Hip FracturePhase 2/3NCT01566136
An Inpatient Rehabilitation Model of Care Targeting Patients With Cognitive Impairment
A Phase 2/3 study testing Rehabilitation Model of Care in people with Hip Fracture, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Hip fractures are a danger to an individual's mobility, independence and ability to live in the community. When patients have a cognitive impairment (such as dementia or delirium) they do not recover as well or go back to their homes as often as those patients who do not have a cognitive impairment. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hip Fracture
- What is being tested?
- Rehabilitation Model of Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2009to Mar 2014
- Phase
- Phase 2/3
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 65 years or older,
- admitted to rehabilitation directly from an acute care hospital after receiving surgery for a hip fracture
- living in the community, home or residential setting (where an individual has services and supports but does not require 24 hour nursing care) prior to sustaining the hip fracture,
- able to speak and understand English
- have a family member or close friend who is familiar with the patients' pre-fracture condition and can act as a collateral informant.
Who cannot join
- they have a pathologic hip fracture
- the hip fracture is associated with multiple trauma
- they have had a previous hip fracture.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Inpatient Rehabilitation Model of Care Targeting Patients With Cognitive
Hip fractures are a danger to an individual's mobility, independence and ability to live in the community. When patients have a cognitive impairment (such as dementia or delirium) they do not recover as well or go back to their homes as often as those patients who do not have a cognitive impairment. Therefore, our team developed a rehabilitation model to care for patients with hip fractures, and specifically for those patients with CI. The model of care is called the Patient Centred Rehabilitation Model of Care (PCRM-CI). This 3 year study will focus on comparing the new model with usual rehabilitation care. This study will also focus on understanding the factors that could influence the use of the model on new rehabilitation units. The investigators hypothesize that patients who have received the new model of care will have better mobility outcomes over time. The investigators will collect data in 2 hospitals, 70 patients receiving the usual care and 70 patients receiving the care in the new model. The team will invite 60 staff and their unit managers as well. This study will help decision makers to use research findings to make better decisions about care of older Canadians.
Read the detailed description
Background: A hip fracture is often a catastrophic event that is a significant threat to an individual's mobility, independence and ability to live in the community. Projections indicate that the incidence of hip fracture will increase nearly four-fold by 2041 in Canada. The course and outcomes of hip fracture patients are often complicated by the presence of dementia and delirium, referred to as cognitive impairment (CI), which limits access to in-patient rehabilitation. In response to this concern, members of our team developed an in-patient rehabilitation model of care for patients with hip fractures, with specific components of the model targeting patients with CI (PCRM-CI). The pre-clinical and phase I testing of the model has been completed, and preliminary evidence exists that patients with and without CI can regain their mobility and function and return to previous living arrangement at discharge from rehabilitation. This proposed 3 year study focuses on phase II, that is, to compare the PCRM-CI with usual rehabilitation care and to gain a better understanding of factors influencing implementation of the model. Decision-making partners for this proposal have identified service gaps within their local health region related to rehabilitation care of patients with hip fractures and are committed to sustaining the model beyond this study. This proposed research addresses the mandate of the current funding opportunity by improving the mobility of cognitively impaired elders, and by enhancing the capacity of research users to apply research evidence in decisions on models of care that can contribute to improved mobility for aging older Canadians.
Research Objectives: Primary Objective: To determine whether, compared to usual care, an inpatient rehabilitation model of care targeting community dwelling individuals with hip fracture and CI (dementia and/or delirium) results in improved mobility at the time of discharge from inpatient rehabilitation.
Secondary Objectives: 1) To determine if the use of the PCRM-CI for persons with hip fracture and CI will result in: i) improved mobility at 6 months post-surgery; ii) greater improvement in physical functioning at the time of discharge from inpatient rehabilitation and at 6 months post-surgery; iii) a higher proportion of patients with hip fracture returning to their previous living situation in the community at discharge and at 6 months post-surgery. 2) To determine whether the PCRM-CI results in similar improvements in mobility at discharge and 6 months post-surgery for patients with and without CI. 3) To evaluate whether the PCRM-CI improves health care providers' (HCPs) attitudes, knowledge, satisfaction and stress. 4) To examine the processes by which the PCRM-CI is implemented.
