Heart Failure Hospital Readmissions and Physical Therapy

Acute Heart Failure Clinical Trial

Official title:

Investigating All-Cause 30-Day Hospital Readmisisons in Patients Discharged From a Tertiary Teaching Hospital With Acute Decompensated Heart Failure Diagnosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03517514
• Other study ID #: Pro00018201
• Status: Completed
• Start date: February 1, 2018
• Est. completion date: August 28, 2019

Study information

• Verified date: August 2019
• Source: The Methodist Hospital System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a dissertation study which is divided into three different studies in order to answer the main research question (Study 3). The primary aim of this research (dissertation) is to investigate all-cause 30-day hospital readmission using functional mobility (5mWT, 30STS, 6MWT, TUG), psychosocial attributes (KCCQ-12, HADS, ESSI), adherence to home exercise program, participation in a supervised exercise program, and number of follow up checkups with physicians or advanced health providers of patients with Acute Decompensated Heart Failure (ADHF) diagnosis who were discharged from a tertiary teaching hospital.

Study 1: What is the effect of acute physical therapy on functional ability in individuals admitted with ADHF? Study 2: What is the effect of acute physical therapy on psychosocial attributes in individuals admitted with ADHF? Study 3: Which factors such as functional mobility (5mWT, 30STS, 6MWT, TUG), psychosocial attributes (KCCQ-12, HADS, ESSI), adherence to home exercise program, participation in a supervised exercise program, and number of follow up checkups with physicians or advanced health providers predict all-cause 30-day hospital readmission in patients discharged from a tertiary, teaching hospital with ADHF diagnosis?

Description:

The research plan is to investigate how acute physical therapy can play a big role in lowering 30-day hospital readmission in patients discharged with acute decompensated heart failure (ADHF). Several factors will be used to investigate and predict 30-day hospital readmission. Such factors are (1) functional mobility; 2) psychosocial attributes; (3) number of follow ups with providers; (4) adherence to home exercise program; (5) and participation in a supervised exercise program. Functional mobility will be measured by four different functional outcome measurements such as 5 meter walk test (5mWT), 30 seconds sit to stand test (30STS), six minute walk test (6MWT), and time up and go test (TUG). The psychosocial attributes will be measured by three different, pen and paper, self-survey questionnaires namely Kansas City Cardiomyopathy Questionnaire-12 (KCCQ12), Hospital Anxiety and Depression Scale (HADS), ENRICHD Social Support Instrument (ESSI). Moreover, once the patient returns home, two phone surveys will be conducted (every two weeks) for a period of 30 days of hospital discharge as a follow up.

For the outcome measurements, the 5mWT is a simple test to measure individual's gait (walking) speed. The 30STS is a simple and easy test to complete in assessing functional lower extremity strength. The 30STS asks individual to stand up (assuming erect posture as much as possible with or without hands support) as many as possible from a regular chair with arm rest within 30 seconds timeframe. The 6MWT is simple and practical test is to measure aerobic capacity by measuring distance of an individual's ability to walk for 6 minutes. The TUG is to measure the time in seconds for a person to rise from sitting from a standard arm chair, rise, walk 10 feet, walk back to the previous arm chair, and sit down. The objective of the TUG test is to classify patient's fall risk. In addition, the functional mobility, basing on the functional outcome measures conducted, will be further assessed at the end of physical therapy service at the hospital by using Global Rating of Scale (GROC). The GROC is a self-survey using 5 point Likert scale, measuring how patient perceives the overall degree of change of improvement or perhaps a lack of improvement.

