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General

Study Overview

Title:

Implementation Research to Evaluate the Ghana Heart Initiative

Study is 3ie funded:

No

Study ID:

RIDIE-STUDY-ID-6375e5614fd49

Initial Registration Date:

11/17/2022

Last Update Date:

10/05/2022

Study Status:

In Development

Location(s):

Ghana

Abstract:

Cardiovascular diseases (CVDs) are a rapidly increasing health challenge in Ghana and have become a leading cause of morbidity and mortality. However, the public health care system of Ghana faces a critical shortage of resources and capacities, seriously hindering an effective response to this mounting CVD burden.

The first phase of the Ghana Heart Initiative (GHI) was a three-year national programme funded by the Bayer AG, designed to improve risk assessment and management of CVD in public health facilities and hospitals in the Greater Accra Region. Its primary objectives were to increase screening, diagnosis, management, and control of CVDs. The programme was implemented in 44 health facilities/hospitals. Despite some variation in programme design, all health facilities/hospitals shared the same core principles: empowering individuals living with CVD, enabling frontline health workers to better address the needs of these individuals and communities, and supporting advocacy and policy that promotes effective care for non-communicable diseases through guideline development, capacity strengthening (training of healthcare professionals), improving equipment availability and establishing a call center.

Heidelberg Institute of Global Health (HIGH) has received funding to conduct an independent and comprehensive evaluation of the GHI programme. The study evaluation will be guided by the RE-AIM (Reach, Effectiveness-Adoption Implementation and Maintenance) evaluation framework and the World Health Organization (WHO) health systems building blocks framework. The primary outcomes of the evaluation are – fidelity, reach, effectiveness, adoption, implementation, maintenance and sustainability. This study adopts a triangulation mixed- and multi-methods quasi-experimental design comparing the impacts/effect of GHI in intervention health facilities versus matched control group health facilities.

Registration Citation:

Categories:

Health, Nutrition, and Population

Additional Keywords:

Cardiovascular diseases, Mixed methods evaluation, Quasi-experimental design, RE-AIM Framework, Ghana

Secondary ID Number(s):

Principal Investigator(s)

Name of First PI:

Prof. Dr. Manuela De Allegri

Affiliation:

Heidelberg Institute of Global Health

Name of Second PI:

Prof. Alfred Edwin Yawson

Affiliation:

University of Ghana Medical School, Community Health

Study Sponsor

Name:

The Deutsche Gesellschaft für Internationale Zusammenarbeit GmbH (GIZ)

Study Sponsor Location:

Germany

Research Partner

Name of Partner Institution:

University of Ghana Medical School, Community Health

Type of Organization:

Research institute/University

Location:

Ghana

Intervention

Intervention Overview

Intervention:

The Ghana Heart Initiative (GHI) has been implemented in the Greater Accra Region since September 2018 with the aim of sustainably improving the “prevention, diagnosis and management of cardiovascular diseases (CVDs)” in Ghana. Since its launch, the GHI has been responsible for enabling 44 healthcare facilities in the region to manage CVD better, providing training to over 650 health professionals. The GHI efforts over the past two years (2020-2022) have focused primarily on:

1. Capacity development: facilitate the strengthening of the skills of healthcare professionals in preventing, diagnosing and managing CVDs;
2. Development of national guidelines: facilitate the development of standardized management guidelines for CVDs in cooperation with the Ministry of Health (MoH);
3. Improvement of equipment access/use: ensuring that there is adequate equipment available for the diagnosis and treatment of CVDs;
4.  Improvement of data management: facilitate improvement of data collection and management across the country;
5. CVD support and call center: establishment of a functioning support center for the risk assessment and management of CVDs.

Theory of Change:

We propose to use a modified health system building blocks framework to guide the evaluation process. Emphasis will be placed on the interaction and interdependence across and within building blocks from a health system perspective. We will also look at how the demand side of health services (community and patients) interacts with the GHI intervention given the context in which the intervention is being implemented. The changes will be followed from both demand and supply side perspectives.

In the GHI, the major activities focused on the development of clinical guidelines, training of health care professionals, provision of essential diagnostic equipment, and strengthening the health data/information management systems are all believed to help the health system attain its mission and vision: health service delivery, quality improvement and assurance, leadership, and governance, and health system capacity. The various components or activities of the GHI are linked with the World Health Organization’s (WHO) six health system building blocks. The WHO’s six building blocks at health facilities enables a comprehensive evaluation of the health system performance, clinical, processes of care and quality of care outcomes. Thus, evaluation of the overall Ghana healthcare system in context of GHI implementation using the WHO health systems building blocks (service delivery, health care professionals, medicines/equipment, health information systems, financing, and leadership/governance) is required to identify gaps as well as provide insights to further scale up and maintenance of the GHI. Further, we link the six health building blocks with the RE-AIM framework to be able to demonstrate the impacts of GHI components across the RE-AIM constructs reach, effectiveness, adoption, implementation and maintenance.

Multiple Treatment Arms Evaluated?

Yes

Implementing Agency

Name of Organization:

The Deutsche Gesellschaft für Internationale Zusammenarbeit GmbH (GIZ)

Type of Organization:

Public Sector, e.g. Government Agency or Ministry

Program Funder

Name of Organization:

Bayer AG

Type of Organization:

Private for profit organization

Intervention Timing

Intervention or Program Started at time of Registration?

Yes

Start Date:

01/01/2020

End Date:

12/30/2023

Evaluation Method

Evaluation Method Overview

Primary (or First) Evaluation Method:

Matching

Other (not Listed) Method:

Additional Evaluation Method (If Any):

Difference in difference/fixed effects

Other (not Listed) Method:

Method Details

Details of Evaluation Approach:

This study is a facility-based study, meaning that, with the exception of the interviews with policy makers and mid to high-level health system officers, all other data collection activities will take place at the facility level. In all surveyed health facilities, we will implement multiple data collection tools, health facility survey, healthcare provider survey to assess knowledge, attitudes, and practices on hypertension and cardiovascular diseases, patient exit survey (cross-sectional survey) and medical records review (retrospective data extraction). In addition to primary data collection, the study will also rely on secondary routine health system data obtained by the study team in fully anonymised format, the District Health Information Management System (DHIMS2).

Outcomes (Endpoints):

Study Objective 1 – Effectiveness Evaluation
Between group (intervention vs. control arm facilities) differences in the following outcome measures:

Safety

a. Proportion of sites having access to treatment guidelines for the management of hypertension and cardiovascular diseases (CVD);
b. Proportion of sites having access to equipment for screening, and diagnosis of hypertension and cardiovascular disease (CVD);
c. Proportion of patients screened, and newly diagnosed with hypertension;
d. Proportion of patients receiving recommended guideline directed medical therapy for hypertension and CVD.

Timeliness

a. Total waiting time for physician consultation;
b. Total in-person physician consultation time;
c. In-patient services: treatment provided in the first 24 hours of hospital admission (ECG, medicines, and reperfusion) for cardiac conditions.

Clinical Outcomes and Quality of Care

a. Proportion of hypertension patients with blood pressure (BP) <140/90 mmHg;
b. Proportion of patients with CVD having BP <130/80 mmHg;
c. Proportion of patients with CVD having LDL cholesterol <70 mg/dl;
d. Composite outcome of cardiovascular mortality, non-fatal myocardial infarction, non-fatal stroke, cardiac related admissions;
e. Proportion of patients achieving behavioural risk factor targets: smoking or tobacco use, alcohol use, physical activity and dietary habits.

Patient centered care

a. Treatment satisfaction;
b. Value in healthcare experience;
c. Proportion of patients in regular follow-up or continued treatment;
d. Out-of-pocket expenditure associated with hypertension and CVD care.

Unit of Analysis:

Health facilities

Hypotheses:

The overarching goal of this study is to conduct a triangulation mixed-methods evaluation of the Ghana Heart Initiative, a supply-side intervention implemented in 44 diverse health facilities (primary to tertiary care level) for prevention and management of cardiovascular diseases in the Greater Accra Region, Ghana.

The specific research questions are:

1. What is the effectiveness of the Ghana Heart Initiative on hypertension and cardiovascular disease related service delivery (processes of care), quality, and health outcomes (behavioural, clinical and biochemical measures) among intervention versus control arm facilities?
2. What is the fidelity of implementation of the Ghana Heart Initiative (by specific intervention components) in the participating health facilities during the study period?
3. What are the stakeholders’ views, including policy makers, healthcare providers, and patients on the Ghana Heart Initiative, and in light of implementation processes, fidelity and future sustainability?
4. What are the costs and value for money of the Ghana Heart Initiative as well as the resources required (budget impact) for nationwide implementation?

Unit of Intervention or Assignment:

Health facilities

Number of Clusters in Sample:

88

Number of Individuals in Sample:

1,200 (600 per group)

Size of Treatment, Control, or Comparison Subsamples:

44 intervention facilities and 44 control facilities

Supplementary Files

Analysis Plan:

Other Documents:

Data

Outcomes Data

Description:

This study is a facility-based study, with the exception of the interviews with policy makers and mid to high-level health system officers, all other data collection activities will take place at the facility level. In all surveyed health facilities, we will implement multiple data collection tools: health facility survey, healthcare provider survey to assess knowledge, attitudes, and practices on hypertension and cardiovascular diseases, patient exit survey, and medical records review.

Data Already Collected?

No

Data Previously Used?

Data Access:

Data Obtained by the Study Researchers?

Data Approval Process:

Approval Status:

Treatment Assignment Data

Participation or Assignment Information:

Yes

Description:

Data Obtained by the Study Researchers?

Data Previously Used?

Data Access:

Data Obtained by the Study Researchers?

Data Approval Process:

Approval Status:

Data Analysis

Data Analysis Status:

Study Materials

Upload Study Materials:

Registration Category

Registration Category:

Prospective, Category 1: Data for measuring impacts have not been collected

Completion

Completion Overview

Intervention Completion Date:

Data Collection Completion Date:

Unit of Analysis:

Clusters in Final Sample:

Total Observations in Final Sample:

Size of Treatment, Control, or Comparison Subsamples:

Findings

Preliminary Report:

Preliminary Report URL:

Summary of Findings:

Paper:

Paper Summary:

Paper Citation:

Data Availability

Data Availability (Primary Data):

Date of Data Availability:

Data URL or Contact:

Access procedure:

Other Materials

Survey:

Survey Instrument Links or Contact:

Program Files:

Program Files Links or Contact:

External Link:

External Link Description:

Description of Changes:

Study Stopped

Date:

Reason: