Team Approach to Polypharmacy Evaluation and Reduction

Polypharmacy Clinical Trial

— TAPER-RCT  

Official title:

Team Approach to Polypharmacy Evaluation and Reduction Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02942927
• Other study ID #: RN293982 - 367123
• Status: Recruiting
• Phase: N/A
• Start date: June 4, 2018
• Est. completion date: December 2024

Study information

• Verified date: October 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 are taking ≥5 medications, will randomly receive the program immediately or at 6 months. 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 effects on patient and health relevant outcome measures as well as qualitative research exploring patients' and clinicians' experiences of reducing medication burden. The results will be used to determine whether this system can be implemented as part of routine preventative care in primary care for older adults.

Description:

Patients will be randomized 1:1 to receive the intervention at study start or delayed appointment 6 months later. Initial baseline data collection from the patient include data 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: 360
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• 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 more 5 or more long-term medications
• Have not had a recent (past 12 months) 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	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	Strengths and weaknesses of intervention	Open ended questions	6 months
Other	Patient experience with deprescribing process (diary)	Patient diaries	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
Other	Cost effectiveness	Incremental cost per Quality Adjusted Life Year (payer perspective)	6 months
Primary	Successful discontinuation (mean difference in number of medications)	Difference in mean number of medications	Baseline, 6 months
Secondary	Quality of life (EQ5D-5L)	EuroQol five dimensions questionnaire (EQ5D-5L)	Baseline, 6 months
Secondary	Quality of life (SF36v2)	The Short Form (36) Health Survey (SF-36-V2)	Baseline, 6 months
Secondary	Cognition	The Mini Mental Status Examination (MMSE)	Baseline, 6 months
Secondary	Fatigue	Avlund Mob-T Scale	Baseline, 6 months
Secondary	Pain	Brief Pain Inventory (Pain interference and Pain severity sub-scales)	Baseline, 6 months
Secondary	Patient enablement	The Patient Enablement Index (PEI)	Baseline, 6 months
Secondary	Sleep	15-D Scale (Sleep Question)	Baseline, 6 months
Secondary	Disease burden	Disease Burden Survey (Bayliss et al., 2009)	Baseline, 6 months
Secondary	Nutritional status	Mini Nutritional Assessment Short-Form (MNA-SF)	Baseline, 6 months
Secondary	Treatment burden	Brief Treatment Burden Scale	Baseline, 6 months
Secondary	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
Secondary	Physical functional capacity and ability	Manty structured validated interview	Baseline, 6 months
Secondary	Physical function capacity and ability (timed-up-and-go)	Timed up and go test (TUG)	Baseline, 6 months
Secondary	Physical function capacity and ability (strength)	Grip strength	Baseline, 6 month
Secondary	Physical function capacity and ability (balance)	Global Rating of Change (Balance)	Baseline, 6 months
Secondary	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
Secondary	Healthcare resource utilization (ED/urgent care visits)	Number of emergency department and urgent care visits from administrative data and self-report	Baseline, 6 months
Secondary	Healthcare resource utilization (primary care visits)	Number of primary care visits from administrative data	baseline, 6 months
Secondary	Successful discontinuation or dose reduction	Composite variable calculate to represent mean number of medications stopped or dose reductions	6 months
Secondary	Successful discontinuation or dose reduction (proportion)	Proportion of patients with successful discontinuations or dose reductions	6 months
Secondary	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
Secondary	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
Secondary	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)	3 months, 6 months
Secondary	Medication self-efficacy	Self-efficacy for appropriate mediation use scale	Baseline, 6 months