Design: A non-equivalent pre-post design will be used to evaluate the PCRM-CI as compared to usual care. All community dwelling (retirement or home) patients following a hip fracture will be eligible to participate. Two facilities will be involved in the study as multi site sampling increases robustness by allowing for comparison and contrast between sites. Study accrual will take about 16 months to complete recruitment and data collection of 70 hip fracture patients in the usual care cohort and 70 patients in the PCRM-CI cohort, based on sample size and attrition estimation from phase I. The investigators will recruit 60 HCPs and their unit managers in the study.
Methods: Baseline data will be collected within 3 days of admission to rehabilitation. Follow-up occurs within 3 days of discharge from rehabilitation and 6 months post-surgery. Patient evaluations will include mobility (mobility and locomotion items of FIMM), physical function (motor-FIM), and living arrangement (collaterals' informants reply). Other variables influencing outcomes that will be collected from the patient include: sex, co-morbidities, age, patients' level of education, social support (live alone, with spouse, or with other), pre fracture status (OARS), and pre-cognitive status (IQCODE). During the patients' stay in rehabilitation, data on dementia (MMSE), delirium screening (CAM) and severity (Delirium Index) will be collected. Lastly, focus groups with HCPs and semi-structured interviews with unit managers will be conducted, and the investigators will collect additional data through intervention logs, and field notes to examine factors influencing the model implementation.
Significance: With the aging of the population, this research will contribute to meeting the emerging health needs of Canadians by improving the provision of services for elders with CI.
- Conditions
- Hip Fracture
- Being tested
- Rehabilitation Model of Care
- Keywords
- hip fracture patients, cognitive impairment, rehabilitation model of care
- Medical subject headings
- Hip Fractures, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation Model of CareBehavioural
Also called Patient Centred Rehabilitation Model of Care
The PCRM-CI model includes the following 5 components: rehabilitation management; dementia management; delirium prevention and management; staff education and support; and family/significant other support and education.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | Current routine rehab care for persons with a hip fracture and CI lacks a well integrated care system within the local hospital network. The usual approach to care at the two sites differ in one major way: patients presenting with a hip fracture to Site 1 receive surgery locally, while those presenting to Site 2 receive surgery at a different hospital because of the absence of an operating suite at this site. Within 2 to 10 days 95% of patients presenting to either site hospital's emergency room with a hip fracture, receive internal fixation or arthroplasty surgery. Patients, including some with mild and moderate CI, are then transferred to in-patient rehabilitation beds at Site 1 or Site 2. Screening of patients for dementia or delirium is not routinely done. |
| Rehabilitation Model of Care | Experimental | Staff will be introduced to five components of the Patient-Centred Rehabilitation Model of Care (PCRM-CI) in a one-day workshop prior to implementing the PCRM-CI model. They will then be provided with eight additional educational sessions throughout the year. A manual detailing all aspects of training, including specifics on how to present the material, ideas for stimulating discussion, and case vignettes to illustrate training concepts was developed for our pilot study and will be used here. We also produced a short video on care of elderly with CI in rehabilitation which will be utilized in the training session. The model will be tested over a one year period with a sustainability plan in place developed by the local hospital network and the two study sites. Receives: Behavioral: Rehabilitation Model of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in mobility at 6 months
Measured: Baseline to 6 months post-surgery
Secondary outcomes (1)
Change from baseline in physical functioning at 6 months
Measured: Baseline to 6 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2012 (estimated)
- Study startAug 2009
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hip FractureStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katherine S McGilton, PhD, Principal investigator, UHN-Toronto Rehab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01566136
- Sponsor's protocol ID
- CIHR DPA-93049
- Status last verified
- Apr 2014
- First submitted
- 21 Mar 2012
- Last updated
- 24 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
McGilton KS, Davis AM, Naglie G, Mahomed N, Flannery J, Jaglal S, Cott C, Stewart S. Evaluation of patient-centered rehabilitation model targeting older persons with a hip fracture, including those with cognitive impairment. BMC Geriatr. 2013 Dec 13;13:136. doi: 10.1186/1471-2318-13-136.
PubMed 24330470McGilton KS, Davis A, Mahomed N, Flannery J, Jaglal S, Cott C, Naglie G, Rochon E. An inpatient rehabilitation model of care targeting patients with cognitive impairment. BMC Geriatr. 2012 May 25;12:21. doi: 10.1186/1471-2318-12-21.
PubMed 22631877
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Inpatient Rehabilitation Model of Care Targeting Patients With Cognitive
- ClinicalTrials.gov ID
- NCT01566136
- Acronym / sponsor ID
- CIHR DPA-93049
- Conditions
- Hip Fracture
- Keywords
- hip fracture patients, cognitive impairment, rehabilitation model of care
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 29 Mar 2012 (estimated)
- 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.
Hip fractures are a danger to an individual's mobility, independence and ability to live in the community. When patients have a cognitive impairment (such as dementia or delirium) they do not recover as well or go back to their homes as often as those patients who do not have a cognitive impairment. Therefore, our team developed a rehabilitation model to care for patients with hip fractures, and specifically for those patients with CI. The model of care is called the Patient Centred Rehabilitation Model of Care (PCRM-CI). This 3 year study will focus on comparing the new model with usual rehabilitation care. This study will also focus on understanding the factors that could influence the use of the model on new rehabilitation units. The investigators hypothesize that patients who have received the new model of care will have better mobility outcomes over time. The investigators will collect data in 2 hospitals, 70 patients receiving the usual care and 70 patients receiving the care in the new model. The team will invite 60 staff and their unit managers as well. This study will help decision makers to use research findings to make better decisions about care of older Canadians.
Detailed description
Background: A hip fracture is often a catastrophic event that is a significant threat to an individual's mobility, independence and ability to live in the community. Projections indicate that the incidence of hip fracture will increase nearly four-fold by 2041 in Canada. The course and outcomes of hip fracture patients are often complicated by the presence of dementia and delirium, referred to as cognitive impairment (CI), which limits access to in-patient rehabilitation. In response to this concern, members of our team developed an in-patient rehabilitation model of care for patients with hip fractures, with specific components of the model targeting patients with CI (PCRM-CI). The pre-clinical and phase I testing of the model has been completed, and preliminary evidence exists that patients with and without CI can regain their mobility and function and return to previous living arrangement at discharge from rehabilitation. This proposed 3 year study focuses on phase II, that is, to compare the PCRM-CI with usual rehabilitation care and to gain a better understanding of factors influencing implementation of the model. Decision-making partners for this proposal have identified service gaps within their local health region related to rehabilitation care of patients with hip fractures and are committed to sustaining the model beyond this study. This proposed research addresses the mandate of the current funding opportunity by improving the mobility of cognitively impaired elders, and by enhancing the capacity of research users to apply research evidence in decisions on models of care that can contribute to improved mobility for aging older Canadians.
Research Objectives: Primary Objective: To determine whether, compared to usual care, an inpatient rehabilitation model of care targeting community dwelling individuals with hip fracture and CI (dementia and/or delirium) results in improved mobility at the time of discharge from inpatient rehabilitation.
Secondary Objectives: 1) To determine if the use of the PCRM-CI for persons with hip fracture and CI will result in: i) improved mobility at 6 months post-surgery; ii) greater improvement in physical functioning at the time of discharge from inpatient rehabilitation and at 6 months post-surgery; iii) a higher proportion of patients with hip fracture returning to their previous living situation in the community at discharge and at 6 months post-surgery. 2) To determine whether the PCRM-CI results in similar improvements in mobility at discharge and 6 months post-surgery for patients with and without CI. 3) To evaluate whether the PCRM-CI improves health care providers' (HCPs) attitudes, knowledge, satisfaction and stress. 4) To examine the processes by which the PCRM-CI is implemented.
Design: A non-equivalent pre-post design will be used to evaluate the PCRM-CI as compared to usual care. All community dwelling (retirement or home) patients following a hip fracture will be eligible to participate. Two facilities will be involved in the study as multi site sampling increases robustness by allowing for comparison and contrast between sites. Study accrual will take about 16 months to complete recruitment and data collection of 70 hip fracture patients in the usual care cohort and 70 patients in the PCRM-CI cohort, based on sample size and attrition estimation from phase I. The investigators will recruit 60 HCPs and their unit managers in the study.
