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Project to Improve Communication About Serious Illness--Hospital Study: Pragmatic Trial (Trial 1) (PICSI-H)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04281784
Recruitment Status : Active, not recruiting
First Posted : February 24, 2020
Last Update Posted : November 29, 2021
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
J. Randall Curtis, University of Washington

Brief Summary:

The objective of this protocol is to test the effectiveness of a Jumpstart intervention on patient-centered outcomes for patients with chronic illness by ensuring that they receive care that is concordant with their goals over time, and across settings and providers. This study will examine the effect of the EHR-based intervention to improve quality of palliative care for patients 55 years or older with chronic, life-limiting illness with a particular emphasis on Alzheimer's disease and related dementias (ADRD). The specific aims are:

  1. To evaluate the effectiveness of a novel EHR-based (electronic health record) clinician Jumpstart guide, compared with usual care, for improving the quality of care; the primary outcome is documentation of a goals-of-care discussion in the period between randomization and 30 days following randomization. Secondary outcomes focus on intensity of care: ICU use, ICU and hospital length of stay, costs of care during the hospitalization, and 7 and 30-day hospital readmissions.
  2. To conduct a mixed-methods evaluation of the implementation of the intervention, guided by the RE-AIM framework for implementation science, incorporating quantitative evaluation of the intervention's reach and adoption, as well as qualitative analyses of interviews with participants, to explore barriers and facilitators to future implementation and dissemination.

Condition or disease Intervention/treatment Phase
Dementia Chronic Disease Neoplasm Metastasis Lung Neoplasm Pulmonary Disease, Chronic Obstructive Heart Failure,Congestive Liver Cirrhosis Kidney Failure, Chronic Lung Diseases, Interstitial Peripheral Vascular Disease Diabetes With End Organ Injury Palliative Care, Patient Care Health Care Quality, Access, and Evaluation Patient Care Inpatients Health Communication Patient Care Planning Behavioral: EHR-based Clinician Jumpstart Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2514 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 for Older Patients With Serious Illness
Actual Study Start Date : April 23, 2020
Actual Primary Completion Date : April 26, 2021
Estimated Study Completion Date : September 26, 2022

Arm Intervention/treatment
Experimental: EHR-based Clinician Jumpstart
The EHR-based Jumpstart Guide will be developed by extracting data from the EHR using automated methods with both inpatient and outpatient notes (e.g., progress notes, specialty consult notes, alerts and care plans) preceding the current hospitalization. It will summarize the presence/absence of POLST, advance directives and DPOA documentation and patients' code status.
Behavioral: EHR-based Clinician Jumpstart
The Jumpstart Guide is a communication-priming intervention for clinicians that addresses hospitalized patients' goals of care. The intervention's goal is to prompt clinicians to provide standard of care which includes a discussion with patients or their legal surrogate decision-maker about their goals of care. The one-page Jumpstart Guide provides information to the clinician about prior advance care planning documentation and code status derived from the EHR. The Jumpstart Guides includes tips to improve goals-of-care communication.
Other Names:
  • Jumpstart Guide Intervention
  • Clinician-facing Jumpstart

No Intervention: Usual Care
The clinicians (hospital teams) for patients in the control group will not receive Jumpstart guides. These subjects will receive usual care.



Primary Outcome Measures :
  1. EHR documentation of Goals of Care discussions [ Time Frame: Assessed for the period between randomization and 30 days following randomization ]
    The primary outcome is the proportion of patients who have a goals-of-care (GOC) discussion that has been documented in the EHR in the period between randomization and 30 days following randomization The proportion is the number of patients with GOC documentation over the number of patients in each study arm. Documentation of goals-of-care discussions will be evaluated using our NLP/ML methods.


Secondary Outcome Measures :
  1. Intensity of care/ICU use: ICU admissions [ Time Frame: Assessed for the period between randomization and 30 days following randomization ]
    Secondary outcomes include measures of intensity of care, including utilization metrics: Number of ICU admissions during the patient's (index) hospital stay will be collected from the EHR.

  2. Intensity of care/ICU use: ICU length of stay [ Time Frame: Assessed for the period between randomization and 30 days following randomization ]
    Secondary outcomes include measures of intensity of care, including utilization metrics: Number of days alive and out of the ICU within 30 days from randomization will be collected from the EHR. Number of ICU days from randomization to hospital discharge or death will also be collected from the EHR.

  3. Intensity of care/Hospital use: Hospital length of stay [ Time Frame: Assessed for the period between randomization and 30 days following randomization ]
    Secondary outcomes include measures of intensity of care, including utilization metrics: Number of days alive and out of the hospital within 30 days from randomization will be collected from the EHR. Number of hospital days from randomization to hospital discharge or death will also be collected from the EHR.

