Team Approach to Polypharmacy Evaluation and Reduction

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Team Approach to Polypharmacy Evaluation and Reduction Randomized Controlled Trial

Conditions
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Multi-morbidity, Medication Therapy Management, Polypharmacy

Intervention / Treatment
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* Other: Medication reduction


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAPER<br>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 | Other: Medication reduction<br>* Systematic approach to reduction in polypharmacy.<br>* Other names: Medication discontinuation/dose reduction;|
| No Intervention: Control<br>Standard of Care as wait list control. Control group will be offered intervention as part of usual clinical care at 6 months. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful discontinuation (mean difference in number of medications) | Difference in mean number of medications | Baseline, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life (EQ5D-5L) | EuroQol five dimensions questionnaire (EQ5D-5L) | Baseline, 6 months | 
| Quality of life (SF36v2) | The Short Form (36) Health Survey (SF-36-V2) | Baseline, 6 months | 
| Cognition | The Mini Mental Status Examination (MMSE) | Baseline, 6 months | 
| Fatigue | Avlund Mob-T Scale | Baseline, 6 months | 
| Pain | Brief Pain Inventory (Pain interference and Pain severity sub-scales) | Baseline, 6 months | 
| Patient enablement | The Patient Enablement Index (PEI) | Baseline, 6 months | 
| Sleep | 15-D Scale (Sleep Question) | Baseline, 6 months | 
| Disease burden | Disease Burden Survey (Bayliss et al., 2009) | Baseline, 6 months | 
| Nutritional status | Mini Nutritional Assessment Short-Form (MNA-SF) | Baseline, 6 months | 
| Treatment burden | Brief Treatment Burden Scale | Baseline, 6 months | 
| 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 | 
| Physical functional capacity and ability | Manty structured validated interview | Baseline, 6 months | 
| Physical function capacity and ability (timed-up-and-go) | Timed up and go test (TUG) | Baseline, 6 months | 
| Physical function capacity and ability (strength) | Grip strength | Baseline, 6 month | 
| Physical function capacity and ability (balance) | Global Rating of Change (Balance) | Baseline, 6 months | 
| 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 | 
| Healthcare resource utilization (ED/urgent care visits) | Number of emergency department and urgent care visits from administrative data and self-report | Baseline, 6 months | 
| Healthcare resource utilization (primary care visits) | Number of primary care visits from administrative data | baseline, 6 months | 
| Successful discontinuation or dose reduction | Composite variable calculate to represent mean number of medications stopped or dose reductions | 6 months | 
| Successful discontinuation or dose reduction (proportion) | Proportion of patients with successful discontinuations or dose reductions | 6 months | 
| 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 | 
| 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 | 
| 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 | 
| Medication self-efficacy | Self-efficacy for appropriate mediation use scale | Baseline, 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Randomized Control Trial, Drug Discontinuation, Patient Preference, eHealth, Polypharmacy, Multimorbidity