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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03906864
Other study ID # slhdoc01
Secondary ID 65 68953250
Status Completed
Phase N/A
First received
Last updated
Start date September 8, 2004
Est. completion date December 26, 2012

Study information

Verified date April 2019
Source St Luke's Hospital, Singapore
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 162
Est. completion date December 26, 2012
Est. primary completion date June 14, 2006
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Care Pathway
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.

Locations

Country Name City State
Singapore St Luke's Hospital, Singapore Singapore

Sponsors (2)

Lead Sponsor Collaborator
St Luke's Hospital, Singapore National University, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary Proportions of patients achieving pre-morbid ambulatory status Pre-morbid ambulatory status is a predictor for post-operative mobility 1 day At discharge
Primary Proportions of patients achieving pre-morbid ambulatory status Pre-morbid ambulatory status is a predictor for post-operative mobility At 6 months
Primary Proportions of patients achieving pre-morbid ambulatory status Pre-morbid ambulatory status is a predictor for post-operative mobility At 1 year
Primary Length of stay in hospital Refers to the average number of days that patients spend in hospital 1 day At discharge
Primary Percentage of patients admitted to nursing home A form of institutional care Up to 1 year after discharge
Secondary 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 up to 1-year post-discharge
Secondary Cumulated mortality Probability or risk of individuals dying from the disease during a specified period 1 year
Secondary 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
6 months and 1 year
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