Table 1 Elements of primary and secondary outcomes
Domain | Specific measurement | Specific metric | Method of aggregation | Time point |
|---|---|---|---|---|
Potential barriers to CACP implementation (aim 1) | Qualitative interviews | Perspectives on acceptability, feasibility, and workflow impact | Content analysis by construct by role, e.g., CP, clinician, administrator | Prior to the start of the enrollment period (− T1) |
CACP effectiveness (aim 2 primary) | EHR review | Days alive out of ED or hospital 0 and T3 | The number of days the patient was alive and out of the ED or hospital (not in hospital, excluding planned hospital admissions for scheduled surgeries, procedures, and/or treatments) between 0 and T3 | Comparison between the groups will be made at T3 |
CACP effectiveness (aim 2 secondary) | EHR review | Unplanned ED visits, hospitalizations, or death (composite endpoint and individual) | The number of events per participant per 30 days, the percent of participants with events within 30 days, and time to event(s). Will report as a composite outcome and individually | Comparison between the groups at T4 and T5 |
CACP effectiveness (aim 2 exploratory) | EHR review | SNF care | The percent of participants admitted to SNF within 30 days of randomization and duration of SNF stay | Comparison between the groups will be made at T3 |
CACP safety (aim 2 secondary) | EHR review | Unplanned hospitalizations, ED visits, falls with injury, medication errors with harm, and death | The percentage of patients with events within 30 days, the total number of events within 30 days, and time to event(s). Will report as a composite outcome and each outcome individually | Comparison between the groups at T3 and the day after randomization to T3 |
HRQoL (aim 2 secondary) | EQ-5D survey | HRQoL scores (0–100) calculated across five domains | The scores will be summarized using mean, SD, minimum, median, and maximum scores by treatment arm at T3 | Comparison between the groups at T3 and the day after randomization to T3 |
Patient experience with treatment and self-management, i.e., treatment burden (aim 2 secondary) | PETS survey | PETS scores calculated for each domain | Domain scores will be summarized using mean, SD, and minimum and maximum scores | Comparison between the groups at T3 and the day after randomization to T3 |
Patient evaluation of CP care (aim 2 secondary) | Surveys items on involvement in care, communication and health information, caring and concern, and care coordination | Patient-reported CP involvement in care | Percentage of patients who respond “strongly agree” or “agree.” | Descriptive assessment of intervention patients in the CACP program at T2 |
Program satisfaction (aim 3 secondary) | Surveys items on program satisfaction | Self-reported satisfaction with CP care and the CACP program | Percentage of respondents who are “extremely satisfied” or “very satisfied.” | Comparison between participant types will be made after enrollment ends |
Program satisfaction and recommendations for improvement and sustainability (aim 3 secondary) | Qualitative interviews | Program satisfaction and recommendations on improvement and sustainability | Perspectives on how well the program meets user needs and whether/how it should be continued | T2 for a sample of patients in the CACP program and after enrollment ends for CPs and referring clinicians |