Project to Improve Communication About Serious Illness--Hospital Study: Pragmatic Trial (Trial 1)

NCT04281784 | Completed Results DMC

• 2 other identifiers: STUDY00007031-A1R01AG006244
• Study Type: interventional
• Target: 2,512
• 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 will examine the effect of the EHR-based intervention to improve quality of palliative care for patients 55 years or older with chronic, life-limiting illness with a particular emphasis on Alzheimer's disease and related dementias (ADRD). The specific aims are:

1. 1.To evaluate the effectiveness of a novel EHR-based (electronic health record) clinician Jumpstart guide, compared with usual care, for improving the quality of care; the primary outcome is documentation of a goals-of-care discussion in the period between randomization and 30 days following randomization. Secondary outcomes focus on intensity of care: ICU use, ICU and hospital length of stay, costs of care during the hospitalization, and 7 and 30-day hospital readmissions.
2. 2.To conduct a mixed-methods evaluation of the implementation of the intervention, guided by the RE-AIM framework for implementation science, incorporating quantitative evaluation of the intervention's 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 Neoplasm; Pulmonary Disease, Chronic Obstructive; Heart Failure，Congestive; Liver Cirrhosis; Kidney Failure, Chronic; Lung Diseases, Interstitial; Peripheral Vascular Disease; Diabetes With End Organ Injury

Keywords

Health care quality, access, and evaluation; Patient care; Inpatients; Health communication; Patient care planning; Palliative care

Outcome Measures

Primary Outcomes (1)

• Proportion of Patients With EHR Documentation of Goals of Care Discussions

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

  Assessed for the period between randomization and 30 days following randomization

Secondary Outcomes (8)

• Intensity of Care/ICU Use: ICU Admissions

  Assessed for the period between randomization and 30 days following randomization

• Intensity of Care/ICU Use: ICU Length of Stay (Number of Days Alive and Out of the ICU)

  Assessed for the period between randomization and 30 days following randomization

• Intensity of Care/Hospital Use: Hospital Length of Stay (Number of Days Alive and Out of the Hospital)

  Assessed for the period between randomization and 30 days following randomization

• Intensity of Care: Hospital Readmissions 30 Days

  Assessed for the period between randomization and 30 days following randomization

• Intensity of Care: ICU Admissions 30 Days

  Assessed for the period between randomization and 30 days following randomization

Study Arms (2)

EHR-based Clinician Jumpstart

EXPERIMENTAL

The EHR-based Jumpstart Guide will be developed by extracting data from the EHR using automated methods with both inpatient and outpatient 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 and patients' code status.

Behavioral: EHR-based Clinician Jumpstart

Usual Care

NO INTERVENTION

The clinicians (hospital teams) for patients in the control group will not receive Jumpstart guides. These subjects will receive usual care.

Interventions

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 Jumpstart Guide provides information to the clinician about prior advance care planning documentation and code status derived from the EHR. The Jumpstart Guides includes tips to improve goals-of-care communication.

Also known as: Jumpstart Guide Intervention, Clinician-facing Jumpstart

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) older than 80 years of age; or 2) 55 years of age or older who meet criteria for serious illness. Serious illness encompasses acute illness (e.g. COVID-19) and chronic illnesses (e.g. those included in 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).
• 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 (UWMC)

Seattle, Washington, 98195, United States

Location

Related Publications (2)

• Curtis JR, Lee RY, Brumback LC, Kross EK, Downey L, Torrence J, Heywood J, LeDuc N, Mallon Andrews K, Im J, Weiner BJ, Khandelwal N, Abedini NC, Engelberg RA. Improving communication about goals of care for hospitalized patients with serious illness: Study protocol for two complementary randomized trials. Contemp Clin Trials. 2022 Sep;120:106879. doi: 10.1016/j.cct.2022.106879. Epub 2022 Aug 10.

  PMID: 35963531 BACKGROUND

• Curtis JR, Lee RY, Brumback LC, Kross EK, Downey L, Torrence J, LeDuc N, Mallon Andrews K, Im J, Heywood J, Brown CE, Sibley J, Lober WB, Cohen T, Weiner BJ, Khandelwal N, Abedini NC, Engelberg RA. Intervention to Promote Communication About Goals of Care for Hospitalized Patients With Serious Illness: A Randomized Clinical Trial. JAMA. 2023 Jun 20;329(23):2028-2037. doi: 10.1001/jama.2023.8812.

  PMID: 37210665 RESULT

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: Janaki Torrence, Research Coordinator
• Organization: University of Washington

jtorrenc@uw.edu

206-402-7357

Study Officials

• Ruth Engelberg, PHD

  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: Research Professor; Cambia Palliative Care Center of Excellence; Pulmonary, Critical Care and Sleep Medicine

Study Record Dates

• First Submitted: February 19, 2020
• First Posted: February 24, 2020
• Study Start: April 23, 2020
• Primary Completion: April 26, 2021
• Study Completion: September 26, 2022
• Last Updated: April 4, 2025
• Results First Posted: August 1, 2022

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)