Hip FracturesNCT03906864
Care Pathway for Sub-acute Hip Rehabilitation
A study testing Care Pathway in people with Hip Fractures, run by St Luke's Hospital, Singapore at 1 site in Singapore.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hip Fractures
- What is being tested?
- Care Pathway
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteSingapore
- Study dates
- 8 Sep 2004to 26 Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients admitted to St Luke's Hospital for the purpose of rehabilitation after a new hip fracture.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Hip Fractures
- Being tested
- Care Pathway
- Keywords
- Critical pathway, length of stay, recovery of function, subacute care
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care PathwayOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Care Pathway |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: At 1 year
Proportions of patients achieving pre-morbid ambulatory status
Pre-morbid ambulatory status is a predictor for post-operative mobility
Measured: 1 day At discharge
Proportions of patients achieving pre-morbid ambulatory status
Pre-morbid ambulatory status is a predictor for post-operative mobility
Measured: At 6 months
Proportions of patients achieving pre-morbid ambulatory status
Pre-morbid ambulatory status is a predictor for post-operative mobility
Measured: At 1 year
Length of stay in hospital
Refers to the average number of days that patients spend in hospital
Measured: 1 day At discharge
Percentage of patients admitted to nursing home
A form of institutional care
Measured: Up to 1 year after discharge
Secondary outcomes (3)
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
Measured: up to 1-year post-discharge
Cumulated mortality
Probability or risk of individuals dying from the disease during a specified period
Measured: 1 year
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
Measured: 6 months and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2019
- Study start8 Sep 2004
- Primary completion14 Jun 2006
- Study completion26 Dec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- St Luke's Hospital, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- National University of Singapore
- Responsible party
- Principal investigator, Boon Yeow, Tan, St Luke's Hospital, Singapore
- Investigators
- Tze Pin Ng, FAMS, PhD, Study chair, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03906864
- Sponsor's protocol ID
- slhdoc01
- Other IDs
- 65 68953250
- Status last verified
- Apr 2019
- First submitted
- 16 Sep 2018
- Last updated
- 8 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34766330
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Care Pathway for Hip Fractures in a Subacute Rehabilitation Setting
- ClinicalTrials.gov ID
- NCT03906864
- Acronym / sponsor ID
- slhdoc01
- Conditions
- Hip Fractures
- Keywords
- Critical pathway, length of stay, recovery of function, subacute care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- St Luke's Hospital, SingaporeUniversity, hospital or other
- Collaborators
- National University of Singapore
- Study start
- 8 Sep 2004 (actual)
- Primary completion
- 14 Jun 2006 (actual)
- Study completion
- 26 Dec 2012 (actual)
- First posted
- 8 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Care PathwayIntervention group had structured assessments and checklists (as part of the integrated care pathway) in addition to usual care. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients admitted to St Luke's Hospital for the purpose of rehabilitation after a new hip fracture.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Care PathwayThe 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. | Other | Intervention group |
Primary outcome
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)
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)
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)
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
Proportions of patients achieving pre-morbid ambulatory status
Time frame: At 6 months
Pre-morbid ambulatory status is a predictor for post-operative mobility
Proportions of patients achieving pre-morbid ambulatory status
Time frame: At 1 year
Pre-morbid ambulatory status is a predictor for post-operative mobility
Length of stay in hospital
Time frame: 1 day At discharge
Refers to the average number of days that patients spend in hospital
Percentage of patients admitted to nursing home
Time frame: Up to 1 year after discharge
A form of institutional care
3 secondary outcomes
Readmissions to an acute hospital for any reason
Time frame: up to 1-year post-discharge
Cumulated mortality
Time frame: 1 year
Quality of life scale-Short form 12 quality of life
Time frame: 6 months and 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2019.
- Derived from this study: PubMed 34766330Handoll 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tze Pin Ng, FAMS, PhD study chair
National University of Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Care Pathway in people with Hip Fractures, run by St Luke's Hospital, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montebello Rehabilitation Factor Score (MRFS) (time frame: 1 day At discharge). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03906864, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2019.