Clinical trial NCT04287101: Post-acute Care for Patients With Hip Fracture
Official title: Home-Based Integrated Post-Acute Care Program for Hip Fracture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Fractures
Activities of Daily Living
Keywords: Hip fractures
Post-acute care
Home-based care
Hospital-based care
Activities of daily living
Cost effectiveness analysis
Lead sponsor: Taipei City Hospital
Sponsor class: OTHER_GOV
First posted: 2020-02-27
Enrollment: 41
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 30-second sit to stand
timeFrame: within 1 year
measure: Activities of daily living Using the Barthel Index (BI)
timeFrame: within 1 year
measure: Functional performance of hip Using the Harris hip score (HHS)
timeFrame: within 1 year
measure: Pain intensity Using the numerical pain rating scale (NPRS)
timeFrame: within 1 year
measure: Quality of lives Using the EuroQol instrument (EQ-5D)
timeFrame: within 1 year
measure: Quality of lives Using the EuroQol instrument (EQ-5D)
timeFrame: within 1 year
measure: Caregiver strain Using the caregiver strain index (CSI)
timeFrame: within 1 year
measure: Medical Costs
timeFrame: within 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei City Hospital
Study officials:
affiliation: Department of Orthopaedic, Taipei City Hospital, Zhongxing Branch
name: Shih-Liang Shih, PhD.
role: PRINCIPAL_INVESTIGATOR
References: