Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03634774 |
| Other study ID # |
ORE22635 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2018 |
| Est. completion date |
September 30, 2019 |
Study information
| Verified date |
December 2019 |
| Source |
University of Waterloo |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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). 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.
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.
