Project to Improve Communication About Serious Illness--Hospital Study: Comparative Effectiveness Trial (Trial 2)

NCT04283994 | Completed Results DMC

• 2 other identifiers: STUDY00007031-B1R01AG006244
• Study Type: interventional
• Target: 756
• Locations: 1 country
• Sites: 3

Brief Summary

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. 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. 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.

Conditions

Dementia; Chronic Disease; Neoplasm Metastasis; Lung Neoplasms; Pulmonary Disease, Chronic Obstructive; Heart Failure, Congestive; Liver Cirrhosis; Kidney Failure, Chronic; Lung Diseases, Interstitial; Peripheral Vascular Disease; Diabetes With End Organ Injury

Keywords

Patient care; Inpatients; Health Communication; Patient Care Planning; Quality of Life; Health care quality, access, and evaluation; Palliative care

Outcome Measures

Primary Outcomes (1)

• EHR Documentation of Goals of Care Discussions

  The primary outcome is the proportion of patients who have a goals-of-care discussion that has been documented in the electronic medical record (EHR) in the period between randomization and 30 days following randomization. The proportion is the number of patients with goals-of-care (GOC) documentation over the number of patients in each study arm. Documentation of goals-of-care discussions will be evaluated using our natural language processing/machine learning (NLP/ML) methods.

  from randomization to 30 days post randomization

Secondary Outcomes (15)

• Intensity of Care: ICU Admissions (30 Days)

  from randomization to 30 days post randomization

• Intensity of Care: ICU Admissions (90 Days)

  from randomization to 90 days post randomization

• Intensity of Care: ICU Admissions (Post-discharge, 7 Days)

  7-days post-discharge

• Intensity of Care: ICU Admissions (Post-discharge, 30 Days)

  30-days post-discharge

• Intensity of Care: Hospital Readmissions (7 Days)

  readmissions in 7 days following discharge

Other Outcomes (11)

• Intensity of Care: Palliative Care Consults Completed (30 Days)

  30-days post randomization

• Intensity of Care: Palliative Care Consults Completed (90 Days)

  90-days post randomization

• All-cause Mortality at 30 Days (Safety Outcome)

  30 days after randomization

Study Arms (3)

Survey-based Patient/Clinician Jumpstart

EXPERIMENTAL

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).

Behavioral: Survey-based Patient/Clinician Jumpstart

EHR-based Clinician Jumpstart

ACTIVE COMPARATOR

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.

Behavioral: EHR-based Clinician Jumpstart

Usual care

NO INTERVENTION

Patients in this arm receive usual care; neither subjects nor providers will receive either version of the Jumpstart Guide.

Interventions

Survey-based Patient/Clinician Jumpstart BEHAVIORAL

The Jumpstart Guide is a communication-priming intervention for clinicians, patients and their families that addresses hospitalized patients' goals of care. The intervention's goal is to prompt clinicians to provide standard of care which includes a discussion with patients or their legal surrogate decision-maker about their goals of care. The Jumpstart takes two forms. One is "EHR-based" and provides information to the clinician about prior advance care planning documentation derived from the EHR. The other is "bi-directional" and patient-specific (Survey-based Patient/Clinician Jumpstart Guide). It provides the same information as the EHR-based Clinician Jumpstart Guide but also includes information about patients' self-reported preferences for communication and care as well as primary barriers and facilitators to this communication. The Jumpstart Guides include tips to improve this communication for clinicians, patients and families.

Also known as: Bidirectional Jumpstart Guide Intervention

Survey-based Patient/Clinician Jumpstart

EHR-based Clinician Jumpstart BEHAVIORAL

The Jumpstart Guide is a communication-priming intervention for clinicians that addresses hospitalized patients' goals of care. The intervention's goal is to prompt clinicians to provide standard of care which includes a discussion with patients or their legal surrogate decision-maker about their goals of care. The one-page EHR-based Clinician Jumpstart Guide provides information to the clinician about prior advance care planning documentation derived from the EHR. The EHR-based Clinician Jumpstart Guide includes tips to improve goals-of-care communication.

Also known as: Clinician-facing Jumpstart Guide Intervention

EHR-based Clinician Jumpstart

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• PATIENTS. Eligible patients will be those who are: 1) equal to or older than 80 years of age; or 2) 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: malignant cancer/leukemia, chronic pulmonary disease, coronary artery disease, heart failure, chronic liver disease, chronic renal disease, dementia, diabetes with end-organ damage, and peripheral vascular disease, 3) English-speaking, 4) admitted for minimum of 12 hours/maximum of 96 hours to participating in-patient services at the participating hospitals, and 5) without documentation in the EHR of a goals-of-care discussion during this admission. Patients without decisional capacity (as documented in the EHR or as identified with a brief six-item screening tool) will be represented by a legal surrogate decision maker/legal next of kin (LNOK) in accordance with Washington State Law RCW 7.70.065.
• SURROGATE/FAMILY. Eligible surrogate/family subjects will be those who are 18 years of age or older, English-speaking, involved in the patient's medical care or decision-making.
• CLINICIANS (Interview). Eligible clinicians will be those who are 18 years of age or older, English-speaking, employed at a participating hospital, and have been the clinician of record for an enrolled patient in the trial.

Sponsors & Collaborators

• University of Washington: lead
• National Institute on Aging (NIA): collaborator

Study Sites (3)

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

UW Medical Center - Northwest

Seattle, Washington, 98133, United States

Location

UW Medical Center - Montlake

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Dementia; Chronic Disease; Neoplasm Metastasis; Lung Neoplasms; Pulmonary Disease, Chronic Obstructive; Heart Failure; Liver Cirrhosis; Kidney Failure, Chronic; Lung Diseases, Interstitial; Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplastic Processes; Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Heart Diseases; Cardiovascular Diseases; Liver Diseases; Digestive System Diseases; Fibrosis; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Vascular Diseases

Results Point of Contact

• Title: Dr. Erin Kross
• Organization: University of Washington

ekross@uw.edu

206-744-4649

Study Officials

• Erin K Kross, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Division of Pulmonary, Critical Care and Sleep Medicine

Study Record Dates

• First Submitted: February 19, 2020
• First Posted: February 25, 2020
• Study Start: July 26, 2021
• Primary Completion: December 1, 2023
• Study Completion: January 27, 2025
• Last Updated: June 24, 2025
• Results First Posted: February 21, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)