Clinical trial NCT03490695: Uptake of Task-Strengthening for Blood Pressure Control
Official title: Uptake of Task-Strengthening Strategy for Hypertension Control Within Community Health Planning Services in Ghana: A Mixed Method Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertension
High Blood Pressure
Cardiovascular Diseases
Lead sponsor: Kintampo Health Research Centre, Ghana
Sponsor class: OTHER
Collaborators: name: NYU Langone Health
name: Kwame Nkrumah University of Science and Technology
name: St. Louis University
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2018-04-06
Enrollment: 700
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: For the first 12-month of the study, the intervention will not be implemented as this is a stepped-wedged design. During this time period, primary outcome (adoption ratings) and secondary outcome (Systolic BP) data will be collected at the CHPS Zones following TASSH training and the PFOs will provide support to their assigned CHPS zones to prepare to implement the TASSH protocol.

Each CHPS zones will then be randomly assigned to one of the two intervention arms: Group A will receive the Practice Facilitation Strategy at 12 months and Group B will initially serve as a Usual Care comparison group. Group B will then receive Practice Facilitation beginning 24 months into the trial, as this is a stepped wedge design. Sustainability for groups A and B will be assessed one year after the end of the intervention.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Rate of adoption of TASSH at the CHPS zones at 12-months
timeFrame: 12 months
Secondary outcomes:
measure: Systolic BP reduction at 12 months (pre- and post-intervention)
timeFrame: 12 months
measure: Mediators of TASSH uptake at CHPS zones at 12 months
timeFrame: 12 months
measure: TASSH sustainability across the participating CHPS zones one year after PF intervention ends as measured by the maintenance of TASSH adoption ratings
timeFrame: 12 months
Other outcomes:
Locations:
city: Kintampo
country: Ghana
facility: Kintampo Health Research Centre
Study officials:
affiliation: NYU Langone Health
name: Gbenga Ogedegbe, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kintampo Health Research Centre, Ghana
name: Kwaku Poku Asante, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Louis University
name: Juliet Iwelunmor, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kwame Nkrumah University of Science and Technology
name: Jacob Plange-Rhule, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kwame Nkrumah University of Science and Technology
name: Kweku Bedu-Addo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Asante KP, Iwelunmor J, Apusiga K, Gyamfi J, Nyame S, Adjei KGA, Aifah A, Adjei K, Onakomaiya D, Chaplin WF, Ogedegbe G, Plange-Rhule J. Uptake of Task-Strengthening Strategy for Hypertension (TASSH) control within Community-Based Health Planning Services in Ghana: study protocol for a cluster randomized controlled trial. Trials. 2020 Oct 2;21(1):825. doi: 10.1186/s13063-020-04667-7.