Post-acute Care for Patients With Hip Fracture

Home-Based Integrated Post-Acute Care Program for Hip Fracture

Background and purpose: Hip fracture, a common injury occurred in people aged over 50, may result in disability, poor quality of life, and higher care stress for their families. Aging population and growing number of hip fractures have increased medical expenses, so developed countries implemented post-acute care (PAC) to reduce acute hospitalization, and to improve the quality of care. PAC services can be delivered by hospital/facility-based and home-based services. Previous studies showed that both services could significantly improve patients' activities of daily living and quality of life, and reduce readmissions, long-term care and costs. Taiwan has implemented PAC plan for hip fractures since 2017, but relevant evidences are limited. Therefore, the purpose of this study is to analyze the efficacy and cost-effectiveness of PAC for patients with hip fractures.

Study Overview

• Status: Completed
• Conditions: Hip Fractures; Activities of Daily Living
• Intervention / Treatment: Other: Post-operative PT and OT

Detailed Description

Methods: This is a prospective cohort study which will recruit patients aged over 50 with hip fractures receiving surgical treatment in the Taipei City Hospital. They will be provided home-based PAC, hospital-based PAC, or no formal PAC based on the medical judgment and patients/families' willingness. The period of PAC will be two to three weeks after the acute hospitalization. Assessments include physical function (30 seconds sit to stand, Barthel index, and Harris Hip Score), numerical pain rating scale, EuroQol instrument (EQ-5D), Caregiver Strain Index, and using of medical resources. The assessments will be on the day before discharge from acute hospitalization, and on the discharge day from post-acute care. The follow-up assessment will be at 1, 3, 6, and 12 months after operation. The cost-effectiveness ratio will be defined as the New Taiwan dollars paid for 1-unit improvement of functional performance and quality of life.

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Taipei City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Aged ≥ 50
2. First hip fracture
3. Stable medical condition

Exclusion Criteria:

1. Hip fracture caused by major trauma or pathological condition
2. Multiple fractures
3. Severe physical disability before the hip fracture
4. Unable to cooperate with treatment
5. Further inpatient treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: home PAC; A home PAC team will care for patients in his/her home within 3 weeks after acute hospitalization. The patient will get a physical therapy (PT) or occupational therapy (OT) 1 to 6 session(s) per week.	Other: Post-operative PT and OT; Strengthening exercise, range-of-motion exercise, functional training, balance training, adjustment for assistive devices, adaptation and modification of the home environment, and patient/caregiver education
ACTIVE_COMPARATOR: hospital PAC; A rehabilitation PAC team will care for patients in the hospital within 3 weeks after acute hospitalization. The patient will have 1 to 2 session(s) of PT or OT on weekdays, and a daily physician visit and nurse care.	Other: Post-operative PT and OT; Strengthening exercise, range-of-motion exercise, functional training, balance training, adjustment for assistive devices, adaptation and modification of the home environment, and patient/caregiver education
NO_INTERVENTION: conventional care group; usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30-second sit to stand	Ask participants to cross their arms at the chest, and to perform sit to stand as more as possible within 30 seconds. Measure the repetitions the participants do. Higher repetition indicates more strength of lower extremities.	within 1 year
Activities of daily living Using the Barthel Index (BI)	Using the Barthel Index (BI) to measure participants' activities of daily living. The self-care domain is self-report by the patient or their families. The mobility domain is observed by the assessor. The greater score indicates more independence.	within 1 year
Functional performance of hip Using the Harris hip score (HHS)	Using the Harris hip score (HHS) to measure participants' functional performance of hip. The pain domain is self-report by the patient. The function, deformity, and range of motion domain are observed by the assessor. The greater score indicates the better functional performance of hip.	within 1 year
Pain intensity Using the numerical pain rating scale (NPRS)	Using the numerical pain rating scale (NPRS) to measure participants' pain intensity. Ask participants to report their pain intensity with the 11-point scale (from 0 no pain to 10 worst possible pain).	within 1 year
Quality of lives Using the EuroQol instrument (EQ-5D)	Part 1: Ask participants to measure their mobility, self-care, usual activities, pain/discomfort, and anxiety/depression with the 3-point scale. The greater score indicates poor quality of life.	within 1 year
Quality of lives Using the EuroQol instrument (EQ-5D)	Part 2: Ask participants to measure their quality of life with a 20-cm visual analog scale. The greater score indicates a better quality of life.	within 1 year
Caregiver strain Using the caregiver strain index (CSI)	Using the caregiver strain index (CSI) to measure the strain of caregiver. Ask them to fill a 13-item questionnaire. Greater value indicates a higher strain.	within 1 year
Medical Costs	Ask participants to record their direct medical cost and indirect medical cost within one year after hip fracture.	within 1 year

Collaborators and Investigators

• Sponsor: Taipei City Hospital
• Investigators: Principal Investigator: Shih-Liang Shih, PhD., Department of Orthopaedic, Taipei City Hospital, Zhongxing Branch

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 2, 2020
• Primary Completion (ACTUAL): December 31, 2020
• Study Completion (ACTUAL): December 31, 2021

Study Registration Dates

• First Submitted: February 25, 2020
• First Submitted That Met QC Criteria: February 26, 2020
• First Posted (ACTUAL): February 27, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 5, 2022
• Last Update Submitted That Met QC Criteria: June 30, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Activities of daily living; Hip fractures; Post-acute care; Home-based care; Cost effectiveness analysis; Hospital-based care
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures
• Other Study ID Numbers: PAC for hip fracture

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No