Trial Outcomes & Findings for Project to Improve Communication About Serious Illness--Hospital Study: Pragmatic Trial (Trial 1) (NCT NCT04281784)

NCT ID: NCT04281784

Last Updated: 2025-04-04

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 2512 participants
• Primary outcome timeframe: Assessed for the period between randomization and 30 days following randomization
• Results posted on: 2025-04-04

Participant Flow

PATIENTS recruited from 4/23/20 to 3/26/21. A waiver of informed consent and HIPAA authorization obtained for screening and enrollment.

4567 potentially eligible patients identified; 4395 patients screened (1883 ineligible, 2512 eligible); 2512 enrolled.

Participant milestones

Measure	EHR-based Clinician Jumpstart The EHR-based Jumpstart Guide will be developed by extracting data from the EHR to identify documents uploaded prior to the current hospitalization. It will summarize the presence/absence of POLST, advance directives and DPOA documentation and patients' code status. EHR-based Clinician Jumpstart: 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.	Usual Care The clinicians (hospital teams) for patients in the control group will not receive Jumpstart guides. These subjects will receive usual care.
Overall Study STARTED	1255	1257
Overall Study COMPLETED	1255	1257
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	EHR-based Clinician Jumpstart n=1255 Participants The EHR-based Jumpstart Guide will be developed by extracting data from the EHR to identify documents uploaded prior to the current hospitalization. It will summarize the presence/absence of POLST, advance directives and DPOA documentation and patients' code status. EHR-based Clinician Jumpstart: 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.	Usual Care n=1257 Participants The clinicians (hospital teams) for patients in the control group will not receive Jumpstart guides. These subjects will receive usual care.	Total n=2512 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	377 Participants n=5 Participants	412 Participants n=7 Participants	789 Participants n=5 Participants
Age, Categorical >=65 years	878 Participants n=5 Participants	845 Participants n=7 Participants	1723 Participants n=5 Participants
Age, Continuous	71.8 years STANDARD_DEVIATION 10.7 • n=5 Participants	71.6 years STANDARD_DEVIATION 10.9 • n=7 Participants	71.7 years STANDARD_DEVIATION 10.8 • n=5 Participants
Sex: Female, Male Female	543 Participants n=5 Participants	513 Participants n=7 Participants	1056 Participants n=5 Participants
Sex: Female, Male Male	712 Participants n=5 Participants	744 Participants n=7 Participants	1456 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	77 Participants n=5 Participants	73 Participants n=7 Participants	150 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1171 Participants n=5 Participants	1176 Participants n=7 Participants	2347 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	21 Participants n=5 Participants	24 Participants n=7 Participants	45 Participants n=5 Participants
Race (NIH/OMB) Asian	143 Participants n=5 Participants	149 Participants n=7 Participants	292 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	4 Participants n=5 Participants	9 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) Black or African American	168 Participants n=5 Participants	148 Participants n=7 Participants	316 Participants n=5 Participants
Race (NIH/OMB) White	882 Participants n=5 Participants	886 Participants n=7 Participants	1768 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	37 Participants n=5 Participants	41 Participants n=7 Participants	78 Participants n=5 Participants
Region of Enrollment United States	1255 participants n=5 Participants	1257 participants n=7 Participants	2512 participants n=5 Participants

PRIMARY outcome

Timeframe: Assessed for the period between randomization and 30 days following randomization

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.

Outcome measures

Measure	EHR-based Clinician Jumpstart n=1255 Participants The EHR-based Jumpstart Guide will be developed by extracting data from the EHR to identify documents uploaded prior to the current hospitalization. It will summarize the presence/absence of POLST, advance directives and DPOA documentation and patients' code status. EHR-based Clinician Jumpstart: 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.	Usual Care n=1257 Participants The clinicians (hospital teams) for patients in the control group will not receive Jumpstart guides. These subjects will receive usual care.
Proportion of Patients With EHR Documentation of Goals of Care Discussions GOC documented	433 Participants	382 Participants
Proportion of Patients With EHR Documentation of Goals of Care Discussions GOC not documented	822 Participants	875 Participants

SECONDARY outcome

Timeframe: Assessed for the period between randomization and 30 days following randomization

Secondary outcomes include measures of intensity of care, including utilization metrics: Number of ICU admissions during the patient's (index) hospital stay will be collected from the EHR.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Assessed for the period between randomization and 30 days following randomization

Secondary outcomes include measures of intensity of care, including utilization metrics: Number of days alive and out of the ICU within 30 days from randomization will be collected from the EHR.

Outcome measures

Measure	EHR-based Clinician Jumpstart n=1257 Participants The EHR-based Jumpstart Guide will be developed by extracting data from the EHR to identify documents uploaded prior to the current hospitalization. It will summarize the presence/absence of POLST, advance directives and DPOA documentation and patients' code status. EHR-based Clinician Jumpstart: 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.	Usual Care n=1255 Participants The clinicians (hospital teams) for patients in the control group will not receive Jumpstart guides. These subjects will receive usual care.
Intensity of Care/ICU Use: ICU Length of Stay (Number of Days Alive and Out of the ICU)	27.90 days Standard Deviation 6.12	27.83 days Standard Deviation 6.19

SECONDARY outcome

Timeframe: Assessed for the period between randomization and 30 days following randomization

Secondary outcomes include measures of intensity of care, including utilization metrics: Number of days alive and out of the hospital within 30 days from randomization will be collected from the EHR.

