjects will also receive weekly automated text messages to encourage adherence to the need for their IP3.'}, {'id': 'OG001', 'title': 'Control Arm: General Pregnancy Text Messages', 'description': '* a pre-intervention questionnaire\n* a narrated powerpoint with general information about the clinic\n* a post-presentation questionnaire\n* text messages sent approximately weekly with general pregnancy information (e.g. today your baby is about the size of an apple)\n* an exit interview\n\nActive Control Arm General pregnancy text messages: Subjects will be given pre and post pre questionnaires, in addition to a narrated Powerpoint presentation about the Clinic. Subjects will also be sent weekly text messages with general pregnancy information.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '3'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'approximately 40 weeks', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention Arm: Weekly IP3 Text Messages', 'description': '* A narrated powerpoint presentation describing the logistical details and medical rationale for components of the IP3 (Individualized Prematurity Prevention Plan). Participants will view the chapters of the presentation that are relevant to their specific IP3. There are a total of 4 possible chapters (lifestyle modifications, cervix length screening/cerclage, progesterone therapy, low dose aspirin). Each chapter of the presentation is \\~ 10 - 15 min in length. Each chapter also includes a 4- 5 questions pre-test and the same questions are delivered as a post-test after the presentation.\n* Print materials including a letter explaining the importance of prenatal care for preterm birth prevention to employers.\n* Text messages sent weekly to encourage the patient to continue with their IP3 and provide basic pregnancy information\n* Formal letter of encouragement from provider at 28 weeks gestation\n\nIntervention Arm Weekly IP3 text messages: Subjects will be provided with a pre and post intervention survey, in addition to a narrated Powerpoint presentation focusing on the logistics of their IP3. Subjects will also receive weekly automated text messages to encourage adherence to the need for their IP3.'}, {'id': 'FG001', 'title': 'Control Arm: General Pregnancy Text Messages', 'description': '* a pre-intervention questionnaire\n* a narrated powerpoint with general information about the clinic\n* a post-presentation questionnaire\n* text messages sent approximately weekly with general pregnancy information (e.g. today your baby is about the size of an apple)\n* an exit interview\n\nActive Control Arm General pregnancy text messages: Subjects will be given pre and post pre questionnaires, in addition to a narrated Powerpoint presentation about the Clinic. Subjects will also be sent weekly text messages with general pregnancy information.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention Arm: Weekly IP3 Text Messages', 'description': '* A narrated powerpoint presentation describing the logistical details and medical rationale for components of the IP3. Participants will view the chapters of the presentation that are relevant to their specific IP3. There are a total of 4 possible chapters (lifestyle modifications, cervix length screening/cerclage, progesterone therapy, low dose aspirin). Each chapter of the presentation is \\~ 10 - 15 min in length. Each chapter also includes a 4- 5 questions pre-test and the same questions are delivered as a post-test after the presentation.\n* Print materials including a letter explaining the importance of prenatal care for preterm birth prevention to employers.\n* Text messages sent weekly to encourage the patient to continue with their IP3 and provide basic pregnancy information\n* Formal letter of encouragement from provider at 28 weeks gestation\n\nIntervention Arm Weekly IP3 text messages: Subjects will be provided with a pre and post intervention survey, in addition to a narrated Powerpoint presentation focusing on the logistics of their IP3. Subjects will also receive weekly automated text messages to encourage adherence to the need for their IP3.'}, {'id': 'BG001', 'title': 'Control Arm: General Pregnancy Text Messages', 'description': '* a pre-intervention questionnaire\n* a narrated powerpoint with general information about the clinic\n* a post-presentation questionnaire\n* text messages sent approximately weekly with general pregnancy information (e.g. today your baby is about the size of an apple)\n* an exit interview\n\nActive Control Arm General pregnancy text messages: Subjects will be given pre and post pre questionnaires, in addition to a narrated Powerpoint presentation about the Clinic. Subjects will also be sent weekly text messages with general pregnancy information.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '30.9', 'spread': '5.3', 'groupId': 'BG000'}, {'value': '32.1', 'spread': '7.0', 'groupId': 'BG001'}, {'value': '31.5', 'spread': '6.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-07-01', 'size': 123719, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-03-30T13:11', 'hasProtocol': True}, {'date': '2020-01-21', 'size': 123551, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-11-23T11:24', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Intervention Arm vs. Active Control Arm'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-01', 'studyFirstSubmitDate': '2019-10-11', 'resultsFirstSubmitDate': '2022-03-31', 'studyFirstSubmitQcDate': '2019-11-01', 'lastUpdatePostDateStruct': {'date': '2022-11-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-11-01', 'studyFirstPostDateStruct': {'date': '2019-11-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-11-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility as Measured by Number of Recruited Eligible Patients Enrolled', 'timeFrame': 'study duration (approximately 14 months)', 'description': 'Enrollment target of 30% of eligible patients recruited.'}, {'measure': 'Acceptability as Measured by Number of Participants Who Completed the Study', 'timeFrame': 'study duration (approximately 14 months)', 'description': 'Completion target of 80% participants retained in study protocol.'}], 'secondaryOutcomes': [{'measure': 'IP3 Adherence as Measured by Number of Participants With Patient and EMR (Electronic Medical Record) Report of Medication Compliance', 'timeFrame': 'approximately 1 year'}, {'measure': 'Pregnancy Specific Anxiety (PSA)', 'timeFrame': 'baseline, 28 weeks', 'description': 'Pregnancy specific anxiety is a 4-question scale. Each question can be answered on a range of 1 to 5. Scores were averaged to produce one mean PSA score ranging from 1-5. Higher scores are negative and denote increased anxiety.'}, {'measure': 'Interpersonal Process of Care (IPC-18) at Protocol Completion - Communication Domain', 'timeFrame': 'protocol completion (approximately 1 year)', 'description': "The IPC is an 18-question questionnaire that asks participants about their experience with receiving care within a specific clinic (in this case the Duke Perinatal Durham Clinic). All IPC items use an identical set of response options: 1='never'; 2='rarely'; 3='sometimes'; 4='usually'; 5='always.' Item responses are averaged, not summed; thus, scores have a possible range of 1-5. All scales are scored so that higher scores indicate higher frequency of the labeled interpersonal process: Lack of clarity (higher scores are negative), Elicits concern (higher scores are positive), and Explain results (higher scores are positive)."}, {'measure': 'Interpersonal Process of Care (IPC-18) at Protocol Completion - Decision Making Domain', 'timeFrame': 'protocol completion (approximately 1 year)', 'description': "The IPC is an 18-question questionnaire that asks participants about their experience with receiving care within a specific clinic (in this case the Duke Perinatal Durham Clinic). All IPC items use an identical set of response options: 1='never'; 2='rarely'; 3='sometimes'; 4='usually'; 5='always.' Item responses are averaged, not summed; thus, scores have a possible range of 1-5. All scales are scored so that higher scores indicate higher frequency of the labeled interpersonal process: Decision Making (higher scores are positive, denoting more collaborative decision making between the clinician and patient)."}, {'measure': 'Interpersonal Process of Care (IPC-18) at Protocol Completion - Interpersonal Style Domain', 'timeFrame': 'protocol completion (approximately 1 year)', 'description': "The IPC is an 18-question questionnaire that asks participants about their experience with receiving care within a specific clinic (in this case the Duke Perinatal Durham Clinic). All IPC items use an identical set of response options: 1='never'; 2='rarely'; 3='sometimes'; 4='usually'; 5='always.' Item responses are averaged, not summed; thus, scores have a possible range of 1-5. All scales are scored so that higher scores indicate higher frequency of the labeled interpersonal process: Emotional support (higher scores are positive), Discrimination due to race/ethnicity (higher scores are negative), Disrespectful to office staff (higher scores are negative)."}, {'measure': 'Change in Maternal Social Support Scale (MSSS)', 'timeFrame': 'baseline to protocol completion (approximately 1 year)', 'description': "The MSSS is a six-question scale that quantifies a pregnant woman's social support. Social factors (lack of family support, low friendship network, lack of help from spouse/partner, conflict with spouse/partner, feeling controlled by spouse/partner, and feeling unloved by spouse/partner) are combined in a 6-item self-report 5-point Likert scale. The total possible score for the scale is between 6 and 30, with higher scores indicating increased support."}, {'measure': 'Gestational Age at Delivery in Weeks', 'timeFrame': 'approximately 40 weeks'}, {'measure': 'Birth Weight in Grams', 'timeFrame': 'approximately 40 weeks'}, {'measure': 'Number of Neonates Admitted to the Newborn Intensive Care Unit (NICU)', 'timeFrame': 'approximately 40 weeks'}, {'measure': 'Length of Delivery Hospital Admission in Days', 'timeFrame': 'approximately 40 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Preterm Birth']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to pilot an intervention that was developed to improve uptake and adhere to an Individualized Prematurity Prevention Plan (IP3) for preterm birth prevention. Non-Hispanic Black (NHB) women are at higher risk for preterm birth compared to other racial and ethnic groups. Building on qualitative data from NHB women with input from a multidisciplinary stakeholder group, a patient-centered intervention was developed to improve uptake and adherence to an IP3 in NHB women.', 'detailedDescription': "The study team will pilot test the intervention via a pilot randomized controlled trial. 60 pregnant NHB women will be recruited who have a history of singleton preterm birth and are currently pregnant with a singleton gestation. Consenting participants will be randomized to the intervention or an active control. The intervention includes: 1) an informational narrated powerpoint presentation that reviews the logistical details of the IP3, 2) structured encouragement via text messages and 3) employment law education sheet. The powerpoints will also be available for review on our you-tube channel for intervention patients. The active control arm includes: 1) a narrated powerpoint describing the Duke Prematurity Prevention Program and 2) text messages with general pregnancy information (i.e. it is safe to take Tylenol in pregnancy). At study intake, we will collect demographic data (age, self-described race, pregnancy history, social history, pregnancy-related anxiety scale, interpersonal processes of care and maternal social support index.\n\nThe team will collect feedback on the intervention based on an intake questionnaire and an exit interview.\n\nInformation will also be collected on adherence to the IP3 based on review of the participant's medical record. The primary aim of the study is to evaluation feasibility and acceptability. These endpoints will be measured via enrollment and participant feedback during the exit interview."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* self described race as Non-Hispanic Black\n* history of prior singleton preterm delivery (before 37 weeks gestation)\n* current singleton gestation\n\nExclusion Criteria:\n\n* women with anomalous fetuses\n* age below 18\\]\n* non-English speaking'}, 'identificationModule': {'nctId': 'NCT04149002', 'briefTitle': 'Improving the Clinical Encounter to Enhance Delivery of an Individualized Prematurity Prevention Plan', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Improving the Clinical Encounter to Enhance Delivery of an Individualized Prematurity Prevention Plan (IP3) - The IMPaCT-IP3 Study', 'orgStudyIdInfo': {'id': 'Pro00103922'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Intervention Arm: Weekly IP3 text messages', 'description': '* A narrated powerpoint presentation describing the logistical details and medical rationale for components of the IP3. Participants will view the chapters of the presentation that are relevant to their specific IP3. There are a total of 4 possible chapters (lifestyle modifications, cervix length screening/cerclage, progesterone therapy, low dose aspirin). Each chapter of the presentation is \\~ 10 - 15 min in length. Each chapter also includes a 4- 5 questions pre-test and the same questions are delivered as a post-test after the presentation.\n* Print materials including a letter explaining the importance of prenatal care for preterm birth prevention to employers.\n* Text messages sent weekly to encourage the patient to continue with their IP3 and provide basic pregnancy information\n* Formal letter of encouragement from provider at 28 weeks gestation', 'interventionNames': ['Behavioral: Intervention Arm Weekly IP3 text messages']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Arm: General pregnancy text messages', 'description': '* a pre-intervention questionnaire\n* a narrated powerpoint with general information about the clinic\n* a post-presentation questionnaire\n* text messages sent approximately weekly with general pregnancy information (e.g. today your baby is about the size of an apple)\n* an exit interview', 'interventionNames': ['Other: Active Control Arm General pregnancy text messages']}], 'interventions': [{'name': 'Intervention Arm Weekly IP3 text messages', 'type': 'BEHAVIORAL', 'description': 'Subjects will be provided with a pre and post intervention survey, in addition to a narrated Powerpoint presentation focusing on the logistics of their IP3. Subjects will also receive weekly automated text messages to encourage adherence to the need for their IP3.', 'armGroupLabels': ['Intervention Arm: Weekly IP3 text messages']}, {'name': 'Active Control Arm General pregnancy text messages', 'type': 'OTHER', 'description': 'Subjects will be given pre and post pre questionnaires, in addition to a narrated Powerpoint presentation about the Clinic. Subjects will also be sent weekly text messages with general pregnancy information.', 'armGroupLabels': ['Control Arm: General pregnancy text messages']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Sarahn Wheeler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}