Demonstration of ALIGN: Aligning Medications With What Matters Most
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 474
- 试验地点
- 2
- 主要终点
- Proportion of patients who stop one or more medications
研究概览
简要总结
The goal of this clinical trial is to test the effectiveness of a pharmacist-led, primary care-based de-prescribing intervention for people living with dementia (PLWD) and the person's care partners.
The intervention consists of the following strategies: 1) a de-prescribing educational brochure designed to activate the patient and care partner; 2) a single telehealth visit in which an embedded clinical pharmacist discusses the benefits and harms of the patient's medications with the patient and care partner in the context of the person's goals and preferences; and 3) pharmacist-PCP communication in which the pharmacist provides tailored de-prescribing recommendations designed to be useful and actionable for the PCP.
The investigators will compare the intervention group with the waitlist control group to see if there is a difference in the primary outcome, the proportion of patients who deprescribe at least one medication by 3 months.
详细描述
PLWD have high rates of polypharmacy. This is due to the high degree of comorbid illnesses and challenging behavioral and psychological symptoms such as apathy and agitation. Guidelines written for individual conditions increase polypharmacy and potentially inappropriate medication (PIM) use, in which risks of medications outweigh benefits, or medications may not align with treatment goals. PIM in PLWD include anticholingerics, psychotropics and opioids, which are prescribed to PLWD in rates that far exceed use in the general older adult population, in spite of the association with harms such as falls, negative cognitive effects, cardiac conduction abnormalities, respiratory suppression and death. Polypharmacy and PIM use among PLWD is associated with adverse drug events, emergency department visits, hospitalizations, and treatment burden, suggesting that in some situations, "the cure may have become the disease."
The use of these and other medications requires nuanced decision-making to balance potential benefits and harms for PLWD. In keeping with principles of person-centered care, people should be on the medicines that will help achieve the persons goals, but not medicines that are likely to be harmful or unhelpful.
Deprescribing statins, antihypertensives, and psychotropic medications in older adults has been shown to be safe, and may lead to improved quality of life, reductions in falls, and improvements in cognitive and psychomotor function. Lessons from successful interventions include the need to target primary care clinicians and patients, and to target more than one class of medications. Most deprescribing interventions have occurred in hospitals, long-term care facilities, or home healthcare, not in primary care - typically the first point of contact with the health care system for PLWD. Few deprescribing studies have addressed care partners of PLWD, despite the enormous strain faced due to medication-related tasks and the person's specific informational and decisional needs and conflicts. These are gaps that the proposed research would address.
The investigator's previous research has shown that care partners want primary care providers (PCPs) to discuss medication-related goals of care as dementia progresses, and to acknowledge the tradeoffs implicit in using medications for symptom management in PLWD. But PCPs cite time pressure and lack of guidance of when and how to stop medications for PLWD as barriers to having these conversations. Pharmacists are ideally suited to help address these problems by providing evidence-based, individualized deprescribing recommendations without increasing demands on PCP time.
The clinical trial consists of the following strategies: 1) direct-to-consumer deprescribing educational materials designed to activate the care partner and PLWD; 2) telehealth visit in which a pharmacist discusses benefits and harms of the medications with the patient and care partner in the context of the person's goals and preferences; and 3) pharmacist-PCP communication in which the pharmacist provides tailored deprescribing recommendations that are actionable for the PCP. Pharmacists will receive a laminated tip sheet and participate in a 20-minute webinar. Decisions about discontinuation or continuation of medications will ultimately be made by the PCP and patient/care partner.
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 years
- •Diagnosis of dementia from International Classification of Diseases (ICD-10) visit codes or from the EHR problem list
- •Five or more medications
- •Only active patients, defined as having >1 visit to the primary care clinic within the past year will be included
- •Care partners:
- •Family or other companions >21 years old who regularly help the patient manage medications.
排除标准
- •As the pragmatic trial will be based on primary care, individuals residing in long-term care facilities or enrolled in hospice will be excluded.
- •Participants must hear well enough to communicate by telephone in English.
研究组 & 干预措施
Intervention
The intervention consists of the following:
- Mailing a deprescribing educational brochure to PLWD and care partners;
- PLWD and/or care partners will receive a single telehealth visit in which an embedded clinical pharmacist discusses 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 designed to be useful and actionable for the PCP.
干预措施: Pharmacist-led deprescribing intervention (Behavioral)
Delayed intervention (wait list control)
The intervention consists of the following:
- Mailing a deprescribing educational brochure to PLWD and care partners;
- PLWD and/or care partners will receive a single telehealth visit in which an embedded clinical pharmacist discusses 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 designed to be useful and actionable for the PCP.
干预措施: Pharmacist-led deprescribing intervention (Behavioral)
结局指标
主要结局
Proportion of patients who stop one or more medications
时间窗: 3 months
The primary outcome for the study will be the proportion of patients who stop ≥1 medication, assessed at 3 months. Discontinuation will be defined as a medication that is listed on the medication list at one time point and not listed at the subsequent time point. Discontinued medications will be measured using data obtained from the Electronic Health Record (EHR).
Patients Who Stop One or More Medications - Per Protocol
时间窗: 3 months
The primary outcome for the study will be the patients who stop ≥1 medication, assessed at 3 months, analyzed per protocol and reported as count of participants. Discontinuation will be defined as a medication that is listed on the medication list at one time point and not listed at the subsequent time point. Discontinued medications will be measured using data obtained from the Electronic Health Record (EHR).
Patients Who Stop One or More Medications - Intention-to-Treat
时间窗: 3 months
The primary outcome for the study will be the patients who stop ≥1 medication, assessed at 3 months, analyzed by intention-to-treat and reported as count of participants. Discontinuation will be defined as a medication that is listed on the medication list at one time point and not listed at the subsequent time point. Discontinued medications will be measured using data obtained from the Electronic Health Record (EHR).
次要结局
- Proportion of patients who stop one or more potentially inappropriate medication (PIM)(3 months)
- Proportion of patients who start one or more new medications(3 months)
- Total number of medications(Baseline and 3 months)
- Patients Who Start One or More New Medications - Per Protocol(3 months)
- Patients Who Start One or More New Medications - Intention-to-Treat(3 months)
- Patients Who Stop One or More Potentially Inappropriate Medication (PIM) - Per Protocol(3 months)
- Patients Who Stop One or More Potentially Inappropriate Medication (PIM) - Intention-to-Treat(3 months)
- Patients Who Start One or More Potentially Inappropriate Medication (PIM) - Per Protocol(3 months)
- Patients Who Start One or More Potentially Inappropriate Medication (PIM) - Intention-to-Treat(3 months)
- Total Number of Medications - Per Protocol(3 months)
- Total Number of Medications - Intention-to-Treat(3 months)
