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Table 1 Adaptation to create the BetterBirth (BB) intervention package used in the randomized control trial

From: Learning before leaping: integration of an adaptive study design process prior to initiation of BetterBirth, a large-scale randomized controlled trial in Uttar Pradesh, India

  Karnataka Pilot First adaptation Second adaptation RCT
Leadership engagement Study lead introduced to district and facility leadership Non-standardized introduction to district and facility leaders Formalized introduction at district and facility including strong focus on motivation to drive adoption Same as in phase II
Education of facility staff 1-day training on the SCC supported by instructional video, and hands-on simulation 3-day training for staff (2 days didactic, 1-day coached practice using the SCC) Semi structured launch including 1–2-day workshop introducing SCC, problem solving, and strong focus on motivation including video and anthem Structured 2-day launch with increased focus on implementation of the SCC with day 2 on-site for official start
Coaching support Core team of head of the hospital and senior physician and labor nurse supplemented by physician from the study team Physician-led team of physician and nurses coaching birth attendants Peer-to-peer model: Nurse coaches for birth attendants (behavior change), physician coach facility leader (systems change and SCC leadership), and childbirth quality coordinator Same with additional focus on district lead to build support for SCC
Coaching provided during normal clinical routines supplemented every 2 weeks by study physician Coaching provided Every 1–2 weeks for 4–6 weeks Coach training using standardized curriculum focused on coaching skills to drive behavior change and barriers framework (opportunity, ability, motivation) with strong focus on motivation
Coach training through review of SCC Coach training through 2-day, on-site workshops focusing on clinical skills Coach training focused more on QI approaches and behavior change
Data feedback loop Subset of baseline observation data feedback to staff to identify quality gaps None Paper-based system used to capture and review observation data by coaching team to identify persisting gaps and behavior change. Apps used to capture study-related data Robust app-based system to provide real-time data feedback on coach observations and essential birth supplies to BB team, facility, and district. All study data continued to be captured by existing apps
Safe birth supplies (SBS) availability Largely available Supply chain gaps Increased focus of coach TL to help the facility head and district leaders leverage existing resources to address gaps Strengthened focus for coaching and advocacy at facility and district levels for strengthening EBS availability
  1. TL physician coach team leader, EBP essential birth practices, RCT randomized control trial