Communication Intervention for Dementia

(PICSI-H Trial)

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new methods to enhance communication between patients with chronic illnesses, such as Alzheimer's, and their healthcare providers. The aim is to ensure that care aligns with patients' personal goals, particularly during hospital stays. The trial compares two approaches to support these conversations: one uses electronic health records (EHR-based Clinician Jumpstart), and the other involves surveys completed by patients or their families (Survey-based Patient/Clinician Jumpstart). Suitable participants include those with serious health conditions, like dementia, who have been hospitalized for at least 12 hours and wish to ensure their care aligns with their preferences. As an unphased trial, this study offers a unique opportunity to improve patient-provider communication and ensure care aligns with personal goals.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this protocol is safe for patients with chronic illness?

Research has shown that the Jumpstart programs, including the EHR-based Clinician Jumpstart and the Survey-based Patient/Clinician Jumpstart, have undergone safety testing. These programs aim to enhance communication about care goals, particularly for individuals with dementia and other long-term illnesses.

The EHR-based Clinician Jumpstart uses electronic health records to guide conversations about patient care goals. No evidence indicates any negative effects from this method. It primarily involves using existing medical records to facilitate discussions between doctors and patients about care preferences.

The Survey-based Patient/Clinician Jumpstart collects information directly from patients or their families through surveys, helping to tailor discussions about care goals. Again, no reports indicate harmful effects from this approach.

Both programs focus on communication and planning, rather than drugs or medical procedures. They aim to improve the quality of discussions about care, ensuring safety and tolerance for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Communication Intervention for Dementia because it offers a fresh approach to enhancing conversations about care goals between patients, families, and clinicians. Unlike standard care, which often lacks structured communication aids, the Survey-based Patient/Clinician Jumpstart Guide utilizes personalized data from surveys and electronic health records. This guide tailors the conversation based on patient preferences and current goals of care, making discussions more relevant and impactful. Meanwhile, the EHR-based Clinician Jumpstart Guide leverages advanced algorithms to extract key documentation from health records, streamlining the process for clinicians to have informed discussions. These innovations aim to bridge communication gaps, ultimately leading to better-aligned care decisions for dementia patients.

What evidence suggests that this trial's interventions could be effective for improving palliative care in patients with Alzheimer's disease and related dementias?

This trial compares two Jumpstart interventions to enhance discussions about care goals recorded in electronic health records. The EHR-based Clinician Jumpstart uses smart tools to summarize key care documents, helping doctors quickly understand patient preferences. Meanwhile, the Survey-based Patient/Clinician Jumpstart includes personal insights from patients or their families, making discussions more personalized and effective. Studies have shown that both methods promise to enhance communication and care quality for those with chronic, life-limiting illnesses, such as Alzheimer's. ^{1 2 4 6 7}

Who Is on the Research Team?

Erin K Kross, MD

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. reporter.nih.gov reporter.nih.gov/project-details/10898719

Project Details - NIH RePORTER This study will provide important data for patients with ADRD, their family caregivers, clinicians, and healthcare systems on the efficacy of the Jumpstart ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05596760

Study Details | NCT05596760 | Promoting Goals-of-Care ... The goal of this clinical trial is to improve communication among clinicians, patients with memory problems, and their family members.

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2790602

Efficacy of a Communication-Priming Intervention on ... The Jumpstart intervention resulted in a significant increase in electronic health record–documented goals-of-care discussions between randomization and ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04283994

Project to Improve Communication About Serious Illness-- ... This trial tests the comparative effectiveness of the survey-based bi-directional Jumpstart, the EHR-based clinician-facing Jumpstart and usual care. Unique to ...

5. withpower.com withpower.com/trial/phase-renal-insufficiency-6-2021-accf2

Communication Intervention for Dementia (PICSI-H 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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11244615/

The electronic health record Risk of Alzheimer's and ... Secondary outcomes include healthcare utilization from the EHR and patient, family member and clinician satisfaction assessed through surveys and interviews.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2274580724003145

Standardizing Electronic Health Record Data on AD/ADRD ... Monitoring the safety, efficacy, and value of approved therapies and care interventions across diverse populations in real time by using SHRD to make it easier ...