NCT01566136

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
198

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2009

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

March 21, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 29, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

April 24, 2014

Status Verified

April 1, 2014

Enrollment Period

4.6 years

First QC Date

March 21, 2012

Last Update Submit

April 23, 2014

Conditions

Keywords

hip fracture patientscognitive impairmentrehabilitation model of care

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in mobility at 6 months

    Baseline to 6 months post-surgery

Secondary Outcomes (1)

  • Change from baseline in physical functioning at 6 months

    Baseline to 6 months post-surgery

Study Arms (2)

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.

Behavioral: Rehabilitation Model of Care

Interventions

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.

Also known as: Patient Centred Rehabilitation Model of Care
Rehabilitation Model of Care

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • they have a pathologic hip fracture
  • the hip fracture is associated with multiple trauma
  • they have had a previous hip fracture.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northumberland Hospital

Cobourg, Ontario, Canada

Location

Related Publications (2)

  • 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.

  • McGilton 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.

MeSH Terms

Conditions

Hip FracturesCognitive Dysfunction

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg InjuriesCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Katherine S McGilton, PhD

    UHN-Toronto Rehab

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2012

First Posted

March 29, 2012

Study Start

August 1, 2009

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

April 24, 2014

Record last verified: 2014-04

Locations