The Outcome and Cost Analysis of Home-care Physical Therapy for Postoperative Hip Fracture Patients

January 11, 2010 updated by: National Taiwan University Hospital

The aims of this study are:

To develop a disease-specific questionnaire for hip fractures.
To find the influences of physical therapy (PT) on patients' function and health-related quality of life (HRQL).
To estimate the quality adjusted life years (QALY) of cases of hip fracture with or without the PT program by a quality-adjusted survival (QAS) method.
To perform cost effectiveness analysis (CEA) to evaluate the effectiveness of PT and as a base to compare it with other health intervention programs.

At the beginning of the study, the investigators will develop the disease-specific questionnaire for hip fractures. Cases of patients with hip fractures hospitalized in orthopedic wards of the National Taiwan University Hospital (NTUH) and Chung-Hsing Hospital of Taipei from August 1, 1989 to July 31, 1999 are the study population during the first year of this study. According to their receiving PT or not during hospitalization, the patients are assigned to a PT or non-PT group. The identification (ID) numbers will be matched with the death certificate file of the Department of Health to verify the survival status. Furthermore, 30 cases per group per year will be randomly sampled to interview their HRQL and evaluate their function with the disease-specific questionnaire for hip fractures. Combining the survival function and HRQL, the QALY could be estimated. Cases of hip fracture admitted to the orthopedic ward of NTUH and receiving a PT program from January 1, 2000 will be the second-year study population in this study. They will be randomly assigned to a group of follow-up PT (group I) or non-follow-up PT (group II). The patients assigned to group I will have a 4-time PT evaluation and treatment at home after discharge from the hospital (1 week, 1 month, 3 months and 6 months after discharge). All patients will be evaluated at discharge, 1 month, 6 months, and 1 year after discharge to follow their survival status, functional status and HRQL. The expected results of this study will be to develop the disease-specific questionnaire for hip fractures, to show the functional outcomes of cases of hip fracture, and to estimate the QALY of them.

Study Overview

Status

Completed

Conditions

Hip Fractures

Intervention / Treatment

Behavioral: home physical therapy

Detailed Description

Hip fracture from fall is the most important cause of disability of the aged. Most of the victims receive surgery (internal fixation or arthroplasty) as the primary treatment. However, during the hospitalization of post-surgery, not all the patients receive physical therapy (PT). The program of PT during hospitalization and after discharge affects the functional recovery and the health-related quality of life (HRQL) significantly in our knowledge. Therefore, the aims of this study are:

To develop the disease-specific questionnaire for hip fracture.
To find the influences of PT on patients' function and HRQL.
To estimate the QALY of cases of hip fracture with or without PT program by quality-adjusted survival (QAS) method.
To perform CEA to evaluate the effectiveness of PT and as a base to compare with other health intervention program.

At the beginning of the study, we will develop the disease-specific questionnaire for hip fracture. And, cases of hip fracture hospitalized in orthopedic wards of National Taiwan University Hospital (NTUH) and Chung-Hsing Hospital of Taipei from August 1, 1989 to July 31, 1999 are the study population of the first year in this study. According to their receiving PT or not during hospitalization, the patients are assigned to PT or non-PT group. Basic data such as ID number, age, sex, comorbidity, pre-injury physical status, operation date, operation type, length of hospitalization, complication, are extracted from their charts. The identification (ID) numbers will be matched with the death certificate file of the Department of Health to make sure the survival status. Furthermore, 30 cases per group per year will be randomly sampled to interview their HRQL and evaluate their function with the disease-specific questionnaire for hip fracture. Combining the survival function and HRQL, the QALY could be estimated. Cases of hip fracture admit to the orthopedic ward of NTUH and receive PT program from Jan. 1, 2000 will be the second-year study population in this study. They will be randomly assigned to group of follow-up PT (group I) or non-follow-up PT (group II). The patients assigned to group I will have 4-time PT evaluation and treatment at home after discharge from hospital (1 week, 1-month, 3-month and 6-month after discharge). All patients will be evaluated at discharge, 1-month, 6-month, and 1-year after discharge to follow their survival status, functional status and HRQL. The patients younger than 65 years old will be further evaluated for their working capacity at the last evaluation. In the third year of this study, medical cost and estimated QALY will be collected to perform the CEA for the effectiveness of PT program during hospitalization and after discharge.

The expected results of this study will be to develop the disease-specific questionnaire for hip fracture, to show the functional outcome of cases with hip fracture, to estimate the QALY of them and to perform a CEA to demonstrate the effectiveness of PT.

Study Type

Interventional

Enrollment (Anticipated)

Phase

Not Applicable

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

Child
Adult
Older Adult

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Hip fracture, post surgery

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

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Quality of Life, Harris score, walking velocity, strength

Collaborators and Investigators

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

Sponsor

National Taiwan University Hospital

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

August 1, 1999

Primary Completion (Actual)

July 1, 2001

Study Completion (Actual)

July 1, 2001

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Estimate)

January 12, 2010

Last Update Submitted That Met QC Criteria

January 11, 2010

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

24368 (Other Identifier: West Virginia University IRB)

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