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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
29

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Canada
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Enhanced care transition
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.
Behavioral: Standard care transition
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Baycrest

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ontario Ministry of Health and Long Term Care

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 5, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 14, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 22, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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