Package of Essential Non-Communicable Diseases (PEN)NCT05880784
PEN Implementation Study
A study testing Reinforcement of Peer coaching and clinical audit and Continuation of usual practice without intervention in people with Package of Essential Non-Communicable Diseases (PEN) and Peer Coaching, run by Shahid Gangalal National Heart Centre at 1 site in Nepal.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Package of Essential Non-Communicable Diseases (PEN), Peer Coaching, Clinical Audit
- What is being tested?
- Reinforcement of Peer coaching and clinical audit and Continuation of usual practice without intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteNepal
- Study dates
- 1 Feb 2022to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- public (primary level) health facilities with at least one PEN-trained staff in Bhaktapur district in Nepal.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this 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
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.
Read the 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
- Being tested
- Reinforcement of Peer coaching and clinical audit, Continuation of usual practice without intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reinforcement of Peer coaching and clinical auditOther
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 interventionOther
No intervention will be carried out, instead usual practice will be evaluated at the start and the end of the study period.
| Study group | Role | What they receive |
|---|---|---|
| Usual Practice | Placebo comparator | 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. Receives: Other: Continuation of usual practice without intervention |
| Peer coaching and clinical audit | Active comparator | 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. Receives: Other: Reinforcement of Peer coaching and clinical audit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
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
Measured: 6 months
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
Measured: 6 months
Clinical audits performed
Number of clinical audits performed (or, Number of clinical audit form filled). Data abstraction from clinical audit documents
Measured: 6 months
Completeness of clinical audit form
Clinical audit scores at 3, 6 and 12 months. Data abstraction from clinical audit documents
Measured: 12 months
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
Measured: 6 months
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
Measured: 6 months
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
Measured: 6 months
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
Measured: 6 months
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
Measured: 6 months
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start1 Feb 2022
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Package of Essential Non-Communicable Diseases (PEN)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahid Gangalal National Heart Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Kathmandu University School of Medical Sciences
- Responsible party
- Sponsor
- Investigators
- Dipanker Prajapati, MBBS, MD, Principal investigator, Shahid Gangalal National Heart Centre, Kathmandu, Nepal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05880784
- Sponsor's protocol ID
- PEN Study
- Status last verified
- Aug 2023
- First submitted
- 28 Apr 2023
- Last updated
- 29 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The quantitative data of the study will include the pre and post-test scores and Likert scale scoring of the Acceptability of Intervention Measure 4-item questionnaire. These data will be included in the study result section. The individual site information and the details of the qualitative and quantitative analysis will be presented in the results section itself after data analysis.
Publications
Prajapati D, Sapkota S, Suwal PS, Aryal A, Maharjan R, Magar SA, Magar KR, Poudel K, Pyakurel P, Vaidya A, Shrestha A. Reinforcement of Peer-Coaching and Clinical Audit to Improve Implementation of Package for Essential Non-Communicable Diseases (PEN) in Nepal: A Pilot Implementation Study Method. JNMA J Nepal Med Assoc. 2025 May;63(285):363-368. doi: 10.31729/jnma.9017. Epub 2025 May 31.
PubMed 41766826
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05880784
- Acronym / sponsor ID
- PEN Study
- Conditions
- Package of Essential Non-Communicable Diseases (PEN), Peer Coaching, Clinical Audit, Mixed Method Implementation Study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Shahid Gangalal National Heart CentreUniversity, hospital or other
- Collaborators
- Kathmandu University School of Medical Sciences
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 30 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Usual Practice | Placebo comparator | Other: Continuation of usual practice without interventionEight 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. |
| Peer coaching and clinical audit | Active comparator | Other: Reinforcement of Peer coaching and clinical auditNine 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- public (primary level) health facilities with at least one PEN-trained staff in Bhaktapur district in Nepal.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reinforcement of Peer coaching and clinical auditThe 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. | Other | Peer coaching and clinical audit |
| Continuation of usual practice without interventionNo intervention will be carried out, instead usual practice will be evaluated at the start and the end of the study period. | Other | Usual Practice |
Primary outcome
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.
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
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
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
Completeness of clinical audit form
Time frame: 12 months
Clinical audit scores at 3, 6 and 12 months. Data abstraction from clinical audit documents
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2023.
- Derived from this study: PubMed 41766826Prajapati D, Sapkota S, Suwal PS, Aryal A, Maharjan R, Magar SA, Magar KR, Poudel K, Pyakurel P, Vaidya A, Shrestha A. Reinforcement of Peer-Coaching and Clinical Audit to Improve Implementation of Package for Essential Non-Communicable Diseases (PEN) in Nepal: A Pilot Implementation Study Method. JNMA J Nepal Med Assoc. 2025 May;63(285):363-368. doi: 10.31729/jnma.9017. Epub 2025 May 31.
- Individual participant dataSharing planned: No. The quantitative data of the study will include the pre and post-test scores and Likert scale scoring of the Acceptability of Intervention Measure 4-item questionnaire. These data will be included in the study result section. The individual site information and the details of the qualitative and quantitative analysis will be presented in the results section itself after data analysis.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dipanker Prajapati, MBBS, MD principal investigator
Shahid Gangalal National Heart Centre, Kathmandu, Nepal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reinforcement of Peer coaching and clinical audit and Continuation of usual practice without intervention in people with Package of Essential Non-Communicable Diseases (PEN) and Peer Coaching, run by Shahid Gangalal National Heart Centre at 1 site in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of Intervention Measure 4-item questionnaire (time frame: 6 months). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05880784, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2023.