Clinical trial NCT03517514: Heart Failure Hospital Readmissions and Physical Therapy
Official title: Investigating All-Cause 30-Day Hospital Readmisisons in Patients Discharged From a Tertiary Teaching Hospital With Acute Decompensated Heart Failure Diagnosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Heart Failure
Keywords: Heart Failure
Physical Therapy
Hospital Readmission
Lead sponsor: The Methodist Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Texas Woman's University
First posted: 2018-05-07
Enrollment: 102
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All medically stable, admitted patients at the hospital that have an admitting diagnosis of acute heart failure (or similar diagnosis) will be screened as potential study participants.

Brief 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?

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: hospital readmission within 30 days
timeFrame: less than or equal to 30 days
Secondary outcomes:
measure: Six Minute Walk Test (6MWT)
timeFrame: Comparing any change between pre-physical therapy treatment (Day 1) to post-physical therapy treatment (defined as time frame: Day 2 to 8 weeks)
measure: 30 seconds Sit to Stand Test (30STS)
timeFrame: Comparing any change between pre-physical therapy treatment (Day 1) to post-physical therapy treatment (defined as time frame: Day 2 to 8 weeks)
measure: Five Meter Walk Test (5mWT)
timeFrame: Comparing any change between pre-physical therapy treatment (Day 1) to post-physical therapy treatment (defined as time frame: Day 2 to 8 weeks)
measure: Time Up and Go Test of Fall Risk (TUG)
timeFrame: Comparing any change between pre-physical therapy treatment (Day 1) to post-physical therapy treatment (defined as time frame: Day 2 to 8 weeks)
measure: Global Rating of Change Scale (GROC)
timeFrame: End of study (post-physical therapy; defined as time frame: Day 2 to 8 weeks)
Other outcomes:
measure: Kansas City Cardiomyopathy Questionnaire (KCCQ)
timeFrame: Comparing any change between pre-physical therapy treatment (Day 1) to post-physical therapy treatment (defined as time frame: Day 2 to 8 weeks)
measure: Hospital Anxiety and Depresssion Scale (HADS)
timeFrame: Comparing any change between pre-physical therapy treatment (Day 1) to post-physical therapy treatment (defined as time frame: Day 2 to 8 weeks)
measure: Enhancing Recovery in Coronary Heart Disease Patients (ENRICHD) Social Support Instrument (ESSI)
timeFrame: Comparing any change between pre-physical therapy treatment (Day 1) to post-physical therapy treatment (defined as time frame: Day 2 to 8 weeks)
Locations:
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
Study officials:
affiliation: The Methodist Hospital Research Institute
name: Bobby C Belarmino, PT,DPT,MA
role: PRINCIPAL_INVESTIGATOR
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