Southeastern Collaboration to Improve Blood Pressure Control
Study Details
Study Description
Brief Summary
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:
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Enhanced Usual Care: Practices are provided with educational materials and tools to enhance patient care
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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
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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
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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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Enhanced usual care 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. |
Behavioral: Enhanced usual care
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.
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| Experimental: Practice facilitation 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 |
Behavioral: Practice Facilitation
ractices 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
Behavioral: Enhanced usual care
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.
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| Experimental: Peer coach 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. |
Behavioral: Peer Coach
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.
Other Names:
Behavioral: Enhanced usual care
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.
|
| Experimental: Peer coach and Practice facilitation 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. |
Behavioral: Practice Facilitation
ractices 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
Behavioral: Peer Coach
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.
Other Names:
Behavioral: Enhanced usual care
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.
|
Outcome Measures
Primary Outcome Measures
- change in blood pressure control control at 12 months [baseline and 12 months]
change in BP control between baseline and follow-up between practices in any of the intervention arms and the enhanced usual care arm
Secondary Outcome Measures
- change in systolic blood pressure at 12 months [baseline and 12 months]
change in systolic blood pressure at 12 months
- change in satisfaction using the patient assessment of chronic illness care" [Baseline, 12 months]
change in satisfaction measured using self report scale "patient assessment of chronic illness care"
- change in satisfaction using the Chronic Illness Resources Survey [Baseline, 12 months]
change in satisfaction measured using self report scale "Chronic Illness Resources Survey"
- change in health related quality of life [Baseline, 12 months]
change in health related quality of life measured using self report scale Short form-12
- change in depressive symptoms [Baseline, 12 months]
change in depressive symptoms measured using self report scale 8 item Patient Health Questionnaire
- change in perceived stress [Baseline, 12 months]
change in perceived stress measured using self report scale 4 item Perceived stress scale
- change in social support [Baseline, 12 months]
change in social support measured using self report scale "Patient-reported outcomes measurement information system (PROMIS) Social functioning scale"
- change in hypertension knowledge [Baseline, 12 months]
change in hypertension knowledge measured using self report scale "Hypertension Knowledge and attitudes"
- change in patient activation measured [Baseline, 12 months]
change in patient activation measured using self report scale 4 item patient activation measure
- change in medication adherence [Baseline, 12 months]
change in medication adherence measured using self report scale "4-item medication adherence scale"
Eligibility Criteria
Criteria
Inclusion Criteria:
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African American adults aged 19-85 years
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Uncontrolled HTN, defined as BP >140/90 mm Hg at the time of study enrollment
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Black Belt resident
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English speaking
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Willing to work with a peer coach
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Willing to sign informed consent
Exclusion Criteria:
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Plans to move out of the area within the next two years
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Advanced illness with limited life expectancy
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Pregnant or plans to get pregnant in the next year
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Advanced chronic kidney disease (estimated glomerular filtration rate <45 ml/min/1.73 m2)
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Unwillingness to work with a peer coach or to sign informed consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Alabama At Birmingham | Birmingham | Alabama | United States | 35205 |
| 2 | UNC Chapel Hill | Chapel Hill | North Carolina | United States | 37599 |
| 3 | East Carolina University | Greenville | North Carolina | United States | 27834 |
Sponsors and Collaborators
- University of Alabama at Birmingham
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- X160722009