Ignite Creation Date:
2024-05-06 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06248190
Status:
RECRUITING
Last Update Posted:
2024-02-08
First Post:
2024-01-17
Brief Title:
ENHANCE-EvideNce Led Co-created HeAlth Systems interventioNs for MLTCs CarE
Sponsor:
University of KwaZulu
Organization:
University of KwaZulu
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ENHANCE
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
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 Africas 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 eg 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 eg 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 eg 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
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 eg 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 eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 201816 | OTHER_GRANT | None | None |
| BREC000050332022 | OTHER | UKZN BREC | None |