Who participated in the decisions about modifications
CHRONIC PAIN
The decision-making process to determine the modifications to the OPTIMIZE trial involved the study team, the study’s patient advisory and external stakeholder panels, and participants enrolled in the OPTIMIZE study prior to the pandemic. Modifications were also discussed and eventually approved by representatives from the funder (PCORI). Modifications were also approved by the study’s single Institutional Review Board.The study team met with the patient advisory panel just prior to the COVID pandemic to help identify reasons for lower-than-expected treatment initiation. Feedback from the patient advisors was that financial concerns may be a reason, and the panel discussed how best to explain the treatment options to participants.The onset of COVID suspended enrollment due to health system restrictions on in-person care and non-essential clinical research. The initial determination of the study team in consultation with representatives from the funder was to wait to resume enrollment until the CHIs could be delivered in person as originally intended. This decision was based on safety concerns associated with in-person care and the potential differential impact of telehealth delivery on the study CHIs, which could negatively influence clinical equipoise because the PT intervention involves physical touch while CBT and MORE do not.As the pandemic persisted, the OPTIMIZE team identified potential modifications that would permit re-starting enrollment. The options were presented to the study’s external advisory panel. This panel included stakeholders representing the perspectives of health systems, payers, and provider groups, as well as persons living with chronic pain. The discussion focused on concerns about the acceptability to patients and effectiveness of delivering PT via telehealth, the potential adverse impact on the ability to include persons with lower economic resources and access to technology if the ability to participate in telehealth were an eligibility requirement, and the likelihood that waivers implemented by insurance providers to permit reimbursement of PT provided via telehealth would persist.Some of the issues discussed with the external advisory panel were further informed by a survey of participants enrolled in the OPTIMIZE trial prior to the COVID enrollment suspension. The survey was conducted in September to October of 2020. Among survey respondents, 9% indicated that access to technology would have been a barrier to telehealth participation, while 43% indicated they would be unwilling to participate in PT delivered via telehealth, compared to 24% indicating unwillingness to participate in telehealth behavioral health sessions [