Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06543394
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-05
Brief Title:
Engaging Patients in Adherence Interventions Using Behavioral Science
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Optimizing Recruitment Methodology for Medication Adherence Interventions The ENGaging Patients in Adherence Interventions UsinG Behavioral SciencE ENGAGE Randomized Factorial Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
ENGAGE-HTN
Brief Summary:
The overarching goal of the proposed research is to prepare an evidence-based clinical pharmacist-delivered medication adherence intervention for sustainable implementation and dissemination Because the effectiveness of the intervention has already been demonstrated in a NIH Stage Model Stage 4 trial called STIC2IT this study will include an NIH Stage Model Stage 5 Effectiveness-Implementation Type 3 Hybrid design in which the primary focus is on testing different implementation methods while secondarily observing clinical effects The overarching hypothesis is that investigators can identify the most impactful elements of a behavioral theory-informed recruitment approach which can be replicable across clinical settings
Accordingly this study will perform testing of behaviorally-informed recruitment approaches in a primary care setting that serves patients from under-resourced communities Patients will be English or Spanish speaking adults 18 years of age identified through the electronic health record EHR as having a primary care clinician at the participating practice as well as uncontrolled hypertension and suboptimal adherence to blood pressure medications based on pharmacy fill data linked to the electronic health record EHR The primary care clinicians of eligible patients identified through the EHR will have the opportunity 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 a preliminary study using prospect theory versus the control letter and 3 intensity of the intervention outreach up to 4 calls vs up to 2 calls
Patients across all arms who agree to be scheduled will receive an appointment with one of the clinical pharmacists trained in the brief negotiated interviewing approach used in the STIC2IT trial The primary outcome will be completion of a clinical pharmacist appointment within 12 weeks of randomization Key secondary outcomes will include scheduled visit rates no-show rates for scheduled appointments pharmacy fill adherence to statins and blood pressure medications over the 3-month follow-up and clinical outcomes including blood pressure as per EHR data in the 3 months after randomization
Accordingly this study will perform testing of behaviorally-informed recruitment approaches in a primary care setting that serves patients from under-resourced communities Patients will be English or Spanish speaking adults 18 years of age identified through the electronic health record EHR as having a primary care clinician at the participating practice as well as uncontrolled hypertension and suboptimal adherence to blood pressure medications based on pharmacy fill data linked to the electronic health record EHR The primary care clinicians of eligible patients identified through the EHR will have the opportunity 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 a preliminary study using prospect theory versus the control letter and 3 intensity of the intervention outreach up to 4 calls vs up to 2 calls
Patients across all arms who agree to be scheduled will receive an appointment with one of the clinical pharmacists trained in the brief negotiated interviewing approach used in the STIC2IT trial The primary outcome will be completion of a clinical pharmacist appointment within 12 weeks of randomization Key secondary outcomes will include scheduled visit rates no-show rates for scheduled appointments pharmacy fill adherence to statins and blood pressure medications over the 3-month follow-up and clinical outcomes including blood pressure as per EHR data in the 3 months after randomization
Detailed Description:
Participants will be recruited from Columbia University Irving Medical Center CUIMC-affiliated primary care clinics that are part of the New York Presbyterian NYP Ambulatory Care Network ACN These clinics provide care to patients in the catchment area of CUIMC which is notable for substantial racial ethnic and economic diversity The study team will identify participants with uncontrolled hypertension last office BP 14090 mmHg who also are nonadherent PDC80 to at least one antihypertensive medication class and meet other study eligibility criteria
Participants will then be will then be randomized using a 23 factorial approach to each of the following conditions such that there will be 8 total arms 1 inclusion of a mailer primer yes vs no 2 a behavioral theory-informed letter script vs usual scripted letter and 3 intensity of the recruitment outreach up to 4 calls vs up to 2 calls Recruitment outreach will be conducted by members of the study team who will be trained to deliver different interventions based on a patients assigned arm Enrollment will be staggered over an approximately 4-month period so as not to overwhelm the scheduling staff and mimic how quality improvement programs are conducted in typical practice
Participants who agree to participate in the adherence counseling session after receiving any of the 8 combinations of recruitment strategies will be scheduled to receive a brief evidence-based medicated adherence counseling session known as brief negotiated interviewing Patients who schedule a counseling session with a clinical pharmacist will receive a reminder call before their appointment This will involve a 30-minute or less telephone or video visit with a nurse or clinical pharmacist who will use a semi-structured guide to confirm the patients treatment regimen engage them in sharing potential barriers to adherence or other factors that may be contributing to poor disease control discuss their readiness to modify behaviors and work with the patient to develop a shared plan
The study will concurrently test whether 1 inclusion of a mailed primer is better than no inclusion 2 whether use of a behavioral theory-informed message-framing strategy in the recruitment letter is better than the usual approach that does not include theory-informed message framing in a recruitment letter and 3 whether increasing the intensity of recruitment outreach after the letter through up to 4 phone calls is better than up to 2 phone calls The primary outcome for the study will be whether or not patients completed the adherence counseling session within 12 weeks of randomization The secondary outcome will be whether patients agreed to have the counseling session scheduled Exploratory outcomes will include the effects on medication adherence blood pressure and LDL cholesterol 3 months after randomization
Participants will then be will then be randomized using a 23 factorial approach to each of the following conditions such that there will be 8 total arms 1 inclusion of a mailer primer yes vs no 2 a behavioral theory-informed letter script vs usual scripted letter and 3 intensity of the recruitment outreach up to 4 calls vs up to 2 calls Recruitment outreach will be conducted by members of the study team who will be trained to deliver different interventions based on a patients assigned arm Enrollment will be staggered over an approximately 4-month period so as not to overwhelm the scheduling staff and mimic how quality improvement programs are conducted in typical practice
Participants who agree to participate in the adherence counseling session after receiving any of the 8 combinations of recruitment strategies will be scheduled to receive a brief evidence-based medicated adherence counseling session known as brief negotiated interviewing Patients who schedule a counseling session with a clinical pharmacist will receive a reminder call before their appointment This will involve a 30-minute or less telephone or video visit with a nurse or clinical pharmacist who will use a semi-structured guide to confirm the patients treatment regimen engage them in sharing potential barriers to adherence or other factors that may be contributing to poor disease control discuss their readiness to modify behaviors and work with the patient to develop a shared plan
The study will concurrently test whether 1 inclusion of a mailed primer is better than no inclusion 2 whether use of a behavioral theory-informed message-framing strategy in the recruitment letter is better than the usual approach that does not include theory-informed message framing in a recruitment letter and 3 whether increasing the intensity of recruitment outreach after the letter through up to 4 phone calls is better than up to 2 phone calls The primary outcome for the study will be whether or not patients completed the adherence counseling session within 12 weeks of randomization The secondary outcome will be whether patients agreed to have the counseling session scheduled Exploratory outcomes will include the effects on medication adherence blood pressure and LDL cholesterol 3 months after randomization
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