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

• Sponsor: University of Washington (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04281784
• Collaborator: National Institute on Aging (NIA) (NIH)
• Enrollment: 2,512
• Locations: 3
• Arms: 2
• Anticipated Duration (Months): 29.1
• Patients Per Site: 837.3
• Patients Per Site Per Month: 28.8

Study Details

Study Description

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. 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. 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.

Condition or Disease	Intervention/Treatment	Phase
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; Palliative Care, Patient Care; Health Care Quality, Access, and Evaluation; Patient Care; Inpatients; Health Communication; Patient Care Planning	Behavioral: EHR-based Clinician Jumpstart	N/A

Detailed Description

OVERVIEW: This is a large pragmatic trial of the Jumpstart intervention designed to promote goals-of-care discussions for older, seriously ill, hospitalized patients. The trial recruits consecutively eligible patients from three UW Medicine hospitals. The Jumpstart Guide is a communication-priming intervention that addresses hospitalized patients' goals of care. It includes information, drawn from the electronic health record (EHR), identifying the dates and locations of prior advance care planning documents (e.g. living wills, healthcare directives, durable power of attorney for healthcare, and Physician Orders for Life Sustaining Treatments (POLST)) and patients' code status. This information is provided by email to patients' clinicians. The Jumpstart Guide includes tips to improve this communication. The trial will assess the effectiveness of the EHR-based clinician Jumpstart as compared with usual care.

This current study is "Trial 1" of the R01 Award funding this trial. Trial 2 was initiated following the completion of recruitment for Trial 1.

SPECIFIC AIM 1 (for Trial 1): Evaluate the efficacy of the EHR-based clinician Jumpstart compared to usual care for improving quality of care.

TRIAL 1 has three components.

Component 1- Subject Identification/Recruitment/Randomization: The investigators will use automated methods with EHR data, including natural language processing/machine learning (NLP/ML) approaches, to identify hospitalized patients with serious illness during the first 2-3 days of this specific admission. Screening reports will be produced daily and include all likely eligible patients. Study staff will use these daily screening reports to review individual records of eligible patients for inclusion and exclusion criteria (i.e. verify eligibility). Patients will not be approached for consent. Eligible patients will be assigned to intervention or comparator in a 1:1 ratio. Patients are randomized using variable size blocks and stratified for hospital and ADRD vs. no ADRD.

Component 2- EHR-based Clinician Jumpstart Guide: The Jumpstart guide is developed by applying NLP/ML algorithms to both inpatient and outpatient EHR notes (e.g., progress notes, specialty consult notes, alerts and care plans) preceding the current hospitalization. It summarizes the presence/absence of POLST, advance directives and DPOA (durable power of attorney) documentation and the patients' code status. It also provides general recommendations to initiating goals of care discussions. Jumpstart guides are prepared for the intervention group only.

Component 3- Delivery of the intervention: For the intervention group, the investigators deliver the Jumpstart guide to the primary hospital team (attending and resident physicians and advanced practice providers) via secure email. The Jumpstart guides are delivered within 1 business day of patient randomization. Study staff monitor the care team of the patient, and if there are any changes, ensure that any new providers receive the Jumpstart guide as well.

Comparator: The hospital teams for patients in the control group do not receive Jumpstart guides.

Outcome Assessment. Outcomes are obtained from the EHR and use, in part, NLP/ML methods. The primary outcome is EHR documentation of goals-of-care discussions in the 30 days following randomization. Secondary outcomes are measures of intensity of care, including utilization metrics (i.e., ICU admissions, ICU and hospital lengths of stay, 30-day hospital readmissions), costs of care during hospital admission, and estimated costs of implementing the intervention.

SPECIFIC AIM 2 (Trial 1): Evaluate implementation of the Jumpstart Guide and identify barriers and facilitators to future implementation.

Qualitative evaluation:

Clinician recruitment: Study staff will recruit clinicians who were involved with the study to participate in a short interview after the clinician's study involvement with the enrolled patient has ended. Clinician participants will be selected using purposive sampling to ensure a diverse group (e.g., age, race/ethnicity, gender, specialty, year of training).

