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Completed

NCT Number: NCT05880784

PEN Implementation Study

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shahid Gangalal National Heart Centre

Kathmandu, Bagmati, Nepal

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Reinforcement of Peer coaching and clinical audit

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.

Continuation of usual practice without intervention

Other

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

Primary outcomes

  1. Acceptability of Intervention Measure 4-item questionnaire

    Time frame: 6 months

    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.

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

    Time frame: 6 months

    Codes and themes from Qualitative Interviews to capture insights, experiences and satisfaction of health facility staff

  3. Completion of peer coaching activities/ orientation

    Time frame: 6 months

    Number of staff who completed peer coaching orientation/ training. Data abstraction from Pre-post evaluation of checklist for supportive supervision & monitoring

  4. Clinical audits performed

    Time frame: 6 months

    Number of clinical audits performed (or, Number of clinical audit form filled). Data abstraction from clinical audit documents

  5. Completeness of clinical audit form

    Time frame: 12 months

    Clinical audit scores at 3, 6 and 12 months. Data abstraction from clinical audit documents

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

    Time frame: 6 months

    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

  7. Time taken to perform a clinical audit activities

    Time frame: 6 months

    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

  8. Health facility staff re-oriented and trained for PEN protocol implementation

    Time frame: 6 months

    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

  9. Additional cost-incurred for peer coaching activities

    Time frame: 6 months

    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

  10. Additional cost for clinical auditing

    Time frame: 6 months

    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

  11. Willingness to continue peer-coaching and clinical audit activities for PEN program implementation and adherence to PEN after intervention duration

    Time frame: 6 months

    Qualitative Interviews with peer-coaches and health facility staff

Sponsors and collaborators

Lead sponsor

Shahid Gangalal National Heart Centre

Other

Collaborators

  • Kathmandu University School of Medical Sciences

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 30, 2023
Registry last updated
Aug 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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