Uptake of Task-Strengthening for Blood Pressure Control

Kintampo Health Research Centre, Ghana

Status: Active, not recruiting

Conditions: Hypertension; High Blood Pressure; Cardiovascular Diseases

Treatments: Other: Usual Care; Other: Practice Facilitation

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03490695

7U01HL138638-04 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

Uptake of a community-based evidence-supported interventions for hypertension control in Ghana are urgently needed to address the cardiovascular disease epidemic and resulting illness, deaths, and societal costs. This study will evaluate the effect of Practice Facilitation on the uptake and maintenance of the evidence-based task-shifting strategies for hypertension control (TASSH) protocol across 70 Community-based Health Planning and Services (CHPS) zones delivered by trained community health officers.

Findings from this study will provide policy makers and other stakeholders the "how to do it" empirical literature on the uptake of evidence-based interventions in Ghana, which may be applicable to other low-income countries.

Full description

Ghana and other countries in sub-Saharan Africa (SSA) are experiencing an epidemic of cardiovascular diseases (CVD) propelled by rapidly increasing rates of hypertension requiring implementation of evidence-based interventions. However, persistent barriers to the uptake of evidence-based interventions in low resource settings including Ghana exist at the systems, organizational and provider levels. At the systems level, lack of leadership support and shortage of staff limit effective uptake of evidence-based hypertension interventions. At the organizational level, the organizational culture, particularly the organization's readiness or openness to change may influence the use of evidence-based hypertension interventions. At the provider-level, implementation climate, lack of training, the culture of individual practices, and provider's knowledge, self-efficacy and attitude towards the evidence-based intervention limits uptake and sustainability of evidence-based interventions. The ubiquity of CHPS zones in Ghana, and their growing involvement with implementing healthcare in every community, with outreach to every doorstep, presents a unique opportunity to evaluate the effectiveness and impact of scaling up evidence-based task-shifting strategies for hypertension (TASSH) control for adults in community settings. Using a mixed methods (quantitative-qualitative) design, the investigators will evaluate practice facilitation (PF) in 70 CHPS compounds utilizing the TASSH program.

The specific aims are as follows: (1) to identify practice capacity for the adoption of TASSH at CHPS compounds and develop a culturally tailored PF strategy using qualitative methods; (2a) Evaluate in a stepped-wedge cluster Randomized Controlled trial (RCT), the effect of the PF strategy vs. Usual Care (UC), on the uptake of TASSH (primary outcome) across the CHPS compounds at 12 months;(2b) Compare in a stepped-wedge cluster RCT, the clinical effectiveness of the PF strategy vs. UC on systolic BP reduction (secondary outcome) among adults with uncontrolled hypertension at 12 months; (3) Evaluate the mediators of the uptake of TASSH across the CHPS zones at 12 months; and (4) Evaluate the sustainability of TASSH implementation across the participating CHPS compounds at 24 months (one year after completion of the trial). Outcomes will be measured every 12 months in all clusters. Guided by Damshroeder's Consolidated Framework for Implementation Research (CFIR) and Glasgow's Reach Effectiveness Adoption Implementation and Maintenance (RE-AIM) framework, the goal of this project is to improve the uptake of evidence-based task-shifting strategies for hypertension control (TASSH) in CHPS zones in Ghana. This proposal is a collaboration between the Kwame Nkrumah University of Science and Technology, Kintampo Health Research Center, New York University (NYU) School of Medicine and Saint Louis University.

Enrollment: 700 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Patients registered to receive care at CHPS zone
• Adults age 40 years and older
• Have BP 140-179/90-100 mm Hg
• Able to provide informed consent

Exclusion Criteria

• Previous diagnosis of diabetes, stroke, heart failure or chronic kidney disease BP>180/100 mm Hg
• Positive urine dipstick for protein
• Pregnant
• Unable to provide informed consent
• Patients with history of stroke, heart failure, diabetes, angina, claudication, and BP>180/100 mm Hg will be referred to a specialist

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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700 participants in 2 patient groups

Practice Facilitation Group A

Experimental group

Description:

After the first 12 months of usual care (No Practice Facilitation), group A will begin to receive the Practice Facilitation (PF) Strategy at the CHPS compounds in addition to Ghana's National Health insurance and the World Health Organization (WHO) CVD Risk Assessment package.

Treatment:

Other: Practice Facilitation

Other: Usual Care

Practice Facilitation Group B

Experimental group

Description:

Group B will receive Usual Care (no PF) between 12-24 months which includes Ghana's National Health Insurance, behavioral counseling and referral to care through the usual care system. After 24 months into the trial, Group B will then receive Practice Facilitation strategy in addition to Ghana's National Health insurance and the World Health Organization (WHO) CVD Risk Assessment package for a duration of another 12 months, as this is a stepped wedge design. During this 12 months period, practice facilitation will end in the Group A arm.

Treatment:

Other: Practice Facilitation

Other: Usual Care