Clinical trial NCT03746392: Project to Improve Communication About Serious Illness - Pilot Study
Official title: Using the Electronic Health Record to Identify and Promote Goals-of-Care Communication
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malignant Neoplasm
Leukemia, Lymphocytic, Chronic, B-Cell
Lung Disease Chronic
Congestive Heart Failure
Liver Failures, Chronic
Renal Insufficiency, Chronic
Dementia
Diabetes Complications
Peripheral Vascular Disease
Frail Elderly
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2018-11-19
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: Inclusion Criteria, Patients: meeting criteria for serious illness (encompassing multiple acute and chronic illnesses) including:

* 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

Exclusion Criteria, Patients:

* unable to complete informed consent procedures and do not have a legal next of kin
* restricted information status (e.g. prisoners)
* pregnant

Inclusion Criteria, Surrogates:

* involved in the care of an eligible patient as the legal next-of-kin
* English-speaking

Exclusion Criteria, Surrogates:

* unable to complete informed consent procedures

Primary outcomes:
measure: Documentation of goals of care
timeFrame: At hospital discharge, an average of 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
Study officials:
affiliation: University of Washington
name: J. Randall Curtis, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.