CREATION Health Readmission Risk Assessment Tool

Completed

• Conditions: Myocardial Infarction; Total Hip Replacement; Stroke; Pneumonia; Total Knee Replacement; Heart Failure; COPD; Coronary Artery Bypass Graft

• Registration Number: NCT03424382
• Lead Sponsor: AdventHealth

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 Timeline

• Study Start: 2017-05-15
• Study First Submitted: 2018-01-23
• Study First Submitted QC: 2018-01-31
• Study First Posted: 2018-02-07
• Primary Completion: 2018-12-05
• Study Completion: 2019-11-26
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-06
• Last Update Posted: 2020-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1218

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Social Determinant Survey Responses	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

Name	Time	Method
Readmission Status	24 Months	Data extraction from each participant's medical record will be used to determine the number of readmissions within 120 days post discharge.

Trial Locations

Locations (1)

Florida Hospital; 🇺🇸 Orlando, Florida, United States