Project to Improve Communication About Serious Illness - Pilot Study

Dementia Clinical Trial

— PICSI-P  

Official title:

Using the Electronic Health Record to Identify and Promote Goals-of-Care Communication

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03746392
• Other study ID #: STUDY00004821
• Status: Completed
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: June 30, 2020

Study information

• Verified date: November 2020
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Congestive Heart Failure
• Dementia
• Diabetes Complications
• End Stage Liver Disease
• Frail Elderly
• Heart Failure
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Liver Failure
• Liver Failures, Chronic
• Lung Disease Chronic
• Lung Diseases
• Malignant Neoplasm
• Peripheral Arterial Disease
• Peripheral Vascular Disease
• Peripheral Vascular Diseases
• Renal Insufficiency
• Renal Insufficiency, Chronic
• Vascular Diseases

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.

Locations

Country	Name	City	State
United States	Harborview Medical Center	Seattle	Washington
United States	University of Washington Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	At hospital discharge, an average of 2 weeks