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

Stroke Clinical Trial

— ENHANCE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06248190
• Other study ID #: 686/2022
• Secondary ID: 201816BREC/00005
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: August 30, 2025

Study information

• Verified date: January 2024
• Source: University of KwaZulu
• Contact: Lara R Fairall, PhD
• Phone: 0835565290
• Email: lara.fairall[@]uct.ac.za
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 1920
• Est. completion date: August 30, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
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	Kleinvlei CHC	Cape Town	Western Cape
South Africa	Kraaifontein CHC	Cape Town	Western Cape
South Africa	Macassar CDC	Cape Town	Western Cape
South Africa	Michael M	Cape Town	Western Cape
South Africa	Mitchells Plain CHC	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	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

Sponsors (6)

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

Country where clinical trial is conducted

South Africa, 

References & Publications (10)

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. — View 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. — View 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. — View Citation

Hurst JR, Dickhaus J, Maulik PK, Miranda JJ, Pastakia SD, Soriano JB, Siddharthan T, Vedanthan R; GACD Multi-Morbidity Working Group. Global Alliance for Chronic Disease researchers' statement on multimorbidity. Lancet Glob Health. 2018 Dec;6(12):e1270-e1271. doi: 10.1016/S2214-109X(18)30391-7. No abstract available. Erratum In: Lancet Glob Health. 2019 Feb;7(2):e190. — View 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. — View Citation

Mayosi BM, Flisher AJ, Lalloo UG, Sitas F, Tollman SM, Bradshaw D. The burden of non-communicable diseases in South Africa. Lancet. 2009 Sep 12;374(9693):934-47. doi: 10.1016/S0140-6736(09)61087-4. Epub 2009 Aug 24. — View Citation

Nguyen H, Manolova G, Daskalopoulou C, Vitoratou S, Prince M, Prina AM. Prevalence of multimorbidity in community settings: A systematic review and meta-analysis of observational studies. J Comorb. 2019 Aug 22;9:2235042X19870934. doi: 10.1177/2235042X19870934. eCollection 2019 Jan-Dec. — View Citation

Oni T, Youngblood E, Boulle A, McGrath N, Wilkinson RJ, Levitt NS. Patterns of HIV, TB, and non-communicable disease multi-morbidity in peri-urban South Africa- a cross sectional study. BMC Infect Dis. 2015 Jan 17;15:20. doi: 10.1186/s12879-015-0750-1. — View Citation

Peer N, Uthman OA, Kengne AP. Rising prevalence, and improved but suboptimal management, of hypertension in South Africa: A comparison of two national surveys. Glob Epidemiol. 2021 Sep 10;3:100063. doi: 10.1016/j.gloepi.2021.100063. eCollection 2021 Nov. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnosis and initiation of treatment during follow-up of one or more additional chronic condition	Number of participants with diagnosis of an additional chronic condition during follow-up (determined from medical records)	12 months
Primary	Intensification or change of treatment during follow-up for at least one of the chronic conditions present at enrolment.	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
Primary	Improved control of at least one condition that was not optimally controlled at baseline	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	Functioning	A generic outcome of the primary outcome disaggregated by functioning (WHODAS-2.0)	12 months
Secondary	Health-related quality of life	A generic outcome of the primary outcome disaggregated by health related quality of life (EQ-5D)	12 months
Secondary	Adherence	A generic outcome of the primary outcome disaggregated by adherence (VAS)	12 months
Secondary	Patient Experience of care	A generic outcome of the primary outcome disaggregated by patient experience of care (PACIC)	12 months
Secondary	Depressive symptoms	A generic outcome of the primary outcome disaggregated by depressive symptoms (PHQ-8)	12 months
Secondary	Patient experience with treatment and self-management	A generic outcome of the primary outcome disaggregated by patient experience with treatment and self-management (PETS)	12 months
Secondary	Heathcare utilisation and cost	Health Utilisation and cost questionnaire	12 months