CREATION Health Readmission Risk Assessment Tool

February 6, 2020 updated by: AdventHealth
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.

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

1218

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Orlando, Florida, United States, 32804
        • Florida Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Inpatients at Florida Hospital Orlando with one of the targeted diagnoses

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AdventHealth

Investigators

  • Principal Investigator: Patricia Robinson, Center for CREATION Health Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2017

Primary Completion (Actual)

December 5, 2018

Study Completion (Actual)

November 26, 2019

Study Registration Dates

First Submitted

January 23, 2018

First Submitted That Met QC Criteria

January 31, 2018

First Posted (Actual)

February 7, 2018

Study Record Updates

Last Update Posted (Actual)

February 7, 2020

Last Update Submitted That Met QC Criteria

February 6, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1004998

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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