ENHANCE-EvideNce Led Co-created HeAlth Systems interventioNs for MLTCs CarE

Summary

The goal of this study is to determine the effect of the ENHANCE intervention in improving clinical outcomes and evaluating the effects of the intervention on implementation processes and outcomes. The specific questions it aims to answer are:

1. To test and estimate the effect of the intervention in people with MLTCs attending

PHCs on:

i. Detection of, and initiation of treatment for, additional chronic conditions ii. Treatment intensification and changes in medication iii. Control of chronic conditions iv. patient reported health-related quality of life and functioning v. health care utilisation and adherence vi. costs of health care
2. To use the RE-AIM framework to assess implementation processes and outcomes through measurements of reach, adoption, implementation, and maintenance.
3. To understand implementation processes and outcomes within the wider context of primary healthcare, provide explanations for the observed effects of the clinical findings and identify recommendations for wider implementation of the ENHANCE intervention.

The participants in the control group will receive usual care at their primary health care facility, which includes the use of the Practical Approach to Care Kit (PACK) or Adult Primary Care (APC) clinical decision support tool. Participants in the intervention group will receive care for their multiple chronic condition by a clinician trained to use the ENHANCE clinical decision support tool (intervention tool), and receive two CHW visits in their home to provide treatment literacy and adherence support.

Conditions

• HIV Infections
• Hypertension
• Diabetes Mellitus
• Asthma
• Depression
• Myocardial Infarction
• Stroke

Interventions

OTHER

ENHANCE intervention (health systems)

The intervention tools include a consolidated clinical decision support tool, health education posters, waiting room talks, medication list for treatment literacy and a patient health diary. Training session are delivered at all intervention sites and include 1 facility team session to introduce the ENHANCE study to the whole team; 3 clinical sessions for nurses and doctors; 2 sessions for community health workers and health promoters; Maintenance sessions to keep the ENHANCE intervention going for at least 12 months

Sponsors & Collaborators

• University of Cape Town

  collaborator OTHER

• King's College London

  collaborator OTHER

• University of East Anglia

  collaborator OTHER

• University of Oxford

  collaborator OTHER

• Medical Research Council, South Africa

  collaborator OTHER

• University of KwaZulu

  lead OTHER

Principal Investigators

• Lara Fairall, PhD · King's College London

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-09-19

Primary Completion

2025-11-01

Completion

2025-11-01

Countries

• South Africa

Study Locations