CREATION Health Readmission Risk Assessment Tool

Stroke Clinical Trial

Official title:

CREATION Health Readmission Risk Assessment Tool

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03424382
• Other study ID #: 1004998
• Status: Completed
• Start date: May 15, 2017
• Est. completion date: November 26, 2019

Study information

• Verified date: February 2020
• Source: Florida Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1218
• Est. completion date: November 26, 2019
• Est. primary completion date: December 5, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	Florida Hospital	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Florida Hospital

Country where clinical trial is conducted

United States, 

References & Publications (12)

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. — View Citation

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. — View Citation

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. Erratum in: N Engl J Med. 2011 Apr 21;364(16):1582. — View Citation

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. Review. — View Citation

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. Erratum in: J Am Geriatr Soc. 2004 Jul;52(7):1228. — View Citation

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, D. J., McDonnell, M. E., Nelson, D. B., Zhao, H. Q.., & Golden, S. H. (2014). A novel tool to predict hospital readmission risk in patients with diabetes and CVD. Diabetes, 63, p. A642.

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. — View Citation

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

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 Months
Secondary	Readmission Status	Data extraction from each participant's medical record will be used to determine the number of readmissions within 120 days post discharge.	24 Months