- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03906864
Care Pathway for Sub-acute Hip Rehabilitation
April 5, 2019 updated by: Boon Yeow, Tan, St Luke's Hospital, Singapore
Integrated Care Pathway for Hip Fractures in a Subacute Rehabilitation Setting
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.
Study Overview
Detailed Description
All patients admitted to St Luke's Hospital, a 185-bed hospital in Singapore providing multidisciplinary stepdown care, from 8 September 2004 to 14 June 2006 for the purpose of rehabilitation after a new hip fracture were included.
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.
Administrative staff allocated patients to either ICP or usual care according to the last digit of their National Registration Identity Card (NRIC) numbers, odd numbers to the intervention group and even numbers to the control group.
Patients were then admitted to 1 of 2 intervention wards or 1 of 3 control wards.
Patients were enrolled by the principal investigators only after moving into their respective wards because of work flow limitations.
Those who refused consent or were excluded remained in their assigned wards and received usual care.
Both intervention and control groups were under the care of multidisciplinary teams but the intervention group had structured assessments and checklists in addition to usual care while the control group had usual care alone.
Study Type
Interventional
Enrollment (Actual)
162
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Singapore, Singapore, 659674
- St Luke's Hospital, Singapore
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients admitted to St Luke's Hospital for the purpose of rehabilitation after a new hip fracture.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control group
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.
|
|
|
Experimental: Intervention group
Intervention group had structured assessments and checklists (as part of the integrated care pathway) in addition to usual care.
|
The intervention group had the following as part of the integrated care pathway:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Montebello Rehabilitation Factor Score (MRFS)
Time Frame: 1 day At discharge
|
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)
Time Frame: At 6 months
|
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)
Time Frame: At 1 year
|
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
Time Frame: 1 day At discharge
|
Pre-morbid ambulatory status is a predictor for post-operative mobility
|
1 day At discharge
|
|
Proportions of patients achieving pre-morbid ambulatory status
Time Frame: At 6 months
|
Pre-morbid ambulatory status is a predictor for post-operative mobility
|
At 6 months
|
|
Proportions of patients achieving pre-morbid ambulatory status
Time Frame: At 1 year
|
Pre-morbid ambulatory status is a predictor for post-operative mobility
|
At 1 year
|
|
Length of stay in hospital
Time Frame: 1 day At discharge
|
Refers to the average number of days that patients spend in hospital
|
1 day At discharge
|
|
Percentage of patients admitted to nursing home
Time Frame: Up to 1 year after discharge
|
A form of institutional care
|
Up to 1 year after discharge
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Readmissions to an acute hospital for any reason
Time Frame: up to 1-year post-discharge
|
An episode when a patient who had been discharged from a hospital is admitted again within a specified time interval
|
up to 1-year post-discharge
|
|
Cumulated mortality
Time Frame: 1 year
|
Probability or risk of individuals dying from the disease during a specified period
|
1 year
|
|
Quality of life scale-Short form 12 quality of life
Time Frame: 6 months and 1 year
|
Scale for short form 12 quality of life 0-100 Scale for Physical Component Summary (PCS) and Scale for Mental Component Summary (MCS), a multipurpose, generic measure of health status 0-100 Interpretation of the score : The higher score, the better |
6 months and 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Tze Pin Ng, FAMS, PhD, National University, Singapore
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 8, 2004
Primary Completion (Actual)
June 14, 2006
Study Completion (Actual)
December 26, 2012
Study Registration Dates
First Submitted
September 16, 2018
First Submitted That Met QC Criteria
April 5, 2019
First Posted (Actual)
April 8, 2019
Study Record Updates
Last Update Posted (Actual)
April 8, 2019
Last Update Submitted That Met QC Criteria
April 5, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- slhdoc01
- 65 68953250 (Other Identifier: St Luke's Hospital)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Study Data/Documents
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hip Fractures
-
Khoo Teck Puat HospitalMinistry of Health, SingaporeActive, not recruitingHip Fracture Surgeries | Post-operative Hip Fractures RecoverySingapore
-
Smith & Nephew, Inc.Terminated
-
Medical Centre LeeuwardenNot yet recruitingHip Fractures (i.e. Femoral Neck or Intertrochanteric Hip Fractures)Netherlands
-
San Giovanni di Dio HospitalRecruitingHip Surgery | Hip ArthroplastyItaly
-
Gaziantep City HospitalCompletedFemoral Neck Fractures | Hip SurgeryTurkey (Türkiye)
-
Carilion ClinicCompleted
-
Sheffield Teaching Hospitals NHS Foundation TrustRecruitingHip FractureUnited Kingdom
-
JointResearchRecruitingHip Fractures (ICD-10 72.01-72.2)Netherlands
-
Oslo University HospitalDiakonhjemmet HospitalCompletedHip Fractures | Trochanteric Fractures | Intertrochanteric FracturesNorway
-
Tel-Aviv Sourasky Medical CenterUnknownIntertrochanteric Fractures of the HipIsrael
Clinical Trials on Care Pathway
-
European Pathway AssociationKU Leuven; University of Eastern PiedmontCompletedPulmonary Disease, Chronic Obstructive
-
European Pathway AssociationKU Leuven; University of Eastern PiedmontCompleted
-
European Pathway AssociationKU LeuvenCompleted
-
Helsinki University Central HospitalActive, not recruitingEncephalitis | Traumatic Brain Injury | Hypoxia-Ischemia, Brain | Brain Hemorrhage | Stroke, Acute IschemicFinland
-
Medical College of WisconsinPediatric Emergency Care Applied Research Network; Nemours Children's Health...RecruitingSickle Cell CrisisUnited States
-
University Hospital, GrenobleUniversity Hospital, Angers; Poitiers University Hospital; Union hospital, Toulouse and other collaboratorsWithdrawnObstructive Sleep Apnea | Obesity Hypoventilation SyndromeFrance
-
Dr. Kris VanhaechtKU Leuven; University of Eastern PiedmontCompletedChronic Obstructive Pulmonary Disease | Proximal Femur FractureBelgium
-
Ilyse KenisKU Leuven; University Ghent; Kom Op Tegen KankerUnknownOncologic DisordersBelgium
-
Norwegian University of Science and TechnologyThe Research Council of Norway; St. Olavs Hospital; Nordmøre and Romsdal Hospital... and other collaboratorsCompleted
-
Gustave Roussy, Cancer Campus, Grand ParisRecruiting