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Project to Improve Communication About Serious Illness--Hospital Study: Comparative Effectiveness Trial (Trial 2) (PICSI-H)

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ClinicalTrials.gov Identifier: NCT04283994
Recruitment Status : Not yet recruiting
First Posted : February 25, 2020
Last Update Posted : February 25, 2020
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 is particularly interested in understanding the effect of the intervention to improve quality of palliative care for patients with Alzheimer's disease and related dementias (ADRD) but will also include other common chronic, life-limiting illnesses. The specific aims are: 1) To evaluate the effectiveness of a survey-based patient/clinician Jumpstart guide compared to an EHR-based clinician Jumpstart guide for improving quality of care; the primary outcome is documentation of a goals-of-care discussion during the hospitalization. Secondary outcomes include: intensity of care (ICU use, ICU and hospital length of stay, costs of care during the hospitalization, and 30-day hospital readmission); patient- and surrogate/family-reported outcomes assessed by survey at 1 and 3 months after randomization including occurrence and quality of goals-of-care communication in the hospital, goal concordant care, psychological symptoms, quality of life, and palliative care needs. 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 Neoplasms 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 Quality of Life Behavioral: Survey-based Patient/Clinician Jumpstart Behavioral: EHR-based Clinician Jumpstart Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 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
Estimated Study Start Date : December 1, 2020
Estimated Primary Completion Date : January 1, 2024
Estimated Study Completion Date : January 1, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Survey-based Patient/Clinician Jumpstart
The Jumpstart Guide will be developed with two types of data: 1) EHR data; and 2) Survey data. Using automated methods and NLP/ML algorithms, the presence/absence of POLST, advance directives and DPOA documentation will be identified from both inpatient and outpatient notes (e.g., progress notes, specialty consult notes, alerts and care plans) preceding the current hospitalization. The survey data will be completed patients or their surrogate/family at enrollment and will provide assessments of the following: a) preferences for discussions about goals of care; b) most important barrier and facilitator for having such discussions; and c) current goals of care. These elements are contained within the Jumpstart guides and the information is tailored to each recipient (i.e., patient, surrogate/family, or clinician).
Behavioral: Survey-based Patient/Clinician Jumpstart
The Jumpstart Guide is a communication-priming intervention for clinicians, patients and their families 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 Jumpstart takes two forms. One is "EHR-based" and provides information to the clinician about prior advance care planning documentation derived from the EHR. The other is "bi-directional" and patient-specific (Survey-based Patient/Clinician Jumpstart Guide). It provides the same information as the EHR-based clinician guide but also includes information about patients' self-reported preferences for communication and care as well as primary barriers and facilitators to this communication. The Jumpstart Guides include tips to improve this communication for clinicians, patients and families.
Other Name: Jumpstart Guide Intervention

Active Comparator: EHR-based Clinician Jumpstart
The EHR-based Jumpstart Guide will be developed by using automated methods and NLP/ML algorithms to both inpatient and outpatient EHR 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. It will not include survey-based information.
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 derived from the EHR. The Jumpstart Guide includes tips to improve goals-of-care communication.
Other Name: Jumpstart Guide Intervention




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 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. Study staff will manually review and compare findings using a randomly-selected sample of charts using our standard EHR abstraction methods; manual chart abstraction will be the gold standard.


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 using our automated and validated methods.

  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 the patient spent in the ICU during their (index) hospital stay will be collected from the EHR using our automated and validated methods.

  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 the patient spent in the hospital during that (index) hospital stay will be collected from the EHR using our automated and validated methods.

  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 collected from the EHR using our automated and validated methods.

  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 using our automated and validated methods.

  6. Intensity of care: Healthcare costs [ Time Frame: 1 and 3 months after 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. Intensity of care: Healthcare utilization [ Time Frame: 1 and 3 months after randomization ]
    Subjects will complete a short healthcare utilization survey in which they will self-report the number of visits to emergency departments, hospitals and/or outpatient clinics during the study period

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

  9. Patient or surrogate/family-reported discussion of goals [ Time Frame: 1 and 3 months after randomization ]
    Subjects will self-report (yes or no) if they had a discussion of goals of care ("the kind of medical care you/your loved one would want") during the index hospitalization. This outcome will be presented as a proportion: the number of subjects reporting a goals-of-care discussion over the number of patients in each study arm.

  10. Quality of Communication (QOC) [ Time Frame: 1 month after randomization ]
    Quality of goals-of-care communication is assessed with the end-of-life communication scale (QOC_eol) of the Quality of Communication (QOC) survey. The QOC_eol subscale is based on 4 to 7 items, with item scores ranging from 0 (worst) to 10 (best).

