CompletedNot Applicable

PEN Implementation Study

Nepal17 participantsStarted 2022-02-01

Plain-language summary

There is a gap in the implementation of PEN services as well as in the monitoring and evaluation of the WHO PEN in Nepal. One reason for such gaps is due to a lack of team-based care in low-resource settings like Nepal. Both peer coaching and clinical audit have been shown to be cost-effective ways to improve NCD care. However, no data is available regarding its implementation and outcome. Besides, there is a lack of a proven module of peer coaching and clinical audit for effective NCD care implementation. To address this gap, the investigators designed an intervention to reinforce peer coaching and clinical audit practices in health facilities to improve WHO PEN implementation for better NCD management in Nepal. Aims of Implementation Research * To assess implementation outcomes (acceptability, adoption, feasibility, penetration, cost and sustainability) of onsite-peer coaching and clinical audit reinforcement intervention on PEN Program implementation at primary healthcare centers. * To evaluate the effectiveness of onsite-peer coaching and clinic audit reinforcement intervention in PEN program delivery at health facilities. * To identify barriers and enabling factors impacting the adoption of onsite-peer coaching and clinical audit in the implementation of the PEN program.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * public (primary level) health facilities with at least one PEN-trained staff in Bhaktapur district in Nepal. Exclusion Criteria: * public (primary level) health facilities without at least one PEN-trained staff in Bhaktapur district in Nepal. * public (primary level) health facilities in other districts in Nepal.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Acceptability of Intervention Measure 4-item questionnaire

Timeframe: 6 months

Acceptability of the intervention by peer coaches and other health facility staff

Timeframe: 6 months

Completion of peer coaching activities/ orientation

Timeframe: 6 months

Clinical audits performed

Timeframe: 6 months

Completeness of clinical audit form

Timeframe: 12 months

Proportion of health facility staff involved in implementation of PEN protocol and routine clinical audits

Timeframe: 6 months

Time taken to perform a clinical audit activities

Timeframe: 6 months

Trial details

NCT IDNCT05880784

SponsorShahid Gangalal National Heart Centre

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-06-30

View on ClinicalTrials.gov More Package of Essential Non-Communicable Diseases (PEN) trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Acceptability of Intervention Measure 4-item questionnaire

Timeframe: 6 months

Acceptability of the intervention by peer coaches and other health facility staff

Timeframe: 6 months

Completion of peer coaching activities/ orientation

Timeframe: 6 months

Clinical audits performed

Timeframe: 6 months

Completeness of clinical audit form

Timeframe: 12 months

Proportion of health facility staff involved in implementation of PEN protocol and routine clinical audits

Timeframe: 6 months

Time taken to perform a clinical audit activities

Timeframe: 6 months