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Project to Improve Communication About Serious Illness - Pilot Study

Using the Electronic Health Record to Identify and Promote Goals-of-Care Communication

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03746392
Acronym
PICSI-P
Enrollment
150
Registered
2018-11-19
Start date
2018-07-01
Completion date
2020-06-30
Last updated
2025-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congestive Heart Failure, Dementia, Diabetes Complications, Frail Elderly, Leukemia, Lymphocytic, Chronic, B-Cell, Liver Failures, Chronic, Lung Disease Chronic, Malignant Neoplasm, Peripheral Vascular Disease, Renal Insufficiency, Chronic

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.

Interventions

BEHAVIORALJumpstart Intervention

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.

Sponsors

University of Washington
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Documentation of Goals of CareAt hospital discharge, an average of 2 weeksPresence of documentation of goals of care discussions in the patient's electronic health record during the index hospitalization

Countries

United States

Participant flow

Participants by arm

ArmCount
Jumpstart Intervention
Jumpstart Intervention: 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.
75
Usual Care
Usual in-patient hospital care.
75
Total150

Baseline characteristics

CharacteristicJumpstart InterventionTotalUsual Care
Age, Continuous62 years61 years60 years
Ethnicity (NIH/OMB)
Hispanic or Latino
8 Participants9 Participants1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
67 Participants141 Participants74 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants2 Participants1 Participants
Race (NIH/OMB)
Asian
0 Participants2 Participants2 Participants
Race (NIH/OMB)
Black or African American
10 Participants19 Participants9 Participants
Race (NIH/OMB)
More than one race
2 Participants10 Participants8 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants1 Participants1 Participants
Race (NIH/OMB)
White
62 Participants116 Participants54 Participants
Region of Enrollment
United States
75 participants150 participants75 participants
Sex: Female, Male
Female
27 Participants66 Participants39 Participants
Sex: Female, Male
Male
48 Participants84 Participants36 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 750 / 75
other
Total, other adverse events
0 / 750 / 75
serious
Total, serious adverse events
0 / 750 / 75

Outcome results

Primary

Documentation of Goals of Care

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

Time frame: At hospital discharge, an average of 2 weeks

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Jumpstart InterventionDocumentation of Goals of Care16 Participants
Usual CareDocumentation of Goals of Care6 Participants
p-value: 0.036Fisher Exact

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026