Team Approach to Polypharmacy Evaluation and Reduction in a Long-Term Care Setting

NCT ID: NCT04055896

Last Updated: 2021-06-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-15
• Study Completion Date: 2021-03-30

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.

Conditions

Long-term Care; Polypharmacy; Frailty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control Group

Standard of Care as wait list control. Control group will be offered intervention as part of usual clinical care at 6 months.

Group Type: NO_INTERVENTION

No interventions assigned to this group

TAPER

The intervention is medication reduction. This arm is comprised of:

1. Medication reconciliation

2. Identification of patient priorities for care

3. Identification of medications that are potentially appropriate for discontinuation/dose reduction

4. Linked pharmacist/family physician consultations with patient to discuss medication with intention to reduce

5. Identification of medications for trial of discontinuation/dose reduction (shared decision making) Pause of medication and clinical monitoring

Group Type: EXPERIMENTAL

Medication Reduction

Intervention Type: OTHER

Systematic approach to reduction in polypharmacy

Interventions

Medication Reduction

Systematic approach to reduction in polypharmacy

Intervention Type: OTHER

Other Intervention Names

Medication discontinuation/dose reduction

Eligibility Criteria

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

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Labarge Optimal Aging

UNKNOWN

Sponsor Role: collaborator

Canadian Frailty Network

OTHER

Sponsor Role: collaborator

McMaster University

OTHER

Sponsor Role: lead

Responsible Party

Derelie Mangin

Professor; Associate Chair and Director, Research David Braley & Nancy Gordon Chair in Family Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dee Mangin, MBChB, DPH, FRNZC, MD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

Holland Christian Homes - Faith Manor

Brampton, Ontario, Canada

Holland Christian Homes - Grace Manor

Brampton, Ontario, Canada

Countries

Canada

Other Identifiers

2727 (Amendment)

Identifier Type: -

Identifier Source: org_study_id