Consent process
COPD
COPD, RECRUITMENT
Participants were invited to enroll in a program to assist with management of their COPD, a referral to SPR and survey follow-up over the course of 1 year. Participants were shown an English/Spanish testimonial video depicting SPR or TelePR during recruitment. If they agreed, they signed consent form 1 which allowed for prospective collection of data over the course of 1 year from the EMR and via phone call, as well as a referral to PR. Participants were then randomized to receive the PR component of the program via either (1) a referral to SPR or (2) a referral to TelePR. As per the modified Zelen Randomized Consent Form (MZRCF) method [The MZRCF method allows researchers to obtain consent from patient participants for longitudinal follow-up in standard of care and then to randomly assign study participants to either the intervention (TelePR) or the control arm (SPR), for which additional informed consent must be obtained for those enrolled in the technology-based arm (i.e., nonstandard arm, consent form 2). We predicted that if a study participant was randomly assigned in a conventional way and did not receive the “high-tech” TelePR intervention, it was likely that they would refuse to continue in the study.After enrollment, participants needed to receive medical clearance to be able to participate in PR. This required confirmation of COPD by a pulmonary function test (PFT) or a pulmonologist’s clinical diagnosis and a medical provider’s determination that the patient could exercise safety. These determinations required an in-person visit to the patient’s pulmonologist and, for those with cardiac medical comorbidities, an additional visit to a cardiologist for medical clearance.