Interview: Using an interview guide developed specifically for this project, interviewers will assess respondents' experience with the intervention and gather suggestions for ways to improve the intervention's content, delivery and implementation, including implementation outcomes (e.g., acceptability, fidelity, penetration, maintenance) that will guide future dissemination of the intervention.

Assessment: Interviews are audio recorded, transcribed, and analyzed using thematic analytic methods.

Quantitative evaluation:

Quantitative evaluation for Specific Aim 2 will be guided by the RE-AIM framework. We will evaluate the intervention's: 1) Reach (% of all identified eligible clinicians, patients and families that participated in the study); 2) Adoption (% of eligible services that participated); and 3) Implementation (the proportion of HTML Jumpstart Guides that were opened by a clinician, proportion of patients for whom an HTML JS guide was sent and for whom a JS was opened by a clinician).

Study Design

• Study Type: Interventional
• Actual Enrollment: 2512 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Using the Electronic Health Record to Identify and Promote Goals-of-Care Communication for Older Patients With Serious Illness
• Actual Study Start Date: Apr 23, 2020
• Actual Primary Completion Date: Apr 26, 2021
• Anticipated Study Completion Date: Sep 26, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: EHR-based Clinician Jumpstart 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; 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.; Other Names: Jumpstart Guide Intervention Clinician-facing Jumpstart
No Intervention: Usual Care The clinicians (hospital teams) for patients in the control group will not receive Jumpstart guides. These subjects will receive usual care.

Outcome Measures

Primary Outcome Measures

1. Proportion of Patients With EHR Documentation of Goals of Care Discussions [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.

Secondary Outcome Measures

1. Intensity of Care/ICU Use: ICU Admissions [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.

2. Intensity of Care/ICU Use: ICU Length of Stay [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.

3. Intensity of Care/Hospital Use: Hospital Length of Stay [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.

4. Intensity of Care: Hospital Readmissions 30 Days [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.

5. Intensity of Care: ICU Readmissions 30 Days [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.

6. Intensity of Care: Healthcare Costs [Assessed for the period between randomization and 30 days following randomization]

   Costs for intervention vs. control will be reported in US dollars and identified from UW Medicine administrative financial databases. Costs will be reported for total hospital costs and disaggregated costs (direct-variable, direct fixed, indirect costs). Direct-variable costs will include supply and drug costs. Direct-fixed costs will include labor, clinical department administration, and overhead fees. Indirect costs represent services provided by cost centers not directly linked to patient care such as information technology and environmental services. Costs for ED (emergency department) days and ICU days will be similarly assessed.

7. All-cause Mortality at 1 Year (Safety Outcome) [1 year after randomization]

   From Washington State death certificates.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Eligibility criteria apply to two subject groups: 1) seriously ill adult patients; 2) hospital clinicians.

Inclusion Criteria:

• PATIENTS. Eligible patients will be those who are: 1) older than 80 years of age; or

1. 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.

Exclusion Criteria:

• Reasons for exclusion for any patient include: restricted status (prisoners or victims of violence); legal or risk management concerns (as determined by the attending physician or via hospital record designation).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Harborview Medical Center	Seattle	Washington	United States	98104
2	UW Medical Center - Northwest	Seattle	Washington	United States	98133
3	UW Medical Center - Montlake (UWMC)	Seattle	Washington	United States	98195

Sponsors and Collaborators

• University of Washington
• National Institute on Aging (NIA)

Investigators

• Principal Investigator: J. Randall Curtis, MD, MPH, University of Washington

Study Documents (Full-Text)

• Study Protocol - Apr 25, 2022
• Statistical Analysis Plan - Apr 25, 2022

More Information

Publications

None provided.