For the Psychosocial Measures, the Kansas City Cardiomyopathy Questionnaire (KCCQ)-12 is a shorter version of the original KCCQ tool. The objective of this test is to quantify self-measurement of physical function, symptoms, social function, self-efficacy and knowledge, and quality of life as it relates to their own heart failure diagnosis. The Hospital Anxiety and Depression Scale (HADS) is a self-reported questionnaire designed to measure the levels of anxiety and depression that an individual is experiencing. The objective of this tool is to serve as a screening tool to identify individuals who may suffer from anxiety and depression. The ENRICHD Social Support Instrument (ESSI) is a seven-item self-report survey that assesses patient's belief of their social support attributes (emotional, instrumental, informational, and appraisal).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: August 28, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• all admitted at Houston Methodist Hospital with a primary diagnosis of acute heart failure or similar type of medical diagnosis

• stable medical state (HR equal or greater than 50 bpm, mean BP of 60 mmHg or better, Oxygen saturation (with or without oxygen supplement) of 90% or better; RR of 15 or better

• 50 years old and over and able to follow 2 simple commands

• establish discharge recommendation to home settings

• ambulatory with or without assitive device(s)

Exclusion Criteria:

• history of psychiatric disorder

• diagnosis of acute kidney injury requiring continuous renal replacement therapy

• diagnosis of major cognitive impairment (dementia, Alzheimer's dse, etc)

• inability to read and understand basic english language

• establish discharge recommendation to post-acute care settings (e.g. SNF, inpatient rehab, LTACH)

• inability to complete any functional mobility test due to musculoskeletal or other disorders

Related Conditions & MeSH terms

• Acute Heart Failure
• Heart Failure

Intervention

Other:
• Physical Therapy service
routine physical therapy care

Locations

Country	Name	City	State
United States	Houston Methodist Hospital	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The Methodist Hospital System	Texas Woman's University

Country where clinical trial is conducted

United States, 

References & Publications (27)

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3. Hines AL BM, Jiang JH SC. Conditions with the largest number of adult hospital readmissions by payer, 2011: Statistical brief #172. Agency for Healthcare Research and Quality (US), Rockville (MD); 2006. http://europepmc.org/abstract/MED/24901179; https://www.ncbi.nlm.nih.gov/books/NBK206781. Accessed July 08, 2017.

Afilalo J, Eisenberg MJ, Morin JF, Bergman H, Monette J, Noiseux N, Perrault LP, Alexander KP, Langlois Y, Dendukuri N, Chamoun P, Kasparian G, Robichaud S, Gharacholou SM, Boivin JF. Gait speed as an incremental predictor of mortality and major morbidity in elderly patients undergoing cardiac surgery. J Am Coll Cardiol. 2010 Nov 9;56(20):1668-76. doi: 10.1016/j.jacc.2010.06.039. — View Citation

Alhurani AS, Dekker RL, Abed MA, Khalil A, Al Zaghal MH, Lee KS, Mudd-Martin G, Biddle MJ, Lennie TA, Moser DK. The association of co-morbid symptoms of depression and anxiety with all-cause mortality and cardiac rehospitalization in patients with heart failure. Psychosomatics. 2015 Jul-Aug;56(4):371-80. doi: 10.1016/j.psym.2014.05.022. Epub 2014 Jun 2. — View Citation

Desai AS, Stevenson LW. Rehospitalization for heart failure: predict or prevent? Circulation. 2012 Jul 24;126(4):501-6. doi: 10.1161/CIRCULATIONAHA.112.125435. — View Citation

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Fisher SR, Graham JE, Ottenbacher KJ, Deer R, Ostir GV. Inpatient Walking Activity to Predict Readmission in Older Adults. Arch Phys Med Rehabil. 2016 Sep;97(9 Suppl):S226-31. doi: 10.1016/j.apmr.2015.09.029. Epub 2016 Jun 2. — View Citation

Fisher SR, Kuo YF, Sharma G, Raji MA, Kumar A, Goodwin JS, Ostir GV, Ottenbacher KJ. Mobility after hospital discharge as a marker for 30-day readmission. J Gerontol A Biol Sci Med Sci. 2013 Jul;68(7):805-10. doi: 10.1093/gerona/gls252. Epub 2012 Dec 19. — View Citation

Garrison C, Cook C. Clinimetrics corner: the Global Rating of Change Score (GRoC) poorly correlates with functional measures and is not temporally stable. J Man Manip Ther. 2012 Nov;20(4):178-81. doi: 10.1179/1066981712Z.00000000022. — View Citation