Outcome measures

Measure	EHR-based Clinician Jumpstart n=1257 Participants The EHR-based Jumpstart Guide will be developed by extracting data from the EHR to identify documents uploaded prior to the current hospitalization. It will summarize the presence/absence of POLST, advance directives and DPOA documentation and patients' code status. EHR-based Clinician Jumpstart: 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.	Usual Care n=1255 Participants The clinicians (hospital teams) for patients in the control group will not receive Jumpstart guides. These subjects will receive usual care.
Intensity of Care/Hospital Use: Hospital Length of Stay (Number of Days Alive and Out of the Hospital)	21.99 days Standard Deviation 8.78	21.63 days Standard Deviation 9.15

SECONDARY outcome

Timeframe: Assessed for the period between randomization and 30 days following randomization

Secondary outcomes include measures of intensity of care, including utilization metrics: Proportion of patients readmitted to the hospital following index hospitalization.

Outcome measures

Measure	EHR-based Clinician Jumpstart n=1255 Participants The EHR-based Jumpstart Guide will be developed by extracting data from the EHR to identify documents uploaded prior to the current hospitalization. It will summarize the presence/absence of POLST, advance directives and DPOA documentation and patients' code status. EHR-based Clinician Jumpstart: 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.	Usual Care n=1257 Participants The clinicians (hospital teams) for patients in the control group will not receive Jumpstart guides. These subjects will receive usual care.
Intensity of Care: Hospital Readmissions 30 Days	265 Participants	251 Participants

SECONDARY outcome

Timeframe: Assessed for the period between randomization and 30 days following randomization

Secondary outcomes include measures of intensity of care, including utilization metrics: Proportion of patients who received ICU care.

Outcome measures

Measure	EHR-based Clinician Jumpstart n=1255 Participants The EHR-based Jumpstart Guide will be developed by extracting data from the EHR to identify documents uploaded prior to the current hospitalization. It will summarize the presence/absence of POLST, advance directives and DPOA documentation and patients' code status. EHR-based Clinician Jumpstart: 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.	Usual Care n=1257 Participants The clinicians (hospital teams) for patients in the control group will not receive Jumpstart guides. These subjects will receive usual care.
Intensity of Care: ICU Admissions 30 Days	336 Participants	348 Participants

SECONDARY outcome

Timeframe: Assessed for the period between randomization and 30 days later

Population: (Data unavailable from Finance Office for two patients.)

Secondary outcomes include measures of intensity of care, including costs of inpatient care, collected from UW Medicine Finance Office and adjusted for inflation.

Outcome measures

Measure	EHR-based Clinician Jumpstart n=1257 Participants The EHR-based Jumpstart Guide will be developed by extracting data from the EHR to identify documents uploaded prior to the current hospitalization. It will summarize the presence/absence of POLST, advance directives and DPOA documentation and patients' code status. EHR-based Clinician Jumpstart: 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.	Usual Care n=1253 Participants The clinicians (hospital teams) for patients in the control group will not receive Jumpstart guides. These subjects will receive usual care.
Total Hospitalization Costs, Randomization to 30 Days After Randomization	21,908.67 US dollars Standard Deviation 33,613.11	22,386.40 US dollars Standard Deviation 32,988.48

SECONDARY outcome

Timeframe: 30 days after randomization

From Washington State death certificates

Outcome measures

Measure	EHR-based Clinician Jumpstart n=1257 Participants The EHR-based Jumpstart Guide will be developed by extracting data from the EHR to identify documents uploaded prior to the current hospitalization. It will summarize the presence/absence of POLST, advance directives and DPOA documentation and patients' code status. EHR-based Clinician Jumpstart: 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.	Usual Care n=1255 Participants The clinicians (hospital teams) for patients in the control group will not receive Jumpstart guides. These subjects will receive usual care.
All-cause Mortality at 30 Days After Randomization (Safety Outcome) Deceased at 30 days	64 Participants	70 Participants
All-cause Mortality at 30 Days After Randomization (Safety Outcome) Alive at 30 days	1193 Participants	1185 Participants

SECONDARY outcome

Timeframe: Index hospital stay

Population: (Data unavailable from Finance Office for two patients.)

Secondary outcomes include measures of intensity of care, including costs of inpatient care, collected from UW Medicine Finance Office and adjusted for inflation. Assessed for the period between randomization and discharge for the index hospital stay.

Outcome measures

Measure	EHR-based Clinician Jumpstart n=1257 Participants The EHR-based Jumpstart Guide will be developed by extracting data from the EHR to identify documents uploaded prior to the current hospitalization. It will summarize the presence/absence of POLST, advance directives and DPOA documentation and patients' code status. EHR-based Clinician Jumpstart: 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.	Usual Care n=1253 Participants The clinicians (hospital teams) for patients in the control group will not receive Jumpstart guides. These subjects will receive usual care.
Total Hospitalization Costs, Randomization to Index Hospitalization Discharge	24,384.68 US dollars Standard Deviation 46,677.43	23,724.06 US dollars Standard Deviation 38,623.82

Adverse Events

EHR-based Clinician Jumpstart

Serious events: 0 serious events

Other events: 0 other events

Deaths: 70 deaths

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 64 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Janaki Torrence, Research Coordinator

University of Washington

Phone: 206-402-7357

Email: jtorrenc@uw.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place