PEN Implementation Study

NCT05880784 | Completed

• 1 other identifier: PEN Study
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (11)

• 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

• 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

• 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

• Clinical audits performed

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

  6 months

• Completeness of clinical audit form

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

  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

  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

  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

  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

  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

  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

  6 months

Study Arms (2)

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.

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.

Other: Reinforcement of Peer coaching and clinical audit

Interventions

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.

Peer coaching and clinical audit

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.

Usual Practice

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• public (primary level) health facilities with at least one PEN-trained staff in Bhaktapur district in Nepal.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shahid Gangalal National Heart Centre: lead
• Kathmandu University School of Medical Sciences: collaborator

Study Sites (1)

Shahid Gangalal National Heart Centre

Kathmandu, Bagmati, Nepal

Location

MeSH Terms

Interventions

Clinical Audit; Methods

Intervention Hierarchy (Ancestors)

Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Investigative Techniques

Study Officials

• Dipanker Prajapati, MBBS, MD

  Shahid Gangalal National Heart Centre, Kathmandu, Nepal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 28, 2023
• First Posted: May 30, 2023
• Study Start: February 1, 2022
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: August 29, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1)