Clinical trial NCT03424382: CREATION Health Readmission Risk Assessment Tool
Official title: CREATION Health Readmission Risk Assessment Tool
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
COPD
Myocardial Infarction
Coronary Artery Bypass Graft
Pneumonia
Total Knee Replacement
Total Hip Replacement
Stroke
Lead sponsor: AdventHealth
Sponsor class: OTHER
First posted: 2018-02-07
Enrollment: 1218
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Inpatients at Florida Hospital Orlando with one of the targeted diagnoses

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.

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

Primary outcomes:
measure: Social Determinant Survey Responses
timeFrame: 24 Months
Secondary outcomes:
measure: Readmission Status
timeFrame: 24 Months
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
Study officials:
affiliation: Center for CREATION Health Research
name: Patricia Robinson
role: PRINCIPAL_INVESTIGATOR
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