Medication Therapy Management, Multi-morbidity, Polypharmacy
Conditions
Brief 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.
Detailed 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.
Interventions
OTHERMedication reduction
Systematic approach to reduction in polypharmacy.
Sponsors
Canadian Institutes of Health Research (CIHR)
David Braley and Nancy Gordon Chair in Family Medicine
RxISK
McMaster University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Single-arm, longitudinal cohort feasibility study.
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility (recruitment number) | 6 months | Number of people who are invited to participate in the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility (proportion completed) | 6 months | Number of participants who complete 6-month data collection divided by the number of people who consented. |
| Feasibility (barriers to recruitment) | 6 months | Challenges to recruitment as identified by pharmacists via field notes and interviews. |
| Feasibility (time to complete surveys) | Baseline, 6 months | Total time to complete all surveys |
| Feasibility (capacity for pharmacist to implement) | 6 months | Challenges regarding implementation for pharmacists from field notes and interviews |
| Feasibility (proportion consented) | 6 months | Number of participants who consent divided by the number of potential participants invited. |
| Feasibility (missing data) | 6 months | Nature and percentage of missing data. |
| Feasibility (variance of measures) | Baseline, 6 months | The calculated range of scores for surveys (where applicable) |
| Feasibility (intervention implementation proportion) | 6 months | Number of plans containing deprescribing actions divided by the total number of plans. |
| Feasibility (issues with TaperMD tool) | 6 months | Communication between pharmacists and research team noting TaperMD issues from regular meetings. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Falls | Baseline, 6 months | Total number of falls resulting in medication consultation or treatment recorded in hospital admission and primary care records, and by patient. |
| Fatigue | Baseline, 6 months | Avlund Mob-T Scale |
| Pain severity and interference | Baseline, 6 months | Brief Pain Inventory (Pain interference and Pain severity sub-scales) |
| Sleep | Baseline, 6 months | 15-D Scale (Sleep Question) |
| Treatment Burden | Baseline, 6 months | Brief Treatment Burden Scale |
| Physical function capacity and ability (MANTY) | Baseline, 6 months | Manty structured validated interview |
| Physical function capacity and ability (balance) | Baseline, 6 months | Global Rating of Change (Balance). |
| Pharmacists/family physician experiences with the deprescribing process | 6 months | Semi-structured interviews; field notes |
| Healthcare resource utilization (ED/urgent care visits) | Baseline, 6 months | Number of emergency department and urgent care visits from administrative data and self-report. |
| Healthcare resource utilization (primary care visits) | Baseline, 6 months | Number of primary care visits from administrative data |
| Changes in medication side effects and symptoms (adverse) | 1 week, 3 month, 6 month | Patient self-report of appearance (new or worsening) of side effects associated with medications. |
| Changes in medication side effects and symptoms (positive) | 1 week, 3 month, 6 month | Patient self-report of disappearance (improvement or disappearance) of side effects associated with medications. |
| Serious adverse events | Baseline, 6 months | 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). |
| Implementation processes | Baseline, 3 months, 6 months | NoMAD survey |
| Satisfaction with care around medications | Baseline, 6 months | 5 point Likert scale single question developed for study |
| Healthcare resource utilization (hospital admissions) | Baseline, 6 months | Number of hospital admissions from administrative data and self-report; proportion of patients with at least one hospitalization. |
| Patient experience with deprescribing process (interview) | 6 months | Semi-structured interview |
| Pharmacists/family physician 5 best/worst aspects of intervention | 6 months | Open ended list |
| Satisfaction with intervention | 6 months | 5 point Likert scale single question developed for study |
| Pharmacists/family physician confidence in medication discontinuation | Baseline, 6 months | 5 point Likert scale single question developed for study |
| Successful discontinuation | 6 months | Mean difference in number of medications |
| Successful discontinuation or dose reduction | 6 months | Composite variable calculate to represent mean number of medications stopped or dose reductions |
| Successful discontinuation or dose reduction (proportion) | 6 month | Proportion of patients with successful discontinuation or dose reduction |
| Quality of life (EQ5D-5L) | Baseline, 6 months | EuroQol five dimensions questionnaire (EQ5D-5L). |
| Quality of life (SF36v2) | Baseline, 6 months | The Short Form (36) Health Survey (SF-36-V2). |
Countries
Canada
Contacts
Primary ContactDee Mangin, MBChB, DPH, FRNZC, MD
Backup ContactLarkin Lamarche, PhD
Outcome results
None listed