• Responsible Party: J. Randall Curtis, Professor, Department of Medicine, SOM: Department of Medicine: Pulmonary, Critical Care and Sleep Medicine, University of Washington
• ClinicalTrials.gov Identifier: NCT04281784
• Other Study ID Numbers: STUDY00007031-A; 1R01AG006244
• First Posted: Feb 24, 2020
• Last Update Posted: Aug 1, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Neoplasms; Neoplasm Metastasis; Lung Neoplasms; Liver Cirrhosis; Lung Diseases; Pulmonary Disease, Chronic Obstructive; Lung Diseases, Interstitial; Renal Insufficiency; Kidney Failure, Chronic; Heart Failure; Vascular Diseases; Peripheral Vascular Diseases; Peripheral Arterial Disease; Chronic Disease

Study Results

Participant Flow

Recruitment Details	PATIENTS recruited from 4/23/20 to 3/26/21. A waiver of informed consent and HIPAA authorization obtained for screening and enrollment.
Pre-assignment Detail	4567 potentially eligible patients identified; 4395 patients screened (1883 ineligible, 2512 eligible); 2512 enrolled.

Arm/Group Title	EHR-based Clinician Jumpstart	Usual Care
Arm/Group Description	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.	The clinicians (hospital teams) for patients in the control group will not receive Jumpstart guides. These subjects will receive usual care.
Period Title: Overall Study
STARTED	1255	1257
COMPLETED	1255	1257
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	EHR-based Clinician Jumpstart	Usual Care	Total
Arm/Group Description	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.	The clinicians (hospital teams) for patients in the control group will not receive Jumpstart guides. These subjects will receive usual care.	Total of all reporting groups
Overall Participants	1255	1257	2512
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	377 30%	412 32.8%	789 31.4%
>=65 years	878 70%	845 67.2%	1723 68.6%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	71.8 (10.7)	71.6 (10.9)	71.7 (10.8)
Sex: Female, Male (Count of Participants)
Female	543 43.3%	513 40.8%	1056 42%
Male	712 56.7%	744 59.2%	1456 58%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	77 6.1%	73 5.8%	150 6%
Not Hispanic or Latino	1171 93.3%	1176 93.6%	2347 93.4%
Unknown or Not Reported	7 0.6%	8 0.6%	15 0.6%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	21 1.7%	24 1.9%	45 1.8%
Asian	143 11.4%	149 11.9%	292 11.6%
Native Hawaiian or Other Pacific Islander	4 0.3%	9 0.7%	13 0.5%
Black or African American	168 13.4%	148 11.8%	316 12.6%
White	882 70.3%	886 70.5%	1768 70.4%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	37 2.9%	41 3.3%	78 3.1%
Region of Enrollment (participants) [Number]
United States	1255 100%	1257 100%	2512 100%

Outcome Measures

1. Primary Outcome

Title	Proportion of Patients With EHR Documentation of Goals of Care Discussions
Description	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.
Time Frame	Assessed for the period between randomization and 30 days following randomization

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	EHR-based Clinician Jumpstart	Usual Care
Arm/Group Description	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.	The clinicians (hospital teams) for patients in the control group will not receive Jumpstart guides. These subjects will receive usual care.
Measure Participants	1255	1257
GOC documented	433 34.5%	382 30.4%
GOC not documented	822 65.5%	875 69.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	EHR-based Clinician Jumpstart, Usual Care
	Comments	Usual care = reference group; intervention arm = comparison group
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.027
	Comments	two-sided test, no adjustment for multiple comparisons
	Method	Regression, Linear
	Comments	Occurrence of discussion regressed on randomization condition, adjusted for ADRD status, hospital, and time between study start & randomization date.
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	0.0421
	Confidence Interval	(2-Sided) 95%; 0.0047 to 0.0777
	Parameter Dispersion	Type: Value:
	Estimation Comments	Robust standard error

2. Secondary Outcome

Title	Intensity of Care/ICU Use: ICU Admissions
Description	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.
Time Frame	Assessed for the period between randomization and 30 days following randomization

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	Intensity of Care/ICU Use: ICU Length of Stay
Description	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.
Time Frame	Assessed for the period between randomization and 30 days following randomization

