Pragmatic design and inclusion of patient-partner representatives improves participant experience in clinical research

David Pogorzelski; Jeffrey L Wells; Debra Marvel; Jana E Palmer; C Daniel Mullins; Michelle Medeiros; Jodi L Gallant; Ella Spicer; Patrick F Bergin; I Leah Gitajn; Devin S Mullin; Greg E Gaski; Robert Hymes; Sofia Bzovsky; Gerard P Slobogean; Sheila Sprague

doi:10.1097/OI9.0000000000000287

Pragmatic design and inclusion of patient-partner representatives improves participant experience in clinical research

OTA Int. 2023 Oct 17;6(4):e287. doi: 10.1097/OI9.0000000000000287. eCollection 2023 Dec.

Authors

David Pogorzelski¹, Jeffrey L Wells², Debra Marvel³, Jana E Palmer³, C Daniel Mullins⁴, Michelle Medeiros⁴, Jodi L Gallant¹, Ella Spicer⁵, Patrick F Bergin⁶, I Leah Gitajn⁷, Devin S Mullin⁷, Greg E Gaski⁸, Robert Hymes⁸, Sofia Bzovsky¹, Gerard P Slobogean⁹, Sheila Sprague^{1

10}

Affiliations

¹ Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, ON, Canada.
² Trauma Survivors Network, University of Maryland Baltimore, Baltimore, MD.
³ Patient Representative, R Adams Cowley Shock Trauma Center, Baltimore, MD.
⁴ Department of Pharmaceutical Health Services Research, University of Maryland School of Pharmacy, Baltimore, MD.
⁵ Division of Orthopaedics, Fraser Health Authority, New Westminster, BC, Canada.
⁶ University of Mississippi Medical Center, Jackson, MS.
⁷ Dartmouth-Hitchcock Medical Center, Dartmouth Geisel School of Medicine, Lebanon, NH.
⁸ Department of Orthopaedic Surgery, Inova Fairfax Medical Campus, Falls Church, VA.
⁹ Department of Orthopaedics, University of Maryland School of Medicine, R Adams Cowley Shock Trauma Center, Baltimore, MD.
¹⁰ Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada.

Abstract

Objectives: Patient engagement in the design and implementation of clinical trials is necessary to ensure that the research is relevant and responsive to patients. The PREP-IT trials, which include 2 pragmatic trials that evaluate different surgical preparation solutions in orthopaedic trauma patients, followed the patient-centered outcomes research (PCOR) methodology throughout the design, implementation, and conduct. We conducted a substudy within the PREP-IT trials to explore participants' experiences with trial participation.

Methods: At the final follow-up visit (12 months after their fracture), patients participating in the PREP-IT trials were invited to participate in the substudy. After providing informed consent, participants completed a questionnaire that asked about their experience and satisfaction with participating in the PREP-IT trials. Descriptive statistics are used to report the findings.

Results: Four hundred two participants participated in the substudy. Most participants (394 [98%]) reported a positive experience, and 376 (94%) participants felt their contributions were appreciated. The primary reasons for participation were helping future patients with fracture (279 [69%]) and to contribute to science (223 [56%]). Two hundred seventeen (46%) participants indicated that their decision to participate was influenced by the minimal time commitment.

Conclusions: Most participants reported a positive experience with participating in the PREP-IT trials. Altruism was the largest motivator for participating in this research. Approximately half of the participants indicated that the pragmatic, low-participant burden design of the trial influenced their decision to participate. Meaningful patient engagement, a pragmatic, and low-burden protocol led to high levels of participant satisfaction.

Keywords: PREP-IT; orthopaedic trauma; patient engagement; patient-centered outcomes research; randomized controlled trials.