~162 spots leftby Apr 2026

Communication Intervention for Dementia

(PICSI-H Trial)

Recruiting in Palo Alto (17 mi)
+3 other locations
EK
Overseen byErin K Kross, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: University of Washington
No Placebo Group

Trial Summary

What is the purpose of this trial?

The objective of this protocol is to test the effectiveness of a Jumpstart intervention on patient-centered outcomes for patients with chronic illness by ensuring that they receive care that is concordant with their goals over time, and across settings and providers. This study is particularly interested in understanding the effect of the intervention to improve quality of palliative care for patients with Alzheimer's disease and related dementias (ADRD) but will also include other common chronic, life-limiting illnesses. The specific aims are: 1. To evaluate the efficacy of the EHR-based clinician-facing Jumpstart, drawn from the electronic medical record (EHR), the survey-based bi-directional Jumpstart, drawn from patient or family completed surveys, and usual care for improving quality of care provided to patients with chronic illness experiencing a hospitalization. The primary outcome is EHR documentation of a goals-of-care discussion, assessed from randomization through 30 days. Secondary outcomes include: a) intensity of care outcomes (e.g., ICU use, ICU and hospital free days, hospital readmissions, costs of hospital care); and b) patient- and family-reported outcomes assessed by surveys at 3-5 days and 4-6 weeks after randomization, including occurrence and quality of goals-of-care discussions in the hospital, goal-concordant care, psychological symptoms, and quality of life. 2. To conduct a mixed-methods evaluation of the implementation of the interventions, guided by the RE-AIM and CFIR frameworks for implementation science, incorporating quantitative evaluation of the interventions' reach and adoption, as well as qualitative analyses of interviews with participants, to explore barriers and facilitators to future implementation and dissemination.

Research Team

EK

Erin K Kross, MD

Principal Investigator

University of Washington

Eligibility Criteria

This trial is for adults over 55 with chronic conditions like cancer, heart failure, or diabetes, or those over 80. They must speak English and have been in the hospital between 12-96 hours without a prior goals-of-care discussion. Surrogates involved in care can join if they're adults and English-speaking. Clinicians must be adults, English-speaking, employed at the participating hospital and caring for an enrolled patient.

Inclusion Criteria

I am a clinician, over 18, speak English, work at a participating hospital, and have treated a patient in this trial.
You are eligible for the study if you are 80 years or older, or 55 years or older with a chronic condition such as cancer, heart disease, kidney disease, dementia, or diabetes with organ damage. You must speak English, have been admitted to the hospital for 12-96 hours, and have not had a goals-of-care discussion during this admission. If you are unable to make decisions for yourself, your legal surrogate decision maker or next of kin will represent you in accordance with Washington State Law RCW 7.70.065.
I will be or have been admitted to the hospital for 12 to 96 hours.
See 13 more

Exclusion Criteria

My family member cannot complete questionnaires due to physical or mental limitations.
Patients under COVID precautions
Patients: Legal or risk management concerns
See 7 more

Treatment Details

Interventions

  • EHR-based Clinician Jumpstart (Behavioural Intervention)
  • Survey-based Patient/Clinician Jumpstart (Behavioural Intervention)
Trial OverviewThe study tests a 'Jumpstart' intervention to improve palliative care quality by promoting discussions about patients' care goals. It compares two methods: one using surveys with patients/clinicians and another using electronic health records (EHR). The main goal is to see if these discussions are documented within hospital stays or up to 30 days.
Participant Groups
3Treatment groups
Experimental Treatment
Active Control
Group I: Survey-based Patient/Clinician JumpstartExperimental Treatment1 Intervention
The Survey-based Patient/Clinician Jumpstart Guide will be developed with two types of data: 1) EHR data; and 2) Survey data. Using automated methods and NLP/ML algorithms, the presence/absence of POLST, advance directives and DPOA documentation will be identified from both inpatient and outpatient notes (e.g., progress notes, specialty consult notes, alerts and care plans) preceding the current hospitalization. The survey data will be completed by patients or their surrogate/family at enrollment and will provide assessments of the following: a) preferences for discussions about goals of care; b) most important barrier and facilitator for having such discussions; and c) current goals of care. These elements are contained within the Jumpstart guides and the information is tailored to each recipient (i.e., patient, surrogate/family, or clinician).
Group II: Usual careActive Control1 Intervention
Patients in this arm receive usual care; neither subjects nor providers will receive either version of the Jumpstart Guide.
Group III: EHR-based Clinician JumpstartActive Control1 Intervention
The EHR-based Clinician Jumpstart Guide will be developed by using automated methods and NLP/ML algorithms to both inpatient and outpatient EHR notes (e.g., progress notes, specialty consult notes, alerts and care plans) preceding the current hospitalization. It will summarize the presence/absence of POLST, advance directives and DPOA documentation. It will not include survey-based information.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials
1,858
Recruited
2,023,000+

Dr. Timothy H. Dellit

University of Washington

Chief Executive Officer since 2023

MD from University of Washington

Dr. Anneliese Schleyer

University of Washington

Chief Medical Officer since 2023

MD, MHA

National Institute on Aging (NIA)

Collaborator

Trials
1,841
Recruited
28,150,000+

Dr. Richard J. Hodes

National Institute on Aging (NIA)

Chief Executive Officer since 1993

MD from Harvard Medical School

Dr. Marie Bernard

National Institute on Aging (NIA)

Chief Medical Officer

MD from Harvard Medical School