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. Author manuscript; available in PMC: 2020 Oct 1.
Published in final edited form as: Contemp Clin Trials. 2019 Sep 6;85:105845. doi: 10.1016/j.cct.2019.105845

Table 3.

Methods of Process Evaluation to Ensure Treatment Fidelity

Goal Strategies
Study Design
Ensure that the treatment dose (number, frequency, length of contact) is adequately described and the same for each participant
• Provide all participants with consistent access to health information
• Provide all intervention group participants with 10 doses of ViCCY over six months
• Use a detailed treatment manual with session agendas and checklist of points to cover to enhance treatment quality and consistency
• Ask all participants to track their use of the health information websites
Plan for Implementation Setbacks
(e.g. coach drops out)
• Hire three health coaches and maintain a pool of qualified coaches so that new ones can be trained if needed
• Track attrition (Research Assistants, coaches, participants) and reasons for dropout
Coach Training
Standardize training to ensure that it is conducted similarly for all health coaches. Train coaches to well-defined performance criteria.
• Train coaches together using standardized training manuals and the same instructors
• Design training to accommodate individual styles while assuring standardization
• Specify performance criteria a priori
• Provide remedial training immediately when problems are detected
Treatment Delivery
Monitor and control for treatment differences
• Monitor all encounters, with deviations from protocol addressed quickly
• As sure that a single coach is assigned to provide ViCCY for each caregiver for continuity
• Audio-record ViCCY sessions and rate randomly chosen for each coach to rate fidelity
• Provide routine supervisory over sight using fidelity ratings to minimize decay or drift
• Assure that coaches self-monitor, completing an intervention log after each contact
Treatment Enactment
Monitor and control for participant perceptions of coach differences (e.g., warmth, credibility)
• Assess participant perceptions of coach characteristics through intermittent phone calls
• Give feedback to coaches and mentor them to rectify concerns
• Analyze treatment enactment data after 50%, 75%, and 100% of participants are recruited and compare by group (ViCCY and health information)94