App for Independence-O (A4i-O) - Expanding a Validated Platform for Complex Behavioral Health to Address Opioid Use Disorder

Recruitment

Recruitment will be conducted through several mechanisms. First, with permission to do so by their clients, clinicians from within and external to CAMH are able to refer their clients to the study by emailing the study team. Participants recruited from Component 1 will be presented with the opportunity to participate in Component 2 via phone call. Clinicians will be made aware of the study via phone call. Potential service provider participants will be approached after they have been identified by the OUD participants who have formally consented to providers being asked to participate with them. Recruitment posters will be sent out to existing partnerships outlined in the component 1 portion of the protocol using the email templates provided. Second, component 2 will leverage the CLEARR recruitment strategy already approved and implemented in the COMPASS outpatient program at CAMH. CLEARR will be used to recruit participants for this research study. All new referrals will be reviewed by the CLEARR coordinator and CLEARR physician for eligibility to participate using minimal inclusion/exclusion criteria outlined. Once a patient is identified as potentially suitable for the research study, the attending physician will be notified via outlook calendar invite or email that their patient may be eligible for the research study. The attending physician will decide whether research is appropriate for the patient and if so, they will ask the patient for consent to be contacted regarding the research study. If the patient provides verbal consent to be contacted to receive more information about the research study, the physician will connect the patient with the CLEARR coordinator or research team who will further explain the research study. No personal health information (PHI) will be given to the research team prior to obtaining the patient's consent. The investigators have attached the letter of approval and the approved protocol to this submission. As part of the CLEARR protocol, willing participants will be pre-screened by a program RA and provided with study options/opportunities to participate based on self-reported criteria. No access to EMR prior to study consent is required for this process. Below is language provided by the SUHR centralized program:

The Substance Use Health Research (SUHR) Centralized Recruitment Database will be used to recruit participants for this study. Designated Research Personnel (DRP) or Study Specific Research personnel will prescreen individuals to support triaging and referral of individuals to prospective studies. Once a potential participant has been triaged, DRP will send preferred contact information to the Study Specific Research personnel who will reach out to the individual to further explain the study. Responses will be passed to the Study Specific Research Personnel only with the potential participant's consent.

Consent Process

Participants will be provided with a clear explanation of the objectives, procedures, risks and benefits of the study and all questions will be answered. Questions will be asked of subjects to ensure that they understand the nature of the research, the risks and potential benefits of study participation, and their rights as research subjects prior to obtaining their signature on the informed consent document. Participants will be informed of their responsibility to tell the research team of any medical conditions, medications, and changes in their health (e.g. pregnancy) while participating in this study. The PI will be consulted if the research analyst has any concerns about the participant's ability to understand any study procedures. Participant understanding will be assessed by the RA using a post-consent discussion quiz about key procedures in the study. If participant can recall and explain most of the procedures they will be asked if they would like to provide consent. If participants understand only the minority of procedures, the PI will be consulted. The PI will discuss the situation with the RA and, based on that conversation, may connect with the prospective participant to follow up and assess further. If it is decided that the individual is not capable of consenting, they will be thanked for their interest and informed that the investigators can't proceed with their participation as they appear to be struggling to understand what is involved. The investigators will not be formally assessing language comprehension or learning disability. The assessment will be based upon their demonstrated ability to understand the conditions of consent and the nature of the study. With participant permission, their clinicians may also be consulted to better understand the participant's capacity to provide consent. The RA may share with the participant's clinician the amount and type of information the participant seemed to have difficulty remembering or understanding from the consent form. In response, the study team will seek to investigate whether the participant's clinician has any concerns with the participant's capacity to understand or provide consent. As consent is an ongoing process, the investigators will continue to educate participants about the nature of the research and address any questions that may arise throughout the course of the study.