Southeastern Collaboration to Improve Blood Pressure Control

The University of Alabama at Birmingham

Status: Completed

Conditions: Hypertension

Treatments: Behavioral: Enhanced usual care; Behavioral: Practice Facilitation; Behavioral: Peer Coach

Study type: Interventional

Funder types: Other

Identifiers

NCT02866669

X160722009

Details and patient eligibility

About

The central objective of this proposal is to rigorously compare two strategies designed to improve BP control in primary care practices serving rural Southeastern African Americans with low socioeconomic status (SES) living in the "Black Belt".

In year 1, we're engaging community members (community members who have experience being community peer advisors or have high blood pressure) to develop the study interventions and protocols. In years 2-5, the investigators will test the interventions.

Year 2-5, Aim 3: Enroll 80 practices and 25 African American patients with uncontrolled HTN at each practice (total n=2000) in a cluster-randomized, controlled, 4-arm pragmatic implementation trial to evaluate the three multi- component, multi-level functional interventions finalized in the UH2 phase compared with enhanced usual care.

The study's 4 arms are:

1. Enhanced Usual Care: Practices are provided with educational materials and tools to enhance patient care
2. Peer Coaching: Patients enrolled in these practices will be matched with a peer coach. The peer coach helps the patient to set goals around self-management, including medications, home monitoring, and diet and exercise, and she helps the patient to strategize how to accomplish the goals, using motivational interviewing techniques
3. Practice Facilitation: Practices randomized to this arm will work with a practice facilitator. Practice facilitation is a highly customized, staged approach to helping a practice to implement process and structural changes to enhance the quality of care and improve patient and staff satisfaction
4. Peer coaching and practice facilitation: Practices randomized to this arm will receive both the peer coach intervention and the practice facilitation intervention. Practice facilitators and peer coaches will receive the same training for this hybrid intervention, but the practice facilitator change packet will add examples of activities that integrate peer coaches.

Enrollment: 1,592 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• African American adults aged 19-85 years
• Uncontrolled HTN, defined as BP >140/90 mm Hg at the time of study enrollment
• Black Belt resident
• English speaking
• Willing to work with a peer coach
• Willing to sign informed consent

Exclusion criteria

• Plans to move out of the area within the next two years
• Advanced illness with limited life expectancy
• Pregnant or plans to get pregnant in the next year
• Advanced chronic kidney disease (estimated glomerular filtration rate <45 ml/min/1.73 m2)
• Unwillingness to work with a peer coach or to sign informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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1,592 participants in 4 patient groups

Enhanced usual care

Active Comparator group

Description:

Practices in the usual enhanced care arm will receive a blood pressure medication algorithm developed using national guidelines and content experts on our study team. Practices will be provided the Joint National Committee (JNC) recommended protocol to measuring blood pressures. Practices will receive a laptop workstation that has access to the Patient Activated Learning System - an online education video system.

Treatment:

Behavioral: Enhanced usual care

Practice facilitation

Experimental group

Description:

Practices that are randomized to the practice facilitation arm will work with a practice facilitator that will help practice staff for 15 months to make practice level changes to improve hypertension control. Practice facilitation is a highly customized, staged approach to helping a practice to implement process and structural changes to enhance the quality of care and improve patient and staff satisfaction

Treatment:

Behavioral: Practice Facilitation

Behavioral: Enhanced usual care

Peer coach

Experimental group

Description:

Participants enrolled from practices that are randomized to the peer coach arm will be matched with peer advisors who will work with the participants for 12 months.

Treatment:

Behavioral: Peer Coach

Behavioral: Enhanced usual care

Peer coach and Practice facilitation

Experimental group

Description:

Practices that are randomized to the practice facilitation arm will work with a practice facilitator that will help practice staff for 15 months to make practice level changes to improve hypertension control. The patients will also be matched with peer advisors who will work with the participants for 12 months.

Treatment:

Behavioral: Peer Coach

Behavioral: Practice Facilitation

Behavioral: Enhanced usual care