Clinical trial NCT05880784: PEN Implementation Study
Official title: Peer Coaching and Clinical Audit to Facilitate Implementation of the Package of Essential Non-Communicable Diseases (PEN) in Nepal: a Mixed Method Implementation Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Package of Essential Non-Communicable Diseases (PEN)
Peer Coaching
Clinical Audit
Mixed Method Implementation Study
Lead sponsor: Shahid Gangalal National Heart Centre
Sponsor class: OTHER
Collaborators: name: Kathmandu University School of Medical Sciences
First posted: 2023-05-30
Enrollment: 17
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is being conducted in public (primary level) health facilities with at least one PEN-trained staff in the Bhaktapur district in Nepal. The seventeen health facilities were randomized into control and intervention groups. Randomization was conducted in excel using the RAND function. Out of 17, nine facilities were categorized into intervention groups and the remaining eight into control groups. The intervention consists of peer coaching and clinical auditing processes reinforcement to promote a team-based care approach for NCD management in the health facilities.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed description: Non-communicable diseases (NCDs) kill approximately 41 million people each year. Over 80% of all premature deaths include NCD-related deaths, such as deaths from cardiovascular diseases (17·9 million deaths annually), cancers (9·3 million), respiratory diseases (4.1 million), and diabetes (2.0 million). Eighty percent of these deaths occur in low- and middle-income countries (LMIC). In Nepal, 51% of all deaths were due to NCDs in 2018. Effective prevention and management to curb mortalities and morbidities from NCDs are possible - and, are widely being implemented. Early detection and management remain central to NCD control.

For early detection and management of NCDs and to prevent life-threatening complications, a cost-effective intervention through an integrated approach, the World Health Organization (WHO) Package of Essential Noncommunicable Diseases Interventions (WHO PEN) was developed. The package provides a holistic guide, including guidelines on screening, diagnosis, treatment and referral processes of NCD patients for early detection and management of chronic diseases within the community with a systematic approach to strengthen the primary health care system.

Furthermore, NCD care is impacted by significant gaps in the capacity of health institutions and systems in terms of training, and availability of adequate resources, including human resources and supplies of necessary medicines. To cope with the shortages of healthcare workers in LMICs, primary care systems can include team-based care strategies according to the WHO PEN strategy.

One of the key aspects of the PEN package to promote NCD management is team-based care. Due to the shortage of physicians and health workers in most countries in the South East and South Asian region, team-based care strategies are added as an integral component of the WHO PEN package. Team-based care is advised in order to provide effective and continuous patient-centered care. WHO PEN package team-based care includes peer coaching and clinical audit.

WHO PEN was introduced in Nepal in 2016 with the main aim to increase access to NCD-related services in the primary health centers and health posts under the Multi-Sectoral Action Plan for NCD Prevention and Control (2014-2020). Nepal Government developed its own PEN Protocol based on WHO PEN Package to promote NCD management. It consists of four protocols for the prevention of heart attack, strokes and kidney disease through integrated management of diabetes and hypertension; health education and counseling on healthy behaviors; prevention of Chronic Obstructive Pulmonary Disease (COPD) and Asthma; and screening and referral of suspected breast and cervical cancer at Primary Health Center (PHC) level. PEN was initially piloted in two districts and expanded to additional 16 districts in 2018. At present primary Cardiovascular Disease (CVD) care using WHO PEN is only available in health facilities in 30 (out of a total of 77) districts.

Eligibility criteria: 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.

Primary outcomes:
measure: Acceptability of Intervention Measure 4-item questionnaire
timeFrame: 6 months
measure: Acceptability of the intervention by peer coaches and other health facility staff
timeFrame: 6 months
measure: Completion of peer coaching activities/ orientation
timeFrame: 6 months
measure: Clinical audits performed
timeFrame: 6 months
measure: Completeness of clinical audit form
timeFrame: 12 months
measure: Proportion of health facility staff involved in implementation of PEN protocol and routine clinical audits
timeFrame: 6 months
measure: Time taken to perform a clinical audit activities
timeFrame: 6 months
measure: Health facility staff re-oriented and trained for PEN protocol implementation
timeFrame: 6 months
measure: Additional cost-incurred for peer coaching activities
timeFrame: 6 months
measure: Additional cost for clinical auditing
timeFrame: 6 months
measure: Willingness to continue peer-coaching and clinical audit activities for PEN program implementation and adherence to PEN after intervention duration
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kathmandu
country: Nepal
facility: Shahid Gangalal National Heart Centre
state: Bagmati
Study officials:
affiliation: Shahid Gangalal National Heart Centre, Kathmandu, Nepal
name: Dipanker Prajapati, MBBS, MD
role: PRINCIPAL_INVESTIGATOR
References: