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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

Must not have

Patients: Non-English speaking

Patients: Without a legal surrogate to participate for them

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 days after randomization

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not speak English.

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I do not have a legal representative to make decisions for me.

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I am unable to understand or sign the consent form.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 days after randomization

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

EHR documentation of Goals of Care discussions

Secondary study objectives

All-cause mortality at 1 year (safety outcome)

Anxiety and depression (HADS)

CollaboRATE

+14 more

Other study objectives

Key Implementation Factors

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 6Eligibility criteria met