Align: Aligning Medications With What Matters Most
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 138
- 试验地点
- 4
- 主要终点
- Feasibility as Assessed by the Number of Pharmacist Messages to the Primary Care Provider (PCP) That Receive an Acknowledgment or Response
研究概览
简要总结
The Aligning Medications with What Matters Most (ALIGN) study will assess the feasibility and preliminary efficacy of a deprescribing intervention to reduce medication regimen complexity and treatment burden for people living with dementia (PLWD) and their care partners.
详细描述
People living with dementia (PLWD) use more medications and have more complex medication regimens than people without dementia. Medication regimen complexity is a major source of burden for family caregivers of PLWD and has been associated with numerous adverse outcomes. Therefore, the investigators propose a novel intervention, ALIGN: Aligning Medications with What Matters Most, to optimize prescribing and reduce medication regimen complexity by focusing on what matters most to the patient and caregiver, beyond rigid adherence to clinical practice guidelines. ALIGN is informed by learnings from OPTIMIZE, the investigator team's patient-centered, pragmatic deprescribing intervention for PLWD in primary care that is currently being prospectively evaluated. OPTIMIZE consists of a patient-level intervention comprised of a deprescribing educational brochure, and a clinician-level intervention comprised of a deprescribing educational session for primary care providers (PCPs), deprescribing "tip sheets" and clinic-level feedback on rates of potentially inappropriate medication prescribing in PLWD. ALIGN builds on OPTIMIZE by more explicitly addressing the informational and decisional needs of caregivers through a shared decision making process facilitated by clinical pharmacists. The investigators propose a pilot study to assess the feasibility and acceptability of ALIGN in two different health care systems, and to identify the most appropriate primary outcome measure for a subsequent embedded pragmatic trial (ePCT). Target enrollment is 60 patient-care partner dyads. Patients will be aged ≥65 years with dementia and >5 chronic medications. Primary outcomes are intervention feasibility and acceptability among patients, care partners and PCPs; and feasibility of the patient-level Medication Regimen Complexity Index and Family Caregiver Medication Administration Hassles Scale at baseline and 3 months. Findings from this pilot study will guide the design, implementation and subsequent evaluation of ALIGN in an ePCT, laying the groundwork to reduce medication regimen complexity and burden for PLWD and their caregivers in diverse primary care settings.
This proposed pragmatic intervention has the following aims:
Specific Aim 1: To assess the feasibility and acceptability of ALIGN in two different health care systems, to guide the subsequent evaluation of the effectiveness of the intervention in an embedded pragmatic trial (ePCT).
Specific Aim 2: To determine the feasibility of the primary and secondary outcome measures for the subsequent ePCT.
- To determine the feasibility of measuring the primary outcome, the patient-level Medication Regimen Complexity Index (pMRCI), within the existing electronic health record (EHR) systems, and to compare it with a more pragmatic measure, chronic medication count, as the primary outcome measure for the ePCT.
- To determine the feasibility of measuring the secondary outcome, the Family Caregiver Medication Administration Hassles Scale (FCMAHS), a caregiver-reported outcome measure.
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
- 是
入选标准
- •Age 65 or greater
- •Diagnosis of dementia from International Classification of Diseases (ICD) -9 or ICD-10 codes
- •At least one other chronic condition
- •Five or more chronic medications (to include all prescription and over-the-counter medications, both scheduled and as needed)
- •Have a primary care physician at the pilot clinic who has enrolled in the study; this will be defined as having had at least 1 previous visit with that physician
- •Care partners:
- •- Family or other companions age 21 years or greater who regularly help the patient with managing medications
排除标准
- •As both the pilot and the planned pragmatic trial will be based in primary care, individuals residing in long term care facilities or enrolled in hospice will be excluded.
- •Individuals who cannot converse comfortably in English will be excluded because the FCMAHS has not been validated in other languages.
研究组 & 干预措施
Intervention
The intervention consists of the following:
- mailing deprescribing educational materials to care partners and people living with dementia (PLWD);
- dyads will receive a telehealth visit with a clinical pharmacist to discuss the benefits and harms of the patient's medications with the patient and care partner in the context of their goals and preferences;
- pharmacist- primary care provider (PCP) communication in which the pharmacist provides tailored deprescribing recommendations to the PCP.
干预措施: Pharmacist-led deprescribing intervention (Behavioral)
Delayed Intervention (wait list control)
The delayed intervention consists of the following:
- mailing deprescribing educational materials to care partners and people living with dementia (PLWD);
- three months after mailing the deprescribing educational materials, dyads will receive a telehealth visit with a clinical pharmacist to discuss the benefits and harms of the patient's medications with the patient and care partner in the context of their goals and preferences.
- pharmacist- primary care provider (PCP) communication in which the pharmacist provides tailored deprescribing recommendations to the PCP.
干预措施: Pharmacist-led deprescribing intervention (Behavioral)
结局指标
主要结局
Feasibility as Assessed by the Number of Pharmacist Messages to the Primary Care Provider (PCP) That Receive an Acknowledgment or Response
时间窗: 3 months after enrollment
We will measure the number of pharmacist's messages that receive an acknowledgment or response from the PCP based on Electronic Medical Record (EMR) review
Feasibility as Assessed by the Number of Contacts Between Pharmacist and Dyad
时间窗: 3 months after enrollment
We will measure the number of contacts between pharmacist and PCP and dyad based on Electronic Medical Record (EMR) review
Feasibility as Assessed by Proportion of Dyads That Opt Out of the Intervention
时间窗: A duration of approximately 8 months
Dyads are comprised of the person living with dementia and their care partner. We will measure the proportion of dyads that opt out of the intervention versus the dyads that agree to participate.
Feasibility as Assessed by the Indirect Time Required by the Pharmacist to Complete the Intervention
时间窗: 3 months after enrollment
We will measure the amount of indirect time that it takes the pharmacist to complete the intervention. We will access from pharmacist's documentation in the Electronic Medical Record (EMR).
Acceptability Will be Assessed by the Acceptance Rates for the Pharmacist's Recommendations
时间窗: 3 months after enrollment
We will measure the acceptance rates for the pharmacist's recommendations as documented in the Electronic Medical Record (EMR)
Feasibility as Assessed by the Number of Contacts Between Pharmacist and PCP
时间窗: 3 months after enrollment
We will measure the number of contacts between pharmacist and PCP based on Electronic Medical Record (EMR) review
Feasibility as Assessed by the Direct Time Required by the Pharmacist to Complete the Intervention
时间窗: 3 months after enrollment
We will measure the amount of direct time that it takes the pharmacist to complete the intervention. We will access from pharmacist's documentation in the Electronic Medical Record (EMR).
Feasibility as Assessed by Percentage of Dyads Who Complete 2 of 2 Pharmacist Phone Calls Based on Documented Status Reports
时间窗: Baseline and 3 months after enrollment
Dyads are comprised of the person living with dementia and their care partner. We will measure the percentage of dyads who complete 2 of 2 pharmacist phone calls based on documented status reports
次要结局
- Total Medication Count(Baseline and 3 months after enrollment)
- Response Rate for the Family Caregiver Medication Administration Hassles Scale (FCMAHS)(Baseline and 3 months after enrollment)
- Family Caregiver Medication Administration Hassles Scale (FCMAHS)(Baseline and 3 months after enrollment)
- Medication Regimen Complexity Index (MRCI)(Baseline and 3 months Baseline and 3 months after enrollment)
- Percentage of Participants With Data Elements Available to Calculate the Medication Regimen Complexity Index (pMRCI)(Baseline and 3 months after enrollment)
- Time to Complete the Family Caregiver Medication Administration Hassles Scale (FCMAHS)(Baseline and 3 months after enrollment)