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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02942927
Other study ID # RN293982 - 367123
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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