DementiaNCT02415504
Comprehensive Care Transition: A Trial of an Enhanced Care Transition Process in Dementia
A study testing Enhanced care transition in people with Dementia and BPSD, run by Baycrest at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 55 years and older
- What is being tested?
- Enhanced care transition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2014to May 2016
- Phase
- Interventional
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Enhanced care transition, Standard care transition
- Keywords
- Care transition, Behavioural and psychological symptoms of dementia, BPSD, Dementia, Persons with dementia, Discharge processes
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced care transitionBehavioural
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.
Standard care transitionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced care transition | Experimental | 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. Receives: Behavioral: Enhanced care transition |
| Standard care transition | Other | 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. Receives: Behavioral: Standard care transition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-Care Transition (PCT) questionnaire
Likert scales and open-ended questions measuring change in the transitioned resident's identified behaviour(s).
Measured: Change in resident's baseline behaviour(s) at 2 and 4 weeks
Secondary outcomes (8)
Social work assessment questionnaire
Likert scales and open-ended questions evaluating the transition process and the post-care transition location.
Measured: At 6 months after baseline
Substitute Decision Maker (SDM) satisfaction questionnaire
Likert scales and open-ended questions measuring the SDM's satisfaction with resident's transition.
Measured: At baseline
Substitute Decision Maker (SDM) satisfaction questionnaire
Likert scales and open-ended questions measuring the SDM's satisfaction with resident's transition.
Measured: Change from baseline at 2 weeks
Substitute Decision Maker (SDM) questionnaire
Likert scales and open-ended questions measuring the SDM's perception of the resident's identified baseline behaviour(s).
Measured: At baseline
Substitute Decision Maker (SDM) questionnaire
Likert scales and open-ended questions measuring the SDM's perception of change in the transitioned resident's identified behaviour(s).
Measured: Change in resident's baseline behaviour(s) at 2 and 4 weeks
Post-Care Transition (PCT) questionnaire
Likert scales and open-ended questions measuring change in the transitioned resident's identified behaviour(s).
Measured: Change in resident's baseline behaviour(s) at 3 and 6 months
Post-Care Transition (PCT) staff satisfaction questionnaire
Likert scales and open-ended questions evaluating staff satisfaction with the resident's transition process.
Measured: Change from baseline at 2 and 4 weeks
Chart review
Resident's additional dependent data collection (e.g., demographics, identified behaviours, Cohen Mansfield Agitation Inventory score, etc.)
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2015 (estimated)
- Study startJul 2014
- Primary completionMay 2016
- Study completionMay 2016
Why it stopped: Funding problems, slow recruitment, PI location change
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 DementiaStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baycrest
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Ministry of Health and Long Term Care
- Responsible party
- Principal investigator, Dr. Colleen Ray, Baycrest
- Investigators
- Colleen Ray, PhD, Principal investigator, Neuropsychology and Cognitive Health at Baycrest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02415504
- Sponsor's protocol ID
- REB14-45
- Status last verified
- Sep 2016
- First submitted
- 5 Dec 2014
- Last updated
- 22 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 22992544Coleman 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.
PubMed 12657078
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Care Transition: A Randomized Control Trial of an Enhanced Care Transition Process in Dementia
- ClinicalTrials.gov ID
- NCT02415504
- Acronym / sponsor ID
- REB14-45
- Keywords
- Care transition, Behavioural and psychological symptoms of dementia, BPSD, Dementia, Persons with dementia, Discharge processes
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding problems, slow recruitment, PI location change
- Enrolment
- 29 participants (actual)
- Lead sponsor
- BaycrestUniversity, hospital or other
- Collaborators
- Ontario Ministry of Health and Long Term Care
- Study start
- Jul 2014
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 14 Apr 2015 (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.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced care transition | Experimental | Behavioral: Enhanced care transitionThe 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. |
| Standard care transition | Other | Behavioral: Standard care transitionThe 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. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Enhanced care transitionEnhanced 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. | Behavioural | Enhanced care transition |
| Standard care transitionStandard 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. | Behavioural | Standard care transition |
Primary outcome
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).
8 secondary outcomes
Social work assessment questionnaire
Time frame: At 6 months after baseline
Substitute Decision Maker (SDM) satisfaction questionnaire
Time frame: At baseline
Substitute Decision Maker (SDM) satisfaction questionnaire
Time frame: Change from baseline at 2 weeks
Substitute Decision Maker (SDM) questionnaire
Time frame: At baseline
Substitute Decision Maker (SDM) questionnaire
Time frame: 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
Post-Care Transition (PCT) staff satisfaction questionnaire
Time frame: Change from baseline at 2 and 4 weeks
Chart review
Time frame: At baseline
Results and safety
The study was stopped early (reason given: Funding problems, slow recruitment, PI location change). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2016.
- Background: PubMed 22992544Viggiano 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.
- Background: PubMed 12657078Coleman 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.
- Individual participant dataSharing planned: No
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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.
Colleen Ray, PhD principal investigator
Neuropsychology and Cognitive Health at Baycrest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced care transition in people with Dementia and BPSD, run by Baycrest 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 3 inclusion and 1 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: stopped early, as of the sponsor's last update on 22 Sep 2016. 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.
Are results available for this study?
The study was stopped early (reason given: Funding problems, slow recruitment, PI location change). Results are not available in the source record.
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?
Post-Care Transition (PCT) questionnaire (time frame: Change in resident's baseline behaviour(s) at 2 and 4 weeks). 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 NCT02415504, 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 22 Sep 2016.