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

Sponsor

University of Washington (Other)

Overall Status

Completed

CT.gov ID

NCT03746392

Collaborator

(none)

150

Enrollment

Locations

Arms

Actual Duration (Months)

Patients Per Site

3.1

Patients Per Site Per Month

Study Details

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	N/A

Study Design

Study Type:

Interventional

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 :

Jul 1, 2018

Actual Primary Completion Date :

Jun 30, 2020

Actual Study Completion Date :

Jun 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

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

Documentation of goals of care [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

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Harborview Medical Center	Seattle	Washington	United States	98104
2	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

Study Documents (Full-Text)

None provided.

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:

NCT03746392

Other Study ID Numbers: