Intervention Program for Elderly Patients With Hip Fracture

Official Title: “Intervention Program for Elderly Patients With Hip Fracture”

Specific Aims

The long-term objective of this study is to examine the effectiveness of an intervention program for older patients with hip fracture. First, an intervention program for elderly patients with hip fracture will be developed and implemented, then, the effectiveness of the intervention program will be examined. The specific aims are as follows:

1. To develop a well conceived and feasible protocol of hospital discharge and sub-acute care that involves the coordinated work of health care professionals (physicians, surgeons, nurses, and physical therapists) and the informal caregivers. The feasibility of implementing such a protocol within the context of an intervention study subject to the constraints of the clinical setting (i.e., CGMH) will be evaluated in a pilot study.

2. To conduct a randomized clinical trial to evaluate the outcomes and costs associated with the proposed hospital discharge/sub-acute care protocol for elderly patients with hip fracture. Both experimental and case study methods will be used. Information on outcome indicators including clinical outcomes, quality of life, self-care ability, family caregiving outcomes, patient and caregiver satisfaction, and services utilization will be collected and compared between the control group and the experimental group.

3. To conduct a validation clinical trial to verify the results of the primary randomized clinical trial and increase the generalization of the study findings.

4. To estimate the cost of this care model and its variations for individual patients.

Hypothesis

1. Elderly patients with hip fracture who participate in the intervention program will significantly better clinical outcomes including range of motion (ROM), muscle strength and endurance, motor control, recovery of walking ability, aerobic and anaerobic capacity, flexibility, body position, and less pain, complications, and mortality than those who do not.

2. Elderly patients with hip fracture who participate in the intervention program will show significantly greater improvement in self-care ability measured by Chinese Functional Independence Measure (FIM) than those who do not.

3. Elderly patients with hip fracture who participate in the intervention program will significantly better quality of life measured by SF-36 Taiwan version than those who do not.

4. Elderly patients with hip fracture who participate in the intervention program will have significantly better family caregiving outcomes measured by the Family Caregiving Consequence Inventory (FCCI) than those who do not.

5. Elderly patients with hip fracture who participate in the intervention program will have significantly less health and personal service utilization including length of hospital stay (LOS), emergency room visits, hospital readmission rate, and home nursing, nursing home and other health service utilization than those who do not.

6. Elderly patients with hip fracture who participate in the intervention program and their family caregivers will have significantly more satisfaction to health care services than those who do not.

The percentage of elderly persons in Taiwan has continually increased, from 2.5% in 1951 to 8.26% in 1998; the current number of elderly is 1,811,335. As in other countries with an increasing aging population, hip fracture represents a major and growing health care problem in Taiwan. Hip fractures resulted in 15,000 hospital admissions in 1997. It is estimated that the incidence rate (per 100, 000) for hip fracture in Taiwan was 211 for Taiwan's elderly population in 1993, 10 times the incidence rate for the general population. Despite advanced treatments, the one-year mortality rate for hip fracture remains significant (15.4%), and a majority of patients never recover completely in terms of activities of daily living. The economic costs of hip fractures among the elderly are huge and families suffer from caregiving burdens. Many studies in the United States have shown that elderly patients with hip fracture can benefit from post-operative rehabilitation, early discharge planning, and transitional care. However, little is known about what interventions should be attempted for these patients and their family caregivers in Taiwan. The purpose of this experimental study is therefore to explore the effectiveness of an intervention program for older patients with hip fracture. The cost of this care model will also be estimated.

An intervention program will be developed in the first year. This program will be administered by a multidisciplinary health care team and will include a geriatric consultation service, an in-hospital and in-home rehabilitation program and a discharge planning component. During the first year, a pilot study consisting of 10 elderly patients with hip fracture and their caregivers in the experimental group and 10 in the control group will test the feasibility of the intervention program and establish a reference point for sample size modification. In the second and third years, a primary clinical trial will be conducted in Chang Gung Memorial Hospital in Lin Kuo. In this studies, 120 subjects who meet the sample criteria will be recruited and randomly assigned to the experimental and control group. Patients in the experimental group will receive regular hospital routine care and the intervention program. Patients in the control group will receive only routine hospital care.

The outcome variables will include clinical outcomes, self-care ability, quality of life, family caregiving outcomes, patient and caregiver's satisfaction, and service utilization; data on those will be collected for one year after hospital discharge and compared between the experimental and control groups. Data on the cost of care will also be collected. A qualitative component will include in-depth interviews with five patients and their family caregivers from the experimental group, five from the control group and five health care providers, to explore the effects of the intervention program in detail. In the fourth and fifth years, a validation clinical trial will be conducted with 120 subjects. The intervention program will be implemented at a different medical center to validate the results of the primary clinical trial. The study results will provide suggestions for intervention protocols for elderly persons with hip fracture and guidelines for the development of intervention programs for other high-risk elderly persons in Taiwan. The findings also provide a reference for clinical and hospital administration decisions.

Intervention(s) in this Clinical Trial

• Other: Interdisciplinary intervention program
  • The intervention program developed for this study included three components: geriatric consultation service, rehabilitation program, and discharge-planning service.

Arms, Groups and Cohorts in this Clinical Trial

• No Intervention: Control group
  • Patients receive only routine hospital care
• Experimental: Experimental group
  • Patients receive regular hospital routine care and interdisciplinary intervention program

Primary Measures

• Quality of life
  • Time Frame: 1 year
    Safety Issue?: No

Secondary Measures

• Clinical outcomes
  • Time Frame: 1 year
    Safety Issue?: Yes
• Self-care ability
  • Time Frame: 1 year
    Safety Issue?: Yes
• Family caregiving outcomes
  • Time Frame: 1 year
    Safety Issue?: Yes
• Patient and caregiver's satisfaction
  • Time Frame: 1 year
    Safety Issue?: No
• Service utilization
  • Time Frame: 1 year
    Safety Issue?: No
• Cost of care
  • Time Frame: 1year
    Safety Issue?: No

Inclusion Criteria:

• Age 60 years or older
• Admitted from emergency room due to hip fracture
• Receiving hip arthroplasty or internal fixation
• Living in northern Taiwan

Exclusion Criteria:

• Severely cognitively impaired and completely unable to follow orders
• Terminally ill

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 60 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Chang Gung Memorial Hospital Other

Overall Clinical Trial Officials and Contacts

Yea-Ing L Shyu, Ph.D. Principal Investigator Chang Gung University  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01052636

Study ID Number: NHRI-EX90-9023PL

ClinicalTrials.gov Identifier: NCT01052636

Health Authority: Taiwan: Institutional Review Board