Team Approach to Polypharmacy Evaluation and Reduction (Pharmacy)

Polypharmacy Clinical Trial

Official title:

Team Approach to Polypharmacy Evaluation and Reduction Pharmacy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03557944
• Other study ID #: 4619
• Status: Recruiting
• Phase: N/A
• Start date: June 16, 2019
• Est. completion date: June 2024

Study information

• Verified date: March 2023
• Source: McMaster University
• Contact: Dee Mangin, MBChB, DPH, FRNZC, MD
• Phone: 905-525-9140
• Email: mangind[@]mcmaster.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

This study uses a single-arm, longitudinal cohort feasibility design. Patients will receive the intervention following baseline data collection. Initial baseline data collection from the patient will include information on demographics, medications, and illness characteristics. The patient will then attend an appointment with a pharmacist to review medications appropriate for discontinuation/dose reduction, after which the patient will meet with their family physician to discuss patient preferences for discontinuation/dose reduction. Both health care providers will have access to TaperMD, a web-based program linked to evidence and tools to support reduction in polypharmacy. Follow-up research assessments will take place at one week, 3 months and 6 months (study end). Outcome assessments and a semi-structured interview will take place at the 6 month appointment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 2024
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

Inclusion Criteria:

• Aged 70 years of age or older

• Patient must have a family doctor

• Participating family doctor as most responsible provider

• Currently taking 5 or more long-term medications

• Has not had a recent comprehensive medication review

• Patient willing to try discontinuation

Exclusion Criteria:

• English language or cognitive skills inadequate to understand and respond to rating scales

• Terminal illness or other circumstance precluding 6 month study period

Related Conditions & MeSH terms

• Medication Therapy Management
• Multi-morbidity
• Polypharmacy

Intervention

Other:
• Medication reduction
Systematic approach to reduction in polypharmacy.

Locations

Country	Name	City	State
Canada	Dr. Dee Mangin	Hamilton	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
McMaster University	Canadian Institutes of Health Research (CIHR), David Braley and Nancy Gordon Chair in Family Medicine, RxISK

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Successful discontinuation	Mean difference in number of medications	6 months
Other	Successful discontinuation or dose reduction	Composite variable calculate to represent mean number of medications stopped or dose reductions	6 months
Other	Successful discontinuation or dose reduction (proportion)	Proportion of patients with successful discontinuation or dose reduction	6 month
Other	Quality of life (EQ5D-5L)	EuroQol five dimensions questionnaire (EQ5D-5L).	Baseline, 6 months
Other	Quality of life (SF36v2)	The Short Form (36) Health Survey (SF-36-V2).	Baseline, 6 months
Other	Falls	Total number of falls resulting in medication consultation or treatment recorded in hospital admission and primary care records, and by patient.	Baseline, 6 months
Other	Fatigue	Avlund Mob-T Scale	Baseline, 6 months
Other	Pain severity and interference	Brief Pain Inventory (Pain interference and Pain severity sub-scales)	Baseline, 6 months
Other	Sleep	15-D Scale (Sleep Question)	Baseline, 6 months
Other	Treatment Burden	Brief Treatment Burden Scale	Baseline, 6 months
Other	Physical function capacity and ability (MANTY)	Manty structured validated interview	Baseline, 6 months
Other	Physical function capacity and ability (balance)	Global Rating of Change (Balance).	Baseline, 6 months
Other	Healthcare resource utilization (hospital admissions)	Number of hospital admissions from administrative data and self-report; proportion of patients with at least one hospitalization.	Baseline, 6 months
Other	Healthcare resource utilization (ED/urgent care visits)	Number of emergency department and urgent care visits from administrative data and self-report.	Baseline, 6 months
Other	Healthcare resource utilization (primary care visits)	Number of primary care visits from administrative data	Baseline, 6 months
Other	Changes in medication side effects and symptoms (adverse)	Patient self-report of appearance (new or worsening) of side effects associated with medications.	1 week, 3 month, 6 month
Other	Changes in medication side effects and symptoms (positive)	Patient self-report of disappearance (improvement or disappearance) of side effects associated with medications.	1 week, 3 month, 6 month
Other	Serious adverse events	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).	Baseline, 6 months
Other	Implementation processes	NoMAD survey	Baseline, 3 months, 6 months
Other	Pharmacists/family physician 5 best/worst aspects of intervention	Open ended list	6 months
Other	Pharmacists/family physician confidence in medication discontinuation	5 point Likert scale single question developed for study	Baseline, 6 months
Other	Pharmacists/family physician experiences with the deprescribing process	Semi-structured interviews; field notes	6 months
Other	Patient experience with deprescribing process (interview)	Semi-structured interview	6 months
Other	Satisfaction with intervention	5 point Likert scale single question developed for study	6 months
Other	Satisfaction with care around medications	5 point Likert scale single question developed for study	Baseline, 6 months
Primary	Feasibility (recruitment number)	Number of people who are invited to participate in the study.	6 months
Secondary	Feasibility (proportion consented)	Number of participants who consent divided by the number of potential participants invited.	6 months
Secondary	Feasibility (proportion completed)	Number of participants who complete 6-month data collection divided by the number of people who consented.	6 months
Secondary	Feasibility (barriers to recruitment)	Challenges to recruitment as identified by pharmacists via field notes and interviews.	6 months
Secondary	Feasibility (time to complete surveys)	Total time to complete all surveys	Baseline, 6 months
Secondary	Feasibility (capacity for pharmacist to implement)	Challenges regarding implementation for pharmacists from field notes and interviews	6 months
Secondary	Feasibility (issues with TaperMD tool)	Communication between pharmacists and research team noting TaperMD issues from regular meetings.	6 months
Secondary	Feasibility (missing data)	Nature and percentage of missing data.	6 months
Secondary	Feasibility (variance of measures)	The calculated range of scores for surveys (where applicable)	Baseline, 6 months
Secondary	Feasibility (intervention implementation proportion)	Number of plans containing deprescribing actions divided by the total number of plans.	6 months