Actively Recruiting
Hybrid Efficacy-effectiveness Trial to Promote Goals-of-care Discussions for Patients With Alzheimer's Disease and Related Dementias and Their Family Caregivers
Led by University of Washington · Updated on 2025-07-08
1800
Participants Needed
3
Research Sites
56 weeks
Total Duration
On this page
Sponsors
U
University of Washington
Lead Sponsor
N
National Institute on Aging (NIA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a communication approach to improve conversations among clinicians, patients with memory problems, and their family members. This trial focuses on patients with Alzheimer's disease and related dementias (ADRD) to see if a simple guide called the "Jumpstart Guide" helps clinicians discuss patients' healthcare goals more effectively. The study compares patients whose clinicians receive the Jumpstart Guide to those receiving usual care, aiming to demonstrate the guide's feasibility and helpfulness. The trial randomly assigns eligible patients to either receive the Jumpstart Guide intervention or usual care. The Jumpstart Guide is created using electronic health record (EHR) data to summarize advance care planning documents and offers tips for clinicians to prompt goals-of-care discussions during routine outpatient visits. The guide is sent to clinicians shortly before the patient’s appointment. Patients and family members are invited to complete surveys at 1, 3, and 12 months after the visit to assess outcomes like palliative needs and psychological symptoms. Some participants and clinicians also take part in interviews to provide feedback on the intervention. Participants are identified and randomized, then monitored for appointment attendance and healthcare outcomes through EHR data. Surveys are collected from patients and family members to understand the impact on care and caregiver perspectives. The main outcome is whether goals-of-care discussions are documented in the EHR within 90 days of randomization. Safety and quality of care are tracked throughout, with follow-up lasting up to 12 months. The study also collects data on healthcare use and patient deaths up to 24 months from enrollment.
CONDITIONS
Brief Title
Promoting Goals-of-Care Discussions for Patients With Memory Problems and Their Caregivers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be cared for as an outpatient at a UW Medicine clinic
- 55 years of age or older
- Have an ICD-10 code for Alzheimer's disease or related dementias documented in the electronic health record within the prior two years
- If followed by a subspecialist and not primary care, have one or more chronic conditions relevant to the specialist
- Family members involved in care are 18 years or older and proficient in English
- Clinicians caring for older adults within UW Medicine clinics, 18 years or older, and proficient in English
You will not qualify if you...
- Restricted status or legal or risk management concerns
- Unable to complete informed consent procedures without a legal surrogate
- Non-English speaking for survey or interview participation
- Patient's clinician has opted out of the study
- Family members with psychological illness or physical/mental limitations preventing study participation
- Clinicians with legal or risk management concerns
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote) for eligibility confirmation
Duration - Up to 1 week before and including the target clinic visit
Participants are randomized to receive either the Jumpstart Guide intervention or usual care. For those in the Jumpstart arm, a tailored guide is created and delivered to their clinician before a scheduled outpatient clinic visit to promote goals-of-care discussions.
1 scheduled outpatient clinic visit (in-person)
Duration - 12 months post target visit
Participants and their family members are invited to complete surveys assessing patient and caregiver outcomes at multiple time points after the target visit to evaluate the impact of the intervention.
Surveys at approximately 1, 3, and 12 months after the target visit; completed in-person, online, or by phone based on participant preference
Duration - Short interviews lasting 20-30 minutes after 12 months follow-up
At the end of the follow-up period, some participants and family members are invited to participate in short interviews to provide feedback on the intervention and study experience.
1 interview (in-person, phone, or video conference)
Trial Site Locations
Total: 3 locations
1
Harborview Medical Center
Seattle, Washington, United States, 98104
Actively Recruiting
2
UW Medical Center
Seattle, Washington, United States, 98195
Actively Recruiting
3
UW Medicine Neighborhood Clinics
Seattle, Washington, United States, 98195
Actively Recruiting
Research Team
E
Elizabeth Nielsen
J
Jessica Walsh
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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