MinMed: Do Older Adults do Better With Less Medication

NCT05307666 | Enrolling By Invitation Phase 4 DMC

• 1 other identifier: Pro00089227
• Study Type: interventional
• Target: 1,800
• Locations: 1 country
• Sites: 1

Brief Summary

Many health care providers believe "less-is-more" for older adults, and evidence suggests minimizing certain medications might improve health outcomes. While this evidence focuses on specific medications believed potentially problematic for seniors, it is really adverse reactions to COMMON medications (e.g. medications lowering blood sugar or treating pain) that bring older adults to emergency departments. Knowing recommended drug doses are lower in seniors, and knowing most adverse drug reactions are dose-related, the investigators are organizing primary care providers (family physicians and nurse practitioners) to invite their patients 80 years and older on 6 or more medications to review with them whether some medications could be safely reduced. For drugs treating a symptom (e.g. heartburn), patients and providers will work together to find the lowest dose that provides the same benefit. For drugs that lower blood pressure or blood sugar, doses will be adjusted to keep blood pressure and blood sugar in the upper end of the target range, a range many providers feel to be safer for older adults. Each provider will invite half their eligible patients to a minimization visit at the start of the study, and invite the other half later - after the health effects of minimizing the early group's medications is assessed. To do this, investigators will compare early minimizers to those whose medicines have not yet changed using electronic health data routinely collected on all Albertans. We hypothesize that minimizing medications will prolong independence, reduce mortality and hospitalization, and improve quality of life. It is important to recognize that the intervention (reviewing all medications and determining the lowest effective doses) is already widely recommended as best practice when prescribing for older adults. Despite this however, such medication reviews only infrequently take place. In this study investigators hope to demonstrate that family physicians can minimize their own prescribing, and that organizing providers in a way that permits such reviews to take place can provide health benefits to patients.

Conditions

Aging; Adverse Drug Interaction; Frailty

Keywords

Polypharmacy; Deprescribing; Minimum effective dose; Geriatric prescribing

Outcome Measures

Primary Outcomes (1)

• Composite of all-cause mortality or nursing home admission

  As indicated in Alberta Health Services (AHS) administrative claims data

  Through study completion, an expected average of 2 years

Secondary Outcomes (16)

• All-cause mortality

  Through study completion, an expected average of 2 years

• Nursing home admission

  Through study completion, an expected average of 2 years

• All-cause unplanned hospitalization or emergency room visit

  Through study completion, an expected average of 2 years

• Non-vertebral fracture

  Through study completion, an expected average of 2 years

• Hospitalization or emergency room visit for myocardial infarction / acute coronary syndrome

  Through study completion, an expected average of 2 years

Study Arms (2)

Medication minimization

EXPERIMENTAL

Patients have a dedicated medication minimization visit with their usual primary care provider to which they bring all of their medications (a so-called "brown bag" medication review).

Other: Medication minimization

Usual Care

NO INTERVENTION

Patients will continue to receive care as appropriate but no dedicated visit to review and minimize medications will be organized as a result of the study. Medications are free to be minimized during the normal course of care should the need arise.

Interventions

Medication minimization OTHER

During the medication minimization visit, and any necessary follow-up visits, patients and providers work together to gradually minimize medication dosages (e.g. reducing 1/4 or 1/2 dose at a time) using the following approach: 1) Medications Treating Symptoms: Find the minimum dose that controls the symptom, 2) Drugs that Lower Blood Pressure: Reduce dosages until systolic BP is in the upper 10mmHg of the target range (e.g. target 130 - 140 mmHg), 3) Drugs That Lower Blood Sugar: Reduce dosages until HbA1c is in the upper 5% of the target range (e.g. target 7.5 - 8.0%).

Medication minimization

Eligibility Criteria

• Age: 80 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Attached to participating primary care providers
• Community dwelling (i.e. not living in a nursing home or supportive living facility)
• ≥80 years of age
• Using ≥6 long-term oral medications (defined as orally administered medications dispensed ≥2 times in the preceding 200 days)

You may not qualify if:

• None

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

Kaye Edmonton Clinic Family Medicine Clinic

Edmonton, Alberta, T6G 1Z1, Canada

Location

Related Links

• Pragmatic Trials Collaborative Website

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Scott Garrison, MD, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: PARTICIPANT / PROVIDER / INVESTIGATOR: Alberta Health Services identifies eligible participants, randomizes them to intervention/control, and advises providers who is in the intervention group. Investigators are unaware who the participants are. Patients themselves are unaware they are in a trial, as MinMed has a waiver of consent (given the intervention is recommended care). Participants are only told their primary care provider is participating in an initiative to minimize medications. OUTCOME ASSESSOR: All outcomes are derived from administrative claims data, including death, reason for hospitalization, community physician diagnoses, medications dispensed, and cost of care. All diagnoses are provided during routine care and the majority will come from physicians (e.g. emergency room physicians and hospitalists / specialists) who will be unaware their patient was enrolled in a community trial that minimized medications. Adjudicators of the claims data will be fully blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: PROBE: Prospective Randomized (patient-level) Open-label Blinded Endpoint-evaluation

Study Record Dates

• First Submitted: March 23, 2022
• First Posted: April 1, 2022
• Study Start: July 28, 2022
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Available co-incident with publication of the main results.
• Access Criteria: Freely available to the general public by direct download from the Pragmatic Trials Collaborative's website.

Locations

CA (1)