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

January 30, 2024 updated by: Inge Petersen, University of KwaZulu

Effectiveness of a Health Systems Strengthening Intervention to Improve Detection, Treatment, and Control of Multiple Long-Term Conditions in Primary Health Care Facilities in the Western Cape and KwaZulu Natal, South Africa

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Control facilities Participants in control facilities will continue to receive usual care. Primary health care of long-term conditions is delivered free-at-point-of-care in public sector primary care facilities which includes the management of HIV, NCDs and mental health problems, according to South Africa's Ideal Clinic and Integrated Clinical Services Management model. This care model, which has combined the long-term care of HIV together with NCDs within each facility, has greatly enabled the feasibility of further interventions specifically addressing MLTCs and includes the Adult Primary Care (APC) or PACK clinical guidance. Patients attending these chronic services usually attend the same clinic regularly, 3 to 6-monthly for periodic monitoring of their chronic conditions. Chronic medication is collected monthly either at the facility (through fast-track queues), or through decentralised chronic medication dispensing systems which provide for collection from a range of sites including community venues (e.g. halls), wellness or adherence clubs, trailers, retail pharmacies (in KZN) or e-Lockers.

Intervention clinics

Participants in intervention clinics will continue with usual care as described for control clinics but in addition will receive the ENHANCE health systems intervention comprising tools and implementation strategies that have been co-developed with stakeholders through an iterative process, drawing on:

i. Evidence on the commonest MLTC combinations ii. Scoping reviews conducted on effectiveness of MLTCS interventions and systems barriers and enablers of person-centred care for MLTCs in LMICs iii. Provincial and district learning collaborative workshops with stakeholders from KZN and Western Cape.

iv. Clinical working groups with clinicians and health workers, a Guidance Oversight Board v. Input from our ENHANCE advocacy academy of 16 people living with MLTCs in the Western Cape and KZN

The intervention targets screening and early identification of other chronic conditions; improving follow-up and support for people with a new diagnosis, at risk of treatment failure (e.g. poorly controlled HIV or diabetes), and strengthen bi-directional referral pathways between the facility and community. Tools and implementation strategies will be layered into existing architecture of the chronic care system and support provision of more person-centred and empowering care across the treatment cascade.

Tools to support the implementation of the health systems intervention comprise:

  • An integrated clinical decision support tool for care of MLTCs drawing on PACK/ APC.
  • A range of patient-focussed materials to support condition, treatment, and systems (care-seeking) literacy (e.g., medication list, posters, scripts for health education talks)
  • A personal health diary (paper-based)

Implementation strategies 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.

Study Type

Interventional

Enrollment (Estimated)

1920

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • South Africa
      • Pietermaritzburg, South Africa
    • KZN
      • Pietermaritzburg, KZN, South Africa
      • Pietermaritzburg, KZN, South Africa
      • Pietermaritzburg, KZN, South Africa
      • Pietermaritzburg, KZN, South Africa
      • Pietermaritzburg, KZN, South Africa
      • Pietermaritzburg, KZN, South Africa
      • Pietermaritzburg, KZN, South Africa
      • Pietermaritzburg, KZN, South Africa
      • Pietermaritzburg, KZN, South Africa
      • Pietermaritzburg, KZN, South Africa
      • Pietermaritzburg, KZN, South Africa
      • Pietermaritzburg, KZN, South Africa
      • Pietermaritzburg, KZN, South Africa
      • Pietermaritzburg, KZN, South Africa
      • Pietermaritzburg, KZN, South Africa
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7700
      • Cape Town, Western Cape, South Africa, 7700
      • Cape Town, Western Cape, South Africa, 7700
      • Cape Town, Western Cape, South Africa, 7700
        • Active, not recruiting
        • Durbanville CHC
      • Cape Town, Western Cape, South Africa, 7700
      • Cape Town, Western Cape, South Africa, 7700
      • Cape Town, Western Cape, South Africa, 7700
      • Cape Town, Western Cape, South Africa, 7700
      • Cape Town, Western Cape, South Africa, 7700
      • Cape Town, Western Cape, South Africa, 7700
      • Cape Town, Western Cape, South Africa, 7700
      • Cape Town, Western Cape, South Africa, 7700
      • Cape Town, Western Cape, South Africa, 7700
      • Cape Town, Western Cape, South Africa, 7700
      • Cape Town, Western Cape, South Africa, 7700
      • Cape Town, Western Cape, South Africa, 7700

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults aged 40 years and older

  • At least two of the following conditions:

    i. HIV (Self-reported current treatment). ii. hypertension (Self-reported current treatment. iii. diabetes (Self-reported current treatment). iv. asthma, (Self-reported current treatment). vi. depression (Self-reported current treatment). vii. previous myocardial infarction (self-reported). viii. previous stroke (self-reported history).

Exclusion Criteria:

  • Participants planning to relocate from either uMgungundlovu KwaZulu Natal and Cape Metro in Western Cape or changing their facilities during the period of the study.
  • Participants who are unable to give informed consent due to loss of capacity.
  • Participants self-reporting pregnancy
  • Participants who cannot communicate in English, isiXhosa, isiZulu, or Afrikaans.
  • Participants who are not willing to receive care for chronic conditions in their homes.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Intervention
  1. Treatment literacy in chronic condition waiting rooms/pick-up points (posters, health promotion talks)
  2. 1-2 longer consultations with ENHANCE guide trained clinician
  3. Treatment literacy event - a contact between a CHW and a person with MLTC in their home (hopefully with carer), at 2 weeks and 4 weeks, using Health Diary
  4. Referrals to additional adherence counselling if necessary
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
No Intervention: Control
Usual care at primary health care clinic, which includes consultation with a clinician using the PACK/APC guide. No additional support is usually provided for care of MLTCs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnosis and initiation of treatment during follow-up of one or more additional chronic condition
Time Frame: 12 months
Number of participants with diagnosis of an additional chronic condition during follow-up (determined from medical records)
12 months
Intensification or change of treatment during follow-up for at least one of the chronic conditions present at enrolment.
Time Frame: 12 months
Number of patients with increase in number of medication or doses or additional medications during the follow up period (determined by capturing of prescriptions at all visits)
12 months
Improved control of at least one condition that was not optimally controlled at baseline
Time Frame: 12 months
This will include:HIV - viral suppression (viral load <50 copies/mL); hypertension - SBP/DBP<140 /90mmHg; diabetes - HbA1c <8%, Asthma Control Test score >16, Depression PHQ8 <10
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functioning
Time Frame: 12 months
A generic outcome of the primary outcome disaggregated by functioning (WHODAS-2.0)
12 months
Health-related quality of life
Time Frame: 12 months
A generic outcome of the primary outcome disaggregated by health related quality of life (EQ-5D)
12 months
Adherence
Time Frame: 12 months
A generic outcome of the primary outcome disaggregated by adherence (VAS)
12 months
Patient Experience of care
Time Frame: 12 months
A generic outcome of the primary outcome disaggregated by patient experience of care (PACIC)
12 months
Depressive symptoms
Time Frame: 12 months
A generic outcome of the primary outcome disaggregated by depressive symptoms (PHQ-8)
12 months
Patient experience with treatment and self-management
Time Frame: 12 months
A generic outcome of the primary outcome disaggregated by patient experience with treatment and self-management (PETS)
12 months
Heathcare utilisation and cost
Time Frame: 12 months
Health Utilisation and cost questionnaire
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of KwaZulu

Collaborators

King's College London
University of Oxford
University of East Anglia
University of Cape Town
Medical Research Council, South Africa

Investigators

  • Study Chair: Helen Schneider, PhD, University of the Western Cape

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2023

Primary Completion (Estimated)

March 31, 2025

Study Completion (Estimated)

August 30, 2025

Study Registration Dates

First Submitted

January 17, 2024

First Submitted That Met QC Criteria

January 30, 2024

First Posted (Actual)

February 8, 2024

Study Record Updates

Last Update Posted (Actual)

February 8, 2024

Last Update Submitted That Met QC Criteria

January 30, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 686/2022
  • 201816 (Other Grant/Funding Number: NIHR)
  • BREC/00005033/2022 (Other Identifier: UKZN BREC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlie the results reported, after deidentification (text, tables, figures, and appendices).

IPD Sharing Time Frame

Beginning 9 months and ending 36 months following article publication.

IPD Sharing Access Criteria

Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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