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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
345
Systematic approach to reduction in polypharmacy.
Dr. Dee Mangin
Hamilton, Ontario, Canada
Successful discontinuation (mean difference in number of medications)
Difference in mean number of medications
Time frame: Baseline, 6 months
Quality of life (EQ5D-5L)
EuroQol five dimensions questionnaire (EQ5D-5L)
Time frame: Baseline, 6 months
Quality of life (SF36v2)
The Short Form (36) Health Survey (SF-36-V2)
Time frame: Baseline, 6 months
Cognition
The Mini Mental Status Examination (MMSE)
Time frame: Baseline, 6 months
Fatigue
Avlund Mob-T Scale
Time frame: Baseline, 6 months
Patient experience of pain
Brief Pain Inventory (Pain interference and Pain severity sub-scales)
Time frame: Baseline, 6 months
Patient enablement
The Patient Enablement Index (PEI)
Time frame: Baseline, 6 months
Sleep
15-D Scale (Sleep Question)
Time frame: Baseline, 6 months
Disease burden
Disease Burden Survey (Bayliss et al., 2009)
Time frame: Baseline, 6 months
Nutritional status
Mini Nutritional Assessment Short-Form (MNA-SF)
Time frame: Baseline, 6 months
Treatment burden
Brief Treatment Burden Scale
Time frame: 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
Time frame: Baseline, 6 months
Physical functional capacity and ability
Manty structured validated interview
Time frame: Baseline, 6 months
Physical function capacity and ability (timed-up-and-go)
Timed up and go test (TUG)
Time frame: Baseline, 6 months
Physical function capacity and ability (strength)
Grip strength
Time frame: Baseline, 6 month
Physical function capacity and ability (balance)
Global Rating of Change (Balance)
Time frame: 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
Time frame: Baseline, 6 months
Healthcare resource utilization (ED/urgent care visits)
Number of emergency department and urgent care visits from administrative data and self-report
Time frame: Baseline, 6 months
Healthcare resource utilization (primary care visits)
Number of primary care visits from administrative data
Time frame: baseline, 6 months
Successful discontinuation or dose reduction
Composite variable calculate to represent mean number of medications stopped or dose reductions
Time frame: 6 months
Successful discontinuation or dose reduction (proportion)
Proportion of patients with successful discontinuations or dose reductions
Time frame: 6 months
Changes in medication side effects and symptoms (adverse)
Patient self-report of appearance (new or worsening) of side effects associated with medications
Time frame: 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
Time frame: 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)
Time frame: 3 months, 6 months
Medication self-efficacy
Self-efficacy for appropriate mediation use scale
Time frame: Baseline, 6 months
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