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.

Introduction: Nepal endorsed and implemented the WHO Package of Essential Non-communicable Disease Intervention. However, its implementation is far from satisfactory. We designed and implemented an intervention to reinforce peer coaching and clinical audit mechanisms in primary-level health facilities, and tested its feasibility and preliminary effectiveness. This paper details the methodology used in designing, implementing and assessing the intervention. Methods: The study adoptes a hybrid type II implementation trial design. The intervention assignment followed a non-blinded, two-arm, parallel randomized controlled trial design with a 1:1 allocation ratio. Seventeen primary-level public health facilities in Bhaktapur district with at least one trained staff were randomized. The clinical staff at the intervention health facilities received peer-coaching and clinical audit reinforcement, while the control group followed their usual practice. The study was conducted over a 12-month duration from Februay 2022, to January, 2023. A mixed-method approach, applying pre-post assessment and thematic analysis, to inform the intervention development and assess implementation outcomes and its effectiveness was adopted. The study was guided by the Proctor framework. Ethical clearance was obtained from the Nepal Health Research Council (Registraion number: 302/2021). Discussion: The tools and methods that guide intervention implementation and assessment have the potential to be replicated in various settings to design strategies to improve Package of Essential Non-communicable Disease Intervention adoption and sustainment. Trial Registration: This trial is registered with ClinicalTrials.gov (www.clinicaltrials.gov), Identifier: NCT05880784.