Green CP, Porter CB, Bresnahan DR, Spertus JA. Development and evaluation of the Kansas City Cardiomyopathy Questionnaire: a new health status measure for heart failure. J Am Coll Cardiol. 2000 Apr;35(5):1245-55. — View Citation

Herman T, Giladi N, Hausdorff JM. Properties of the 'timed up and go' test: more than meets the eye. Gerontology. 2011;57(3):203-10. doi: 10.1159/000314963. Epub 2010 May 20. — View Citation

Hernandez AF, Greiner MA, Fonarow GC, Hammill BG, Heidenreich PA, Yancy CW, Peterson ED, Curtis LH. Relationship between early physician follow-up and 30-day readmission among Medicare beneficiaries hospitalized for heart failure. JAMA. 2010 May 5;303(17):1716-22. doi: 10.1001/jama.2010.533. — View Citation

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Kamper SJ, Maher CG, Mackay G. Global rating of change scales: a review of strengths and weaknesses and considerations for design. J Man Manip Ther. 2009;17(3):163-70. — View Citation

McCabe N, Butler J, Dunbar SB, Higgins M, Reilly C. Six-minute walk distance predicts 30-day readmission after acute heart failure hospitalization. Heart Lung. 2017 Jul - Aug;46(4):287-292. doi: 10.1016/j.hrtlng.2017.04.001. Epub 2017 May 24. — View Citation

McIlvennan CK, Eapen ZJ, Allen LA. Hospital readmissions reduction program. Circulation. 2015 May 19;131(20):1796-803. doi: 10.1161/CIRCULATIONAHA.114.010270. — View Citation

Mitchell PH, Powell L, Blumenthal J, Norten J, Ironson G, Pitula CR, Froelicher ES, Czajkowski S, Youngblood M, Huber M, Berkman LF. A short social support measure for patients recovering from myocardial infarction: the ENRICHD Social Support Inventory. J Cardiopulm Rehabil. 2003 Nov-Dec;23(6):398-403. — View Citation

Ross JS, Chen J, Lin Z, Bueno H, Curtis JP, Keenan PS, Normand SL, Schreiner G, Spertus JA, Vidán MT, Wang Y, Wang Y, Krumholz HM. Recent national trends in readmission rates after heart failure hospitalization. Circ Heart Fail. 2010 Jan;3(1):97-103. doi: 10.1161/CIRCHEARTFAILURE.109.885210. Epub 2009 Nov 10. — View Citation

Schmitt J, Abbott JH. Global ratings of change do not accurately reflect functional change over time in clinical practice. J Orthop Sports Phys Ther. 2015 Feb;45(2):106-11, D1-3. doi: 10.2519/jospt.2015.5247. Epub 2015 Jan 8. — View Citation

Snaith RP. The Hospital Anxiety And Depression Scale. Health Qual Life Outcomes. 2003 Aug 1;1:29. — View Citation

Spertus JA, Jones PG. Development and Validation of a Short Version of the Kansas City Cardiomyopathy Questionnaire. Circ Cardiovasc Qual Outcomes. 2015 Sep;8(5):469-76. — View Citation

Stern AF. The hospital anxiety and depression scale. Occup Med (Lond). 2014 Jul;64(5):393-4. doi: 10.1093/occmed/kqu024. — View Citation

Tabata M, Shimizu R, Kamekawa D, Kato M, Kamiya K, Akiyama A, Kamada Y, Tanaka S, Noda C, Masuda T. Six-minute walk distance is an independent predictor of hospital readmission in patients with chronic heart failure. Int Heart J. 2014;55(4):331-6. Epub 2014 Jun 5. — View Citation

Vaglio J Jr, Conard M, Poston WS, O'Keefe J, Haddock CK, House J, Spertus JA. Testing the performance of the ENRICHD Social Support Instrument in cardiac patients. Health Qual Life Outcomes. 2004 May 13;2:24. — View Citation

