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Communication Intervention for Dementia (PICSI-H Trial)

N/A
Waitlist Available
Led By Ruth A Engelberg, PhD
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients: Equal to or older than 55 years of age with one or more chronic conditions used by the Dartmouth Atlas to study end-of-life care
Clinicians (Interview): English-speaking
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 days after randomization
Awards & highlights

PICSI-H Trial Summary

This trial is testing whether or not the Jumpstart intervention can improve patient-centered outcomes for those with chronic illness. The study will specifically look at Alzheimer's disease and related dementias, but will also include other common chronic illnesses. The trial will assess the efficacy of the intervention by measuring quality of care, intensity of care outcomes, and patient- and family-reported outcomes. There will also be a mixed-methods evaluation of the implementation of the intervention to explore barriers and facilitators to future implementation and dissemination.

Who is the study for?
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.Check my eligibility
What is being tested?
The 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.See study design
What are the potential side effects?
Since this trial involves communication interventions rather than medications, there are no direct medical side effects expected from participation. However, discussing serious illness may cause emotional discomfort or distress.

PICSI-H Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 55 or older with one or more long-term health conditions.
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I am a clinician who speaks English.
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I am 80 years old or older.

PICSI-H Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 days after randomization
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 days after randomization for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
EHR documentation of Goals of Care discussions
Secondary outcome measures
All-cause mortality at 1 year (safety outcome)
Anxiety and depression (HADS)
CollaboRATE
+14 more
Other outcome measures
Key Implementation Factors

PICSI-H Trial Design

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 Location

Who is running the clinical trial?

National Institute on Aging (NIA)NIH
1,668 Previous Clinical Trials
28,004,446 Total Patients Enrolled
2 Trials studying Patient Care Planning
3,712 Patients Enrolled for Patient Care Planning
University of WashingtonLead Sponsor
1,738 Previous Clinical Trials
1,843,733 Total Patients Enrolled
3 Trials studying Patient Care Planning
5,232 Patients Enrolled for Patient Care Planning
Ruth A Engelberg, PhDPrincipal InvestigatorUniversity of Washington
2 Previous Clinical Trials
1,547 Total Patients Enrolled

Media Library

EHR-based Clinician Jumpstart Clinical Trial Eligibility Overview. Trial Name: NCT04283994 — N/A
Patient Care Planning Research Study Groups: Survey-based Patient/Clinician Jumpstart, Usual care, EHR-based Clinician Jumpstart
Patient Care Planning Clinical Trial 2023: EHR-based Clinician Jumpstart Highlights & Side Effects. Trial Name: NCT04283994 — N/A
EHR-based Clinician Jumpstart 2023 Treatment Timeline for Medical Study. Trial Name: NCT04283994 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment still underway for this research project?

"The clinical trial has been actively recruiting participants since July 26th 2021, as attested to on the official website of clinicaltrials.gov. The listing was recently updated on February 16th 2022."

Answered by AI

What is the participant count for this clinical investigation?

"Affirmative. Clinicaltrials.gov's records demonstrate that this study is actively recruiting participants, with the original post being shared on July 26th 2021 and the last update occurring February 16th 2022. The project requires 600 patients to be enrolled over 3 research sites."

Answered by AI

Who else is applying?

What state do they live in?
Washington
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
~169 spots leftby Apr 2025