Behavioral Interventions for High Blood Pressure

(ENGAGE-HTN Trial)

Overseen By Ian Kronish, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Must be taking: Blood pressure medications

Disqualifiers: Pregnancy, Dementia, Terminal conditions

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

584 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, since the study focuses on improving adherence to blood pressure medications, it seems likely that you will continue taking them.

What data supports the effectiveness of the treatment Engaging Patients in Adherence Interventions Using Behavioral Science for high blood pressure?

Research shows that interventions aimed at improving medication adherence can help control high blood pressure, as many patients struggle to stick to their treatment plans. By addressing behavioral aspects, these interventions can lead to better blood pressure management and reduce the risk of heart-related issues. ^{1 2 3 4 5}

Is the behavioral intervention for high blood pressure safe for humans?

The research does not provide specific safety data for the behavioral intervention itself, but it focuses on improving medication adherence, which generally involves safe strategies like simplifying medication routines and encouraging self-monitoring. ^{1 6 7 8 9}

How is the treatment 'Engaging Patients in Adherence Interventions Using Behavioral Science' different from other treatments for high blood pressure?

This treatment is unique because it focuses on using behavioral science to improve patients' adherence to their medication regimen, which is a common issue in managing high blood pressure. Unlike traditional treatments that primarily rely on medication, this approach aims to address the behavioral aspects of treatment adherence, potentially leading to better blood pressure control. ^{2 3 10 11 12}

What is the purpose of this trial?

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 (yes/no), (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.

Eligibility Criteria

This trial is for English or Spanish speaking adults over 18 with uncontrolled high blood pressure and poor medication adherence, identified through their primary care records. Their doctors can choose to exclude them from the trial if necessary.

Inclusion Criteria

Office BP >=140/90 mmHg at most recent office visit

I haven't taken my blood pressure medication as prescribed in the last 6 months.

Receive care at a Columbia-affiliated primary care clinic in the Ambulatory Care Network

Exclusion Criteria

I am not pregnant, do not have dementia, and do not have a terminal condition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Recruitment

Testing of behaviorally-informed recruitment approaches in a primary care setting

4 months

Multiple outreach attempts (up to 4 calls)

Adherence Counseling

Participants receive a brief evidence-based medication adherence counseling session

12 weeks

1 visit (telephone or video)

Follow-up

Participants are monitored for medication adherence and clinical outcomes

3 months

Treatment Details

Interventions

• Engaging Patients in Adherence Interventions Using Behavioral Science

Trial Overview The study tests different ways to recruit patients using behavioral science techniques for a pharmacist-led medication adherence program. It involves up to four phone calls and various recruitment letters, comparing which combination is most effective.

Participant Groups

Group I: Postcard/control letter/4 calls Active Control 3 Interventions

Mailed a priming postcard, followed by a usual care control recruitment letter, followed by up to 4 phone call attempts to schedule patient to attend an adherence counseling session with a clinical pharmacist trained in brief negotiated interviewing

Group II: Postcard/behavioral letter/4 calls Active Control 3 Interventions

Mailed a priming postcard, followed by a prospect theory-informed recruitment letter, followed by up to 4 phone call attempts to schedule patient to attend an adherence counseling session with a clinical pharmacist trained in brief negotiated interviewing

Group III: No postcare/control letter/2 calls Active Control 2 Interventions

Mailed a usual care control recruitment letter that is not preceded by a priming postcard, followed by up to 2 phone call attempts to schedule patient to attend an adherence counseling session with a clinical pharmacist trained in brief negotiated interviewing

Group IV: Postcard/behavioral letter/2 calls Active Control 3 Interventions

Mailed a priming postcard, followed by a prospect theory-informed recruitment letter, followed by up to 2 phone call attempts to schedule patient to attend an adherence counseling session with a clinical pharmacist trained in brief negotiated interviewing

Group V: No postcard/behavioral letter/4 calls Active Control 2 Interventions

Mailed a prospect-theory informed recruitment letter that is not preceded by a priming postcard, followed by up to 4 phone call attempts to schedule patient to attend an adherence counseling session with a clinical pharmacist trained in brief negotiated interviewing

Group VI: No postcard/control letter/4 calls Active Control 2 Interventions

Mailed a usual care control recruitment letter that is not preceded by a priming postcard, followed by up to 4 phone call attempts to schedule patient to attend an adherence counseling session with a clinical pharmacist trained in brief negotiated interviewing

Group VII: No postcard/behavioral letter/2 calls Active Control 2 Interventions

Mailed a prospect theory-informed recruitment letter that is not preceded by a priming postcard, followed by up to 2 phone call attempts to schedule patient to attend an adherence counseling session with a clinical pharmacist trained in brief negotiated interviewing

Group VIII: Postcard/control letter/2 calls Active Control 3 Interventions

Mailed a priming postcard, followed by a usual care control recruitment letter, followed by up to 2 phone call attempts to schedule patient to attend an adherence counseling session with a clinical pharmacist trained in brief negotiated interviewing

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Brigham and Women's Hospital

Collaborator

Trials

1,694

Recruited

14,790,000+

Findings from Research

A systematic review of 11 studies found that using health behavioral models, like the Self-Regulation Model and Social Cognitive Theory, can potentially improve medication adherence in adults with hypertension, with two studies showing significant improvements.

Despite some positive results, the overall effectiveness of these interventions remains unclear, highlighting the need for more rigorously designed studies that effectively apply these health behavioral models to enhance adherence to antihypertensive medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of interventions using health behavioral theories to improve medication adherence among patients with hypertension. Nili, M., Mohamed, R., Kelly, KM.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Impact of interventions on medication adherence and blood pressure control in patients with essential hypertension: a systematic review by the ISPOR medication adherence and persistence special interest group. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Effectiveness and content analysis of interventions to enhance medication adherence in hypertension: a systematic review and meta-analysis protocol. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Intervention strategies to improve adherence among hypertensives: review and recommendations. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Effectiveness and content analysis of interventions to enhance medication adherence and blood pressure control in hypertension: A systematic review and meta-analysis. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Barriers to adherence and hypertension control in a racially diverse representative sample of elderly primary care patients. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

A hybrid 4-item Krousel-Wood Medication Adherence Scale predicts cardiovascular events in older hypertensive adults. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Adherence to pharmacologic management of hypertension. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Medication adherence among rural, low-income hypertensive adults: a randomized trial of a multimedia community-based intervention. [2021]

9. England pubmed.ncbi.nlm.nih.gov

A systematic review of interventions using health behavioral theories to improve medication adherence among patients with hypertension. [2021]

10. Ireland pubmed.ncbi.nlm.nih.gov

Take Control of Your Blood Pressure (TCYB) study: a multifactorial tailored behavioral and educational intervention for achieving blood pressure control. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Adherence to Antihypertensive Therapy. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Randomized pilot study of a behavioral feedback intervention to improve medication adherence in older adults with hypertension. [2022]