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DementiaCHOICE+NCT03634774

CHOICE Plus Program: Supporting Relationship-centred Mealtimes for Long-term Care

A study testing CHOICE+ Training Program in people with Dementia and Long-term Care, run by University of Waterloo at 3 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Enhancing the mealtime experience through changing the social and physical aspects of dining holds the potential to not only improve food intake among residents, but enhance their quality of life. The CHOICE+ Program is designed to support relationship-centred mealtimes in long-term care (LTC). Read more about this study

Who is it for?
Any age
Conditions the study is for
Dementia, Long-term Care
What is being tested?
CHOICE+ Training Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
153 participants
Where
3 sitesCanada
Study dates
1 Apr 2018to 30 Sep 2019
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Residents living in the CHOICE+ study units at three long-term care homes in South-Western Ontario

Who cannot join

  • Residents who do not live in the chosen area for these homes, or live in different homes

Trial locations and contacts

3 sites in 1 country.

Canada3 sites
  • Erin Mills Lodge

    Mississauga

  • Extendicare Bayview

    North York

  • Christie Gardens

    Toronto

Other trials in Canada

About this study

Enhancing the mealtime experience through changing the social and physical aspects of dining holds the potential to not only improve food intake among residents, but enhance their quality of life. The CHOICE+ Program is designed to support relationship-centred mealtimes in long-term care (LTC). This current study will pilot the CHOICE+ Program over the course of 18 months in three LTC homes with the support of a single external facilitator. The research team will collect data at mealtimes and from staff, residents and family members to determine what changes occurred and how this impacted the mealtime experience. The results of this study will provide insight into the efficacy of the CHOICE+ Program and if the program holds potential to improve mealtimes for residents in LTC through relationship-centered dining, as well as capacity building among those who live and work in the home to identify areas for improvement and work together to make change.

Read the detailed description

This study employs a stepped wedged design that includes three long-term care homes (Site A, Site B, Site C) located within Southern Ontario. Each LTC home will have approximately 12 months to implement the CHOICE+ Program and demonstrate sustainability for the last few weeks; the study will run for 18 months due to the staggered entry of sites into the intervention (Site A: Month 1; Site B: Month 4; Site C: Month 7).

Over the course of 12 months for each Site, the CHOICE+ Program components will be delivered to a single care unit using a 4-phase approach. Transitions from one phase to the next will be entirely dependent upon the context and readiness of those participants involved in the study (i.e., timing between phases may differ amongst LTC homes). A single external facilitator from the University of Waterloo will lead this implementation process. The principal investigator (PI; H. Keller) will assist in guiding the external facilitator through the implementation process and support debriefing sessions. A blinded trained assessor will conduct mealtime experience audits (Mealtime Scan Plus) every 12 weeks starting at Month 1 for Sites A, B, and C, regardless of the implementation start times (i.e., Site A at Month 1; Site B and Month 4; Site C and Month 7). A physical dining room audit will be conducted at four time points (Dining Environment Audit Protocol). Staff, resident and family/volunteer dining experience questionnaires will be completed at four time points as well. Below is sequential description of the implementation process of the CHOICE+ Program in a single site, while accounting for pre-implementation activities:

PHASE 1: PRE-DEVELOPMENT (Week 0)

  • PI and facilitator meets with LTC home management/administrators (i.e., Unit Care Coordinators (UCC), Director of Food Service (DFS), Registered Dietitian (RD), and General Manager (GM)) to describe purpose of CHOICE+ Program, address questions and ensure commitment. Once roles and responsibilities are discussed and agreed upon, the researchers will tour the care unit to obtain an understanding of specific contextual factors. A CHOICE+ Newsletter item for residents, family, and volunteers will be distributed to raise awareness of the program. A CHOICE+ Information Letter will be distributed to all staff members, posters with information session dates and times will be posted, and information brochures will be available around the care unit for care staff, residents, family members, and volunteers.

PHASE 2: DEVELOPMENT (Week 1 - Week 8)

  • Weeks 1-2: In-services and/or informal connections made by the external facilitator to raise awareness and promote the CHOICE+ Program among care staff, residents, family members, and volunteers on the care unit. Feedback and knowledge exchange with care unit will be sought during these information sessions to gain contextual understanding of specific needs of that care unit's mealtimes.
  • MTS+ Audit 1 data collection by assessor using Mealtime Scan for Long-Term Care PLUS (MTS+), a validated tool to assess the psychosocial and physical environments of a mealtime. Prior to the start of MTS+ Data Collection, posters notifying residents, staff, family members, and volunteers that observations are taking place will be posted in the dining areas.
  • The Dining Environment Audit Protocol (DEAP) is completed when the dining room is empty.
  • Week 3: CHOICE+ Dining Team (CDT) that includes residents, family members, care staff (minimum 2), volunteers (if available on unit), and management (minimum 1) will be formed to work closely with external facilitator and care unit to identify aspects of mealtimes that need improvement and support. Two Mealtime Champions (MT Champions) will be identified by the group and/or management as leaders and will act as the key contacts for the facilitator. As part of the team building process and to raise awareness, the CDT will complete a questionnaire about their organization's readiness to make change. As this is a change management step, an information letter and consent for will not be used. The Team Mealtime Experience Questionnaire (TMEQ) will be administered by the facilitator to participating care staff to reflect upon their role in the dining room during meals after informed written consent is provided. Residents, family members, and volunteers will have the option of completing a Dining Experience Questionnaire (DEQ) to share their feelings about mealtimes on the care unit. A separate questionnaire will be available for residents and family members/volunteers and informed written consent or assent in the event the resident is unable to sign a consent form will be provided.
  • Weeks 4-8: Training and equipping the CDT on CHOICE+ Principles and change management approaches will take place over 4 meetings hosted by the external facilitator. The themes of these meetings include Meeting #1: CDT Role and CHOICE+ Program overview; Meeting #2: CHOICE+ Education Modules; Meeting #3: Feedback of Audit 1 MTS+, TMEQ, DEAP, and DEQ results. Results will be shared first with the CDT then with the rest of the care unit for review and reflection using the most appropriate communication methods identified by the CDT (i.e., bulletin boards, huddles, posters, etc.); and Meeting #4: Process of making change and priority setting.

PHASE 3: INTENSIVE (Weeks 9-36)

  • Weeks 9-10: All care staff on the unit and those residents and family members who are interested in participating in CHOICE+, in addition to the CDT, will complete the CHOICE+ Education Modules (mobile based short videos). In situations where there are new members of the care unit (i.e., care staff, residents and their family members) will also be provided with this education.
  • Weeks 9-12: CDT engages with broader care unit to share Audit 1 MTS+, DEAP, TMEQ, and DEQ results to obtain feedback. Communication methods that are most suited to the care unit, for example, posters, meetings, bulletin boards, etc., will be used to share these audit findings. The CDT will engage with the broader care unit to select those mealtime areas for improvement that are most important to neighbours, care staff, and family members.
  • Weeks 12-36: The CDT will take these priority areas and work as a team to identify how to make changes and improvements using a variety of behaviour change techniques using a Plan-Do-Study-Act (PDSA) cycle framework. Once a practice change is becoming embedded, a new priority for improvement will be worked through by the CDT and PDSA cycles used to test the improvement. The CDT will be responsible for on-going monitoring of the PDSA cycles in the care unit with support from the facilitator until Week 36 where the facilitator will then begin to reduce their role and the CDT will take on full leadership of the changes being made on the care unit.
  • Data collection will using the TMEQ, MTS+, DEAP, and DEQ will follow a schedule for all three sites (see below in "Data Collection") with results fed back to the CDT and the unit team to support change in practice. Mealtime Practices Checklist and Dining Room Checklist will be used as change management activities and self-reflection by the CDT and unit team. As use of these checklists is part of the change process directed by the CDT, informed consent will not be used prior to completion and if forms are collected they will be anonymous for summarization and discussion.

PHASE 4: SUSTAINING (WEEKS 37-52)

  • Week 37-52: The sustaining phase will involve ensuring that any new care staff, residents and their family members have access to the CHOICE+ Education Modules. CDT will continue to work the process of change by identifying what needs to improve, how to make the change and completing small tests with PDSA cycles to work through the improvement or new process. DEAP, MTS+, TMEQ, and DEQ results will continue to be provided to the CDT to support change practices and they will continue to use the Mealtime Practices Checklist and other informal self-monitoring data to embed changes. The CDT will continue to hold weekly meetings to monitor the progress of the PDSA cycles and make any necessary modifications to the action plan or its implementation strategies. The facilitator will help the CDT to develop a sustainability plan for the CHOICE+ Program, after which the facilitator will remove herself from the care unit and limit communication either via phone or email with the CDT.
  • Data collection will using TMEQ, MTS+, DEAP, and DEQ will follow a schedule for all three sites (see below) with results fed back to the CDT and the unit tem to support change in practice. Mealtime Practices Checklist and Dining Room Checklist will be used as change management activities and self-reflection by the CDT and unit team.
  • Week 48-52: External facilitator will complete key informant semi-structured interviews with CDT members including care staff home management residents family members), and volunteers on the CHOICE+ program. It is anticipated than between 10-15 interviews will be conducted at each site. Standard informed consent/assent process will be followed for each potential interview participant.
Being tested
CHOICE+ Training Program
Keywords
meals, staff training
Medical subject headings
Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CHOICE+ Training ProgramOther

    CHOICE+ is a program where team members and other stakeholders are engaged in making changes to dining in a long term care home to improve the experience. An external coach supports behaviour change.

Study groups in NCT03634774
Study groupRoleWhat they receive
Step 1 CHOICE+ExperimentalReceives the intervention first
Receives: Other: CHOICE+ Training Program
Step 2 CHOICE+OtherReceived intervention four months after baseline
Receives: Other: CHOICE+ Training Program
Step 3 CHOICE+OtherReceives intervention eight months after baseline
Receives: Other: CHOICE+ Training Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mealtime Scan

    Observational instrument that objectively measures the mealtime experience

    Measured: 16 months

Secondary outcomes (2)
  1. Team member Mealtime Experience

    This 23 item questionnaire rates team member experience with dining

    Measured: Before /after 12 months of intervention

  2. Resident/Family member dining quality

    This five item questionnare provides the perspective of residents and family on the dining experience

    Measured: Baseline/after 12 months of intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2018
  2. Study start1 Apr 2018
  3. Primary completion30 Aug 2019
  4. Study completion30 Sep 2019

Resources

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
Model description
Step-wedge design; all three groups receive the intervention but two are wait list control for varied amounts of time
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
153 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03634774
Sponsor's protocol ID
ORE22635
Acronym
CHOICE+
Status last verified
Dec 2019
First submitted
14 Aug 2018
Last updated
20 Dec 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing CHOICE+ Training Program in people with Dementia and Long-term Care, run by University of Waterloo at 3 sites 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 1 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: finished, as of the sponsor's last update on 20 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Mealtime Scan (time frame: 16 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 20 Dec 2019.

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