Population Health Approach to Optimizing and Deprescribing Medications in Older Adults
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number of all-cause hospitalizations
研究概览
简要总结
This randomized controlled pragmatic pilot study examines the feasibility and acceptability of a population health-based deprescribing intervention that leverages a polypharmacy risk prediction model. It includes four arms (2 intervention and 2 control arms) and uses a parallel arm study design.
详细描述
This pilot clinical trial will examine the feasibility and acceptability of a medication management intervention that uses risk stratification to identify older adults (including older adults with Mild Cognitive Impairment or Alzheimer's Disease and Related Dementias) at greatest risk for polypharmacy-related adverse events. The intervention will use a risk prediction model to identify potential study participants for inclusion and enroll them and their care partners into a polypharmacy clinic. The study will stratify patients by cognitive impairment status. The risk prediction model includes variables such as: age, sex, recent healthcare encounters, current and past medications, current and past lab tests, current and past diagnoses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients will be invited to enroll in the study if they are in the top decile of risk selected by a risk prediction model of polypharmacy-related adverse events. The risk prediction model includes variables such as: age, sex, recent healthcare encounters, current and past medications, current and past lab tests, current and past diagnoses.
- •65 years of age or older
- •Have a primary care clinician within the Cedars-Sinai Health System who uses MyCSLink (electronic health record used by Cedars-Sinai).
- •Part of a Cedars-Sinai Health System population health registry (e.g., enrolled in an Accountable Care Organization, Medicare Advantage plan, or Primary Care First program)
- •Diagnosis of Mild Cognitive Impairment or Dementia at baseline (for one intervention group) on the problem list
排除标准
- •Patients for whom there is an active substance use disorder (defined by a physician) and thus for whom the intervention may not be appropriate
- •Patients with an organ transplant
- •Visits with a Cedars-Sinai Medical Center pharmacist for a polypharmacy consult within the last 6 months
- •Patients who previously indicated in the EHR that they wish to opt out of participating in research studies.
- •Patients enrolled in CS360, a program for highly complex medical patients, who already receive polypharmacy services.
研究组 & 干预措施
Patient-tailored deprescribing assessment and intervention (MCI and Dementia diagnosis)
Patients are identified for enrollment via a risk prediction model and enrolled in a pharmacist-led polypharmacy clinic. The pharmacist will conduct a comprehensive medication review, which will include: medication reconciliation, assessment of patient risk factors, identification of potentially inappropriate medications, identification of potential prescribing omissions, shared decision-making with the patient and/or caregiver, and confirmation of the results with the prescriber. Once the prescriber has approved the recommendations, the pharmacist will make the appropriate changes to the medication regimen, will provide tailored medication education and counseling and will follow-up with the patient at least once per month to assess side effects, adverse effects, and provide support. This arm specifically includes only patients with a diagnosis of Mild Cognitive Impairment (MCI) or Alzheimer's Disease and Related Dementias (ADRD) at enrollment.
干预措施: Patient-tailored deprescribing assessment and intervention (Behavioral)
Usual care (MCI and Dementia diagnosis)
Patients in the comparator arm will see their primary care clinician as needed. This arm specifically includes patients with a diagnoses of Mild Cognitive Impairment (MCI) or Alzheimer's Disease and Related Dementias (ADRD) at enrollment.
Patient-tailored deprescribing assessment and intervention (no MCI and Dementia diagnosis)
Patients are identified for enrollment via a risk prediction model and enrolled in a pharmacist-led polypharmacy clinic. The pharmacist will conduct a comprehensive medication review, which will include: medication reconciliation, assessment of patient risk factors, identification of potentially inappropriate medications, identification of potential prescribing omissions, shared decision-making with the patient and/or caregiver, and confirmation of the results with the prescriber. Once the prescriber has approved the recommendations, the pharmacist will make the appropriate changes to the medication regimen, will provide tailored medication education and counseling and will follow-up with the patient at least once per month to assess side effects, adverse effects, and provide support. This arm specifically includes only patients with NO diagnosis of Mild Cognitive Impairment (MCI) or Alzheimer's Disease and Related Dementias (ADRD) at enrollment.
干预措施: Patient-tailored deprescribing assessment and intervention (Behavioral)
Usual care (no MCI and Dementia diagnosis)
Patients in the comparator arm will see their primary care clinician as needed. This arm specifically includes patients with NO diagnoses of Mild Cognitive Impairment (MCI) or Alzheimer's Disease and Related Dementias (ADRD) at enrollment.
结局指标
主要结局
Number of all-cause hospitalizations
时间窗: 12 months after enrollment
Number of all-cause inpatient visits (including observation visits) 12 months after enrollment.
次要结局
- Total number of medications(Baseline, 12 months)
- Total number of potentially inappropriate medications(Baseline, 12 months)
- Number of medications with a dose reduction >10% over 12 months(12 months)
- Number of medications discontinued for 90 days or more which are re-prescribed(Baseline, 12 months)
- Number of times per day the patient is taking medications(Baseline, 12 months)
- Number of potential prescribing omissions (PPOs) based on the STOPP/START criteria(12 months)
- Number of drug-related problems(Baseline, 12 months)
- Number of potential pharmacy recommendations(Baseline, 12 months)
- Change in risk prediction model score(12 months)
研究者
Michelle Keller
Research Scientist I
Cedars-Sinai Medical Center