  11. SUPPORT questions [ Time Frame: 1 and 3 months after randomization ]
    Concordance between the care patients want and the care they are receiving will be measured with two questions from the SUPPORT study. The first defines patients' preferences: "If the patient had to make a choice at this time, would the patient prefer a course of treatment focused on extending life as much as possible, even if it means having more pain and discomfort, or would the patient want a plan of care focused on relieving pain and discomfort as much as possible, even if that means not living as long?" The second question assesses perceptions of current treatment using the same two options. The outcome is a dichotomous variable of whether the preference matches the report of care received. Although this creates a "false dichotomy" in that many patients want both, this "forced choice" helps identify a patient's top priority.

  12. Anxiety and depression (HADS) [ Time Frame: 1 and 3 months after randomization ]
    Symptoms of depression and anxiety assessed with the Hospital Anxiety and Depression Scale (HADS). The HADS is a reliable, valid 14-item, 2-domain (anxiety and depression) tool used to assess symptoms of psychological distress. Seven items evaluate anxiety and seven evaluate depression. Each item is scored on a 4-point scale (ranging from 0-3) with scores for each subscale (anxiety and depression) ranging from 0-21. HADS has been used in over 700 studies with evidence of reliability, validity and responsiveness among seriously ill patients and their family members and has become a standard measure for patients and family members after serious illness.

  13. Impact of Event Scale-6 (IES-6) [ Time Frame: 1 and 3 months after randomization ]
    The Impact of Event Scale-6 (IES-6), derived from the IES-R, uses 6 self-report items to assess subjective distress caused by a traumatic event. Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely").

  14. SF12 [ Time Frame: 1 and 3 months after randomization ]
    We will use the SF12 which has been used with patients with chronic illness and with older populations, and for proxy completion. It has good psychometric characteristics including internal reliability (Cronbach alphas >=0.70), test-retest reliability (r>0.73), and validity supported by confirmatory factor analysis and hypothesis testing. The minimally clinically important difference has been estimated between 4-7 points, and it has demonstrated responsiveness to interventions as well as change over time. Family members will be asked to complete the SF12 both for themselves and also for patients by proxy.


Other Outcome Measures:
  1. Key Implementation Factors [ Time Frame: 3 months after randomization ]
    Qualitative interviews after individual participation. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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 three subject groups: 1) seriously ill adult patients; 2) adult surrogate legal next of kin of the patients; and 3) hospital clinicians.

Inclusion Criteria:

  • PATIENTS. Eligible patients will be those who are: 1) older than 80 years of age; or 2) older than 65 years of age with one or more chronic conditions used by 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. Patients without decisional capacity (as documented in the EHR or as identified with a brief six-item screening tool) will be represented by a legal surrogate decision maker/legal next of kin (LNOK) in accordance with Washington State Law RCW 7.70.065.
  • SURROGATE/FAMILY. Eligible surrogate/family subjects will be those who are 18 years of age or older, English-speaking, involved in the patient's medical care or decision-making.
  • 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 in include: restricted status (prisoners or victims of violence); legal or risk management concerns (as determined by the attending physician or via hospital record designation); unable to complete informed consent procedures; and without a legal surrogate to participate for them. Patients who are non-English speaking (and therefore unable to complete survey materials) are excluded. Reasons for exclusion for any surrogate/family subject include: non-English speaking (and therefore unable to complete study materials), legal or risk management concerns (as determined by the attending physician or via hospital record designation); psychological illness or morbidity; and physical or mental limitations preventing ability to complete questionnaires.

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): NCT04283994


Contacts
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Contact: J. Randall Curtis, MD, MPH 206-744-3356 jrc@uw.edu
Contact: Ruth A. Engelberg, PhD 206-744-9523 rengel@uw.edu

Locations
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United States, Washington
Harborview Medical Center
Seattle, Washington, United States, 98104
Contact: J. Randall Curtis, MD, MPH    206-744-3356    jrc@uw.edu   
UW Medical Center - Northwest
Seattle, Washington, United States, 98133
Contact: J. Randall Curtis, MD, MPH    206-744-3356    jrc@uw.edu   
UW Medical Center - Montlake (UWMC)
Seattle, Washington, United States, 98195
Contact: J. Randall Curtis, MD, MPH    206-744-3356    jrc@uw.edu   
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: NCT04283994    
Other Study ID Numbers: STUDY00007031-B
1R01AG006244 ( U.S. NIH Grant/Contract )
First Posted: February 25, 2020    Key Record Dates
Last Update Posted: February 25, 2020
Last Verified: February 2020
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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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
Neoplasms
Heart Diseases
Cardiovascular Diseases
Respiratory Tract Diseases
Neoplastic Processes
Pathologic Processes
Liver Diseases
Digestive System Diseases
Disease Attributes
Lung Diseases, Obstructive
Kidney Diseases
Urologic Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms