Table 5 Process feasibility results: eligibility, data collection, and unblinding

Challenges with determining the extent to which participants meet eligibility criteria

Ability to identify and mitigate challenges that arise during recruitment and eligibility checking in larger trial

• The list of potential participants from the EMR was a snapshot in time; medication changes that occurred after this were not reflected, and some potential participants did not know if they were on > 5 log-term medications. Mitigation: the researcher confirmed participants were on 5 or more long-term medications during the initial recruitment phone call; this was then confirmed by the current medication list provided by their community pharmacy

Nature of challenges in terms of participants’ understanding and ability to respond to the surveys

Ability to identify and mitigate challenges that arise during data collection appointments in larger trial

• One participant spoke English but had trouble with reading the answer options in English and concentrating throughout the length of the interview. Mitigation: a family member was engaged for help with translation for a participant of the answer options. Exclusion criteria will cover in main RCT

• Hearing or vision impairments and fatigue in concentration made some interviews longer. Mitigation: questions and/or answer options were repeated carefully, and interviews could be split, breaks were taken during data collection appointments, or the appointment was broken into multiple, shorter sessions

Number and nature of instances of unblinding

Less than 10 instances of unblinding; ability to identify and mitigate challenges that arise during instances of unblinding in larger trial

Occurrence (n = 6)

Follow-up action

Study staff triggered unblinding:

1. Pharmacist had issue with TaperMD login and asked blinded research assistant assessing outcomes (BRAO) for assistance

2. Pharmacist showed message with patient’s name on it to the BRAO when they required assistance

3. Participant also called BRAO about problem with appointment scheduling after the BRAO had been unblinded

The operational manual was updated to note these examples of unblinding and amend processes to prevent including assigning roles not related to outcome assessment to other researchers to avoid contamination risk. These participants were included in analyses

Participant triggered unblinding:

1. Participant told BRAO what occurred in terms of medication changes when called to set up 6-month data collection appointment

2. Question in health utilization questionnaire asks about visits to pharmacists, if participants tell BRAO about seeing a pharmacist and providing more details about seeing the pharmacist (versus just stating they saw a pharmacist)

3. Participant asks BRAO when they will be seeing the pharmacist and receiving the intervention when called to make 6-month data collection appointment