Trial Outcomes & Findings for Project to Improve Communication About Serious Illness--Hospital Study: Comparative Effectiveness Trial (Trial 2) (NCT NCT04283994)

Last Updated: 2025-06-24

Results Overview

The primary outcome is the proportion of patients who have a goals-of-care discussion that has been documented in the electronic medical record (EHR) in the period between randomization and 30 days following randomization. The proportion is the number of patients with goals-of-care (GOC) documentation over the number of patients in each study arm. Documentation of goals-of-care discussions will be evaluated using our natural language processing/machine learning (NLP/ML) methods.

Recruitment status

COMPLETED

Study phase

Target enrollment

756 participants

Primary outcome timeframe

from randomization to 30 days post randomization

Results posted on

2025-06-24

Participant Flow

Patients and family/friend surrogates were screened and recruited from July 2021 to October 2023. Potential subjects were approached in the hospital by a research coordinator to assess interest and eligibility. Enrollees completed baseline surveys and were randomized. Patients and family were approached for interviews between December 2021 and May 2023. Clinicians were recruited for interviews in October 2020 (from Trial 1) and from January 2022 to May 2023 (from Trial 2).

9262 patients were screened for eligibility, 6575 were excluded. 2687 patients/surrogates were approached for recruitment, 1563 were excluded as ineligible, 451 declined participation. Eligibility window expired for another 56 patient/surrogates. 617 subjects were enrolled and randomized for the primary outcome.

Participant milestones

Participant milestones
Measure	Survey-based Bi-directional Jumpstart [Patient] Patients: Randomized \& completing follow-up assessments	EHR-based Clinician-facing Jumpstart [Patient] Patients: Randomized \& completing follow-up assessments	Usual Care [Patient] Patients: Randomized \& completing follow-up assessments	Survey-based Bi-directional Jumpstart [Family] Surrogate participants completing follow-up assessments	EHR-based Clinician-facing Jumpstart [Family] Surrogate participants completing follow-up assessments	Usual Care [Family] Surrogate participants completing follow-up assessments	Clinicians Interview subjects only \[T1/T2\]
Overall Study STARTED	203	205	209	33	36	40	30
Overall Study Completed T2Q Survey [3-5 Days Post]	99	112	118	23	23	28	0
Overall Study Completed After-death (ADQ) Survey	0	0	0	2	3	3	0
Overall Study Completed T3Q Survey [4-6 Weeks Post]	118	109	124	26	22	23	0
Overall Study Completed Qualitative Interview	8	2	0	5	0	0	0
Overall Study COMPLETED	176	181	192	32	36	39	30
Overall Study NOT COMPLETED	27	24	17	1	0	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Survey-based Bi-directional Jumpstart [Patient] Patients: Randomized \& completing follow-up assessments	EHR-based Clinician-facing Jumpstart [Patient] Patients: Randomized \& completing follow-up assessments	Usual Care [Patient] Patients: Randomized \& completing follow-up assessments	Survey-based Bi-directional Jumpstart [Family] Surrogate participants completing follow-up assessments	EHR-based Clinician-facing Jumpstart [Family] Surrogate participants completing follow-up assessments	Usual Care [Family] Surrogate participants completing follow-up assessments	Clinicians Interview subjects only \[T1/T2\]
Overall Study Death	11	20	11	0	0	0	0
Overall Study Withdrawal by Subject	16	4	6	1	0	1	0

Baseline Characteristics

Diagnoses were only collected for the 617 patient subjects.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Survey-based Bi-directional Jumpstart [Patient] n=203 Participants Patients: Randomized \& completing follow-up assessments	EHR-based Clinician-facing Jumpstart [Patient] n=205 Participants Patients: Randomized \& completing follow-up assessments	Usual Care [Patient] n=209 Participants Patients: Randomized \& completing follow-up assessments	Survey-based Bi-directional Jumpstart [Family] n=33 Participants Surrogate participants completing follow-up assessments	EHR-based Clinician-facing Jumpstart [Family] n=36 Participants Surrogate participants completing follow-up assessments	Usual Care [Family] n=40 Participants Surrogate participants completing follow-up assessments	Clinicians n=30 Participants Interview subjects only \[T1/T2\]	Total n=756 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=203 Participants	0 Participants n=205 Participants	0 Participants n=209 Participants	0 Participants n=33 Participants	0 Participants n=36 Participants	0 Participants n=40 Participants	0 Participants n=30 Participants	0 Participants n=756 Participants
Age, Categorical Between 18 and 65 years	62 Participants n=203 Participants	67 Participants n=205 Participants	63 Participants n=209 Participants	17 Participants n=33 Participants	22 Participants n=36 Participants	27 Participants n=40 Participants	29 Participants n=30 Participants	287 Participants n=756 Participants
Age, Categorical >=65 years	141 Participants n=203 Participants	138 Participants n=205 Participants	146 Participants n=209 Participants	16 Participants n=33 Participants	14 Participants n=36 Participants	13 Participants n=40 Participants	1 Participants n=30 Participants	469 Participants n=756 Participants
Age, Continuous	71 years n=203 Participants	72 years n=205 Participants	71 years n=209 Participants	65 years n=33 Participants	61.5 years n=36 Participants	62 years n=40 Participants	38 years n=30 Participants	70 years n=756 Participants
Sex: Female, Male Female	87 Participants n=203 Participants	94 Participants n=205 Participants	92 Participants n=209 Participants	15 Participants n=33 Participants	26 Participants n=36 Participants	25 Participants n=40 Participants	16 Participants n=30 Participants	355 Participants n=756 Participants
Sex: Female, Male Male	116 Participants n=203 Participants	111 Participants n=205 Participants	117 Participants n=209 Participants	18 Participants n=33 Participants	10 Participants n=36 Participants	15 Participants n=40 Participants	14 Participants n=30 Participants	401 Participants n=756 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=203 Participants	6 Participants n=205 Participants	5 Participants n=209 Participants	0 Participants n=33 Participants	2 Participants n=36 Participants	3 Participants n=40 Participants	2 Participants n=30 Participants	30 Participants n=756 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	190 Participants n=203 Participants	195 Participants n=205 Participants	202 Participants n=209 Participants	33 Participants n=33 Participants	34 Participants n=36 Participants	37 Participants n=40 Participants	28 Participants n=30 Participants	719 Participants n=756 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=203 Participants	4 Participants n=205 Participants	2 Participants n=209 Participants	0 Participants n=33 Participants	0 Participants n=36 Participants	0 Participants n=40 Participants	0 Participants n=30 Participants	7 Participants n=756 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=203 Participants	4 Participants n=205 Participants	2 Participants n=209 Participants	0 Participants n=33 Participants	0 Participants n=36 Participants	0 Participants n=40 Participants	0 Participants n=30 Participants	8 Participants n=756 Participants
Race (NIH/OMB) Asian	5 Participants n=203 Participants	11 Participants n=205 Participants	7 Participants n=209 Participants	0 Participants n=33 Participants	4 Participants n=36 Participants	1 Participants n=40 Participants	5 Participants n=30 Participants	33 Participants n=756 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=203 Participants	3 Participants n=205 Participants	0 Participants n=209 Participants	0 Participants n=33 Participants	0 Participants n=36 Participants	1 Participants n=40 Participants	0 Participants n=30 Participants	6 Participants n=756 Participants
Race (NIH/OMB) Black or African American	12 Participants n=203 Participants	17 Participants n=205 Participants	15 Participants n=209 Participants	2 Participants n=33 Participants	2 Participants n=36 Participants	1 Participants n=40 Participants	0 Participants n=30 Participants	49 Participants n=756 Participants
Race (NIH/OMB) White	175 Participants n=203 Participants	163 Participants n=205 Participants	177 Participants n=209 Participants	31 Participants n=33 Participants	28 Participants n=36 Participants	32 Participants n=40 Participants	24 Participants n=30 Participants	630 Participants n=756 Participants
Race (NIH/OMB) More than one race	1 Participants n=203 Participants	1 Participants n=205 Participants	1 Participants n=209 Participants	0 Participants n=33 Participants	1 Participants n=36 Participants	2 Participants n=40 Participants	1 Participants n=30 Participants	7 Participants n=756 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=203 Participants	6 Participants n=205 Participants	7 Participants n=209 Participants	0 Participants n=33 Participants	1 Participants n=36 Participants	3 Participants n=40 Participants	0 Participants n=30 Participants	23 Participants n=756 Participants
Region of Enrollment United States	203 participants n=203 Participants	205 participants n=205 Participants	209 participants n=209 Participants	33 participants n=33 Participants	36 participants n=36 Participants	40 participants n=40 Participants	30 participants n=30 Participants	756 participants n=756 Participants
Diagnoses dementia, confirmed via manual screening	24 Participants n=203 Participants • Diagnoses were only collected for the 617 patient subjects.	25 Participants n=205 Participants • Diagnoses were only collected for the 617 patient subjects.	28 Participants n=209 Participants • Diagnoses were only collected for the 617 patient subjects.	—	—	—	—	77 Participants n=617 Participants • Diagnoses were only collected for the 617 patient subjects.
Diagnoses non-hematologic cancer	40 Participants n=203 Participants • Diagnoses were only collected for the 617 patient subjects.	46 Participants n=205 Participants • Diagnoses were only collected for the 617 patient subjects.	38 Participants n=209 Participants • Diagnoses were only collected for the 617 patient subjects.	—	—	—	—	124 Participants n=617 Participants • Diagnoses were only collected for the 617 patient subjects.
Diagnoses hematologic cancer	2 Participants n=203 Participants • Diagnoses were only collected for the 617 patient subjects.	0 Participants n=205 Participants • Diagnoses were only collected for the 617 patient subjects.	7 Participants n=209 Participants • Diagnoses were only collected for the 617 patient subjects.	—	—	—	—	9 Participants n=617 Participants • Diagnoses were only collected for the 617 patient subjects.
Diagnoses chronic obstructive pulmonary disease (COPD)	46 Participants n=203 Participants • Diagnoses were only collected for the 617 patient subjects.	46 Participants n=205 Participants • Diagnoses were only collected for the 617 patient subjects.	49 Participants n=209 Participants • Diagnoses were only collected for the 617 patient subjects.	—	—	—	—	141 Participants n=617 Participants • Diagnoses were only collected for the 617 patient subjects.
Diagnoses other chronic pulmonary disease	52 Participants n=203 Participants • Diagnoses were only collected for the 617 patient subjects.	44 Participants n=205 Participants • Diagnoses were only collected for the 617 patient subjects.	57 Participants n=209 Participants • Diagnoses were only collected for the 617 patient subjects.	—	—	—	—	153 Participants n=617 Participants • Diagnoses were only collected for the 617 patient subjects.
Diagnoses coronary artery disease (CAD)	84 Participants n=203 Participants • Diagnoses were only collected for the 617 patient subjects.	74 Participants n=205 Participants • Diagnoses were only collected for the 617 patient subjects.	83 Participants n=209 Participants • Diagnoses were only collected for the 617 patient subjects.	—	—	—	—	241 Participants n=617 Participants • Diagnoses were only collected for the 617 patient subjects.
Diagnoses congestive heart failure (CHF)	74 Participants n=203 Participants • Diagnoses were only collected for the 617 patient subjects.	72 Participants n=205 Participants • Diagnoses were only collected for the 617 patient subjects.	76 Participants n=209 Participants • Diagnoses were only collected for the 617 patient subjects.	—	—	—	—	222 Participants n=617 Participants • Diagnoses were only collected for the 617 patient subjects.
Diagnoses peripheral vascular disease (PVD)	43 Participants n=203 Participants • Diagnoses were only collected for the 617 patient subjects.	50 Participants n=205 Participants • Diagnoses were only collected for the 617 patient subjects.	50 Participants n=209 Participants • Diagnoses were only collected for the 617 patient subjects.	—	—	—	—	143 Participants n=617 Participants • Diagnoses were only collected for the 617 patient subjects.
Diagnoses liver disease	31 Participants n=203 Participants • Diagnoses were only collected for the 617 patient subjects.	27 Participants n=205 Participants • Diagnoses were only collected for the 617 patient subjects.	23 Participants n=209 Participants • Diagnoses were only collected for the 617 patient subjects.	—	—	—	—	81 Participants n=617 Participants • Diagnoses were only collected for the 617 patient subjects.
Diagnoses diabetes	63 Participants n=203 Participants • Diagnoses were only collected for the 617 patient subjects.	55 Participants n=205 Participants • Diagnoses were only collected for the 617 patient subjects.	57 Participants n=209 Participants • Diagnoses were only collected for the 617 patient subjects.	—	—	—	—	175 Participants n=617 Participants • Diagnoses were only collected for the 617 patient subjects.
Diagnoses renal disease	47 Participants n=203 Participants • Diagnoses were only collected for the 617 patient subjects.	49 Participants n=205 Participants • Diagnoses were only collected for the 617 patient subjects.	48 Participants n=209 Participants • Diagnoses were only collected for the 617 patient subjects.	—	—	—	—	144 Participants n=617 Participants • Diagnoses were only collected for the 617 patient subjects.
Hospital Site County [HMC]	47 Participants n=203 Participants • Hospital site is only relevant for the 617 patient subjects who were randomized; and for the clinicians who worked at those locations.	49 Participants n=205 Participants • Hospital site is only relevant for the 617 patient subjects who were randomized; and for the clinicians who worked at those locations.	51 Participants n=209 Participants • Hospital site is only relevant for the 617 patient subjects who were randomized; and for the clinicians who worked at those locations.	—	—	—	3 Participants n=30 Participants • Hospital site is only relevant for the 617 patient subjects who were randomized; and for the clinicians who worked at those locations.	150 Participants n=647 Participants • Hospital site is only relevant for the 617 patient subjects who were randomized; and for the clinicians who worked at those locations.
Hospital Site University [UW-ML]	81 Participants n=203 Participants • Hospital site is only relevant for the 617 patient subjects who were randomized; and for the clinicians who worked at those locations.	81 Participants n=205 Participants • Hospital site is only relevant for the 617 patient subjects who were randomized; and for the clinicians who worked at those locations.	82 Participants n=209 Participants • Hospital site is only relevant for the 617 patient subjects who were randomized; and for the clinicians who worked at those locations.	—	—	—	7 Participants n=30 Participants • Hospital site is only relevant for the 617 patient subjects who were randomized; and for the clinicians who worked at those locations.	251 Participants n=647 Participants • Hospital site is only relevant for the 617 patient subjects who were randomized; and for the clinicians who worked at those locations.
Hospital Site Community [UW-NW]	75 Participants n=203 Participants • Hospital site is only relevant for the 617 patient subjects who were randomized; and for the clinicians who worked at those locations.	75 Participants n=205 Participants • Hospital site is only relevant for the 617 patient subjects who were randomized; and for the clinicians who worked at those locations.	76 Participants n=209 Participants • Hospital site is only relevant for the 617 patient subjects who were randomized; and for the clinicians who worked at those locations.	—	—	—	7 Participants n=30 Participants • Hospital site is only relevant for the 617 patient subjects who were randomized; and for the clinicians who worked at those locations.	233 Participants n=647 Participants • Hospital site is only relevant for the 617 patient subjects who were randomized; and for the clinicians who worked at those locations.
Hospital Site More than one location	0 Participants n=203 Participants • Hospital site is only relevant for the 617 patient subjects who were randomized; and for the clinicians who worked at those locations.	0 Participants n=205 Participants • Hospital site is only relevant for the 617 patient subjects who were randomized; and for the clinicians who worked at those locations.	0 Participants n=209 Participants • Hospital site is only relevant for the 617 patient subjects who were randomized; and for the clinicians who worked at those locations.	—	—	—	2 Participants n=30 Participants • Hospital site is only relevant for the 617 patient subjects who were randomized; and for the clinicians who worked at those locations.	2 Participants n=647 Participants • Hospital site is only relevant for the 617 patient subjects who were randomized; and for the clinicians who worked at those locations.
Hospital Site Unknown/Not recorded	0 Participants n=203 Participants • Hospital site is only relevant for the 617 patient subjects who were randomized; and for the clinicians who worked at those locations.	0 Participants n=205 Participants • Hospital site is only relevant for the 617 patient subjects who were randomized; and for the clinicians who worked at those locations.	0 Participants n=209 Participants • Hospital site is only relevant for the 617 patient subjects who were randomized; and for the clinicians who worked at those locations.	—	—	—	11 Participants n=30 Participants • Hospital site is only relevant for the 617 patient subjects who were randomized; and for the clinicians who worked at those locations.	11 Participants n=647 Participants • Hospital site is only relevant for the 617 patient subjects who were randomized; and for the clinicians who worked at those locations.
Relationship to patient Spouse/partner	—	—	—	12 Participants n=33 Participants • Relationship to patient was only relevant for the family/friend surrogates of the patients.	9 Participants n=36 Participants • Relationship to patient was only relevant for the family/friend surrogates of the patients.	9 Participants n=40 Participants • Relationship to patient was only relevant for the family/friend surrogates of the patients.	—	30 Participants n=109 Participants • Relationship to patient was only relevant for the family/friend surrogates of the patients.
Relationship to patient Adult child	—	—	—	11 Participants n=33 Participants • Relationship to patient was only relevant for the family/friend surrogates of the patients.	21 Participants n=36 Participants • Relationship to patient was only relevant for the family/friend surrogates of the patients.	25 Participants n=40 Participants • Relationship to patient was only relevant for the family/friend surrogates of the patients.	—	57 Participants n=109 Participants • Relationship to patient was only relevant for the family/friend surrogates of the patients.
Relationship to patient Sibling	—	—	—	6 Participants n=33 Participants • Relationship to patient was only relevant for the family/friend surrogates of the patients.	3 Participants n=36 Participants • Relationship to patient was only relevant for the family/friend surrogates of the patients.	3 Participants n=40 Participants • Relationship to patient was only relevant for the family/friend surrogates of the patients.	—	12 Participants n=109 Participants • Relationship to patient was only relevant for the family/friend surrogates of the patients.
Relationship to patient Parent	—	—	—	0 Participants n=33 Participants • Relationship to patient was only relevant for the family/friend surrogates of the patients.	0 Participants n=36 Participants • Relationship to patient was only relevant for the family/friend surrogates of the patients.	0 Participants n=40 Participants • Relationship to patient was only relevant for the family/friend surrogates of the patients.	—	0 Participants n=109 Participants • Relationship to patient was only relevant for the family/friend surrogates of the patients.
Relationship to patient Other relative	—	—	—	1 Participants n=33 Participants • Relationship to patient was only relevant for the family/friend surrogates of the patients.	2 Participants n=36 Participants • Relationship to patient was only relevant for the family/friend surrogates of the patients.	3 Participants n=40 Participants • Relationship to patient was only relevant for the family/friend surrogates of the patients.	—	6 Participants n=109 Participants • Relationship to patient was only relevant for the family/friend surrogates of the patients.
Relationship to patient Friend	—	—	—	3 Participants n=33 Participants • Relationship to patient was only relevant for the family/friend surrogates of the patients.	1 Participants n=36 Participants • Relationship to patient was only relevant for the family/friend surrogates of the patients.	0 Participants n=40 Participants • Relationship to patient was only relevant for the family/friend surrogates of the patients.	—	4 Participants n=109 Participants • Relationship to patient was only relevant for the family/friend surrogates of the patients.

PRIMARY outcome

Timeframe: from randomization to 30 days post randomization

Population: All randomized participants

Outcome measures

Outcome measures
Measure	Survey Based Bi-directional Jumpstart Guide Intervention n=203 Participants Patient-or-LNOK-Proxy	EHR Based Clinician-facing Jumpstart Guide Intervention n=205 Participants Patient-or-LNOK-Proxy	Usual Care: No Intervention n=209 Participants Patient-or-LNOK-Proxy
EHR Documentation of Goals of Care Discussions	0.271 Proportion of participants	0.317 Proportion of participants	0.206 Proportion of participants

SECONDARY outcome

Timeframe: from randomization to 30 days post randomization

Population: All randomized participants

Any new ICU admissions or readmissions collected from the EHR.

Outcome measures

Outcome measures
Measure	Survey Based Bi-directional Jumpstart Guide Intervention n=203 Participants Patient-or-LNOK-Proxy	EHR Based Clinician-facing Jumpstart Guide Intervention n=205 Participants Patient-or-LNOK-Proxy	Usual Care: No Intervention n=209 Participants Patient-or-LNOK-Proxy
Intensity of Care: ICU Admissions (30 Days)	0.0887 Count of admissions per participant Standard Deviation 0.302	0.0634 Count of admissions per participant Standard Deviation 0.282	0.0622 Count of admissions per participant Standard Deviation 0.279

SECONDARY outcome

Timeframe: from randomization to 90 days post randomization

Population: All randomized participants

Any new ICU admissions or readmissions collected from the EHR.

Outcome measures

Outcome measures
Measure	Survey Based Bi-directional Jumpstart Guide Intervention n=203 Participants Patient-or-LNOK-Proxy	EHR Based Clinician-facing Jumpstart Guide Intervention n=205 Participants Patient-or-LNOK-Proxy	Usual Care: No Intervention n=209 Participants Patient-or-LNOK-Proxy
Intensity of Care: ICU Admissions (90 Days)	0.118 Count of admissions per participant Standard Deviation 0.367	0.117 Count of admissions per participant Standard Deviation 0.391	0.0957 Count of admissions per participant Standard Deviation 0.354

SECONDARY outcome

Timeframe: 7-days post-discharge

Population: All randomized participants

Any ICU admissions or readmissions collected from the EHR. Censored at 90 days post-randomization.

Outcome measures

Outcome measures
Measure	Survey Based Bi-directional Jumpstart Guide Intervention n=203 Participants Patient-or-LNOK-Proxy	EHR Based Clinician-facing Jumpstart Guide Intervention n=205 Participants Patient-or-LNOK-Proxy	Usual Care: No Intervention n=209 Participants Patient-or-LNOK-Proxy
Intensity of Care: ICU Admissions (Post-discharge, 7 Days)	0.015 Count of admissions per participant Standard Deviation 0.121	0.010 Count of admissions per participant Standard Deviation 0.099	0.000 Count of admissions per participant Standard Deviation 0.000

SECONDARY outcome

Timeframe: 30-days post-discharge

Population: All randomized participants

Any ICU admissions or readmissions collected from the EHR. Censored at 90 days post-randomization.

Outcome measures

Outcome measures
Measure	Survey Based Bi-directional Jumpstart Guide Intervention n=203 Participants Patient-or-LNOK-Proxy	EHR Based Clinician-facing Jumpstart Guide Intervention n=205 Participants Patient-or-LNOK-Proxy	Usual Care: No Intervention n=209 Participants Patient-or-LNOK-Proxy
Intensity of Care: ICU Admissions (Post-discharge, 30 Days)	0.030 Count of admissions per participant Standard Deviation 0.170	0.034 Count of admissions per participant Standard Deviation 0.207	0.024 Count of admissions per participant Standard Deviation 0.153

SECONDARY outcome

Timeframe: readmissions in 7 days following discharge

Population: All randomized participants

Any hospital readmissions in 7 days following discharge; collected from the EHR. Censored at 90 days post-randomization.

Outcome measures

Outcome measures
Measure	Survey Based Bi-directional Jumpstart Guide Intervention n=203 Participants Patient-or-LNOK-Proxy	EHR Based Clinician-facing Jumpstart Guide Intervention n=205 Participants Patient-or-LNOK-Proxy	Usual Care: No Intervention n=209 Participants Patient-or-LNOK-Proxy
Intensity of Care: Hospital Readmissions (7 Days)	0.0394 Count of admissions per participant Standard Deviation 0.195	0.0732 Count of admissions per participant Standard Deviation 0.261	0.0766 Count of admissions per participant Standard Deviation 0.267

SECONDARY outcome

Timeframe: readmissions in 30 days following discharge

Population: All randomized participants

Any hospital readmissions in 30 days following discharge collected from the EHR. Censored at 90 days post-randomization.

Outcome measures

Outcome measures
Measure	Survey Based Bi-directional Jumpstart Guide Intervention n=203 Participants Patient-or-LNOK-Proxy	EHR Based Clinician-facing Jumpstart Guide Intervention n=205 Participants Patient-or-LNOK-Proxy	Usual Care: No Intervention n=209 Participants Patient-or-LNOK-Proxy
Intensity of Care: Hospital Readmissions (30 Days)	0.128 Count of admissions per participant Standard Deviation 0.335	0.176 Count of admissions per participant Standard Deviation 0.463	0.230 Count of admissions per participant Standard Deviation 0.475

SECONDARY outcome

Timeframe: from randomization to 30 days post randomization

Population: All randomized participants

Number of days alive and out of the ICU within 30 days from randomization, collected from the EHR.

Outcome measures

Outcome measures
Measure	Survey Based Bi-directional Jumpstart Guide Intervention n=203 Participants Patient-or-LNOK-Proxy	EHR Based Clinician-facing Jumpstart Guide Intervention n=205 Participants Patient-or-LNOK-Proxy	Usual Care: No Intervention n=209 Participants Patient-or-LNOK-Proxy
Intensity of Care: ICU Free Days (30 Days)	28.1 Number of days per participant Standard Deviation 5.81	27.9 Number of days per participant Standard Deviation 6.17	28.5 Number of days per participant Standard Deviation 4.72

SECONDARY outcome

Timeframe: from randomization to 90 days post randomization

Population: All randomized participants

Number of days alive and out of the ICU within 90 days from randomization, collected from the EHR.

Outcome measures

Outcome measures
Measure	Survey Based Bi-directional Jumpstart Guide Intervention n=203 Participants Patient-or-LNOK-Proxy	EHR Based Clinician-facing Jumpstart Guide Intervention n=205 Participants Patient-or-LNOK-Proxy	Usual Care: No Intervention n=209 Participants Patient-or-LNOK-Proxy
Intensity of Care: ICU Free Days (90 Days)	83.8 Number of days per participant Standard Deviation 19.3	79.9 Number of days per participant Standard Deviation 24.3	83.1 Number of days per participant Standard Deviation 19.5

SECONDARY outcome

Timeframe: from randomization to 30 days post randomization

Population: All randomized participants

Number of days alive and out of the hospital within 30 days from randomization; collected from the EHR.

Outcome measures

Outcome measures
Measure	Survey Based Bi-directional Jumpstart Guide Intervention n=203 Participants Patient-or-LNOK-Proxy	EHR Based Clinician-facing Jumpstart Guide Intervention n=205 Participants Patient-or-LNOK-Proxy	Usual Care: No Intervention n=209 Participants Patient-or-LNOK-Proxy
Intensity of Care: Hospital Free Days (30 Days)	21.6 Number of days per participant Standard Deviation 8.42	20.8 Number of days per participant Standard Deviation 9.16	20.8 Number of days per participant Standard Deviation 8.51

SECONDARY outcome

Timeframe: from randomization to 90 days post randomization

Population: All randomized participants

Number of days alive and out of the hospital within 90 days from randomization; collected from the EHR.

Outcome measures

Outcome measures
Measure	Survey Based Bi-directional Jumpstart Guide Intervention n=203 Participants Patient-or-LNOK-Proxy	EHR Based Clinician-facing Jumpstart Guide Intervention n=205 Participants Patient-or-LNOK-Proxy	Usual Care: No Intervention n=209 Participants Patient-or-LNOK-Proxy
Intensity of Care: Hospital Free Days (90 Days)	75.2 Number of days per participant Standard Deviation 21.6	70.5 Number of days per participant Standard Deviation 26.6	71.6 Number of days per participant Standard Deviation 24.4

SECONDARY outcome

Timeframe: 3-5 days after randomization

Population: Participants for which there is a response (potentially by a proxy) to this survey question. One response excluded as it was recorded as having occurred on day of randomization.

Subjects will self-report (yes or no) if they had a discussion of goals of care ("the kind of medical care you/your loved one would want") during the index hospitalization. Responses of "unsure" are included in the sample and not counted as missing. This outcome is presented as a proportion: the number of participants reporting a goals-of-care discussion over the number of patients in each study arm.

Outcome measures

Outcome measures
Measure	Survey Based Bi-directional Jumpstart Guide Intervention n=135 Participants Patient-or-LNOK-Proxy	EHR Based Clinician-facing Jumpstart Guide Intervention n=122 Participants Patient-or-LNOK-Proxy	Usual Care: No Intervention n=146 Participants Patient-or-LNOK-Proxy
Patient or Surrogate/Family-reported Discussion of Goals (3-5 Days)	48 Participants	39 Participants	62 Participants

SECONDARY outcome

Timeframe: 4-6 weeks after randomization

Population: Participants for which there is a response (potentially by a proxy) to this survey question. Includes instances of proxies reporting on the measure after the death of a participant

Subjects will self-report (yes or no) if they had a discussion of goals of care ("the kind of medical care you/your loved one would want") during the index hospitalization. Responses of "unsure" are included in the sample and not counted as missing. This outcome is presented as a proportion: the number of subjects reporting a goals-of-care discussion over the number of patients in each study arm.

Outcome measures

Outcome measures
Measure	Survey Based Bi-directional Jumpstart Guide Intervention n=144 Participants Patient-or-LNOK-Proxy	EHR Based Clinician-facing Jumpstart Guide Intervention n=132 Participants Patient-or-LNOK-Proxy	Usual Care: No Intervention n=150 Participants Patient-or-LNOK-Proxy
Patient or Surrogate/Family-reported Discussion of Goals (4-6 Weeks)	62 Participants	51 Participants	57 Participants

SECONDARY outcome

Timeframe: 3-5 days after randomization

Population: Participants for which there is a response (potentially by a proxy) which is numeric or can be converted to numeric for each of the 4 component questions. One response excluded as it was recorded as having occurred on day of randomization.

Quality of goals-of-care communication is assessed with the end-of-life communication scale (QOC\_eol) of the Quality of Communication (QOC) survey. The QOC\_eol subscale is based on 4 items, with item scores ranging from 0 (worst) to 10 (best). Responses of "My doctor has not done this" are converted into a rating of 0. Scores from the 4 items are summed together, resulting in a total score that ranges from 0 (worst) to 40 (best).

Outcome measures

Outcome measures
Measure	Survey Based Bi-directional Jumpstart Guide Intervention n=107 Participants Patient-or-LNOK-Proxy	EHR Based Clinician-facing Jumpstart Guide Intervention n=117 Participants Patient-or-LNOK-Proxy	Usual Care: No Intervention n=131 Participants Patient-or-LNOK-Proxy
Quality of Communication (QOC)	18.4 Points on the scale Standard Deviation 14.4	18.4 Points on the scale Standard Deviation 14.2	18.7 Points on the scale Standard Deviation 14.7

SECONDARY outcome

Timeframe: 3-5 days after randomization

Population: Participants for which there is a response (potentially by a proxy) to both component questions. One response excluded as it was recorded as having occurred on day of randomization.

Concordance between the care patients want and the care they are receiving is measured with two questions from the SUPPORT study. The first defines patients' preferences: "If you/patient had to make a choice at this time, would you/they prefer a course of treatment focused on extending life as much as possible, even if it means having more pain and discomfort, or would you/they want a plan of care focused on relieving pain and discomfort as much as possible, even if that means not living as long?" The second question assesses perceptions of current treatment using the same two options. Responses of "unsure" are included in the sample and not counted as missing. The outcome is a dichotomous variable of whether the preference matches the report of care received.

Outcome measures

Outcome measures
Measure	Survey Based Bi-directional Jumpstart Guide Intervention n=116 Participants Patient-or-LNOK-Proxy	EHR Based Clinician-facing Jumpstart Guide Intervention n=126 Participants Patient-or-LNOK-Proxy	Usual Care: No Intervention n=141 Participants Patient-or-LNOK-Proxy
SUPPORT Questions (3-5 Days)	46 Participants	64 Participants	56 Participants

SECONDARY outcome

Timeframe: 4-6 weeks after randomization

Population: Participants for which there is a response (potentially by a proxy) to both component questions.

Outcome measures

Outcome measures
Measure	Survey Based Bi-directional Jumpstart Guide Intervention n=134 Participants Patient-or-LNOK-Proxy	EHR Based Clinician-facing Jumpstart Guide Intervention n=123 Participants Patient-or-LNOK-Proxy	Usual Care: No Intervention n=143 Participants Patient-or-LNOK-Proxy
SUPPORT Questions (4-6 Weeks)	67 Participants	67 Participants	67 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 30-days post randomization

Population: All randomized participants

Any palliative care consults within 30-days post randomization

Outcome measures

Outcome measures
Measure	Survey Based Bi-directional Jumpstart Guide Intervention n=203 Participants Patient-or-LNOK-Proxy	EHR Based Clinician-facing Jumpstart Guide Intervention n=205 Participants Patient-or-LNOK-Proxy	Usual Care: No Intervention n=209 Participants Patient-or-LNOK-Proxy
Intensity of Care: Palliative Care Consults Completed (30 Days)	0.0493 Count of consults per participant Standard Deviation 0.217	0.0829 Count of consults per participant Standard Deviation 0.279	0.0574 Count of consults per participant Standard Deviation 0.271

OTHER_PRE_SPECIFIED outcome

Timeframe: 90-days post randomization

Population: All randomized participants

Any palliative care consults within 90-days post randomization

Outcome measures

Outcome measures
Measure	Survey Based Bi-directional Jumpstart Guide Intervention n=203 Participants Patient-or-LNOK-Proxy	EHR Based Clinician-facing Jumpstart Guide Intervention n=205 Participants Patient-or-LNOK-Proxy	Usual Care: No Intervention n=209 Participants Patient-or-LNOK-Proxy
Intensity of Care: Palliative Care Consults Completed (90 Days)	0.0640 Count of consults per participant Standard Deviation 0.245	0.107 Count of consults per participant Standard Deviation 0.340	0.0670 Count of consults per participant Standard Deviation 0.286

OTHER_PRE_SPECIFIED outcome

Timeframe: 30 days after randomization

Population: All randomized participants

From the electronic medical record and Washington State death certificates.

Outcome measures

Outcome measures
Measure	Survey Based Bi-directional Jumpstart Guide Intervention n=203 Participants Patient-or-LNOK-Proxy	EHR Based Clinician-facing Jumpstart Guide Intervention n=205 Participants Patient-or-LNOK-Proxy	Usual Care: No Intervention n=209 Participants Patient-or-LNOK-Proxy
All-cause Mortality at 30 Days (Safety Outcome)	11 Participants	18 Participants	14 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 120 days after randomization

Population: All randomized participants

From the electronic medical record and Washington State death certificates.

Outcome measures

Outcome measures
Measure	Survey Based Bi-directional Jumpstart Guide Intervention n=203 Participants Patient-or-LNOK-Proxy	EHR Based Clinician-facing Jumpstart Guide Intervention n=205 Participants Patient-or-LNOK-Proxy	Usual Care: No Intervention n=209 Participants Patient-or-LNOK-Proxy
All-cause Mortality at 120 Days (Safety Outcome)	21 Participants	37 Participants	30 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 30-days post randomization

Population: All participants contribute person-days until their death, the goals or care discussion, or 30 days post-randomization.

Time to first goals of care discussion reported per person-day; collected from electronic health record. All participants contribute person-days until their death, the goals or care discussion, or 30 days post-randomization.

Outcome measures

Outcome measures
Measure	Survey Based Bi-directional Jumpstart Guide Intervention n=203 Participants Patient-or-LNOK-Proxy	EHR Based Clinician-facing Jumpstart Guide Intervention n=205 Participants Patient-or-LNOK-Proxy	Usual Care: No Intervention n=209 Participants Patient-or-LNOK-Proxy
Goals-of Care Discussions: Time to First Goals of Care Discussion	0.0120 Incidence rate (per person-day)	0.0147 Incidence rate (per person-day)	0.0082 Incidence rate (per person-day)

OTHER_PRE_SPECIFIED outcome

Timeframe: 4-6 weeks after randomization

Population: Participants for which there is a response (all HADS questions asked about the person taking the survey, so no proxies could answer) which are numeric scores for each of the component questions.

Symptoms of depression and anxiety assessed with the Hospital Anxiety and Depression Scale (HADS). The HADS is a reliable, valid 14-item, 2-domain (anxiety and depression) tool used to assess symptoms of psychological distress. Seven items evaluate anxiety. Each item is scored on a 4-point scale (ranging from 0-3) with scores for each subscale (anxiety and depression) ranging from 0-21. Higher scores reflect more symptoms of anxiety or depression.

Outcome measures

Outcome measures
Measure	Survey Based Bi-directional Jumpstart Guide Intervention n=107 Participants Patient-or-LNOK-Proxy	EHR Based Clinician-facing Jumpstart Guide Intervention n=102 Participants Patient-or-LNOK-Proxy	Usual Care: No Intervention n=115 Participants Patient-or-LNOK-Proxy
Anxiety (HADS Subscale)	5.79 Points on the scale Standard Deviation 4.14	5.59 Points on the scale Standard Deviation 4.25	6.20 Points on the scale Standard Deviation 4.36

OTHER_PRE_SPECIFIED outcome

Timeframe: 4-6 weeks after randomization

Symptoms of depression and anxiety assessed with the Hospital Anxiety and Depression Scale (HADS). The HADS is a reliable, valid 14-item, 2-domain (anxiety and depression) tool used to assess symptoms of psychological distress. Seven items evaluate depression. Each item is scored on a 4-point scale (ranging from 0-3) with scores for each subscale (anxiety and depression) ranging from 0-21. Higher scores reflect more symptoms of anxiety or depression.

Outcome measures

Outcome measures
Measure	Survey Based Bi-directional Jumpstart Guide Intervention n=109 Participants Patient-or-LNOK-Proxy	EHR Based Clinician-facing Jumpstart Guide Intervention n=103 Participants Patient-or-LNOK-Proxy	Usual Care: No Intervention n=116 Participants Patient-or-LNOK-Proxy
Depression (HADS Subscale)	5.94 Points on the scale Standard Deviation 4.05	6.32 Points on the scale Standard Deviation 3.90	5.48 Points on the scale Standard Deviation 3.81

OTHER_PRE_SPECIFIED outcome

Timeframe: 4-6 weeks after randomization

Population: Participants for which there is a response (potentially by a proxy) which is numeric for each of the 5 component questions.

The EuroQol 5 Dimension 5 Level (EQ-5D-5L) is a self-report survey that measures quality of life across 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The 5 questions ask about problems with these domains, with response options on a 4-point Likert scale ranging from 1 (slight) to 4 (unable). Scores from the 5 questions are summed together, resulting in a total score ranging from 5 to 20. Higher scores reflect lower quality of life.

Outcome measures

Outcome measures
Measure	Survey Based Bi-directional Jumpstart Guide Intervention n=134 Participants Patient-or-LNOK-Proxy	EHR Based Clinician-facing Jumpstart Guide Intervention n=122 Participants Patient-or-LNOK-Proxy	Usual Care: No Intervention n=142 Participants Patient-or-LNOK-Proxy
EuroQol 5 Dimensions 5 Level (EQ-5D-5L)	7.20 Points on the scale Standard Deviation 4.23	7.11 Points on the scale Standard Deviation 4.65	6.85 Points on the scale Standard Deviation 4.66

OTHER_PRE_SPECIFIED outcome

Timeframe: 3-5 days after randomization

Population: Participants for which there is a numeric response (potentially by a proxy) for each of the 3 component questions. One response excluded as it was recorded as having occurred on day of randomization.

The CollaboRATE is patient- or proxy-reported measure of shared decision-making. This 3-question measure asks questions about how much effort was made by doctors and members of the healthcare team to help you understand your/their health issues, listen to what matters most to you/them about your/their health issues, and include what matters most to you/them in choosing what to do next. Answers range from 0 (no effort) to 4 (every effort). Scores from the 3 questions are summed together, resulting in a total score ranging from 0 (no effort) to 12 (highest effort). Higher scores reflect more engagement in shared decision-making.

Outcome measures

Outcome measures
Measure	Survey Based Bi-directional Jumpstart Guide Intervention n=113 Participants Patient-or-LNOK-Proxy	EHR Based Clinician-facing Jumpstart Guide Intervention n=131 Participants Patient-or-LNOK-Proxy	Usual Care: No Intervention n=143 Participants Patient-or-LNOK-Proxy
CollaboRATE	8.14 Points on the scale Standard Deviation 2.87	8.16 Points on the scale Standard Deviation 3.01	8.44 Points on the scale Standard Deviation 2.66

OTHER_PRE_SPECIFIED outcome

Timeframe: 3-5 days after randomization

Population: Participants for which there is a numeric response (potentially by a proxy) for this survey question. One response excluded as it was recorded as having occurred on day of randomization.

Concordance between the care patients want and the care they are receiving is measured by an investigator-developed question: "Do you think that your current medical care is in line with your goals?" Scale ranges from 0 (Not at all) to 4 (Completely). Higher scores reflect better goal-concordance.

Outcome measures

Outcome measures
Measure	Survey Based Bi-directional Jumpstart Guide Intervention n=119 Participants Patient-or-LNOK-Proxy	EHR Based Clinician-facing Jumpstart Guide Intervention n=130 Participants Patient-or-LNOK-Proxy	Usual Care: No Intervention n=141 Participants Patient-or-LNOK-Proxy
Goal Concordance (3-5 Days)	3.05 Points on the scale Standard Deviation 1.04	3.15 Points on the scale Standard Deviation 0.881	3.06 Points on the scale Standard Deviation 0.935

OTHER_PRE_SPECIFIED outcome

Timeframe: 4-6 weeks after randomization

Population: Participants for which there is a numeric response (potentially by a proxy) for this survey question. Includes instances of proxies reporting on the measure after the death of a participant.

Outcome measures

Outcome measures
Measure	Survey Based Bi-directional Jumpstart Guide Intervention n=139 Participants Patient-or-LNOK-Proxy	EHR Based Clinician-facing Jumpstart Guide Intervention n=131 Participants Patient-or-LNOK-Proxy	Usual Care: No Intervention n=146 Participants Patient-or-LNOK-Proxy
Goal Concordance (4-6 Weeks)	3.06 Points on the scale Standard Deviation 0.870	3.08 Points on the scale Standard Deviation 0.977	3.03 Points on the scale Standard Deviation 0.961

Adverse Events

Survey-based Bi-directional Jumpstart [Patient]

Serious events: 0 serious events

Other events: 0 other events

Deaths: 22 deaths

EHR-based Clinician-facing Jumpstart [Patient]

Serious events: 0 serious events

Other events: 0 other events

Deaths: 38 deaths

Usual Care [Patient]

Serious events: 0 serious events

Other events: 0 other events

Deaths: 30 deaths

Survey-based Bi-directional Jumpstart [Family]

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

EHR-based Clinician-facing Jumpstart [Family]

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care [Family]

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Clinicians

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Erin Kross

University of Washington

Phone: 206-744-4649

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place