Post-acute Care for Patients With Hip Fracture

NCT04287101 | Completed

• 1 other identifier: PAC for hip fracture
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (3)

home PAC

EXPERIMENTAL

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

hospital PAC

ACTIVE COMPARATOR

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

conventional care group

NO INTERVENTION

usual care

Interventions

Post-operative PT and OT OTHER

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

home PAC; hospital PAC

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged ≥ 50
• First hip fracture
• Stable medical condition

You may not qualify if:

• Hip fracture caused by major trauma or pathological condition
• Multiple fractures
• Severe physical disability before the hip fracture
• Unable to cooperate with treatment
• Further inpatient treatment

Sponsors & Collaborators

• Taipei City Hospital: lead

Study Sites (1)

Taipei City Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Hip Fractures

Interventions

Postoperative Period

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Perioperative Period; Surgical Procedures, Operative; Patient Care; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Shih-Liang Shih, PhD.

  Department of Orthopaedic, Taipei City Hospital, Zhongxing Branch

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Orthopedics

Study Record Dates

• First Submitted: February 25, 2020
• First Posted: February 27, 2020
• Study Start: March 2, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2021
• Last Updated: July 5, 2022

Record last verified: 2022-06

Locations

TW (1)