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Project to Improve Communication About Serious Illness - Pilot Study (PICSI-P)

Primary Purpose

Malignant Neoplasm, Leukemia, Lymphocytic, Chronic, B-Cell, Lung Disease Chronic

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Jumpstart Intervention
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Malignant Neoplasm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria, Patients: meeting criteria for serious illness (encompassing multiple acute and chronic illnesses) including:

  • those used by the Dartmouth Atlas to study end-of-life care in the US: malignant cancer/leukemia, chronic pulmonary disease, coronary artery disease, congestive heart failure, chronic liver disease, chronic renal disease, dementia, diabetes with end-organ damage, and peripheral vascular disease.
  • patients over age 65 with markers of frailty: albumin level <3.0 within 48 hours of admission and weight loss of ≥10 pounds in the past year.
  • hospitalized patients over age 80.
  • English-speaking

Exclusion Criteria, Patients:

  • unable to complete informed consent procedures and do not have a legal next of kin
  • restricted information status (e.g. prisoners)
  • pregnant

Inclusion Criteria, Surrogates:

  • involved in the care of an eligible patient as the legal next-of-kin
  • English-speaking

Exclusion Criteria, Surrogates:

  • unable to complete informed consent procedures

Sites / Locations

  • Harborview Medical Center
  • University of Washington Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Jumpstart Intervention

Usual Care

Arm Description

Outcomes

Primary Outcome Measures

Documentation of goals of care
Presence or absence of documentation of goals of care discussions in the patient's electronic health record during the current hospitalization

Secondary Outcome Measures

Full Information

First Posted
November 9, 2018
Last Updated
November 3, 2020
Sponsor
University of Washington
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1. Study Identification

Unique Protocol Identification Number
NCT03746392
Brief Title
Project to Improve Communication About Serious Illness - Pilot Study
Acronym
PICSI-P
Official Title
Using the Electronic Health Record to Identify and Promote Goals-of-Care Communication
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This two-year pilot study will test whether a one-page "Jumpstart Form" will affect goals-of-care discussions in the hospital. This form will be provided to clinicians and will include patient-specific information about preferences for goals-of-care communication and for care, as well as tips to improve this communication. Jumpstart forms will also be provided to patients or, if they are unable to communicate, their surrogates/family members. The information on the form will be obtained from questionnaires. The form is tailored to help patients and surrogates talk with clinicians about goals of care. This study is based on a successful application of Jumpstart Form in the outpatient clinic setting.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Neoplasm, Leukemia, Lymphocytic, Chronic, B-Cell, Lung Disease Chronic, Congestive Heart Failure, Liver Failures, Chronic, Renal Insufficiency, Chronic, Dementia, Diabetes Complications, Peripheral Vascular Disease, Frail Elderly

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Jumpstart Intervention
Arm Type
Experimental
Arm Title
Usual Care
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Jumpstart Intervention
Intervention Description
The intervention has 4 steps: use electronic medical record (EHR) to identify seriously ill, hospitalized patients with no documentation of a goals-of-care (GOC) discussion during their current admission; the enrolled patient or his/her surrogate completes a survey assessing preferences for discussions about GOC, barriers to having such discussions, and current GOC which is used to create a "Jumpstart" form designed to prompt and guide a GOC discussion between the patient or surrogate and the clinicians caring for the patient; use natural language processing/machine learning (NLP/ML) approach to identify GOC discussions or advance directives in the EHR that occurred prior to admission and include this information on the Jumpstart form; and, deliver the Jumpstart form to the primary clinician team. The patient or surrogate is also provided with a version of the form.
Primary Outcome Measure Information:
Title
Documentation of goals of care
Description
Presence or absence of documentation of goals of care discussions in the patient's electronic health record during the current hospitalization
Time Frame
At hospital discharge, an average of 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria, Patients: meeting criteria for serious illness (encompassing multiple acute and chronic illnesses) including: those used by the Dartmouth Atlas to study end-of-life care in the US: malignant cancer/leukemia, chronic pulmonary disease, coronary artery disease, congestive heart failure, chronic liver disease, chronic renal disease, dementia, diabetes with end-organ damage, and peripheral vascular disease. patients over age 65 with markers of frailty: albumin level <3.0 within 48 hours of admission and weight loss of ≥10 pounds in the past year. hospitalized patients over age 80. English-speaking Exclusion Criteria, Patients: unable to complete informed consent procedures and do not have a legal next of kin restricted information status (e.g. prisoners) pregnant Inclusion Criteria, Surrogates: involved in the care of an eligible patient as the legal next-of-kin English-speaking Exclusion Criteria, Surrogates: unable to complete informed consent procedures
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J. Randall Curtis, MD, MPH
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35363271
Citation
Lee RY, Kross EK, Downey L, Paul SR, Heywood J, Nielsen EL, Okimoto K, Brumback LC, Merel SE, Engelberg RA, Curtis JR. Efficacy of a Communication-Priming Intervention on Documented Goals-of-Care Discussions in Hospitalized Patients With Serious Illness: A Randomized Clinical Trial. JAMA Netw Open. 2022 Apr 1;5(4):e225088. doi: 10.1001/jamanetworkopen.2022.5088.
Results Reference
derived

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Project to Improve Communication About Serious Illness - Pilot Study

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