Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05527028 |
| Other study ID # |
001 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2022 |
| Est. completion date |
January 31, 2024 |
Study information
| Verified date |
March 2023 |
| Source |
McMaster University |
| Contact |
Laurie Perrett |
| Phone |
289-426-0854 |
| Email |
perrettl[@]mcmaster.ca |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
In long-term care, staff provide help to residents with bathing, dressing, eating, walking,
toileting, transferring, and moving in bed. Some residents can do more for themselves than
others. This study will compare two groups of residents who require the same level of help
from staff. Over eight weeks, one group will receive occupational therapy services provided
by OT students and the other group will not. After the eight weeks, the level of help that
each group of people requires will be looked at to see if there are any differences.
Description:
A pilot study to determine if Occupational Therapy (OT) directed service in long-term care
maintain a resident's self-performance in activities of daily living: Study protocol for a
single-site trial
INTRODUCTION AND BACKGROUND
In Canada, a significant gap exists in providing resident-focused services to individuals in
long-term care homes (LTCHs) to promote maintenance of function and participation in
activities of daily living (McArthur et al., 2015; Ontario Society of Occupational Therapy,
OSOT, 2020). People who live in LTCHs are frail, have some form of cognitive impairment, and
live with at least one chronic health condition (McArthur et al., 2017; Ontario Long-Term
Care Association, OLTCA, 2019, Shakeel et al., 2015). Upon admission to an LTCH, an alarming
number of individuals experience a stark decline in function in activities of daily living
(Crocker et al., 2013). Furthermore, the number of residents who require extensive assistance
with activities of daily living (ADLs), such as grooming, getting dressed, and eating is also
rising. For example, in 2018, 86% of long-term care residents in Ontario required extensive
assistance with ADLs (OLTCA, 2019). However, this alarming trend may bring to question if
this is an accurate representation of residents' true abilities or possibly the lack of
resident-focused services that support a restorative care philosophy, in which allows
individuals to maintain current abilities or decelerate functional decline after admission to
LTC.
The lack of rehabilitation services in LTCHs is disturbing. Residents should have access to
services that aim to prevent further rapid decline in function or participation in activities
of daily living (ADLs). The LTCH Act in Ontario states that "Every resident has the right to
receive care and assistance towards independence based on a restorative care philosophy to
maximize independence to the greatest extent possible." (Long-Term Care Homes Acts, 2007,
2-3). Nationally, OT accounts for only 4.0% of the rehabilitation services presently provided
within LTCHs. Ontario has the lowest percentage of LTCH residents' access to OT across Canada
(Canadian Institute of Health Information, 2019). OT-directed services in LTCHs can address
specific resident needs related to daily living activities by identifying and help to lessen
risks residents are face with in LTCH, which often result in increased care demands for the
LTCH team (OSOT, 2020). Evidently, long-term homes in Ontario are challenged to pilot
alternative ways in which a restorative care approach can be modelled and delivered in LTC
for residents to fulfill this mandate.
According to the 2021 Ontario budget announcement, the province pledged to increase the
average direct care to four hours a day in long-term care and hire more than 27,000 new staff
positions, including allied health professionals (Ontario Ministry of Finance, 2021). With
this influx of new funding and additional human resources, the current delivery model of
rehabilitation services in long-term care must be re-considered. Furthermore, a pilot to test
an innovative model of OT-directed service delivery to facilitate a restorative care
philosophy is necessary to maximize resident function and level of participation in daily
activities.
A registered occupational therapist will direct student occupational therapists to assess and
develop resident-focused interventions to be implemented and evaluated by the long-term care
team. We seek to understand if OT-directed services delivered by student OTs will demonstrate
maintenance of function in long-term care home residents.
We propose a two-phase study that will use a pilot design first to test the ability to
identify eligible residents, implement the model, and assess outcomes (Pilot Study), which
will inform the design of a more extensive outcomes study (Main Trial).
