- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02415504
Comprehensive Care Transition: A Trial of an Enhanced Care Transition Process in Dementia
September 20, 2016 updated by: Dr. Colleen Ray, Baycrest
Comprehensive Care Transition: A Randomized Control Trial of an Enhanced Care Transition Process in Dementia
This pilot study examines the impact of an enhanced care transition process vs. usual care for persons with dementia admitted to a transitional unit (hospital or LTC) for management of behavioural and psychological symptoms of dementia (BPSD) with a planned discharge to long term care (LTC) facilities or other hospital units.
Deficiencies in discharge processes can contribute to poor outcomes (e.g., readmissions), and there is a dearth of research on how to improve care transitions for persons with BPSD.
The investigators aim to improve the care transition process for persons with dementia and BPSD utilizing an enhanced care transition process that will contain up to 6 elements: integrated behavioural care plans, videos, patient specific briefcase containing activities to reduce BPSD, in-person care transition meeting, in-person care demonstration (when possible), and follow up visits with a transition team.
The ability to determine the effect of enhanced care transitions on the clinical course of patients with planned discharge to LTC or hospital may allow for improved outcomes and an overall increased efficiency of post discharge care.
Study Overview
Status
Terminated
Intervention / Treatment
Detailed Description
The investigators have formulated an enhanced care transition process based on factors that have been documented to support care transitions in other clinical populations (e.g., Coleman, 2003 on persons with continuous complex needs; Viggiano, et al., 2012 on persons with mental health issues), along with novel package elements based on the investigators' experience working with persons with dementia and BPSD.
The investigators propose to conduct a preliminary analysis of patient and staff outcomes comparing an enhanced care transition process with a control group receiving usual care.
The investigators' proposed enhanced care transition process will contain 5 elements: 1. Unified transfer care document adapted to the post-care transition location 2. Videos of BPSD management to better communicate care provision, 3. Provision to -the post-care transition location a patient specific briefcase containing activities that help to reduce BPSD, 4. In-person care transition meeting between sites, including the family, to transfer knowledge, 5.
In person care demonstration (when possible), and 6.
Follow-up visits post transition with a transition team (a service already in existence but not consistently used).
The investigators hope that with improved communication, discharge locations will be better equipped to manage BPSD, and reduce the likelihood of adverse events for both patients and staff.
Study Type
Interventional
Enrollment (Actual)
29
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M6A 2E1
- Baycrest
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
55 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients on behavioural transitional support unit's at Baycrest (Behavioural Neurology Unit, transitional Behavioural Support Unit) who are admitted for behavioural and psychological symptoms of dementia (BPSD)
- Diagnosed with a degenerative dementia
- Over 55 years old at the time of discharge, with a planned discharge to a long-term care (LTC) facility or another hospital unit will be eligible for the study
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Enhanced care transition
The enhanced care transition will offer: (1) an integrated behavioural care plan, (2) an in- person discharge meeting including family, post-care transition staff (LTC or another hospital unit) and unit staff, (3) videos of responsive behaviours and non-pharmacological interventions, (4) a briefcase of favoured activities, (5) an in-person care demonstration, and (6) involvement of a transitional care team.
|
Enhanced care transition discharge package: (1) an integrated behavioural care plan, (2) an in-person discharge meeting including family, post-care transition staff (LTC or another hospital unit) and unit staff, (3) videos of responsive behaviours and non-pharmacological interventions, (4) a briefcase of favoured activities, (5) an in-person care demonstration, and (6) involvement of a transitional care team.
|
|
Other: Standard care transition
The standard care transition varies by unit, and either consists of: (1) a discipline specific care plan, (2) a phone discharge meeting between unit staff and post-care transition staff (LTC or another hospital unit) and (3) a follow-up phone call with social work OR (1) a discipline specific care plan, (2) an in-person meeting between unit staff and (family) caregivers, (3) involvement of a transitional care team, and (4) a follow-up phone call with social work.
|
Standard care transition discharge package: The standard care transition varies by unit, and either consists of: (1) a discipline specific care plan, (2) a phone discharge meeting between unit staff and post-care transition staff (LTC or another hospital unit) and (3) a follow-up phone call with social work OR (1) a discipline specific care plan, (2) an in-person meeting between unit staff and (family) caregivers, (3) involvement of a transitional care team, and (4) a follow-up phone call with social work.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Post-Care Transition (PCT) questionnaire
Time Frame: Change in resident's baseline behaviour(s) at 2 and 4 weeks
|
Likert scales and open-ended questions measuring change in the transitioned resident's identified behaviour(s).
|
Change in resident's baseline behaviour(s) at 2 and 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Social work assessment questionnaire
Time Frame: At 6 months after baseline
|
Likert scales and open-ended questions evaluating the transition process and the post-care transition location.
|
At 6 months after baseline
|
|
Substitute Decision Maker (SDM) satisfaction questionnaire
Time Frame: At baseline
|
Likert scales and open-ended questions measuring the SDM's satisfaction with resident's transition.
|
At baseline
|
|
Substitute Decision Maker (SDM) satisfaction questionnaire
Time Frame: Change from baseline at 2 weeks
|
Likert scales and open-ended questions measuring the SDM's satisfaction with resident's transition.
|
Change from baseline at 2 weeks
|
|
Substitute Decision Maker (SDM) questionnaire
Time Frame: At baseline
|
Likert scales and open-ended questions measuring the SDM's perception of the resident's identified baseline behaviour(s).
|
At baseline
|
|
Substitute Decision Maker (SDM) questionnaire
Time Frame: Change in resident's baseline behaviour(s) at 2 and 4 weeks
|
Likert scales and open-ended questions measuring the SDM's perception of change in the transitioned resident's identified behaviour(s).
|
Change in resident's baseline behaviour(s) at 2 and 4 weeks
|
|
Post-Care Transition (PCT) questionnaire
Time Frame: Change in resident's baseline behaviour(s) at 3 and 6 months
|
Likert scales and open-ended questions measuring change in the transitioned resident's identified behaviour(s).
|
Change in resident's baseline behaviour(s) at 3 and 6 months
|
|
Post-Care Transition (PCT) staff satisfaction questionnaire
Time Frame: Change from baseline at 2 and 4 weeks
|
Likert scales and open-ended questions evaluating staff satisfaction with the resident's transition process.
|
Change from baseline at 2 and 4 weeks
|
|
Chart review
Time Frame: At baseline
|
Resident's additional dependent data collection (e.g., demographics, identified behaviours, Cohen Mansfield Agitation Inventory score, etc.)
|
At baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Colleen Ray, PhD, Neuropsychology and Cognitive Health at Baycrest
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Viggiano T, Pincus HA, Crystal S. Care transition interventions in mental health. Curr Opin Psychiatry. 2012 Nov;25(6):551-8. doi: 10.1097/YCO.0b013e328358df75.
- Coleman EA. Falling through the cracks: challenges and opportunities for improving transitional care for persons with continuous complex care needs. J Am Geriatr Soc. 2003 Apr;51(4):549-55. doi: 10.1046/j.1532-5415.2003.51185.x.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2014
Primary Completion (Actual)
May 1, 2016
Study Completion (Actual)
May 1, 2016
Study Registration Dates
First Submitted
December 5, 2014
First Submitted That Met QC Criteria
April 9, 2015
First Posted (Estimate)
April 14, 2015
Study Record Updates
Last Update Posted (Estimate)
September 22, 2016
Last Update Submitted That Met QC Criteria
September 20, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REB14-45
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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