MinMed: Do Fewer Medications, and Lower Medication Doses, Result in Better Health Outcomes for Those 80 Years of Age and Older
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 入组人数
- 1,800
- 试验地点
- 1
- 主要终点
- Composite of all-cause mortality or nursing home admission
研究概览
简要总结
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.
详细描述
PURPOSE
To organize primary care providers, and their older patients with polypharmacy, in a way that permits them to collaboratively determine the lowest effective dose of all amenable medications. And, in so doing, to provide randomized controlled trial evidence as to whether minimizing medication doses improves health outcomes in this population.
HYPOTHESIS
- Primary care providers can easily reduce medication doses in their own patients when organized appropriately to do so.
- Determining and utilizing the minimum effective dose of all medications will prolong independence, reduce hospitalization, and potentially prolong life.
JUSTIFICATION
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 80 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- 未提供
研究组 & 干预措施
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.
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).
干预措施: Medication minimization (Other)
结局指标
主要结局
Composite of all-cause mortality or nursing home admission
时间窗: Through study completion, an expected average of 2 years
As indicated in Alberta Health Services (AHS) administrative claims data
次要结局
- Total cost of care(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 hypoglycemia(Through study completion, an expected average of 2 years)
- Acute care costs(Through study completion, an expected average of 2 years)
- Number of oral medications minimized and % of baseline oral medications minimized(Through 6-months post randomization)
- All-cause unplanned hospitalization or emergency room visit(Through study completion, an expected average of 2 years)
- Hospitalization or emergency room visit for congestive heart failure(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)
- Hospitalization or emergency room visit for stroke(Through study completion, an expected average of 2 years)
- Nursing home admission(Through study completion, an expected average of 2 years)
- All-cause mortality(Through study completion, an expected average of 2 years)
- Hospitalization or emergency room visit for hyperglycemia(Through study completion, an expected average of 2 years)
- Hospitalization or emergency room visit for hypertension(Through study completion, an expected average of 2 years)
- Hospitalization or emergency room visit for hypotension(Through study completion, an expected average of 2 years)
- Community care costs(Through study completion, an expected average of 2 years)
- Number of all medications minimized and % of all baseline medications minimized(Through 6-months post randomization)