PEN Implementation Study

Clinical Audit Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05880784
• Other study ID #: PEN Study
• Status: Completed
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: August 2023
• Source: Shahid Gangalal National Heart Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Clinical Audit
• Noncommunicable Diseases

Intervention

Other:
• Reinforcement of Peer coaching and clinical audit
The goal of the proposed research study is to test the effectiveness and feasibility of an intervention to enhance peer coaching and clinic audit activities to facilitate the implementation of the Package of Essential Non- Communicable Diseases (PEN) in Nepal.
• Continuation of usual practice without intervention
No intervention will be carried out, instead usual practice will be evaluated at the start and the end of the study period.

Locations

Country	Name	City	State
Nepal	Shahid Gangalal National Heart Centre	Kathmandu	Bagmati

Sponsors (2)

Lead Sponsor	Collaborator
Shahid Gangalal National Heart Centre	Kathmandu University School of Medical Sciences

Country where clinical trial is conducted

Nepal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability of Intervention Measure 4-item questionnaire	Higher score indicate higher acceptability. Score will range from 1 to 5 with Scores 4 and 5 representing higher scores and scores 1 and 2 will represent lower scores. Higher scores will represent better acceptability.	6 months
Primary	Acceptability of the intervention by peer coaches and other health facility staff	Codes and themes from Qualitative Interviews to capture insights, experiences and satisfaction of health facility staff	6 months
Primary	Completion of peer coaching activities/ orientation	Number of staff who completed peer coaching orientation/ training. Data abstraction from Pre-post evaluation of checklist for supportive supervision & monitoring	6 months
Primary	Clinical audits performed	Number of clinical audits performed (or, Number of clinical audit form filled). Data abstraction from clinical audit documents	6 months
Primary	Completeness of clinical audit form	Clinical audit scores at 3, 6 and 12 months. Data abstraction from clinical audit documents	12 months
Primary	Proportion of health facility staff involved in implementation of PEN protocol and routine clinical audits	Number of health facility staff implementing PEN protocol and routine clinical audit activities/ Number of total health facility staff engaged in patient care activities.; Routine observation and data abstraction from clinical audit document	6 months
Primary	Time taken to perform a clinical audit activities	Time spent to complete a single clinical audit activity. Time spent for clinical audit activities in a month; Routine observation and data abstraction from clinical audit document	6 months
Primary	Health facility staff re-oriented and trained for PEN protocol implementation	Number of staff re-oriented to conduct peer coaching, plus Number of staff trained by the peer coaches and involved in PEN protocol implementation.; Data abstraction from training and intervention evaluation document form	6 months
Primary	Additional cost-incurred for peer coaching activities	Cost of intervention package development and training. Additional time for clinical auditing. Data abstraction from financial report; cost estimation for the time and resource involved in health facility	6 months
Primary	Additional cost for clinical auditing	Cost of intervention package development and training. Additional time for clinical auditing. Data abstraction from financial report; cost estimation for the time and resource involved in health facility	6 months
Primary	Willingness to continue peer-coaching and clinical audit activities for PEN program implementation and adherence to PEN after intervention duration	Qualitative Interviews with peer-coaches and health facility staff	6 months