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Trial record 1 of 1 for:    NCT05307666
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MinMed: Do Older Adults do Better With Less Medication

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05307666
Recruitment Status : Enrolling by invitation
First Posted : April 1, 2022
Last Update Posted : August 5, 2022
Sponsor:
Information provided by (Responsible Party):
University of Alberta

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.


Condition or disease Intervention/treatment Phase
Aging Adverse Drug Interaction Frailty Other: Medication minimization Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: PROBE: Prospective Randomized (patient-level) Open-label Blinded Endpoint-evaluation
Masking: Double (Investigator, Outcomes Assessor)
Masking Description:

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.

Primary Purpose: Prevention
Official Title: MinMed: Do Fewer Medications, and Lower Medication Doses, Result in Better Health Outcomes for Those 80 Years of Age and Older
Actual Study Start Date : July 28, 2022
Estimated Primary Completion Date : September 30, 2024
Estimated Study Completion Date : September 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicines

Arm Intervention/treatment
Experimental: Medication minimization
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
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%).

No Intervention: Usual Care
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.



Primary Outcome Measures :
  1. Composite of all-cause mortality or nursing home admission [ Time Frame: Through study completion, an expected average of 2 years ]
    As indicated in Alberta Health Services (AHS) administrative claims data


Secondary Outcome Measures :
  1. All-cause mortality [ Time Frame: Through study completion, an expected average of 2 years ]
    As indicated in Alberta Health Services (AHS) administrative claims data

  2. Nursing home admission [ Time Frame: Through study completion, an expected average of 2 years ]
    As indicated in Alberta Health Services (AHS) administrative claims data

  3. All-cause unplanned hospitalization or emergency room visit [ Time Frame: Through study completion, an expected average of 2 years ]
    As indicated in Alberta Health Services (AHS) administrative claims data. Excludes elective surgery and planned procedures / planned follow-up

  4. Non-vertebral fracture [ Time Frame: Through study completion, an expected average of 2 years ]
    As indicated in Alberta Health Services (AHS) administrative claims data

  5. Hospitalization or emergency room visit for myocardial infarction / acute coronary syndrome [ Time Frame: Through study completion, an expected average of 2 years ]
    As indicated in Alberta Health Services (AHS) administrative claims data

  6. Hospitalization or emergency room visit for stroke [ Time Frame: Through study completion, an expected average of 2 years ]
    As indicated in Alberta Health Services (AHS) administrative claims data

  7. Hospitalization or emergency room visit for congestive heart failure [ Time Frame: Through study completion, an expected average of 2 years ]
    As indicated in Alberta Health Services (AHS) administrative claims data

  8. Hospitalization or emergency room visit for hyperglycemia [ Time Frame: Through study completion, an expected average of 2 years ]
    As indicated in Alberta Health Services (AHS) administrative claims data

  9. Hospitalization or emergency room visit for hypoglycemia [ Time Frame: Through study completion, an expected average of 2 years ]
    As indicated in Alberta Health Services (AHS) administrative claims data

  10. Hospitalization or emergency room visit for hypertension [ Time Frame: Through study completion, an expected average of 2 years ]
    As indicated in Alberta Health Services (AHS) administrative claims data

  11. Hospitalization or emergency room visit for hypotension [ Time Frame: Through study completion, an expected average of 2 years ]
    As indicated in Alberta Health Services (AHS) administrative claims data

  12. Acute care costs [ Time Frame: Through study completion, an expected average of 2 years ]
    Using CIHI case mix grouper methods utilizing resource intensity weight and length of stay, and ambulatory case costing methods, to estimate hospital and outpatient costs respectively

  13. Community care costs [ Time Frame: Through study completion, an expected average of 2 years ]
    Using physician claims and prescription drug costs

  14. Total cost of care [ Time Frame: Through study completion, an expected average of 2 years ]
    Sum of acute and community care costs

  15. Number of oral medications minimized and % of baseline oral medications minimized [ Time Frame: Through 6-months post randomization ]
    Number (and % relative to baseline) of oral long-term medications with ≥ 50% reduction in number of milligrams (mg) dispensed during the 6-months post-randomization as compared to the 6-months pre-randomization, broken down by medication class. Long-term medications are defined as those with 2 or more dispensings in the 200 days prior to randomization.

  16. Number of all medications minimized and % of all baseline medications minimized [ Time Frame: Through 6-months post randomization ]
    Number (and % relative to baseline) of all long-term medications with ≥ 50% reduction in number of milligrams (mg) dispensed during the 6-months post-randomization as compared to the 6-months pre-randomization, broken down by medication class. Long-term medications are defined as those with 2 or more dispensings in the 200 days prior to randomization.



Information from the National Library of Medicine

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Ages Eligible for Study:   80 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Attached to participating primary care providers
  2. Community dwelling (i.e. not living in a nursing home or supportive living facility)
  3. ≥80 years of age
  4. Using ≥6 long-term oral medications (defined as orally administered medications dispensed ≥2 times in the preceding 200 days)

Exclusion Criteria:

None


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05307666


Locations
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Canada, Alberta
Kaye Edmonton Clinic Family Medicine Clinic
Edmonton, Alberta, Canada, T6G 1Z1
Sponsors and Collaborators
University of Alberta
Investigators
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Principal Investigator: Scott Garrison, MD, PhD University of Alberta
Additional Information:
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Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT05307666    
Other Study ID Numbers: Pro00089227
First Posted: April 1, 2022    Key Record Dates
Last Update Posted: August 5, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: A de-identified analytic dataset with all non-identifying participant level data (baseline characteristics, analytic covariates, and outcomes) will be made available on the Pragmatic Trials Collaborative Website co-incident with publication of the trial results.
Supporting Materials: Study Protocol
Statistical Analysis Plan (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.
URL: http://PragmaticTrials.ca

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Alberta:
Polypharmacy
Deprescribing
Minimum effective dose
Geriatric prescribing
Additional relevant MeSH terms:
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Frailty
Pathologic Processes