Category | Feasibility research question | Outcome (method of collection) | Pre-specified criteria for success |
---|---|---|---|
Process | What is the recruitment, refusal, and drop-out rate of participants, pharmacists, and family physicians? | Number of clinicians and participants enrolled Number of patient participants enrolled, not interested, and dropped out of study before 6-month period (master file) | 50% of invited pharmacists and family physicians enrol 20% of invited patients enrol Less than 20% enrolled patients withdraw |
What are the challenges with determining to extent to which participants meet eligibility criteria? | Description (recruitment file, researcher call notes) | Ability to mitigate challenges that arise during recruitment and eligibility checking in larger trial | |
What is the nature of challenges in terms of participants’ understanding of, and ability to respond to, the surveys? | Description (field notes by research team) | Ability to mitigate challenges that arise during data collection appointments in larger trial | |
What is the number and nature of any instances of unblinding? | Description (field notes by the research team) | Less than 10 instances of unblinding; all instances can be mitigated in larger trial | |
Resources | What is the length of time to complete the surveys? | Duration of visits, number of participants needing multiple visits to complete collection for time point (program records) | Less than 50% of participants require more than 1 visit to complete data collection; less than 2 h required for data collection visits |
How much travel time does the research team do to complete visits? | Estimated time (recruitment file) | Less than 50% of visits require ≥ 30 min of travel time | |
Management | What is the nature of data entry problems? | Description (field notes by research team) | Ability to mitigate common data entry errors (e.g., data missing at random, data syncing issues, problems with database) in larger trial |
Scientific | What is the nature of any adverse events associated with the intervention or study process? | Number and description (field notes by research team, 1 week, 3- and 6-month check-in data collection forms) | No serious adverse events associated with the intervention or study process |
What is the variance, potential floor and ceiling effects, for research outcomes? | Range of scores for each variable (according to survey) | No floor or ceiling effects detected; moderate to high levels of variance detected |