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Trial record 4 of 8 for:    19339721 [PUBMED-IDS]

CREATION Health Readmission Risk Assessment Tool

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ClinicalTrials.gov Identifier: NCT03424382
Recruitment Status : Recruiting
First Posted : February 7, 2018
Last Update Posted : March 28, 2019
Sponsor:
Information provided by (Responsible Party):
Florida Hospital

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.

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Study Type : Observational
Estimated Enrollment : 1240 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: CREATION Health Readmission Risk Assessment Tool
Actual Study Start Date : May 15, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : January 2020

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.



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.



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

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


Contacts
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Contact: Jo Wheeler, RN 407-609-9022 jo.wheeler@flhosp.org
Contact: Jasmine Jones, MPA 407-303-7128 jasmine.jones@flhosp.org

Locations
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United States, Florida
Florida Hospital Recruiting
Orlando, Florida, United States, 32804
Contact: Jo Wheeler, RN    407-609-9022    jo.wheeler@flhosp.org   
Contact: Jasmine Jones, MPA    407.303.7128    jasmine.jones@flhosp.org   
Principal Investigator: Patricia Robinson         
Sponsors and Collaborators
Florida Hospital
Investigators
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Principal Investigator: Patricia Robinson Center for CREATION Health Research

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.
Rubin, D. J., McDonnell, M. E., Nelson, D. B., Zhao, H. Q.., & Golden, S. H. (2014). A novel tool to predict hospital readmission risk in patients with diabetes and CVD. Diabetes, 63, p. A642.
Tabachnick, B. G., & Fidell, L. S. (2007). Using multivariate statistics (5th edition). Boston: Pearson Press.

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Responsible Party: Florida Hospital
ClinicalTrials.gov Identifier: NCT03424382     History of Changes
Other Study ID Numbers: 1004998
First Posted: February 7, 2018    Key Record Dates
Last Update Posted: March 28, 2019
Last Verified: March 2019
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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Pneumonia
Myocardial Infarction
Infarction
Heart Diseases
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Vascular Diseases
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections