Care Pathway for Sub-acute Hip Rehabilitation
Primary Purpose
Hip Fractures
Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Care Pathway
Sponsored by
About this trial
This is an interventional health services research trial for Hip Fractures focused on measuring Critical pathway, length of stay, recovery of function, subacute care
Eligibility Criteria
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.
Sites / Locations
- St Luke's Hospital, Singapore
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control group
Intervention group
Arm Description
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 had structured assessments and checklists (as part of the integrated care pathway) in addition to usual care.
Outcomes
Primary Outcome Measures
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)
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)
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)
Proportions of patients achieving pre-morbid ambulatory status
Pre-morbid ambulatory status is a predictor for post-operative mobility
Proportions of patients achieving pre-morbid ambulatory status
Pre-morbid ambulatory status is a predictor for post-operative mobility
Proportions of patients achieving pre-morbid ambulatory status
Pre-morbid ambulatory status is a predictor for post-operative mobility
Length of stay in hospital
Refers to the average number of days that patients spend in hospital
Percentage of patients admitted to nursing home
A form of institutional care
Secondary Outcome Measures
Readmissions to an acute hospital for any reason
An episode when a patient who had been discharged from a hospital is admitted again within a specified time interval
Cumulated mortality
Probability or risk of individuals dying from the disease during a specified period
Quality of life scale-Short form 12 quality of life
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
Full Information
NCT ID
NCT03906864
First Posted
September 16, 2018
Last Updated
April 5, 2019
Sponsor
St Luke's Hospital, Singapore
Collaborators
National University of Singapore
1. Study Identification
Unique Protocol Identification Number
NCT03906864
Brief Title
Care Pathway for Sub-acute Hip Rehabilitation
Official Title
Integrated Care Pathway for Hip Fractures in a Subacute Rehabilitation Setting
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
September 8, 2004 (Actual)
Primary Completion Date
June 14, 2006 (Actual)
Study Completion Date
December 26, 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St Luke's Hospital, Singapore
Collaborators
National University of Singapore
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures
Keywords
Critical pathway, length of stay, recovery of function, subacute care
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Single Blind
Allocation
Randomized
Enrollment
162 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Intervention group had structured assessments and checklists (as part of the integrated care pathway) in addition to usual care.
Intervention Type
Other
Intervention Name(s)
Care Pathway
Intervention Description
The intervention group had the following as part of the integrated care pathway:
Medical assessment on admission for risk factors for falls.
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.
Physiotherapy and occupational therapy guidelines with recommended milestones (set for the full, partial and non-weight bearing groups)
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.
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.
Primary Outcome Measure Information:
Title
Montebello Rehabilitation Factor Score (MRFS)
Description
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)
Time Frame
1 day At discharge
Title
Montebello Rehabilitation Factor Score (MRFS)
Description
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)
Time Frame
At 6 months
Title
Montebello Rehabilitation Factor Score (MRFS)
Description
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)
Time Frame
At 1 year
Title
Proportions of patients achieving pre-morbid ambulatory status
Description
Pre-morbid ambulatory status is a predictor for post-operative mobility
Time Frame
1 day At discharge
Title
Proportions of patients achieving pre-morbid ambulatory status
Description
Pre-morbid ambulatory status is a predictor for post-operative mobility
Time Frame
At 6 months
Title
Proportions of patients achieving pre-morbid ambulatory status
Description
Pre-morbid ambulatory status is a predictor for post-operative mobility
Time Frame
At 1 year
Title
Length of stay in hospital
Description
Refers to the average number of days that patients spend in hospital
Time Frame
1 day At discharge
Title
Percentage of patients admitted to nursing home
Description
A form of institutional care
Time Frame
Up to 1 year after discharge
Secondary Outcome Measure Information:
Title
Readmissions to an acute hospital for any reason
Description
An episode when a patient who had been discharged from a hospital is admitted again within a specified time interval
Time Frame
up to 1-year post-discharge
Title
Cumulated mortality
Description
Probability or risk of individuals dying from the disease during a specified period
Time Frame
1 year
Title
Quality of life scale-Short form 12 quality of life
Description
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
Time Frame
6 months and 1 year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tze Pin Ng, FAMS, PhD
Organizational Affiliation
National University of Singapore
Official's Role
Study Chair
Facility Information:
Facility Name
St Luke's Hospital, Singapore
City
Singapore
ZIP/Postal Code
659674
Country
Singapore
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34766330
Citation
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.
Results Reference
derived
Learn more about this trial
Care Pathway for Sub-acute Hip Rehabilitation
We'll reach out to this number within 24 hrs