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 so many together can do more harm than good. This study will test a program focused on medication reduction involving patient, pharmacist and physician using current technology aimed at reducing the harms of polypharmacy. Reducing the risk of adverse effects from drugs or the interactions between them involves prioritizing the most important ones according to the patient's preference and stopping those which may no longer be necessary. Reducing the dose also reduces the risk of drug side effects. Patients, aged over 69 years taking ≥5 medications, will randomly receive the program immediately or at 6 months. The program involves information gathering from the patient, medication review with the pharmacist and then a consultation with the family doctor 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 a clinical pathway incorporating monitoring and follow up systems. This study will examine effects on patient and health relevant outcome measures as well as patients' and clinicians' experiences of the program. The results will be used to determine whether this system can be implemented as part of routine preventative care in 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. The intervention includes initial baseline data collection from the patient including 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 his/her family physician to discuss patient preferences for discontinuation/dose reduction. Follow up appointments will take place at one week, 3 months and 6 months (study end). Questionnaires and a semi-structured interview will take place at the 6 month appointment. After six months, the control group will be offered the intervention.

Official Title
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Team Approach to Polypharmacy Evaluation and Reduction: Feasibility Study

Conditions
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Comorbidity, Medication Therapy Management

Intervention / Treatment
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* Other: TAPER program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 70 years of age or older Participating family doctor as most responsible provider Patient of McMaster Family Health Team Currently taking 5 or more medications Have not had a recent comprehensive medication review Patient consents Exclusion Criteria: English language or cognitive skills inadequate to understand and respond to rating scales Terminal illness or other circumstance precluding 13 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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAPER program<br>The intervention arm is comprised of: Identification of medications that are appropriate for discontinuation/dose reduction. Linked pharmacist/family physician consultations with patient to discuss medication discontinuation/dose reduction. | Other: TAPER program<br>* Patients will be randomized to receive the TAPER program at study start or delayed intervention at 6 months.<br>* Other names: Medication Discontinuation/Dose Reduction;|
| No Intervention: Control<br>Standard of Care as wait list control | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful discontinuation (Difference in mean number of medications) | Difference in mean number of medications per patient. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life (EQ-5D) | EQ-5D | 6 months | 
| Nutritional Status (Mini Nutritional Assessment Short-Form) | Mini Nutritional Assessment Short-Form; | 6 months | 
| Patient experience of deprescribing (Thematic analysis of semi structured interviews) | Thematic analysis of semi structured interviews | 6 months | 
| Physical Functional Capacity (Manty structured validated interview) | Manty structured validated interview | 6 months | 
| Falls (self report number of falls) | self report number of falls | 6 months | 
| Adverse Events (patient self report or clinician report) | patient self report or clinician report | 6 months | 
| Health Resource Utilization (Number of hospital admissions and emergency dept visits) | Number of hospital admissions and emergency dept visits | 6 months | 
| Cognition (The Mini Mental Status Examination) | The Mini Mental Status Examination | 6 months | 
| Fatigue (Avlund Mob-T Scale) | Avlund Mob-T Scale | 6 months | 
| Patient Enablement (Patient Enablement Index) | Patient Enablement Index | 6 months | 
| Self-Efficacy (Stanford Self-Efficacy Scale) | Stanford Self-Efficacy Scale | 6 months | 
| Patient self report of change in quality of life/morbidity (Global Impression Scale) | Global Impression Scale | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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polypharmacy, multimorbidity, randomized controlled trial, drug discontinuation, patient preference, eHealth