  4. Intensity of care: Hospital Readmissions 30 days [ Time Frame: Assessed for the period between randomization and 30 days following randomization ]
    Secondary outcomes include measures of intensity of care, including utilization metrics: Number of hospital readmissions between randomization and 30 days following randomization will be collected from the EHR.

  5. Intensity of care: ICU Readmissions 30 days [ Time Frame: Assessed for the period between randomization and 30 days following randomization ]
    Secondary outcomes include measures of intensity of care, including utilization metrics: Number of ICU readmissions between randomization and 30 days following randomization will be collected from the EHR.

  6. Intensity of care: Healthcare costs [ Time Frame: Assessed for the period between randomization and 30 days following randomization ]
    Costs for intervention vs. control will be reported in US dollars and identified from UW Medicine administrative financial databases. Costs will be reported for total hospital costs and disaggregated costs (direct-variable, direct fixed, indirect costs). Direct-variable costs will include supply and drug costs. Direct-fixed costs will include labor, clinical department administration, and overhead fees. Indirect costs represent services provided by cost centers not directly linked to patient care such as information technology and environmental services. Costs for ED (emergency department) days and ICU days will be similarly assessed.

  7. All-cause mortality at 1 year (safety outcome) [ Time Frame: 1 year after randomization ]
    From Washington State death certificates.


Other Outcome Measures:
  1. Key Implementation Factors (Qualitative) [ Time Frame: 3 months after randomization ]
    Qualitative interviews after individual participation has concluded. Interviews will be guided by the RE-AIM and Consolidated Framework for Implementation Research (CFIR) to explore the factors associated with implementation (e.g., reach, maintenance, feasibility, inner and outer settings, individuals, and processes of care.) Individual constructs within these domains were chosen to fit this specific intervention and context.

  2. Key Implementation Factors (Quantitative) [ Time Frame: 3 months after completion of Trial ]

    Quantitative evaluation is guided by the RE-AIM framework. We will evaluate the following components of RE-AIM:

    1. Reach: assessed as the proportion of eligible participants (clinicians, patients, families) included in study activities/total number identified, eligible participants.
    2. Adoption: assessed as the proportion of eligible services who participated/ total number of eligible services
    3. Implementation: assessed as the proportion of HTML Jumpstarts that were opened / the total number of HTML Jumpstarts delivered, as well as the proportion of patients for whom an HTML JS guide was sent and for whom a JS was opened by a clinician.



Information from the National Library of Medicine

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

Eligibility criteria apply to two subject groups: 1) seriously ill adult patients; 2) hospital clinicians.

Inclusion Criteria:

  • PATIENTS. Eligible patients will be those who are: 1) older than 80 years of age; or 2) 55 years of age or older who meet criteria for serious illness. Serious illness encompasses acute illness (e.g. COVID-19) and chronic illnesses (e.g. those included in the Dartmouth Atlas to study end-of-life care: malignant cancer/leukemia, chronic pulmonary disease, coronary artery disease, heart failure, chronic liver disease, chronic renal disease, dementia, diabetes with end-organ damage, and peripheral vascular disease).
  • CLINICIANS (Interview). Eligible clinicians will be those who are 18 years of age or older, English-speaking, employed at a participating hospital, and have been the clinician of record for an enrolled patient in the trial.

Exclusion Criteria:

  • Reasons for exclusion for any patient include: restricted status (prisoners or victims of violence); legal or risk management concerns (as determined by the attending physician or via hospital record designation).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04281784


Locations
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United States, Washington
Harborview Medical Center
Seattle, Washington, United States, 98104
UW Medical Center - Northwest
Seattle, Washington, United States, 98133
UW Medical Center - Montlake (UWMC)
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
National Institute on Aging (NIA)
Investigators
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Principal Investigator: J. Randall Curtis, MD, MPH University of Washington
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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: NCT04281784    
Other Study ID Numbers: STUDY00007031-A
1R01AG006244 ( U.S. NIH Grant/Contract )
First Posted: February 24, 2020    Key Record Dates
Last Update Posted: November 29, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms
Neoplasm Metastasis
Lung Neoplasms
Liver Cirrhosis
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Interstitial
Renal Insufficiency
Kidney Failure, Chronic
Heart Failure
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Chronic Disease
Heart Diseases
Cardiovascular Diseases
Neoplastic Processes
Pathologic Processes
Respiratory Tract Diseases
Fibrosis
Liver Diseases
Digestive System Diseases
Disease Attributes
Lung Diseases, Obstructive
Kidney Diseases
Urologic Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Atherosclerosis