Team Approach to Polypharmacy Evaluation and Reduction in a Long-Term Care Setting: A Feasibility Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- McMaster University
- Enrollment
- 15
- Locations
- 2
- Primary Endpoint
- Successful Discontinuation (Difference in mean number of medications; reduction in dose)
Study Overview
Brief Summary
Medication side effects and interactions between medications are very common in older adults and are related to negative health outcomes. In this study, the investigators will test a new process aimed at reducing unnecessary medication use and drug side effects in seniors using the best medical evidence and patient preferences for treatment. This study will assess how feasible the implementation of this intervention is within a long-term care facility as well as if it is possible. Participants in two long-term care facilities will participate in this study. Measures will include feasibility outcomes regarding the logistics of the intervention as well as patients outcomes (falls, hospitalizations, and medications) collected before and after implementation. This trial will be a randomized control trial with an adaptive trial design.
Detailed Description
There are substantial associations between polypharmacy and reduced function from older adults and this is likely to be important in frail older adults both in long term care and in the community. The reversibility of drug-induced mobility impairment is unclear therefore the investigators plan to investigate signals of any impact of reducing polypharmacy on mobility. The investigators chose the long-term care setting given the presence of complete medication administration records and this patient population's high prevalence of polypharmacy and risk of adverse drug events. TaperMD is an electronic tool for systematic medication reduction that incorporates patient priorities, electronic screening for potentially harmful medicines,supporting evidence tools and a monitoring pathway to support medication reduction. This study will examine the feasibility of this tool in a long-term care setting as well as examine. Participants in two long-term care facilities will participate in this study. Measures will include feasibility outcomes regarding the logistics of the intervention as well as patients outcomes (falls, hospitalizations, and medications) collected before and after implementation. The study will be an adaptive trial design with two phases. Phase 1 will be an internal pilot. This will allow the investigators to re-evaluate and modify outcome measures and processes as necessary. Phase 2 of this trial will allow for continuation after adjustments to the process or design has been made in a larger randomized controlled trial.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 70 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •residing in 2 long-term care facilities in Brampton, ON
- •on 5 or more long-term medications
- •70 years of age or older
- •adequate English language
Exclusion Criteria
- •terminal illness or other circumstance precluding 6 month study period
- •recent (within 12 months) comprehensive medication review
Arms & Interventions
TAPER
The intervention is medication reduction. This arm is comprised of:
- Medication reconciliation
- Identification of patient priorities for care
- Identification of medications that are potentially appropriate for discontinuation/dose reduction
- Linked pharmacist/family physician consultations with patient to discuss medication with intention to reduce
- Identification of medications for trial of discontinuation/dose reduction (shared decision making) Pause of medication and clinical monitoring
Intervention: Medication Reduction (Other)
Control Group
Standard of Care as wait list control. Control group will be offered intervention as part of usual clinical care at 6 months.
Outcomes
Primary Outcomes
Successful Discontinuation (Difference in mean number of medications; reduction in dose)
Time Frame: 6 months
Difference in mean number of medications; number of medications reduced in dose
Secondary Outcomes
- Difference in level of cognition(Baseline, 6 months)
- Time to complete measures(Baseline, 6 months)
- Difference in level of quality of life(Baseline, 6 months)
- Difference in number of falls(Baseline, 6 months)
- Difference in level of sleep(Baseline, 6 months)
- Changes in medication side effects and symptoms (adverse)(1-week, 3 months, 6 months)
- Changes in medication side effects and symptoms (positive)(1-week, 3 months, 6 months)
- Difference in number of serious adverse events(1-week, 3 months, 6 months)
- Difference in level of physical functioning capacity and ability(Baseline, 6 months)
- Difference in level of performance of activities of daily living(Baseline, 6 months)
- Difference in level of frailty(Baseline, 6 months)
- Difference in level of healthcare utilization use (hospitalizations)(Baseline, 6 months)
- Difference in level of healthcare utilization use (emergency department visits)(Baseline, 6 months)
- Difference in level of healthcare utilization use (physician visits)(Baseline, 6 months)
- Enrollment rate(6 months)
- Completion rate(6 months)
- Difference in level of mood(Baseline, 6 months)
- Difference in level of concern over falling(Baseline, 6 months)
- Difference in level of pain(Baseline, 6 months)
- Difference in level of incontinence(Baseline, 6 months)
Investigators
Derelie Mangin
Professor; Associate Chair and Director, Research David Braley & Nancy Gordon Chair in Family Medicine
McMaster University