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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

Tracking Information
First Submitted Date January 23, 2018
First Posted Date February 7, 2018
Last Update Posted Date March 28, 2019
Actual Study Start Date May 15, 2017
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 31, 2018)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03424382 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: January 31, 2018)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title CREATION Health Readmission Risk Assessment Tool
Official Title CREATION Health Readmission Risk Assessment Tool
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Inpatients at Florida Hospital Orlando with one of the targeted diagnoses
Condition
  • Heart Failure
  • COPD
  • Myocardial Infarction
  • Coronary Artery Bypass Graft
  • Pneumonia
  • Total Knee Replacement
  • Total Hip Replacement
  • Stroke
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 31, 2018)
1240
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 2020
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Jo Wheeler, RN 407-609-9022 jo.wheeler@flhosp.org
Contact: Jasmine Jones, MPA 407-303-7128 jasmine.jones@flhosp.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03424382
Other Study ID Numbers 1004998
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Florida Hospital
Study Sponsor Florida Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Patricia Robinson Center for CREATION Health Research
PRS Account Florida Hospital
Verification Date March 2019