ENHANCE-EvideNce Led Co-created HeAlth Systems interventioNs for MLTCs CarE
- Conditions
- HIV InfectionsHypertensionDiabetes MellitusDepressionMyocardial InfarctionAsthmaStroke
- Interventions
- Other: ENHANCE intervention (health systems)
- Registration Number
- NCT06248190
- Lead Sponsor
- University of KwaZulu
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1837
-
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).
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention ENHANCE intervention (health systems) 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
- Primary Outcome Measures
Name Time Method Diagnosis and initiation of treatment during follow-up of one or more additional chronic condition 12 months Number of participants with diagnosis of an additional chronic condition during follow-up (determined from medical records)
Intensification or change of treatment during follow-up for at least one of the chronic conditions present at enrolment. 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)
Improved control of at least one condition that was not optimally controlled at baseline 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
- Secondary Outcome Measures
Name Time Method Health-related quality of life 12 months A generic outcome of the primary outcome disaggregated by health related quality of life (EQ-5D)
Adherence 12 months A generic outcome of the primary outcome disaggregated by adherence (VAS)
Functioning 12 months A generic outcome of the primary outcome disaggregated by functioning (WHODAS-2.0)
Patient Experience of care 12 months A generic outcome of the primary outcome disaggregated by patient experience of care (PACIC)
Depressive symptoms 12 months A generic outcome of the primary outcome disaggregated by depressive symptoms (PHQ-8)
Patient experience with treatment and self-management 12 months A generic outcome of the primary outcome disaggregated by patient experience with treatment and self-management (PETS)
Heathcare utilisation and cost 12 months Health Utilisation and cost questionnaire
Trial Locations
- Locations (32)
Eastwood Clinic
🇿🇦Pietermaritzburg, KZN, South Africa
Esigodini Clinic
🇿🇦Pietermaritzburg, KZN, South Africa
Gcumisa Clinic
🇿🇦Pietermaritzburg, KZN, South Africa
Gomane Clinic
🇿🇦Pietermaritzburg, KZN, South Africa
Howick Clinic
🇿🇦Pietermaritzburg, KZN, South Africa
Impilwenhle Clinic
🇿🇦Pietermaritzburg, KZN, South Africa
Injabulo Clinic
🇿🇦Pietermaritzburg, KZN, South Africa
Mafatini Clinic
🇿🇦Pietermaritzburg, KZN, South Africa
Mphophomeni Clinic
🇿🇦Pietermaritzburg, KZN, South Africa
Ndaleni Clinic
🇿🇦Pietermaritzburg, KZN, South Africa
Northdale Clinic
🇿🇦Pietermaritzburg, KZN, South Africa
Pata Clinic
🇿🇦Pietermaritzburg, KZN, South Africa
Richmond Clinic
🇿🇦Pietermaritzburg, KZN, South Africa
Songonzima Clinic
🇿🇦Pietermaritzburg, KZN, South Africa
Willowfontein CHC
🇿🇦Pietermaritzburg, KZN, South Africa
Delft CHC
🇿🇦Cape Town, Western Cape, South Africa
Dr Abdurahman CHC
🇿🇦Cape Town, Western Cape, South Africa
DuNoon CHC
🇿🇦Cape Town, Western Cape, South Africa
Durbanville CHC
🇿🇦Cape Town, Western Cape, South Africa
Elsies CHC
🇿🇦Cape Town, Western Cape, South Africa
Gugulethu CHC
🇿🇦Cape Town, Western Cape, South Africa
Gustrouw CDC
🇿🇦Cape Town, Western Cape, South Africa
Hanover Park CHC
🇿🇦Cape Town, Western Cape, South Africa
Heideveld CHC
🇿🇦Cape Town, Western Cape, South Africa
Michael M
🇿🇦Cape Town, Western Cape, South Africa
Retreat CHC
🇿🇦Cape Town, Western Cape, South Africa
Vanguard CHC
🇿🇦Cape Town, Western Cape, South Africa
Caluza Clinic
🇿🇦Pietermaritzburg, South Africa
Kleinvlei CHC
🇿🇦Cape Town, Western Cape, South Africa
Kraaifontein CHC
🇿🇦Cape Town, Western Cape, South Africa
Macassar CDC
🇿🇦Cape Town, Western Cape, South Africa
Mitchells Plain CHC
🇿🇦Cape Town, Western Cape, South Africa