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	Intensity of Care/Hospital Use: Hospital Length of Stay
Description	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.
Time Frame	Assessed for the period between randomization and 30 days following randomization

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Secondary Outcome

Title	Intensity of Care: Hospital Readmissions 30 Days
Description	Secondary outcomes include measures of intensity of care, including utilization metrics: Proportion of patients readmitted to the hospital following index hospitalization.
Time Frame	Assessed for the period between randomization and 30 days following randomization

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	EHR-based Clinician Jumpstart	Usual Care
Arm/Group Description	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.	The clinicians (hospital teams) for patients in the control group will not receive Jumpstart guides. These subjects will receive usual care.
Measure Participants	1255	1257
Count of Participants [Participants]	265 21.1%	251 20%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	EHR-based Clinician Jumpstart, Usual Care
	Comments	Usual care = reference group; intervention arm = comparison group
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.475
	Comments	two-sided test, no adjustment for multiple comparisons
	Method	Regression, Linear
	Comments	Readmission (0, 1) regressed on randomization condition (0=usual care, 1=intervention), adjusted for ADRD status, and hospital site.
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	0.012
	Confidence Interval	(2-Sided) 95%; -0.020 to 0.043
	Parameter Dispersion	Type: Value:
	Estimation Comments	Robust standard error

6. Secondary Outcome

Title	Intensity of Care: ICU Readmissions 30 Days
Description	Secondary outcomes include measures of intensity of care, including utilization metrics: Proportion of patients who received ICU care.
Time Frame	Assessed for the period between randomization and 30 days following randomization

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	EHR-based Clinician Jumpstart	Usual Care
Arm/Group Description	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.	The clinicians (hospital teams) for patients in the control group will not receive Jumpstart guides. These subjects will receive usual care.
Measure Participants	1255	1257
Count of Participants [Participants]	336 26.8%	348 27.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	EHR-based Clinician Jumpstart, Usual Care
	Comments	Usual care = reference group; intervention arm = comparison group
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.610
	Comments	two-sided test, no adjustment for multiple comparisons
	Method	Regression, Linear
	Comments	ICU care (0,1) regressed on randomization condition (0=usual care, 1=intervention), adjusted for ADRD status, and hospital site.
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	-0.009
	Confidence Interval	(2-Sided) 95%; -0.043 to 0.025
	Parameter Dispersion	Type: Value:
	Estimation Comments	Robust standard error

7. Secondary Outcome

Title	Intensity of Care: Healthcare Costs
Description	Costs for intervention vs. control will be reported in US dollars and identified from UW Medicine administrative financial databases. Costs will be reported for total hospital costs and disaggregated costs (direct-variable, direct fixed, indirect costs). Direct-variable costs will include supply and drug costs. Direct-fixed costs will include labor, clinical department administration, and overhead fees. Indirect costs represent services provided by cost centers not directly linked to patient care such as information technology and environmental services. Costs for ED (emergency department) days and ICU days will be similarly assessed.
Time Frame	Assessed for the period between randomization and 30 days following randomization

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

8. Secondary Outcome

Title	All-cause Mortality at 1 Year (Safety Outcome)
Description	From Washington State death certificates.
Time Frame	1 year after randomization

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	Randomization through one year following randomization.
Adverse Event Reporting Description	No study-related Serious Adverse Events are expected. The Jumpstart intervention is a communication intervention and is unlikely to result in fatal or life-threatening outcomes.
Arm/Group Title	EHR-based Clinician Jumpstart		Usual Care
Arm/Group Description	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. 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.		The clinicians (hospital teams) for patients in the control group will not receive Jumpstart guides. These subjects will receive usual care.
All Cause Mortality
	EHR-based Clinician Jumpstart		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	70/1255 (5.6%)		64/1257 (5.1%)
Serious Adverse Events
	EHR-based Clinician Jumpstart		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1255 (0%)		0/1257 (0%)
Other (Not Including Serious) Adverse Events
	EHR-based Clinician Jumpstart		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1255 (0%)		0/1257 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.