Table 2 Description of first iteration of the IRIS-AR support strategy, prior to key informant interviews
IRIS intervention component | Description of intervention | Operationalization of intervention strategy |
|---|---|---|
Inform | A counseling session and information booklets to ensure participants are sufficiently informed on: • the risk of venothrombotic events; risks of study participation • the study purpose, intervention and participant expectations • common concerns/questions pertaining to VTE-PRO trial processes | Eligible participants will meet with a study coordinator who will thoroughly explain the VTE-PRO trial and counsel study patients or their caregivers. In this context, counseling refers to identifying and addressing specific patient concerns regarding the study. Counseling fosters intrinsic motivation and addresses patient concerns otherwise unknown to the study team. A standardized discussion template will be used to make notes specific to each patient. This will aid the research team in identifying supports that are acceptable to the individual patient. The counseling session will take place in-hospital, for approximately 20 min, following initial consent. Eligible participants will also be provided with a standardized information booklet that will address common concerns pertaining to injections, fear of randomization, and study processes. The booklet will also contain testimonials by previous participants regarding their experiences and recommendations on how to remain compliant with the daily injections. Participants will have the option to utilize any of the components provided in the remaining IRIS-AR components (‘remind’, ‘involve’, ‘support’), as per their individual needs |
Remind | Daily or weekly tailored reminders via text message, telephone, and/or email (as per patient preference). | Study coordinators will send messages tailored to the concerns, needs and milestones of each individual patient. If employed actively and creatively, these prompts may demonstrate a significant impact on study retention, at a relatively low cost |
Involve | Following participant consent, caregivers and/or family members/friends will be invited to participate in the ‘inform’ session. | Caregivers/family members/friends will participate in the ‘inform’ session to understand all study processes, participant responsibilities, and will be afforded the opportunity to ask questions to the study coordinator Caregivers/family members/friends will be encouraged to remind the participant to administer the daily injection Caregivers/family members/friends may be trained to administer the injection to the participant, in the event that the participate is unable/fearful and/or does not wish to use the ICC nursing support |
Support | Following participant consent, the at-home team of the ICC program will travel to the participants’ home to administer the daily injection, for participants unable to administer/fearful of administering injection | A nurse will travel to the participant’s home to administer the needle. The nurse will work with the patient to overcome fears of the needle and will encourage the patient to self-administer the injection |