Table 4.

Procedures for Ensuring Fidelity of Study Design, Methods, and Intervention Delivery

Types of fidelity	Procedures to ensure fidelity	Fidelity assessment
Theory and design	• Intervention development based on a well-defined conceptual model and systematic review of literature	• Utilize evidence-based PC intervention guide based on multiple prior trials
	• Standardization of intervention dose with clear feasibility data based on prior work	• Measure number of PC intervention visits and visit duration using electronic PC clinician encounter survey
	• Minimization of cross-contamination effects given both groups will receive PC	• Measure number of in-person PC visits in the telehealth group and telephone visits in the in-person group
Training	• Development of comprehensive guides and standard operating procedures for site PIs, clinical research coordinators, and PC clinicians	• Complete review of site investigator, research coordinator, and PC intervention guides and training videos
	• Initial in-person training of lead site investigators and PC clinicians on PC intervention and use of telehealth	• Complete training of all site investigators and lead PC clinicians in protocol administration and intervention delivery
	• Initial in-person training of site research coordinators on study procedures and use of telehealth	• Complete training of all site research coordinators on study procedures, protocol implementation, and use of technology
	• Onsite training at each participating site with all PC clinicians providing care to study patients	• Assess pre- and postknowledge that PC clinicians and research coordinators acquired during training
	• Monthly conference calls (led by MGH team) with site investigators to address study issues	• Send meeting minutes from conference calls to all site investigators and PC clinicians
	• Monthly conference calls (led by MGH team) with research coordinators to address study procedures	• Send meeting minutes from conference calls to all site research coordinators
	• Annual retraining seminar through videoconferencing with lead site investigators and PC clinicians	• Assess pre- and postknowledge that lead site investigators and PC clinicians acquired during retraining
Intervention delivery by PC clinicians	• Utilization of PC intervention guide with standardized content areas	• Conduct ongoing training of any new staff in standardized PC intervention guide/videos
	• Completion of electronic survey after each study visit to record the content and topics that the PC clinician addressed	• Review PC electronic surveys quarterly to ensure adherence to content (by MGH team). These findings will be discussed during monthly meetings with lead site investigators
	• Documentation of clinical encounter using a standardized visit note template in site health record	• Review a random sample of PC visit notes quarterly to ensure adherence to content (by lead site investigators)

PIs, principal investigators.