NCT03746392

Brief Summary

This two-year pilot study will test whether a one-page "Jumpstart Form" will affect goals-of-care discussions in the hospital. This form will be provided to clinicians and will include patient-specific information about preferences for goals-of-care communication and for care, as well as tips to improve this communication. Jumpstart forms will also be provided to patients or, if they are unable to communicate, their surrogates/family members. The information on the form will be obtained from questionnaires. The form is tailored to help patients and surrogates talk with clinicians about goals of care. This study is based on a successful application of Jumpstart Form in the outpatient clinic setting.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2018

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 9, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 19, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
5.1 years until next milestone

Results Posted

Study results publicly available

August 22, 2025

Completed
Last Updated

August 22, 2025

Status Verified

August 1, 2025

Enrollment Period

2 years

First QC Date

November 9, 2018

Results QC Date

July 17, 2025

Last Update Submit

August 6, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Documentation of Goals of Care

    Presence of documentation of goals of care discussions in the patient's electronic health record during the index hospitalization

    At hospital discharge, an average of 2 weeks

Study Arms (2)

Jumpstart Intervention

EXPERIMENTAL
Behavioral: Jumpstart Intervention

Usual Inpatient Hospital Care

NO INTERVENTION

Interventions

The intervention has 4 steps: use electronic medical record (EHR) to identify seriously ill, hospitalized patients with no documentation of a goals-of-care (GOC) discussion during their current admission; the enrolled patient or his/her surrogate completes a survey assessing preferences for discussions about GOC, barriers to having such discussions, and current GOC which is used to create a "Jumpstart" form designed to prompt and guide a GOC discussion between the patient or surrogate and the clinicians caring for the patient; use natural language processing/machine learning (NLP/ML) approach to identify GOC discussions or advance directives in the EHR that occurred prior to admission and include this information on the Jumpstart form; and, deliver the Jumpstart form to the primary clinician team. The patient or surrogate is also provided with a version of the form.

Jumpstart Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • those used by the Dartmouth Atlas to study end-of-life care in the US: malignant cancer/leukemia, chronic pulmonary disease, coronary artery disease, congestive heart failure, chronic liver disease, chronic renal disease, dementia, diabetes with end-organ damage, and peripheral vascular disease.
  • patients over age 65 with markers of frailty: albumin level \<3.0 within 48 hours of admission and weight loss of ≥10 pounds in the past year.
  • hospitalized patients over age 80.
  • English-speaking

You may not qualify if:

  • unable to complete informed consent procedures and do not have a legal next of kin
  • restricted information status (e.g. prisoners)
  • pregnant
  • involved in the care of an eligible patient as the legal next-of-kin
  • English-speaking
  • unable to complete informed consent procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

Related Publications (1)

  • Lee RY, Kross EK, Downey L, Paul SR, Heywood J, Nielsen EL, Okimoto K, Brumback LC, Merel SE, Engelberg RA, Curtis JR. Efficacy of a Communication-Priming Intervention on Documented Goals-of-Care Discussions in Hospitalized Patients With Serious Illness: A Randomized Clinical Trial. JAMA Netw Open. 2022 Apr 1;5(4):e225088. doi: 10.1001/jamanetworkopen.2022.5088.

MeSH Terms

Conditions

NeoplasmsLeukemia, Lymphocytic, Chronic, B-CellHeart FailureEnd Stage Liver DiseaseRenal Insufficiency, ChronicDementiaDiabetes ComplicationsPeripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Leukemia, B-CellLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHeart DiseasesCardiovascular DiseasesLiver FailureHepatic InsufficiencyLiver DiseasesDigestive System DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersDiabetes MellitusEndocrine System DiseasesVascular Diseases

Results Point of Contact

Title
Program Coordinator (Elizabeth Nielsen)
Organization
University of Washington

Study Officials

  • Ruth Engelberg, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

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
ResearchProfessor, Department of Medicine, SOM: Department of Medicine: Pulmonary, Critical Care and Sleep Medicine

Study Record Dates

First Submitted

November 9, 2018

First Posted

November 19, 2018

Study Start

July 1, 2018

Primary Completion

June 30, 2020

Study Completion

June 30, 2020

Last Updated

August 22, 2025

Results First Posted

August 22, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations