NCT02866669

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:

  1. 1.Enhanced Usual Care: Practices are provided with educational materials and tools to enhance patient care
  2. 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. 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,592

participants targeted

Target at P75+ for not_applicable hypertension

Timeline
Completed

Started May 2017

Longer than P75 for not_applicable hypertension

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 15, 2016

Completed
9 months until next milestone

Study Start

First participant enrolled

May 3, 2017

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2021

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

October 5, 2023

Completed
Last Updated

October 5, 2023

Status Verified

October 1, 2023

Enrollment Period

3.8 years

First QC Date

June 13, 2016

Results QC Date

December 22, 2021

Last Update Submit

October 4, 2023

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Blood Pressure Control (Systolic Pressure Less Than 140 mm Hg and Diastolic Pressure Less Than 90 mm Hg) at 12 Months

    Blood pressure (BP) control is defined as systolic pressure less than 140 mm Hg and diastolic pressure less than 90 mm Hg. Difference in BP control at 12 month follow-up between trial arms. BP was assessed in the practice by a research assistant using a standardized protocol at baseline, 6, and 12 months.

    12 months

Secondary Outcomes (9)

  • Change in Systolic Blood Pressure Between Baseline and 12 Months

    12 months

  • Change in Satisfaction With Chronic Illness Care Between Baseline and 12 Months

    12 months

  • Change in Physical Component Summary Score (PCS) of the Short Form 12 (SF12)

    12 months

  • Change in the Mental Component Summary Score (MCS) From the Short Form 12 (SF12)

    12 months

  • Self-reported ED Visit or Evidence of an ED Visit at Chart Review Between Baseline and 6 Months

    between baseline and 6 months

  • +4 more secondary outcomes

Other Outcomes (4)

  • Self-reported Stroke

    12 months

  • Change in Instrumental Support

    12 months

  • Change in Perceived Emotional Support

    12 months

  • +1 more other outcomes

Study Arms (4)

Enhanced usual care

ACTIVE COMPARATOR

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

Practice facilitation

EXPERIMENTAL

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 FacilitationBehavioral: Enhanced usual care

Peer coach

EXPERIMENTAL

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 CoachBehavioral: Enhanced usual care

Peer coach and Practice facilitation

EXPERIMENTAL

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 FacilitationBehavioral: Peer CoachBehavioral: Enhanced usual care

Interventions

Practice FacilitationBEHAVIORAL

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

Peer coach and Practice facilitationPractice facilitation
Peer CoachBEHAVIORAL

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.

Also known as: Taking Control of Your Health
Peer coachPeer coach and Practice facilitation
Enhanced usual careBEHAVIORAL

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.

Enhanced usual carePeer coachPeer coach and Practice facilitationPractice facilitation

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Alabama At Birmingham

Birmingham, Alabama, 35205, United States

Location

UNC Chapel Hill

Chapel Hill, North Carolina, 37599, United States

Location

East Carolina University

Greenville, North Carolina, 27834, United States

Location

Related Publications (6)

  • Safford MM, Cummings DM, Halladay JR, Shikany JM, Richman J, Oparil S, Hollenberg J, Adams A, Anabtawi M, Andreae L, Baquero E, Bryan J, Sanders-Clark D, Johnson E, Richman E, Soroka O, Tillman J, Cherrington AL. Practice Facilitation and Peer Coaching for Uncontrolled Hypertension Among Black Individuals: A Randomized Clinical Trial. JAMA Intern Med. 2024 May 1;184(5):538-546. doi: 10.1001/jamainternmed.2024.0047.

    PMID: 38497987DERIVED

  • Sutton KF, Richman EL, Rees JR, Pugh-Nicholson LL, Craft MM, Peaden SH, Soroka O, Mackey M, Cummings DM, Cherrington AL, Safford MM, Halladay JR; Southeastern Collaboration to Improve Blood Pressure Writing Group. Implementing practice facilitation in research: how facilitators spend their time guiding practices to improve blood pressure control. Implement Sci Commun. 2023 Jul 31;4(1):89. doi: 10.1186/s43058-023-00470-y.

    PMID: 37525267DERIVED

  • Shikany JM, Safford MM, Cherrington AL, Halladay JR, Anabtawi M, Richman EL, Adams AD, Holt C, Oparil S, Soroka O, Cummings DM. Recruitment and retention of primary care practices in the Southeastern Collaboration to Improve Blood Pressure Control. Contemp Clin Trials Commun. 2023 Jan 16;32:101059. doi: 10.1016/j.conctc.2023.101059. eCollection 2023 Apr.

    PMID: 36718176DERIVED

  • Cummings DM, Adams A, Patil S, Cherrington A, Halladay JR, Oparil S, Soroka O, Ringel JB, Safford MM. Treatment Intensity, Prescribing Patterns, and Blood Pressure Control in Rural Black Patients with Uncontrolled Hypertension. J Racial Ethn Health Disparities. 2023 Oct;10(5):2505-2512. doi: 10.1007/s40615-022-01431-2. Epub 2022 Oct 21.

    PMID: 36271193DERIVED

  • Finch AJ, Ringel JB, Dargar S, Halladay J, Cene C, Cherrington A, Cummings D, Safford MM. Greater Social Functioning Associated With Lower Depressive Symptomatology Among Black Belt African Americans Enrolled in the Southeastern Collaboration to Improve Blood Pressure Control Study. Prim Care Companion CNS Disord. 2022 Feb 3;24(1):21m02988. doi: 10.4088/PCC.21m02988.

    PMID: 35114739DERIVED

  • Sutton KF, Richman EL, Rees JR, Pugh-Nicholson LL, Craft MM, Peaden SH, Mackey M, Halladay JR; Southeastern Collaboration to Improve Blood Pressure Writing Group. Successful Trial of Practice Facilitation for Plan, Do, Study, Act Quality Improvement. J Am Board Fam Med. 2021 Sep-Oct;34(5):991-1002. doi: 10.3122/jabfm.2021.05.210140.

    PMID: 34535524DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Results Point of Contact

Title
Dr. Andrea Cherrington
Organization
University of Alabama at Birmingham
acherrington@uabmc.edu
205-996-2885

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 13, 2016

First Posted

August 15, 2016

Study Start

May 3, 2017

Primary Completion

February 28, 2021

Study Completion

February 28, 2021

Last Updated

October 5, 2023

Results First Posted

October 5, 2023

Record last verified: 2023-10

Locations

US(3)