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An Inpatient Rehabilitation Model of Care Targeting Patients With Cognitive Impairment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01566136
Recruitment Status : Completed
First Posted : March 29, 2012
Last Update Posted : April 24, 2014
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Tracking Information
First Submitted Date  ICMJE March 21, 2012
First Posted Date  ICMJE March 29, 2012
Last Update Posted Date April 24, 2014
Study Start Date  ICMJE August 2009
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 28, 2012)
Change from baseline in mobility at 6 months [ Time Frame: Baseline to 6 months post-surgery ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 28, 2012)
Change from baseline in physical functioning at 6 months [ Time Frame: Baseline to 6 months post-surgery ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Inpatient Rehabilitation Model of Care Targeting Patients With Cognitive Impairment
Official Title  ICMJE An Inpatient Rehabilitation Model of Care Targeting Patients With Cognitive
Brief 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. 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Hip Fracture
Intervention  ICMJE Behavioral: 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.
Other Name: Patient Centred Rehabilitation Model of Care
Study Arms  ICMJE
  • No Intervention: Usual care
    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.
  • Experimental: Rehabilitation Model of Care
    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.
    Intervention: Behavioral: Rehabilitation Model of Care
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 23, 2014)
198
Original Estimated Enrollment  ICMJE
 (submitted: March 28, 2012)
140
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • they have a pathologic hip fracture
  • the hip fracture is associated with multiple trauma
  • they have had a previous hip fracture.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01566136
Other Study ID Numbers  ICMJE CIHR DPA-93049
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Health Network, Toronto
Study Sponsor  ICMJE University Health Network, Toronto
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Katherine S McGilton, PhD UHN-Toronto Rehab
PRS Account University Health Network, Toronto
Verification Date April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP