NCT04281784: PICSI-H

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

Completed NA Results posted Last updated 4 April 2025

What this trial tests

NA trial testing EHR-based Clinician Jumpstart in Dementia in 2,512 participants. Completed in 26 September 2022.

Timeline

23 April 2020

Primary endpoint
26 April 2021

26 September 2022

Quick facts

Lead sponsor	University of Washington
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	supportive care
Enrollment	2,512
Start date	23 April 2020
Primary completion	26 April 2021
Estimated completion	26 September 2022
Sites	3 locations across United States

Drugs / interventions tested

• EHR-based Clinician Jumpstart

Conditions studied

• Dementia — all drugs for Dementia →
• Chronic Disease — all drugs for Chronic Disease →
• Neoplasm Metastasis — all drugs for Neoplasm Metastasis →
• Lung Neoplasm — all drugs for Lung Neoplasm →

Sponsor

University of Washington

Who can join

18 and older, any sex, with Dementia or Chronic Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Proportion of Patients With EHR Documentation of Goals of Care Discussions Primary · 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.

Group	Value	95% CI
EHR-based Clinician Jumpstart	433
Usual Care	382
EHR-based Clinician Jumpstart	822
Usual Care	875

Intensity of Care/ICU Use: ICU Length of Stay (Number of Days Alive and Out of the ICU) Secondary · 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.

Group	Value	95% CI
Usual Care	27.90	± 6.12
EHR-based Clinician Jumpstart	27.83	± 6.19

Intensity of Care/Hospital Use: Hospital Length of Stay (Number of Days Alive and Out of the Hospital) Secondary · 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.

Group	Value	95% CI
Usual Care	21.99	± 8.78
EHR-based Clinician Jumpstart	21.63	± 9.15

Intensity of Care: Hospital Readmissions 30 Days Secondary · 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.

Group	Value	95% CI
EHR-based Clinician Jumpstart	265
Usual Care	251

Intensity of Care: ICU Admissions 30 Days Secondary · 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.

Group	Value	95% CI
EHR-based Clinician Jumpstart	336
Usual Care	348

Total Hospitalization Costs, Randomization to 30 Days After Randomization Secondary · Assessed for the period between randomization and 30 days later

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

Group	Value	95% CI
Usual Care	21,908.67	± 33,613.11
EHR-based Clinician Jumpstart	22,386.40	± 32,988.48

All-cause Mortality at 30 Days After Randomization (Safety Outcome) Secondary · 30 days after randomization

From Washington State death certificates

Group	Value	95% CI
Usual Care	64
EHR-based Clinician Jumpstart	70
Usual Care	1193
EHR-based Clinician Jumpstart	1185

Total Hospitalization Costs, Randomization to Index Hospitalization Discharge Secondary · Index hospital stay

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.

Group	Value	95% CI
Usual Care	24,384.68	± 46,677.43
EHR-based Clinician Jumpstart	23,724.06	± 38,623.82

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Intervention to Promote Communication About Goals of Care for Hospitalized Patients With Serious Illness: A Randomized Clinical Trial.
   Curtis JR, Lee RY, Brumback LC, Kross EK, et al · · 2023 · cited 70× · PMID 37210665 · DOI 10.1001/jama.2023.8812
2. A modular pipeline for natural language processing-screened human abstraction of a pragmatic trial outcome from electronic health records.
   Lee RY, Li KS, Sibley J, Cohen T, et al · · 2026 · PMID 41680079 · DOI 10.1177/17407745251405386
3. Corrigendum to "Improving communication about goals of care for hospitalized patients with serious illness: Study protocol for two complementary randomized trials"[Contemporary Clinical Trials 2022;120:106879].
   Curtis JR, Lee RY, Brumback LC, Kross EK, et al · · 2025 · PMID 40373357 · DOI 10.1016/j.cct.2025.107944