Promoting Goals-of-Care Discussions for Patients With Memory Problems and Their Caregivers

NCT05596760 | Recruiting DMC

• 2 other identifiers: STUDY00015800R01AG078169
• Study Type: interventional
• Target: 1,800
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Dementia; Dementia, Vascular; Mixed Dementias; Alzheimer Disease; Huntington Disease; Lewy Body Disease; Creutzfeldt-Jakob Syndrome; Frontotemporal Lobar Degeneration; Cognitive Dysfunction; Cognitive Aging; Chronic Disease; Palliative Care, Patient Care; Health Care Quality, Access, and Evaluation; Patient Care; Health Communication; Patient Care Planning; Quality of Life

Outcome Measures

Primary Outcomes (1)

• EHR documentation of Goals of Care discussions

  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.

  90 days following randomization

Secondary Outcomes (1)

• Anxiety and depression (HADS)

  30 days following randomization.

Study Arms (2)

Jumpstart Guide

EXPERIMENTAL

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.

Behavioral: Jumpstart Guide

Usual Care

NO INTERVENTION

Clinicians of patients in the Usual Care arm will not receive a Jumpstart Guide.

Interventions

Jumpstart Guide BEHAVIORAL

The Jumpstart Guide 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 memory problems through suggestions and tips on the Jumpstart Guide.

Jumpstart Guide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be cared for as an outpatient at a UW Medicine clinic
• 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).

You may not qualify if:

• 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
• Identified (via the patient or the EHR) as the person most involved in care for an eligible patient in the trial
• years of age or older
• English language proficiency
• 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
• Physician or advance practice provider caring for older adults within UW Medicine clinics

Sponsors & Collaborators

• University of Washington: lead
• National Institute on Aging (NIA): collaborator

Study Sites (3)

Harborview Medical Center

Seattle, Washington, 98104, United States

RECRUITING

UW Medical Center

Seattle, Washington, 98195, United States

RECRUITING

UW Medicine Neighborhood Clinics

Seattle, Washington, 98195, United States

RECRUITING

MeSH Terms

Conditions

Dementia; Dementia, Vascular; Mixed Dementias; Alzheimer Disease; Huntington Disease; Lewy Body Disease; Creutzfeldt-Jakob Syndrome; Frontotemporal Lobar Degeneration; Cognitive Dysfunction; Chronic Disease

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Cerebrovascular Disorders; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Tauopathies; Neurodegenerative Diseases; Basal Ganglia Diseases; Chorea; Dyskinesias; Movement Disorders; Heredodegenerative Disorders, Nervous System; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cognition Disorders; Parkinsonian Disorders; Synucleinopathies; Prion Diseases; Central Nervous System Infections; Infections; TDP-43 Proteinopathies; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Erin Kross, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth Nielsen

CONTACT

206 744-9516; eniels9@u.washington.edu

Jessica Walsh

CONTACT

206.573.6246; jess2@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor: School of Medicine, Pulmonary, Critical Care and Sleep Medicine

Study Record Dates

• First Submitted: October 14, 2022
• First Posted: October 27, 2022
• Study Start: September 11, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)