Table 1 Data analysis plan
Research question | Hypothesis | Outcome measure | Timing | Method of analysis |
|---|---|---|---|---|
What is the effect of a structured medication discontinuation clinical pathway designed to reduce polypharmacy on mean number of medications and patterns of discontinuation compared to usual practice? | Reduction in mean number of medications | Mean number of medications (primary outcome) | T0, T6 | Linear regression |
Proportion of participants with successful reduction in medication number or dose | T6 | Logistic regression | ||
Composite variable of mean number of medication discontinuations and/or dose reductions | T6 | Linear regression | ||
What is the effect of a structured medication discontinuation clinical pathway designed to reduce polypharmacy on patient quality of life, cognition, mobility-related fatigue, nutritional status, physical function capacity, pain, sleep, patient enablement, medication self-efficacy, medication confusion, grip strength, falls and adverse events, and hospital admissions compared to usual practice? | Improved disease and treatment burden, quality of life, cognition, fatigue, nutritional status, physical function capacity and ability, pain, sleep, patient enablement, medication self-efficacy and lower/fewer falls, healthcare utilization, and adverse events will be reported in the intervention arm compared to the control arm at 6-months | Disease burden | T0, T6 | Linear regression |
Treatment burden | T0, T6 | Linear regression | ||
Quality of life | T0, T6 | Linear regression for all continuous outcomes, Logistic regression for Categorical outcomes and Count data models (e.g., Poisson/negative binomial regression, zero-inflated models) for count outcomes | ||
T0, T6 | ||||
Cognition | T0, T6 | |||
Fatigue | T0, T6 | |||
Nutritional status | T0, T6 | |||
Physical function capacity and ability | T0, T6 | |||
T0, T6 | ||||
T0, T6 | ||||
T0, T6 | ||||
Number of Falls | T0, T6 | |||
Pain | T0, T6 | |||
Sleep | T0, T6 | |||
Patient enablement | T0, T6 | |||
Medication self-efficacy | T0, T6 | |||
Healthcare resource utilization (number of hospitalizations, emergency department visits, primary care visits, proportion of patients with at least one hospitalizations) | T0, T6 | |||
T0, T6 | ||||
T0, T6 | ||||
T0, T6 | ||||
Number of Serious adverse events and beneficial withdrawal | T1, T3, T6 | |||
What is the cost-effectiveness of the structured medication discontinuation clinical pathway designed to reduce polypharmacy? | Not applicable | Cost per QALY | T6 | Cost utility analysis |
What is the experience of patients as they go through a structured medication discontinuation clinical pathway designed to reduce polypharmacy? | Not applicable | Lived experience with deprescribing process | T6 | Descriptive analysis of Semi-structured interview/patient diaries |
Satisfaction with the intervention (5-point Likert scale) | T6 | Descriptive statistics (M, SD) | ||
Satisfaction with care around medications (5-point Likert scale) | T0, T6 | Linear regression | ||
Strengths and weaknesses of intervention | T6 | Descriptive analysis | ||
What are the experiences of the pharmacist and family physician of managing patients through the deprescribing process? | Not applicable | Lived experience with deprescribing process | T6 | Thematic analysis of semi-structured interviews/field notes |
Confidence in medication discontinuation (5-point Likert scale) | T0, T6 | Linear regression | ||
Five best/worst aspects of intervention | T6 | Descriptive analysis | ||
Implementation processes | Early/late implementation | Descriptive analysis |