Hybrid Efficacy-effectiveness Trial to Promote Goals-of-care Discussions for Patients With Alzheimer's Disease and Related Dementias and Their Family Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,802
- 试验地点
- 3
- 主要终点
- EHR documentation of Goals of Care discussions
研究概览
简要总结
The goal of this clinical trial is to improve communication among clinicians, patients with memory problems, and their family members. We are testing a way to help clinicians have better conversations to address patients' goals for their healthcare. To do this, we created a simple, short guide called the "Jumpstart Guide." The goal of this research study is to show that using this kind of guide is possible and can be helpful for patients and their families. Patients' clinicians may receive a Jumpstart Guide before the patient's clinic visit. Researchers will compare patients whose clinician received a Jumpstart Guide to patients whose clinician did not receive a guide to see if more patients in the Jumpstart Guide group had conversations about the patient's goals for their healthcare. Patients and their family members will also be asked to complete surveys after the visit with their clinician.
详细描述
This is an NIH Stage III hybrid efficacy-effectiveness trial that also capitalizes on insights from the hybrid effectiveness-implementation design. This is a parallel group randomized trial randomizing patients with ADRD to Jumpstart or usual care. Jumpstart is designed to promote and guide goals-of-care discussions for patients with serious illness through suggestions and "tips" on the Jumpstart Guide. The guide also includes patient-specific information gathered from the EHR on the presence of advance directives and POLST forms. This trial is also pragmatic because we will enroll all eligible patients; Jumpstart guides will be delivered to clinicians caring for all patients in the intervention arm. Patient-reported outcomes will only be collected from patients and families willing to complete surveys. The primary outcome, EHR documentation of goals-of-care discussions, will be collected for all patients.
The study includes 4 steps:
Step 1. Patient Identification and randomization. Patients are randomized at the time of confirmation of eligibility to one of two study arms: the Jumpstart intervention or usual care.
Jumpstart is a communication-priming intervention for clinicians, patients and their families in the outpatient setting. The intervention's goal is to prompt clinicians to provide, during a scheduled (non-urgent) clinic visit, standard of care which includes a discussion with patients (and/or their LNOKs) about their goals of care. It is designed to promote and guide these discussions for older adults with ADRD through suggestions and tips on the Jumpstart guide.
Step 2. Creation of EHR-based Jumpstart Guide. For patients randomized to intervention, a "clinician-facing" Jumpstart guide is created. The Jumpstart guide is developed from EHR data, using automated retrieval routines to summarize the presence or absence of Physician Orders for Life Sustaining Treatment (POLST), advance directives, and durable power of attorney (DPOA) for health care documentation. This information is used to populate the Jumpstart guide with tailored recommendations to clinicians for initiating or continuing goals of care discussions at the patient's upcoming "target visit" appointment. No Jumpstart guides are created for patients in the comparator arm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria:
- •Be cared for as an outpatient at a UW Medicine clinic
- •55 years of age or older
- •Have an ICD-10 code for ADRD documented in the EHR within the prior two years
- •If patients are cared for in a primary care setting within UW Medicine or by a geriatrician or neurologist, only a diagnosis of ADRD is required for eligibility.
- •If patients have ADRD and are not followed by a primary care clinician at UW Medicine but are followed by a subspecialist, eligible patients must also have an ICD-10 code for one or more of seven chronic conditions used by the Dartmouth Atlas, relevant for the specialist they see, to ensure that goals-of care discussions are applicable for these specialists in the care of the enrolled patient. These conditions by specialist are: malignant cancer/leukemia (oncologist), chronic pulmonary disease (pulmonologist), coronary artery disease or heart failure (cardiologist), chronic liver disease (hepatologist), chronic renal disease (nephrologist), and diabetes with end-organ damage (endocrinologist).
排除标准
- •restricted status, legal or risk management concerns
- •without capacity to complete informed consent procedures and without a legal surrogate to enroll them (for the survey component or qualitative interviews)
- •non-English speaking (for the survey component or qualitative interviews)
- •patients of a clinician who has opted-out of the study will not be eligible for the study under the care of that clinician but may be eligible if they also receive care from another clinician in a participating clinic
- •FAMILY MEMBERS
- •Inclusion Criteria:
- •Identified (via the patient or the EHR) as the person most involved in care for an eligible patient in the trial
- •18 years of age or older
- •English language proficiency
- •Exclusion Criteria:
- •legal or risk management concerns
- •psychological illness or morbidity preventing completion of study materials
- •physical or mental limitations preventing completion of study materials
- •non-English speaking
- •Not all patients will have an eligible family member to enroll.
- •Inclusion Criteria:
- •Physician or advance practice provider caring for older adults within UW Medicine clinics
- •18 years of age or older
- •English language proficiency
- •(Interviews) Identified as clinician of record for an enrolled patient in the trial and received a Jumpstart guide
- •Exclusion Criteria:
- •legal or risk management concerns
研究组 & 干预措施
Usual Care
Clinicians of patients in the Usual Care arm will not receive a Jumpstart Guide.
Jumpstart Guide
The Jumpstart Guide is developed using automated methods. It summarizes the presence/absence of POLST, advance directives and DPOA documentation. The Jumpstart Guide also provides tips for conducting discussion about goals of care.
干预措施: Jumpstart Guide (Behavioral)
结局指标
主要结局
EHR documentation of Goals of Care discussions
时间窗: 90 days following randomization
The primary outcome is the proportion of patients who have a goals-of-care discussion that has been documented in the EHR in the period by 90 days following randomization. The proportion is the number of patients with GOC documentation over the number of patients in each study arm.
次要结局
- Anxiety and depression (HADS)(30 days following randomization.)
研究者
Erin Kross
Associate Professor: School of Medicine, Pulmonary, Critical Care and Sleep Medicine
University of Washington