- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03746392
Project to Improve Communication About Serious Illness - Pilot Study (PICSI-P)
November 3, 2020 updated by: J. Randall Curtis, University of Washington
Using the Electronic Health Record to Identify and Promote Goals-of-Care Communication
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
150
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98195
- University of Washington Medical Center
-
Seattle, Washington, United States, 98104
- Harborview Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Usual Care
|
|
Experimental: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
At hospital discharge, an average of 2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2018
Primary Completion (Actual)
June 30, 2020
Study Completion (Actual)
June 30, 2020
Study Registration Dates
First Submitted
November 9, 2018
First Submitted That Met QC Criteria
November 16, 2018
First Posted (Actual)
November 19, 2018
Study Record Updates
Last Update Posted (Actual)
November 4, 2020
Last Update Submitted That Met QC Criteria
November 3, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Hepatic Insufficiency
- Heart Diseases
- Cardiovascular Diseases
- Respiratory Tract Diseases
- Immune System Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Kidney Diseases
- Urologic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Liver Diseases
- Atherosclerosis
- Leukemia
- Leukemia, B-Cell
- End Stage Liver Disease
- Heart Failure
- Liver Failure
- Renal Insufficiency, Chronic
- Lung Diseases
- Vascular Diseases
- Peripheral Arterial Disease
- Peripheral Vascular Diseases
- Renal Insufficiency
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
- Diabetes Complications
Other Study ID Numbers
- STUDY00004821
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diabetes Complications
-
Hennepin Healthcare Research InstituteCompletedHyperglycemia | Diabetes Mellitus, Type 2 | Diabetes Mellitus | Complications of Diabetes Mellitus | Diabetes-Related ComplicationsUnited States
-
Royal Prince Alfred Hospital, Sydney, AustraliaMerck Sharp & Dohme LLCCompletedDiabetes Related Complications
-
University of Trás-os-Montes and Alto DouroCompletedType 2 Diabetes Mellitus | Diabetes-Related ComplicationsPortugal
-
Seoul St. Mary's HospitalUnknownComplications of Diabetes MellitusKorea, Republic of
-
University of AvignonCompletedDiabetes-related ComplicationsFrance
-
Albert Einstein College of MedicineJuvenile Diabetes Research Foundation; National Institutes of Health (NIH)Completed
-
Naestved HospitalUnknown
-
University of Campinas, BrazilConselho Nacional de Desenvolvimento Científico e Tecnológico; ANS PharmaUnknownDiabetes Mellitus, Type 2 | Insulin Resistance | Diabetes-Related ComplicationsBrazil
-
University of AarhusUnknownDiabetes Mellitus, Type 2 | Diabetic Neuropathies | Autonomic Neuropathy | Diabetic Complications Neurological | Polyneuropathy DiabetesDenmark
-
Rambam Health Care CampusUnknown
Clinical Trials on Jumpstart Intervention
-
University of WashingtonNational Institute on Aging (NIA)CompletedLiver Cirrhosis | Neoplasm Metastasis | Pulmonary Disease, Chronic Obstructive | Dementia | Kidney Failure, Chronic | Chronic Disease | Peripheral Vascular Disease | Lung Diseases, Interstitial | Health Communication | Lung Neoplasm | Heart Failure,Congestive | Patient Care | Health Care Quality, Access, and Evaluation and other conditionsUnited States
-
University of WashingtonNational Institute on Aging (NIA)Active, not recruitingLiver Cirrhosis | Quality of Life | Lung Neoplasms | Neoplasm Metastasis | Pulmonary Disease, Chronic Obstructive | Dementia | Kidney Failure, Chronic | Chronic Disease | Peripheral Vascular Disease | Lung Diseases, Interstitial | Health Communication | Heart Failure,Congestive | Patient Care | Health Care Quality... and other conditionsUnited States
-
University of WashingtonNational Institute on Aging (NIA)RecruitingPromoting Goals-of-Care Discussions for Patients With Memory Problems and Their Caregivers (PICSI-M)Liver Cirrhosis | Quality of Life | Neoplasm Metastasis | Pulmonary Disease, Chronic Obstructive | Peripheral Vascular Diseases | Dementia | Kidney Failure, Chronic | Chronic Disease | Lung Diseases, Interstitial | Health Communication | Lung Neoplasm | Heart Failure,Congestive | Patient Care | Health Care Quality... and other conditionsUnited States
-
Hamilton Health Sciences CorporationMcMaster University; Edwards LifesciencesRecruitingAortic Valve Stenosis | Transcatheter Aortic Valve ReplacementCanada
-
University of ConnecticutNational Institute of Mental Health (NIMH)Completed
-
University of WashingtonRecruiting
-
University of MichiganArthrex, Inc.CompletedShoulder Pain | Shoulder Osteoarthritis | Shoulder Arthritis | Shoulder Arthropathy Associated With Other ConditionsUnited States
-
Milton S. Hershey Medical CenterTerminatedShoulder Arthropathy Associated With Other ConditionsUnited States
-
Biolux Research Holdings, Inc.TerminatedOrthodontic Tooth MovementCanada
-
University of California, San FranciscoNational Cancer Institute (NCI)CompletedColorectal Carcinoma | Healthy Subject | Health Status UnknownUnited States