PEN Implementation Study

NCT ID: NCT05880784

Last Updated: 2023-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2023-06-30

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.

Conditions

Package of Essential Non-Communicable Diseases (PEN); Peer Coaching; Clinical Audit; Mixed Method Implementation Study

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Usual Practice

Eight primary healthcare centers in the Bhaktapur district of Nepal will be selected as a control group. The centers will be assessed for the baseline PEN service evaluation and at the end of one year, evaluation will be performed again in the centers for any change in the PEN services.

Group Type: PLACEBO_COMPARATOR

Continuation of usual practice without intervention

Intervention Type: OTHER

No intervention will be carried out, instead usual practice will be evaluated at the start and the end of the study period.

Peer coaching and clinical audit

Nine primary healthcare centers in the Bhaktapur district of Nepal will be selected as an intervention group. The centers will be assessed for the baseline PEN service evaluation and then will be provided the peer coaching and clinical audit sensitization within 6 months of the intervention period. At the end of one year, an evaluation will be performed again in the centers for any change in the PEN services.

Group Type: ACTIVE_COMPARATOR

Reinforcement of Peer coaching and clinical audit

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kathmandu University School of Medical Sciences

OTHER

Sponsor Role: collaborator

Shahid Gangalal National Heart Centre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dipanker Prajapati, MBBS, MD

Role: PRINCIPAL_INVESTIGATOR

Shahid Gangalal National Heart Centre, Kathmandu, Nepal

Locations

Shahid Gangalal National Heart Centre

Kathmandu, Bagmati, Nepal

Countries

Nepal

Other Identifiers

PEN Study

Identifier Type: -

Identifier Source: org_study_id