Communication Intervention for Dementia

(PICSI-H Trial)

Recruiting at 3 trial locations

Overseen By Ruth A. Engelberg, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Disqualifiers: Prisoners, Non-English speaking, COVID precautions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

756 Participants Needed

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

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

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.

I am 55 or older with one or more long-term health conditions.

Exclusion Criteria

My family member cannot complete questionnaires due to physical or mental limitations.

Patients under COVID precautions

Patients: Legal or risk management concerns

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

In-person during hospital stay

Intervention Delivery

Delivery of Jumpstart intervention to clinicians and patients/surrogates, including EHR-based and survey-based guides

1-3 days post-randomization

In-person and via secure email

Follow-up

Participants are monitored for goals-of-care discussions and quality of communication

4-6 weeks

Surveys at 3-5 days and 4-6 weeks post-randomization

Outcome Assessment

Assessment of EHR documentation and patient/surrogate-reported outcomes

30 days post-randomization

Treatment Details

Interventions

• EHR-based Clinician Jumpstart
• Survey-based Patient/Clinician Jumpstart

Trial Overview 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.

Participant Groups

Group I: Survey-based Patient/Clinician Jumpstart Experimental Treatment 1 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 care Active Control 1 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 Jumpstart Active Control 1 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.

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+