Methods: Baseline data will be collected within 3 days of admission to rehabilitation. Follow-up occurs within 3 days of discharge from rehabilitation and 6 months post-surgery. Patient evaluations will include mobility (mobility and locomotion items of FIMM), physical function (motor-FIM), and living arrangement (collaterals' informants reply). Other variables influencing outcomes that will be collected from the patient include: sex, co-morbidities, age, patients' level of education, social support (live alone, with spouse, or with other), pre fracture status (OARS), and pre-cognitive status (IQCODE). During the patients' stay in rehabilitation, data on dementia (MMSE), delirium screening (CAM) and severity (Delirium Index) will be collected. Lastly, focus groups with HCPs and semi-structured interviews with unit managers will be conducted, and the investigators will collect additional data through intervention logs, and field notes to examine factors influencing the model implementation.
Significance: With the aging of the population, this research will contribute to meeting the emerging health needs of Canadians by improving the provision of services for elders with CI.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –Current routine rehab care for persons with a hip fracture and CI lacks a well integrated care system within the local hospital network. The usual approach to care at the two sites differ in one major way: patients presenting with a hip fracture to Site 1 receive surgery locally, while those presenting to Site 2 receive surgery at a different hospital because of the absence of an operating suite at this site. Within 2 to 10 days 95% of patients presenting to either site hospital's emergency room with a hip fracture, receive internal fixation or arthroplasty surgery. Patients, including some with mild and moderate CI, are then transferred to in-patient rehabilitation beds at Site 1 or Site 2. Screening of patients for dementia or delirium is not routinely done. |
| Rehabilitation Model of Care | Experimental | Behavioral: Rehabilitation Model of CareStaff will be introduced to five components of the Patient-Centred Rehabilitation Model of Care (PCRM-CI) in a one-day workshop prior to implementing the PCRM-CI model. They will then be provided with eight additional educational sessions throughout the year. A manual detailing all aspects of training, including specifics on how to present the material, ideas for stimulating discussion, and case vignettes to illustrate training concepts was developed for our pilot study and will be used here. We also produced a short video on care of elderly with CI in rehabilitation which will be utilized in the training session. The model will be tested over a one year period with a sustainability plan in place developed by the local hospital network and the two study sites. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 65 years or older,
- admitted to rehabilitation directly from an acute care hospital after receiving surgery for a hip fracture
- living in the community, home or residential setting (where an individual has services and supports but does not require 24 hour nursing care) prior to sustaining the hip fracture,
- able to speak and understand English
- have a family member or close friend who is familiar with the patients' pre-fracture condition and can act as a collateral informant.
Key exclusion criteria (3 listed)
- they have a pathologic hip fracture
- the hip fracture is associated with multiple trauma
- they have had a previous hip fracture.
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 |
|---|---|---|
| Rehabilitation Model of CareAlso: Patient Centred Rehabilitation Model of CareThe PCRM-CI model includes the following 5 components: rehabilitation management; dementia management; delirium prevention and management; staff education and support; and family/significant other support and education. | Behavioural | Rehabilitation Model of Care |
Primary outcome
Change from baseline in mobility at 6 months
Time frame: Baseline to 6 months post-surgery
1 secondary outcome
Change from baseline in physical functioning at 6 months
Time frame: Baseline to 6 months post-surgery
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 24 Apr 2014.
- Derived from this study: PubMed 24330470McGilton KS, Davis AM, Naglie G, Mahomed N, Flannery J, Jaglal S, Cott C, Stewart S. Evaluation of patient-centered rehabilitation model targeting older persons with a hip fracture, including those with cognitive impairment. BMC Geriatr. 2013 Dec 13;13:136. doi: 10.1186/1471-2318-13-136.
- Derived from this study: PubMed 22631877McGilton KS, Davis A, Mahomed N, Flannery J, Jaglal S, Cott C, Naglie G, Rochon E. An inpatient rehabilitation model of care targeting patients with cognitive impairment. BMC Geriatr. 2012 May 25;12:21. doi: 10.1186/1471-2318-12-21.
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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.
Katherine S McGilton, PhD principal investigator
UHN-Toronto Rehab
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Rehabilitation Model of Care in people with Hip Fracture, run by University Health Network, Toronto at 1 site in Canada.
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 5 inclusion and 3 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 24 Apr 2014. 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 Canada. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change from baseline in mobility at 6 months (time frame: Baseline to 6 months post-surgery). 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 NCT01566136, which also lists 2 linked publications.
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 24 Apr 2014.