Improving healthcare conversations for patients with memory issues and their caregivers
Hybrid Efficacy-effectiveness Trial to Promote Goals-of-care Discussions for Patients With Alzheimer's Disease and Related Dementias and Their Family Caregivers
This study is testing a new tool called the 'Jumpstart Guide' to see if it helps older patients with memory issues and their caregivers have better conversations about healthcare goals during doctor visits.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1800 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Washington Academic / other |
| Locations | 3 sites (Seattle, Washington and 2 other locations) |
| Trial ID | NCT05596760 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to enhance communication between clinicians, patients with memory problems, and their family members by implementing a tool called the 'Jumpstart Guide.' This guide is designed to facilitate discussions about patients' healthcare goals during outpatient visits. Patients aged 55 and older with documented memory issues will be randomly assigned to either receive the Jumpstart Guide or standard care. The effectiveness of the intervention will be assessed by comparing the documentation of goals-of-care discussions in electronic health records between the two groups.
Who should consider this trial
Good fit: Ideal candidates for this study are outpatient individuals aged 55 and older with a diagnosis of Alzheimer's disease or related dementias.
Not a fit: Patients who are younger than 55 or do not have a documented diagnosis of Alzheimer's disease or related dementias may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved patient-centered care and better alignment of treatment with patients' healthcare goals.
How similar studies have performed: Other studies have shown promise in improving communication and care planning for patients with serious illnesses, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
PATIENTS 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). Exclusion Criteria: * 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. CLINICIANS 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
Where this trial is running
Seattle, Washington and 2 other locations
- Harborview Medical Center — Seattle, Washington, United States (Recruiting)
- UW Medical Center — Seattle, Washington, United States (Recruiting)
- UW Medicine Neighborhood Clinics — Seattle, Washington, United States (Recruiting)
Study contacts
- Principal investigator: Erin Kross, MD — University of Washington
- Study coordinator: Elizabeth Nielsen
- Email: eniels9@u.washington.edu
- Phone: 206 744-9516
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.