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CREATION Health Readmission Risk Assessment Tool

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: NCT03424382
Recruitment Status : Completed
First Posted : February 7, 2018
Last Update Posted : February 7, 2020
Sponsor:
Information provided by (Responsible Party):
AdventHealth

Study Description
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Brief Summary:
This study occurs in two phases. Phase 1 involves initial item development and measurement validation of a new tool for identifying hospitalized patients at high risk for preventable readmission. Primary tasks include item construction and content validation, data collection, analysis, and instrument refinement. Phase 2 involves administering the refined instrument to a new group of patients to determine final item content for the instrument, its factor structure, and its predictive validity.

Condition or disease
Heart Failure COPD Myocardial Infarction Coronary Artery Bypass Graft Pneumonia Total Knee Replacement Total Hip Replacement Stroke

Detailed Description:
Participants will complete the instrument on an electronic device provided by research staff in the hospital room. If an individual is unable to complete the instrument, the participant may have another individual input answers on the electronic device. Hospitalized patients (n = 1240: 620 in Phase 1 and 620 in Phase 2) with a variety of chronic diseases will be recruited into the study. Study coordinators will recruit participants with the following diagnoses: heart failure, chronic obstructive pulmonary disease, acute myocardial infarction, coronary artery bypass graft, pneumonia, total knee or hip replacement, and stroke. These diagnoses were chosen because of the frequency with which patients are readmitted after discharge.
Study Design
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Study Type : Observational
Actual Enrollment : 1218 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: CREATION Health Readmission Risk Assessment Tool
Actual Study Start Date : May 15, 2017
Actual Primary Completion Date : December 5, 2018
Actual Study Completion Date : November 26, 2019
Groups and Cohorts
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Group/Cohort
Phase I
Participants will complete an intake form and assessment tool survey on an electronic device provided by research staff in their hospital room. If an individual is unable to complete the instrument, he or she may have another individual enter his or her answers on the electronic device.
Phase II
Participants will complete an intake form and assessment tool survey on an electronic device provided by research staff in their hospital room. If an individual is unable to complete the instrument, he or she may have another individual enter his or her answers on the electronic device.


Outcome Measures
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Primary Outcome Measures :
  1. Social Determinant Survey Responses [ Time Frame: 24 Months ]
    An Investigator developed measurement instrument (survey) will be used to gather participant self reported responses to questions regarding spirituality, nutrition, sleep, activity level, interpersonal relationships, home environment and access to transportation. Participants will be provided a five point Likert Scale to express agreement or disagreement with the questions.


Secondary Outcome Measures :
  1. Readmission Status [ Time Frame: 24 Months ]
    Data extraction from each participant's medical record will be used to determine the number of readmissions within 120 days post discharge.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Inpatients at Florida Hospital Orlando with one of the targeted diagnoses
Criteria

Inclusion Criteria:

  • Primary or secondary admission diagnosis of heart failure, chronic obstructive pulmonary disease, acute myocardial infarction, coronary artery bypass graft, pneumonia, total knee or hip replacement, or stroke.
  • Age 21 and over
  • Able to provide informed consent
  • Able to speak and read English
  • Able to complete an electronic survey or relay answers to questions to another party who may complete the survey for the participant
  • Resides in Central Florida and anticipates continued residence in Central Florida for the next 120 days
  • Planned discharge to a non-hospital or residential care environment

Exclusion Criteria:

  • Under age 21
  • Does not speak or read English
  • Permanent residence is outside Central Florida
  • Not of cognitive capacity to provide valid responses
  • Dementia or cognitive impairment that renders subject unable to provide informed consent
  • Prescribed a known psychoactive medication that might reasonably affect the ability of the participant to provide valid responses
Contacts and Locations
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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): NCT03424382


Locations
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United States, Florida
Florida Hospital
Orlando, Florida, United States, 32804
Sponsors and Collaborators
AdventHealth
Investigators
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Principal Investigator: Patricia Robinson Center for CREATION Health Research
More Information
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Publications:
Floyd, F. J., & Widaman, K. F. (1995). Factor analysis in the development and refinement of clinical assessment instruments. Psychological Assessment, 7 (3), 286-299.
Gorsuch, R. L. (1983). Factor analysis (2nd edition). New York: Laurence Earlbaum.
National Medicare readmission findings: Recent data and trends. Centers for Medicare and Medicaid Services [Internet]. 2012. Available from: http://www.academyhealth.org/files/2012/sunday/ brennan.pdf.
Report to the congress: Promoting greater efficiency in Medicare. Medicare Payment Advisory Commission [Internet]. 2007 June 2007. Available from: http://www.caretransitions.org/documents/ MedPAC%20report.pdf.
Tabachnick, B. G., & Fidell, L. S. (2007). Using multivariate statistics (5th edition). Boston: Pearson Press.

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Responsible Party: AdventHealth
ClinicalTrials.gov Identifier: NCT03424382    
Other Study ID Numbers: 1004998
First Posted: February 7, 2018    Key Record Dates
Last Update Posted: February 7, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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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Myocardial Infarction
Infarction
Heart Diseases
Cardiovascular Diseases
Ischemia
 Pathologic Processes
Necrosis
Myocardial Ischemia
Vascular Diseases