Table 2 IMPROVE-IT HRM study outcomes and measures
| Â | Outcomes | Criteria for success | Outcome measure | Method of analysis | When assessed |
|---|---|---|---|---|---|
A. Feasibility outcomes | |||||
 A1. Primary feasibility outcomes | A1.1 Participant recruitment rates | ≥ 30% of those eligible will be considered success | Percentage recruited and rate of recruitment (of those screened, of those eligible, and of those approached) | Counts (%) over time | Baseline |
A1.2 Participant retention rate | ≥ 90% is considered success | Percentage of those recruited who complete at least end-study outcome | Counts (%) end study | End of study | |
A1.3 Intervention adherence | ≥ 90% is considered success | Percentage of those recruited who completed each phase of the study (baseline, virtual visits, end of study outcomes) | Counts (%) over time | End of study | |
A1.4 Study resource utilization | < US $1500 per patient recruited and completing the study | Study costs per patient recruited to end follow-up | Cost of personnel, supplies, travel, etc. to run the study | End of study | |
 A2. Secondary feasibility outcomes | A2.1 Clinical Pharmacology & Toxicology (CPT) Recommendation Acceptance — Primary Team | > 50% medication recommendations | % CPT recommendations per patient accepted (continued or implemented) | Counts (%) after consult | Hospital discharge |
A2.2 CPT recommendation acceptance — patients | > 50% medication recommendations | % CPT recommendations per patient that were initially followed by patient | Counts (%) after consult | Hospital discharge | |
A2.3 CPT recommendation adherence — Patients | ≥ 90% is considered success | % CPT recommendations per patient still being followed at end of study | Counts (%) | End of study | |
A2.4 CPT consultation volume capacity | Number of eligible patients available to approach is > 3 per day | Volume of eligible patients available to approach per week | Counts | Baseline | |
A2.5 Potential to intervene entirely virtually | > 90% patients can be managed through follow-up entirely by virtual care platform | Number (%) patients entering follow-up who do not require an unscheduled in-person visit Number of follow-up visits conducted using secure videoconference platform | Counts (%) | End of study | |
B. Clinical outcomes | Hypothesis | Â | |||
 B1. Primary clinical outcomes | B1.1 Drug therapy problems improved | Intervention group will have more improved drug therapy problems compared to control group (e.g., dose adjusted, discontinued, interacting drugs removed) | Percentage of baseline drug therapy problems identified by APEQ that have been improved by end of study | Mean difference in APEQ score changes | End of study |
 B2. Secondary clinical outcomes | B2.1 Adverse drug events | Intervention will have lower event rates | Event rate counts from end of study interviews using Leape and Bates scale | Counts (%) | End of study |
B2.2 Medication errors | Intervention will have fever medication errors | NCC-MERP definition | Counts (%) | End of study | |
B2.3 Number of medications | Intervention will have more medications deprescribed per patient | Number of medications end study compared to baseline | Counts | End of study | |
B2.4 Patient problems with medications | Intervention will have fewer medication problems, including better adherence | COMPETE Medication Problems Questionnaire | Difference in mean group scores | End of study | |
B2.5 Medication knowledge - patient | Intervention will have higher scores | Medication knowledge assessment form | Difference in mean group scores | Baseline and Eed of study | |
B2.6 Coordination and continuity of care | Intervention will have higher ratings | Coordination and Continuity of Care Questionnaire | Difference in mean group scores | End of study | |
B2.7 Patient quality of life | Intervention will improve more | EQ5D-5L and MedQOL | Difference in mean group change scores | End of study | |
B2.8 Patient satisfaction with care | Intervention will have higher scores | Patient Satisfaction Questionnaire | Descriptive analysis | End of study | |
B2.9 Provider satisfaction with care | Intervention will have higher scores | Physician, pharmacist Study Satisfaction Questionnaire | Descriptive analysis | End of study | |
B2.10 Cost-effectiveness/Â health resource utilization | Intervention will be cost-effective using a threshold of US $50,000 per QALY | Cost per adverse drug events avoided and incremental cost per quality-adjusted life-years (QALYs) using EQ5D-5L utilities | Economic analysis | End of study | |