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

• ClinicalTrials.gov Identifier: NCT03746392
• Recruitment Status: Completed
• First Posted: November 19, 2018
• Last Update Posted: November 4, 2020
• Sponsor: University of Washington
• Information provided by (Responsible Party): J. Randall Curtis, University of Washington

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.

Condition or disease	Intervention/treatment	Phase
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	Behavioral: Jumpstart Intervention	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 150 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
• Actual Study Start Date: July 1, 2018
• Actual Primary Completion Date: June 30, 2020
• Actual Study Completion Date: June 30, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Jumpstart Intervention	Behavioral: Jumpstart Intervention; 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.
No Intervention: Usual Care

Outcome Measures

Primary Outcome Measures :

1. Documentation of goals of care [ Time Frame: At hospital discharge, an average of 2 weeks ]
   Presence or absence of documentation of goals of care discussions in the patient's electronic health record during the current hospitalization

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Washington

Harborview Medical Center

Seattle, Washington, United States, 98104

University of Washington Medical Center

Seattle, Washington, United States, 98195

Sponsors and Collaborators

University of Washington

Investigators

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

More Information

• 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: NCT03746392
• Other Study ID Numbers: STUDY00004821
• First Posted: November 19, 2018
• Last Update Posted: November 4, 2020
• Last Verified: November 2020

Individual Participant Data (IPD) Sharing Statement:

• 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:

Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell; Liver Failure; End Stage Liver Disease; Lung Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Heart Failure; Vascular Diseases; Peripheral Vascular Diseases; Peripheral Arterial Disease; Diabetes Complications; Heart Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Neoplasms; Kidney Diseases; Urologic Diseases; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Leukemia; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases