Team Approach to Polypharmacy Evaluation and Reduction (Pharmacy)
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|ClinicalTrials.gov Identifier: NCT03557944|
Recruitment Status : Suspended (COVID-19 protocols have curtailed recruitment. We anticipate resuming the study when safe to do so.)
First Posted : June 15, 2018
Last Update Posted : June 7, 2021
In an aging population, most seniors suffer from multiple chronic conditions. When the number of medications taken is ≥5 (polypharmacy), the burden of taking multiple concurrent medications can do more harm than good. Seniors take an average of 7 regular medications and studies link polypharmacy with adverse effects on morbidity, function and health service use. However, it is not clear to what extent these are reversible if medication burden is reduced.
This trial will test the effects on medication numbers and patient health outcomes of an intervention to polypharmacy. This study will test a program focused on medication reduction number and dose. Prioritizing medications according to the patient's preference as reducing the dose also reduces the risk of drug side effects.
Patients, aged 70 years of age or older and taking ≥5 medications will receive the TAPER program. The program involves information gathering from the patient, including systematically seeking patients priorities and preferences, medication review with the pharmacist and then a consultation with the family doctor. The intervention is focused on discontinuing/reducing the dose of medications where possible using a 'pause and monitor' framework to assess the need for restart. An electronic program that detects drug adverse effects and flags potentially inappropriate medications will be integrated into an electronic clinical pathway incorporating monitoring and follow-up systems.
This study will examine whether implementing a deprescribing care pathway with community pharmacists as point-of-entry can signal improvements in prescribing and patient health outcomes in older adults with polypharmacy.
|Condition or disease||Intervention/treatment||Phase|
|Multi-morbidity Medication Therapy Management Polypharmacy||Other: Medication reduction||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Single-arm, longitudinal cohort feasibility study.|
|Masking:||None (Open Label)|
|Official Title:||Team Approach to Polypharmacy Evaluation and Reduction Pharmacy|
|Actual Study Start Date :||June 16, 2019|
|Estimated Primary Completion Date :||October 2022|
|Estimated Study Completion Date :||June 2023|
The intervention is medication reduction. This arm is comprised of:
Other: Medication reduction
Systematic approach to reduction in polypharmacy.
Other Name: Medication discontinuation/dose reduction
- Feasibility (recruitment number) [ Time Frame: 6 months ]Number of people who are invited to participate in the study.
- Feasibility (proportion consented) [ Time Frame: 6 months ]Number of participants who consent divided by the number of potential participants invited.
- Feasibility (proportion completed) [ Time Frame: 6 months ]Number of participants who complete 6-month data collection divided by the number of people who consented.
- Feasibility (barriers to recruitment) [ Time Frame: 6 months ]Challenges to recruitment as identified by pharmacists via field notes and interviews.
- Feasibility (time to complete surveys) [ Time Frame: Baseline, 6 months ]Total time to complete all surveys
- Feasibility (capacity for pharmacist to implement) [ Time Frame: 6 months ]Challenges regarding implementation for pharmacists from field notes and interviews
- Feasibility (issues with TaperMD tool) [ Time Frame: 6 months ]Communication between pharmacists and research team noting TaperMD issues from regular meetings.
- Feasibility (missing data) [ Time Frame: 6 months ]Nature and percentage of missing data.
- Feasibility (variance of measures) [ Time Frame: Baseline, 6 months ]The calculated range of scores for surveys (where applicable)
- Feasibility (intervention implementation proportion) [ Time Frame: 6 months ]Number of plans containing deprescribing actions divided by the total number of plans.
- Successful discontinuation [ Time Frame: 6 months ]Mean difference in number of medications
- Successful discontinuation or dose reduction [ Time Frame: 6 months ]Composite variable calculate to represent mean number of medications stopped or dose reductions
- Successful discontinuation or dose reduction (proportion) [ Time Frame: 6 month ]Proportion of patients with successful discontinuation or dose reduction
- Quality of life (EQ5D-5L) [ Time Frame: Baseline, 6 months ]EuroQol five dimensions questionnaire (EQ5D-5L).
- Quality of life (SF36v2) [ Time Frame: Baseline, 6 months ]The Short Form (36) Health Survey (SF-36-V2).
- Falls [ Time Frame: Baseline, 6 months ]Total number of falls resulting in medication consultation or treatment recorded in hospital admission and primary care records, and by patient.
- Fatigue [ Time Frame: Baseline, 6 months ]Avlund Mob-T Scale
- Pain severity and interference [ Time Frame: Baseline, 6 months ]Brief Pain Inventory (Pain interference and Pain severity sub-scales)
- Sleep [ Time Frame: Baseline, 6 months ]15-D Scale (Sleep Question)
- Treatment Burden [ Time Frame: Baseline, 6 months ]Brief Treatment Burden Scale
- Physical function capacity and ability (MANTY) [ Time Frame: Baseline, 6 months ]Manty structured validated interview
- Physical function capacity and ability (balance) [ Time Frame: Baseline, 6 months ]Global Rating of Change (Balance).
- Healthcare resource utilization (hospital admissions) [ Time Frame: Baseline, 6 months ]Number of hospital admissions from administrative data and self-report; proportion of patients with at least one hospitalization.
- Healthcare resource utilization (ED/urgent care visits) [ Time Frame: Baseline, 6 months ]Number of emergency department and urgent care visits from administrative data and self-report.
- Healthcare resource utilization (primary care visits) [ Time Frame: Baseline, 6 months ]Number of primary care visits from administrative data
- Changes in medication side effects and symptoms (adverse) [ Time Frame: 1 week, 3 month, 6 month ]Patient self-report of appearance (new or worsening) of side effects associated with medications.
- Changes in medication side effects and symptoms (positive) [ Time Frame: 1 week, 3 month, 6 month ]Patient self-report of disappearance (improvement or disappearance) of side effects associated with medications.
- Serious adverse events [ Time Frame: Baseline, 6 months ]Any event that requires in-patient hospitalization or prolongation of existing hospitalization, causes congenital malformation, results in persistent or significant disability or incapacity, is life-threatening or results in death (Health Canada (2011) Guidance Document for Industry - Reporting Adverse Reactions to Marketed Health Products).
- Implementation processes [ Time Frame: Baseline, 3 months, 6 months ]NoMAD survey
- Pharmacists/family physician 5 best/worst aspects of intervention [ Time Frame: 6 months ]Open ended list
- Pharmacists/family physician confidence in medication discontinuation [ Time Frame: Baseline, 6 months ]5 point Likert scale single question developed for study
- Pharmacists/family physician experiences with the deprescribing process [ Time Frame: 6 months ]Semi-structured interviews; field notes
- Patient experience with deprescribing process (interview) [ Time Frame: 6 months ]Semi-structured interview
- Satisfaction with intervention [ Time Frame: 6 months ]5 point Likert scale single question developed for study
- Satisfaction with care around medications [ Time Frame: Baseline, 6 months ]5 point Likert scale single question developed for study
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03557944
|Dr. Dee Mangin|
|Hamilton, Ontario, Canada, L8S 4K1|