NCT03906864

Brief Summary

The effectiveness of integrated care pathways for hip fractures in sub-acute rehabilitation settings is not known. The study objective was to assess if a hip fracture integrated care pathway at a sub-acute rehabilitation facility would result in better functional outcomes, shorter length of stay and fewer institutionalisations. A randomised controlled trial on an integrated care pathway was conducted for hip fracture patients in a sub-acute rehabilitation setting. The study supports the use of integrated care pathways in sub-acute rehabilitation settings to reduce length of stay whilst achieving the same functional gains.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
162

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 8, 2004

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2006

Completed
6.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 26, 2012

Completed
5.7 years until next milestone

First Submitted

Initial submission to the registry

September 16, 2018

Completed
7 months until next milestone

First Posted

Study publicly available on registry

April 8, 2019

Completed
Last Updated

April 8, 2019

Status Verified

April 1, 2019

Enrollment Period

1.8 years

First QC Date

September 16, 2018

Last Update Submit

April 5, 2019

Conditions

Hip Fractures

Keywords

Critical pathway, length of stay, recovery of function, subacute care

Outcome Measures

Primary Outcomes (8)

  • Montebello Rehabilitation Factor Score (MRFS)

    MRFS is a recognised measure of hip fracture patients' functional outcome, calculated with the following formula, using the Modified Barthel Index (MBI) scores (which scores the degree of independence of a subject from any assistance up to a maximum score of 100)

    1 day At discharge

  • Montebello Rehabilitation Factor Score (MRFS)

    MRFS is a recognised measure of hip fracture patients' functional outcome, calculated with the following formula, using the Modified Barthel Index (MBI) scores (which scores the degree of independence of a subject from any assistance up to a maximum score of 100)

    At 6 months

  • Montebello Rehabilitation Factor Score (MRFS)

    MRFS is a recognised measure of hip fracture patients' functional outcome, calculated with the following formula, using the Modified Barthel Index (MBI) scores (which scores the degree of independence of a subject from any assistance up to a maximum score of 100)

    At 1 year

  • Proportions of patients achieving pre-morbid ambulatory status

    Pre-morbid ambulatory status is a predictor for post-operative mobility

    1 day At discharge

  • Proportions of patients achieving pre-morbid ambulatory status

    Pre-morbid ambulatory status is a predictor for post-operative mobility

    At 6 months

  • Proportions of patients achieving pre-morbid ambulatory status

    Pre-morbid ambulatory status is a predictor for post-operative mobility

    At 1 year

  • Length of stay in hospital

    Refers to the average number of days that patients spend in hospital

    1 day At discharge

  • Percentage of patients admitted to nursing home

    A form of institutional care

    Up to 1 year after discharge

Secondary Outcomes (3)

  • Readmissions to an acute hospital for any reason

    up to 1-year post-discharge

  • Cumulated mortality

    1 year

  • Quality of life scale-Short form 12 quality of life

    6 months and 1 year

Study Arms (2)

Control group

NO INTERVENTION

Usual care consisted of 2 half hourly therapy sessions per day from Monday to Friday and medical ward rounds 3 times a week. Multidisciplinary rounds were conducted every 2 weeks. Any specific goals or interventions were at the discretion of the managing team.

Intervention group

EXPERIMENTAL

Intervention group had structured assessments and checklists (as part of the integrated care pathway) in addition to usual care.

Other: Care Pathway

Interventions

Care PathwayOTHER

The intervention group had the following as part of the integrated care pathway: 1. Medical assessment on admission for risk factors for falls. 2. A weekly assessment of complications including pain, deep venous thrombosis, anaemia, wounds and pressure ulcers, etc. The Confusion Assessment Method and the Geriatric Depression Scale were utilized. 3. Physiotherapy and occupational therapy guidelines with recommended milestones (set for the full, partial and non-weight bearing groups) 4. Physiotherapy Clinical Outcome Variables Scale (PTCOVS)16 was used by the physiotherapists in the intervention group to assess the baseline mobility, to define outcome goals and to direct treatment plans. 5. A postoperative hip precaution handout (containing information on avoiding hip prosthesis dislocation in patients with total hip replacement or hemiarthroplasty) was given to patients and their caregivers.

Intervention group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients admitted to St Luke's Hospital for the purpose of rehabilitation after a new hip fracture.

You may not qualify if:

  • Patients were excluded if any of the following criteria were present: (i) Pre-morbid non-ambulatory status, (ii) nursing home residents, (iii) palliative care patients, and (iv) patients previously enlisted for the trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Luke's Hospital, Singapore

Singapore, 659674, Singapore

Location

Related Publications (1)

  • Handoll HH, Cameron ID, Mak JC, Panagoda CE, Finnegan TP. Multidisciplinary rehabilitation for older people with hip fractures. Cochrane Database Syst Rev. 2021 Nov 12;11(11):CD007125. doi: 10.1002/14651858.CD007125.pub3.

    PMID: 34766330DERIVED

MeSH Terms

Conditions

Hip Fractures

Interventions

Critical Pathways

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

Patient Care PlanningComprehensive Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Tze Pin Ng, FAMS, PhD

    National University of Singapore

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Single Blind
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Executive Officer, Medical Director, Medical Division

Study Record Dates

First Submitted

September 16, 2018

First Posted

April 8, 2019

Study Start

September 8, 2004

Primary Completion

June 14, 2006

Study Completion

December 26, 2012

Last Updated

April 8, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)