Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06569290
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-22
Brief Title:
Refinement and Testing of Recruitment Methodology for Behavioral Medication Adherence Interventions Using Behavioral Science-based Approaches
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Refinement and Testing of Recruitment Methodology for Behavioral Medication Adherence Interventions Using Behavioral Science-based Approaches
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STIC2IT-2
Brief Summary:
The overarching goal of the proposed research is to prepare the clinical pharmacist intervention for sustainable implementation and dissemination Because the effectiveness of the intervention has already been demonstrated in a NIH Stage Model IV trial the investigators propose an Effectiveness-Implementation Type 3 Hybrid design in which the primary focus is on testing different implementation methods while secondarily observing clinical effects The investigators overarching hypothesis is to identify the most impactful elements of a behavioral theory-informed recruitment approach which can be replicable across clinical settings
Accordingly the investigators propose to perform testing of a behaviorally-informed recruitment approaches in a community-based setting Like the previous Tele-Pharmacy Intervention to Improve Treatment Adherence STIC2IT trial NCT02512276 participants will be English or Spanish speaking adults 18 years of age identified through the electronic health record EHR as having poor disease control andor poor medication adherence for diabetes The primary care physicians of eligible patients identified through the EHR will be contacted to opt-out any patients they wish not to be included Patients will then be randomized to each of the following conditions such that there will be 8 total arms 1 inclusion of a mailer primer yesno 2 the most successful recruitment letter from the preliminary study using prospect theory versus the control letter and 3 intensity of the intervention outreach 4 calls vs 2 calls The investigators plan to enroll 584 participants who meet the inclusion criteria with 73 patients per each of the 8 study arms
Patients across all arms who agree to be scheduled will receive an appointment with one of the clinical pharmacists within the established BMC pharmacist program The primary outcome will be completion of a clinical pharmacist appointment within 8 weeks after randomization Key secondary outcomes will include scheduled visit rates no-show rates for scheduled appointments medication adherence over the 3-month follow-up and clinical outcomes including HbA1c levels measured using EHR data in the 3 months after randomization The medication adherence and clinical outcomes will be used for the Aim 2 evaluation
Accordingly the investigators propose to perform testing of a behaviorally-informed recruitment approaches in a community-based setting Like the previous Tele-Pharmacy Intervention to Improve Treatment Adherence STIC2IT trial NCT02512276 participants will be English or Spanish speaking adults 18 years of age identified through the electronic health record EHR as having poor disease control andor poor medication adherence for diabetes The primary care physicians of eligible patients identified through the EHR will be contacted to opt-out any patients they wish not to be included Patients will then be randomized to each of the following conditions such that there will be 8 total arms 1 inclusion of a mailer primer yesno 2 the most successful recruitment letter from the preliminary study using prospect theory versus the control letter and 3 intensity of the intervention outreach 4 calls vs 2 calls The investigators plan to enroll 584 participants who meet the inclusion criteria with 73 patients per each of the 8 study arms
Patients across all arms who agree to be scheduled will receive an appointment with one of the clinical pharmacists within the established BMC pharmacist program The primary outcome will be completion of a clinical pharmacist appointment within 8 weeks after randomization Key secondary outcomes will include scheduled visit rates no-show rates for scheduled appointments medication adherence over the 3-month follow-up and clinical outcomes including HbA1c levels measured using EHR data in the 3 months after randomization The medication adherence and clinical outcomes will be used for the Aim 2 evaluation
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None