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Heart FailureNCT03424382

CREATION Health Readmission Risk Assessment Tool

An observational study of Heart Failure and COPD, run by AdventHealth at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Heart Failure, COPD, Myocardial Infarction
How many people
1,218 participants
Where
1 siteUnited States
Study dates
15 May 2017to 26 Nov 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Inpatients at Florida Hospital Orlando with one of the targeted diagnoses

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Florida Hospital

    Orlando, Florida, 32804

Other trials in United States

About this study

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.

Read the 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.

Medical subject headings
Heart Failure, Pulmonary Disease, Chronic Obstructive, Myocardial Infarction, Pneumonia, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03424382
Study groupRoleWhat they receive
Phase IParticipants 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 IIParticipants 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Social Determinant Survey Responses

    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.

    Measured: 24 Months

Secondary outcomes (1)

  1. Readmission Status

    Data extraction from each participant's medical record will be used to determine the number of readmissions within 120 days post discharge.

    Measured: 24 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2018
  2. Study start15 May 2017
  3. Primary completion5 Dec 2018
  4. Study completion26 Nov 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,218 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03424382
Sponsor's protocol ID
1004998
Status last verified
Feb 2020
First submitted
23 Jan 2018
Last updated
7 Feb 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Baltodano PA, Webb-Vargas Y, Soares KC, Hicks CW, Cooney CM, Cornell P, Burce KK, Pawlik TM, Eckhauser FE. A validated, risk assessment tool for predicting readmission after open ventral hernia repair. Hernia. 2016 Feb;20(1):119-29. doi: 10.1007/s10029-015-1413-2. Epub 2015 Aug 19.

    PubMed 26286089

  • Banoff KM, Milner K, Rimar J, Greer AE, Canavan M. Assessment of a Novel Tool for Identifying Hospitalized Patients with Heart Failure at Risk for 30-Day Readmission, High Cost, and Longer Length of Stay. Nurs Econ. 2016 Jul-Aug;34(4):172-81.

    PubMed 29975022

  • 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.

  • Jencks SF, Williams MV, Coleman EA. Rehospitalizations among patients in the Medicare fee-for-service program. N Engl J Med. 2009 Apr 2;360(14):1418-28. doi: 10.1056/NEJMsa0803563.

    PubMed 19339721

  • Kansagara D, Englander H, Salanitro A, Kagen D, Theobald C, Freeman M, Kripalani S. Risk prediction models for hospital readmission: a systematic review. JAMA. 2011 Oct 19;306(15):1688-98. doi: 10.1001/jama.2011.1515.

    PubMed 22009101

  • 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.

  • Naylor MD, Brooten DA, Campbell RL, Maislin G, McCauley KM, Schwartz JS. Transitional care of older adults hospitalized with heart failure: a randomized, controlled trial. J Am Geriatr Soc. 2004 May;52(5):675-84. doi: 10.1111/j.1532-5415.2004.52202.x.

    PubMed 15086645

  • 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 DJ, Handorf EA, Golden SH, Nelson DB, McDonnell ME, Zhao H. DEVELOPMENT AND VALIDATION OF A NOVEL TOOL TO PREDICT HOSPITAL READMISSION RISK AMONG PATIENTS WITH DIABETES. Endocr Pract. 2016 Oct;22(10):1204-1215. doi: 10.4158/E161391.OR.

    PubMed 27732098

  • Stauffer BD, Fullerton C, Fleming N, Ogola G, Herrin J, Stafford PM, Ballard DJ. Effectiveness and cost of a transitional care program for heart failure: a prospective study with concurrent controls. Arch Intern Med. 2011 Jul 25;171(14):1238-43. doi: 10.1001/archinternmed.2011.274.

    PubMed 21788541

  • Tabachnick, B. G., & Fidell, L. S. (2007). Using multivariate statistics (5th edition). Boston: Pearson Press.

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Failure and COPD, run by AdventHealth at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Social Determinant Survey Responses (time frame: 24 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03424382, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2020.

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