Walenkamp MM, de Muinck Keizer RJ, Goslings JC, Vos LM, Rosenwasser MP, Schep NW. The Minimum Clinically Important Difference of the Patient-rated Wrist Evaluation Score for Patients With Distal Radius Fractures. Clin Orthop Relat Res. 2015 Oct;473(10):3235-41. doi: 10.1007/s11999-015-4376-9. Epub 2015 Jun 4. Erratum in: Clin Orthop Relat Res. 2015 Sep;473(9):3063. — View Citation

Wilson CM, Kostsuca SR, Boura JA. Utilization of a 5-Meter Walk Test in Evaluating Self-selected Gait Speed during Preoperative Screening of Patients Scheduled for Cardiac Surgery. Cardiopulm Phys Ther J. 2013 Sep;24(3):36-43. — View Citation

Yamada S, Shimizu Y, Suzuki M, Izumi T; PTMaTCH collaborators. Functional limitations predict the risk of rehospitalization among patients with chronic heart failure. Circ J. 2012;76(7):1654-61. Epub 2012 Apr 7. — View Citation

* Note: There are 27 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Kansas City Cardiomyopathy Questionnaire (KCCQ)	A 23-item, self-administered subjective questionnaire, to measure the quality of life of individuals living with heart failure regarding their physical function, heart failure symptoms, social and physical function with a score of 0 to 100, where the higher the number, the better the health status.	Comparing any change between pre-physical therapy treatment (Day 1) to post-physical therapy treatment (defined as time frame: Day 2 to 8 weeks)
Other	Hospital Anxiety and Depresssion Scale (HADS)	A self-reported score measuring the level of anxiety and depression in the past week where the total score of anxiety and depression is 0 to 21, with the higher range from 8- 21 as borderline to abnormal.	Comparing any change between pre-physical therapy treatment (Day 1) to post-physical therapy treatment (defined as time frame: Day 2 to 8 weeks)
Other	Enhancing Recovery in Coronary Heart Disease Patients (ENRICHD) Social Support Instrument (ESSI)	Seven item self-reported survey to measure an individual's perceived level of social support.	Comparing any change between pre-physical therapy treatment (Day 1) to post-physical therapy treatment (defined as time frame: Day 2 to 8 weeks)
Primary	hospital readmission within 30 days	Identification of patient hospital readmission within 30 days of discharge (day 0).	less than or equal to 30 days
Secondary	Six Minute Walk Test (6MWT)	Compare measured total walking distance (in feet) within 6 minutes time	Comparing any change between pre-physical therapy treatment (Day 1) to post-physical therapy treatment (defined as time frame: Day 2 to 8 weeks)
Secondary	30 seconds Sit to Stand Test (30STS)	Measurement of the total number of times a patient can complete a sit to stand task within 30 seconds, using a standard chair with arm rest (quantity of tasks)	Comparing any change between pre-physical therapy treatment (Day 1) to post-physical therapy treatment (defined as time frame: Day 2 to 8 weeks)
Secondary	Five Meter Walk Test (5mWT)	Measurement of walking speed (in meter/seconds) over a 5 meter walking distance	Comparing any change between pre-physical therapy treatment (Day 1) to post-physical therapy treatment (defined as time frame: Day 2 to 8 weeks)
Secondary	Time Up and Go Test of Fall Risk (TUG)	To classify patient's risk of falls will measure the time (in seconds) it takes to complete the task of standing up from a chair, walk 10 feet, turn around, and return to previous sitting position.	Comparing any change between pre-physical therapy treatment (Day 1) to post-physical therapy treatment (defined as time frame: Day 2 to 8 weeks)
Secondary	Global Rating of Change Scale (GROC)	To rate a 4 question, 11 point Likert scale per question, regarding a person's perception of the change in (1) walking distance, (2) walking speed, (3) risk of falls, and (4) number of times of complete sit to stand task after completing acute physical therapy services	End of study (post-physical therapy; defined as time frame: Day 2 to 8 weeks)

External Links

•   Heart Failure matters
•   What is Heart failure?