Table 2.

Stakeholder Engagement and Impact on Trial Design and Throughout the Course of Pragmatic Clinical Trials.

Principal Investigator	Stakeholder Group Engaged	Structural Elements
Heapy	WH-PBRN	Early protocol shared with each WH-PBRN site Stakeholders provided input as to how intervention would work, or not work, at their facilities Feedback used to select research sites based on logistical concerns such as number of potential women veteran participants and availability of staff to assist with recruitment
S. Taylor and S. Zeliadt	Veteran stakeholders CIH providers PCPs	Providers joined conference calls to provide input on key elements of study intervention Veterans and other stakeholders contributed to study design, CIH intervention components, and outcome measures CIH providers facilitated communication with facility leadership and other providers to minimize interference of trial protocol on clinical care
J. Fritz and D. Rohn	TRICARE beneficiaries PCPs PTs	Stakeholder feedback incorporated into recruitment plan and data-collection process
S. Hastings, S. George	PTs	Stakeholders reviewed and developed discipline-specific training materials, intervention pathways, and remote delivery of service plans Identified concern that full day training session not feasible for many staff
C. Goertz, C. Long	Veteran stakeholders DCs Clinic directors Site PIs SCs	Feedback on study protocol, data collection, and training procedures from DCs and SCs Feedback on treatment scheduling protocols based on interviews with veteran stakeholders and clinician input Site PI, clinic directors, and DC input on staffing levels of DCs
M. Rosen, S. Martino	PCPs	Busy clinics allow little time for participation in face-to-face interviews Emailed 10-minute surveys for stakeholders to complete on the quality of communication and interactions among different workgroups in providing pain care services for veterans with musculoskeletal conditions.
Ilfeld	Anesthesiologists, surgeons, recovery room nursing staff	Anesthesiologists reviewed the protocol and helped develop a clinical pathway to optimize intervention timing and efficiency Surgeons reviewed the protocol and helped develop outcome measures most appropriate for ambulatory surgical procedures Nursing staff identified possible surgical delays and helped develop protocols to avoid delays
S. Farrokhi, C. Dearth, E. Russell Esposito	PTs, PT clinic leadership	Challenge identified that multiple research studies were recruiting patients with chronic pain at same DOD sites Identified concern that full-day training session during weekdays could reduce patient access and interfere with clinical workflow Stakeholders actively participated in developing discipline-specific training materials and training session structure to minimize interference of trial protocol on clinical care
D. Burgess	Women Veterans and VA Leaders in women’s health	Facilitator-training module developed to address specific needs and experiences of women veterans Meditations recorded in both male and female voices Recruitment and course materials designed to avoid being potentially disturbing to women

Abbreviations: complementary and integrated health, CIH; Department of Defense, DOD; primary care provider, PCP; PT, physical therapist; DOD healthcare, TRICARE; VA Women's Health Research Network, WH-PBRN, Doctor of chiropractic, DC; principal investigator, PI; study coordinator, SC; Veterans Affairs, VA.