Heart Failure Hospital Readmissions and Physical Therapy

August 28, 2019 updated by: Bobby Belarmino PT,DPT,MA, The Methodist Hospital Research Institute

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

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?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Observational

Enrollment (Actual)

102

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
    • Texas
      • Houston, Texas, United States, 77030
        • Houston Methodist 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

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hospital readmission within 30 days
Time Frame: less than or equal to 30 days
Identification of patient hospital readmission within 30 days of discharge (day 0).
less than or equal to 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Six Minute Walk Test (6MWT)
Time Frame: Comparing any change between pre-physical therapy treatment (Day 1) to post-physical therapy treatment (defined as time frame: Day 2 to 8 weeks)
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)
30 seconds Sit to Stand Test (30STS)
Time Frame: Comparing any change between pre-physical therapy treatment (Day 1) to post-physical therapy treatment (defined as time frame: Day 2 to 8 weeks)
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)
Five Meter Walk Test (5mWT)
Time Frame: Comparing any change between pre-physical therapy treatment (Day 1) to post-physical therapy treatment (defined as time frame: Day 2 to 8 weeks)
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)
Time Up and Go Test of Fall Risk (TUG)
Time Frame: Comparing any change between pre-physical therapy treatment (Day 1) to post-physical therapy treatment (defined as time frame: Day 2 to 8 weeks)
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)
Global Rating of Change Scale (GROC)
Time Frame: End of study (post-physical therapy; defined as time frame: Day 2 to 8 weeks)
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)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time Frame: Comparing any change between pre-physical therapy treatment (Day 1) to post-physical therapy treatment (defined as time frame: Day 2 to 8 weeks)
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)
Hospital Anxiety and Depresssion Scale (HADS)
Time Frame: Comparing any change between pre-physical therapy treatment (Day 1) to post-physical therapy treatment (defined as time frame: Day 2 to 8 weeks)
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)
Enhancing Recovery in Coronary Heart Disease Patients (ENRICHD) Social Support Instrument (ESSI)
Time Frame: Comparing any change between pre-physical therapy treatment (Day 1) to post-physical therapy treatment (defined as time frame: Day 2 to 8 weeks)
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)

Collaborators and Investigators

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

Sponsor

The Methodist Hospital Research Institute

Collaborators

Texas Woman's University

Investigators

  • Principal Investigator: Bobby C Belarmino, PT,DPT,MA, The Methodist Hospital Research Institute

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

Helpful Links

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)

February 1, 2018

Primary Completion (Actual)

January 31, 2019

Study Completion (Actual)

August 28, 2019

Study Registration Dates

First Submitted

April 6, 2018

First Submitted That Met QC Criteria

May 4, 2018

First Posted (Actual)

May 7, 2018

Study Record Updates

Last Update Posted (Actual)

August 29, 2019

Last Update Submitted That Met QC Criteria

August 28, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00018201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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