Clinical trial NCT06248190: ENHANCE-EvideNce Led Co-created HeAlth Systems interventioNs for MLTCs CarE
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: HIV Infections
Hypertension
Diabetes Mellitus
Asthma
Depression
Myocardial Infarction
Stroke
Keywords: Multiple Chronic Conditions
Person Centered Care
Health Systems Intervention
Lead sponsor: University of KwaZulu
Sponsor class: OTHER
Collaborators: name: University of Cape Town
name: King's College London
name: University of East Anglia
name: University of Oxford
name: Medical Research Council, South Africa
First posted: 2024-02-08
Enrollment: 1837
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study will be a type 2 hybrid trial, testing the effect of the intervention in improving clinical outcomes, and also testing and observing the effects of the intervention on implementation processes and outcomes using the RE-AIM (reach, effectiveness, adoption, implementation, maintenance) framework. The trial will be a cluster randomised parallel arm trial with embedded process evaluation.
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Diagnosis and initiation of treatment during follow-up of one or more additional chronic condition
timeFrame: 12 months
measure: Intensification or change of treatment during follow-up for at least one of the chronic conditions present at enrolment.
timeFrame: 12 months
measure: Improved control of at least one condition that was not optimally controlled at baseline
timeFrame: 12 months
Secondary outcomes:
measure: Functioning
timeFrame: 12 months
measure: Health-related quality of life
timeFrame: 12 months
measure: Adherence
timeFrame: 12 months
measure: Patient Experience of care
timeFrame: 12 months
measure: Depressive symptoms
timeFrame: 12 months
measure: Patient experience with treatment and self-management
timeFrame: 12 months
measure: Heathcare utilisation and cost
timeFrame: 12 months
Other outcomes:
Locations:
city: Pietermaritzburg
country: South Africa
facility: Eastwood Clinic
state: KZN
city: Pietermaritzburg
country: South Africa
facility: Esigodini Clinic
state: KZN
city: Pietermaritzburg
country: South Africa
facility: Gcumisa Clinic
state: KZN
city: Pietermaritzburg
country: South Africa
facility: Gomane Clinic
state: KZN
city: Pietermaritzburg
country: South Africa
facility: Howick Clinic
state: KZN
city: Pietermaritzburg
country: South Africa
facility: Impilwenhle Clinic
state: KZN
city: Pietermaritzburg
country: South Africa
facility: Injabulo Clinic
state: KZN
city: Pietermaritzburg
country: South Africa
facility: Mafatini Clinic
state: KZN
city: Pietermaritzburg
country: South Africa
facility: Mphophomeni Clinic
state: KZN
city: Pietermaritzburg
country: South Africa
facility: Ndaleni Clinic
state: KZN
city: Pietermaritzburg
country: South Africa
facility: Northdale Clinic
state: KZN
city: Pietermaritzburg
country: South Africa
facility: Pata Clinic
state: KZN
city: Pietermaritzburg
country: South Africa
facility: Richmond Clinic
state: KZN
city: Pietermaritzburg
country: South Africa
facility: Songonzima Clinic
state: KZN
city: Pietermaritzburg
country: South Africa
facility: Willowfontein CHC
state: KZN
city: Cape Town
country: South Africa
facility: Delft CHC
state: Western Cape
city: Cape Town
country: South Africa
facility: Dr Abdurahman CHC
state: Western Cape
city: Cape Town
country: South Africa
facility: DuNoon CHC
state: Western Cape
city: Cape Town
country: South Africa
facility: Durbanville CHC
state: Western Cape
city: Cape Town
country: South Africa
facility: Elsies CHC
state: Western Cape
city: Cape Town
country: South Africa
facility: Gugulethu CHC
state: Western Cape
city: Cape Town
country: South Africa
facility: Gustrouw CDC
state: Western Cape
city: Cape Town
country: South Africa
facility: Hanover Park CHC
state: Western Cape
city: Cape Town
country: South Africa
facility: Heideveld CHC
state: Western Cape
city: Cape Town
country: South Africa
facility: Kleinvlei CHC
state: Western Cape
city: Cape Town
country: South Africa
facility: Kraaifontein CHC
state: Western Cape
city: Cape Town
country: South Africa
facility: Macassar CDC
state: Western Cape
city: Cape Town
country: South Africa
facility: Michael M
state: Western Cape
city: Cape Town
country: South Africa
facility: Mitchells Plain CHC
state: Western Cape
city: Cape Town
country: South Africa
facility: Retreat CHC
state: Western Cape
city: Cape Town
country: South Africa
facility: Vanguard CHC
state: Western Cape
city: Pietermaritzburg
country: South Africa
facility: Caluza Clinic
Study officials:
affiliation: University of the Western Cape
name: Helen Schneider, PhD
role: STUDY_CHAIR
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citation: Gouda HN, Charlson F, Sorsdahl K, Ahmadzada S, Ferrari AJ, Erskine H, Leung J, Santamauro D, Lund C, Aminde LN, Mayosi BM, Kengne AP, Harris M, Achoki T, Wiysonge CS, Stein DJ, Whiteford H. Burden of non-communicable diseases in sub-Saharan Africa, 1990-2017: results from the Global Burden of Disease Study 2017. Lancet Glob Health. 2019 Oct;7(10):e1375-e1387. doi: 10.1016/S2214-109X(19)30374-2.
citation: Kamkuemah M, Gausi B, Oni T. Missed opportunities for NCD multimorbidity prevention in adolescents and youth living with HIV in urban South Africa. BMC Public Health. 2020 Jun 1;20(1):821. doi: 10.1186/s12889-020-08921-0.
citation: Herman AA, Stein DJ, Seedat S, Heeringa SG, Moomal H, Williams DR. The South African Stress and Health (SASH) study: 12-month and lifetime prevalence of common mental disorders. S Afr Med J. 2009 May;99(5 Pt 2):339-44.
citation: COVID-19 Mental Disorders Collaborators. Global prevalence and burden of depressive and anxiety disorders in 204 countries and territories in 2020 due to the COVID-19 pandemic. Lancet. 2021 Nov 6;398(10312):1700-1712. doi: 10.1016/S0140-6736(21)02143-7. Epub 2021 Oct 8.
citation: Roomaney RA, van Wyk B, Turawa EB, Pillay-van Wyk V. Multimorbidity in South Africa: a systematic review of prevalence studies. BMJ Open. 2021 Oct 6;11(10):e048676. doi: 10.1136/bmjopen-2021-048676.