1.2 PILOT OBJECTIVES AND RESEARCH QUESTIONS
The objectives of the Pilot Study will be to determine if:
- Potential participants can be identified and are willing consent to the Pilot Study
- If the intervention can be implemented as intended
- Outcomes can be measured consistently
PRIMARY RESEARCH QUESTION: Will the provision of occupational therapy intervention, provided
by student occupational therapists for 30 minutes a day for eight weeks, maintain resident
performance in activities of daily living in long-term care as reported using the Modified
Barthel Index?
SECONDARY RESEARCH QUESTION:
Does the provision of occupational therapy intervention provided by student occupational
therapists for 30 minutes a day for eight weeks result in improved resident health status as
measured using the EuroQoL-5D Health Questionnaire?
DESCRIPTION OF THE POPULATION TO BE STUDIED, INCLUSION AND STUDY POPULATION
The study population will be residents living at one of the long-term care homes in the
Hamilton, St. Joseph's Villa in Dundas, Ontario. These residents will be selected from two
home areas with a similar staff complement and similar resident profile. The level of
registered and non-registered staff are similar on both units, as are the life enrichment
programs offered. Each home area has between 26 and 32 residents. A total of 16 residents
will be selected (eight from each home area).
SUBJECT RECRUITMENT
The Resident Assessment Instrument (RAI) Coordinator will identify residents who meet the
eligibility criteria and provide the contact details to the primary investigator. The PI will
send a letter to potential participants and, when consent is provided, to the families of
those residents, describing the study and informing that the PI will be in contact. If, upon
contact, the resident agrees, the PI or a co-investigator will meet with the potential
participant to inform about the study and request consent. Family members will also be
encouraged to also attend.
SAMPLE SIZE
A feasibility sample size will be determined based on the number of residents on each unit
who meet the eligibility and inclusion criteria for this study. Based on the 2019-2020
Profile of Residents Ontario in Residential and Hospital-Based Continuing Care 38% of
residents scored a 3 or below on the ADL Hierarchy Scale and 66.4% scored a 3 or below on the
CPS. Therefore, given the total of residents on both homes areas is 58 a sample size of 16
residents will be chosen. We anticipate, based on this historical Ontario resident data,
approximately 22 out of the 58 residents will have an ADL Hierarchy Scale of less or equal to
three and 39 residents out of 58 will have a CPS score of less or equal to three.
3.0 STUDY DESIGN The pilot study will be a two-group randomized controlled clinical trial. A
total of 16 residents will be allocated in equal proportions to either intervention or no
intervention (usual care). Evaluations will be conducted pre-intervention, post-intervention,
and at five months post-randomization.
3.1 DESCRIPTION OF METHODOLOGY Investigators will review the Resident Assessment
Instrument-Minimum Data Set (RAI-MDS) data provided by the RAI Coordinator at the Long-Term
Care Home to identify eligible candidates for occupational therapy intervention based on ADL
Long Form, ADL Hierarchy Score and Cognitive Performance Scale. Sixteen residents will be
selected (eight from each home area).
A letter and information flyer about the study will be sent to residents and family members
(as appropriate) explaining this protocol to those residents eligible to participate. The
primary investigator (DCE) and student investigators will obtain verbal and written consent
from residents or their designate to participate.
Baseline data will be collected using the following measures:
- Modified Barthel Index
- EuroQoL-5D Health Questionnaire
3.2 RANDOMIZATION
Residents who meet study eligibility criteria and provide consent to participate will be
randomly assigned to either the control or intervention group with a 1:1 allocation as per a
computer-generated randomisation schedule stratified by baseline score ADL Hierarchy and ADL
Long Form Score completed within 5 months of the intervention planned timeframe.
3.3 BLINDING
Once residents are randomly allocated, the Modified Barthel Index and EQ-5D-5L will be
administered to all residents by two independent assessors at week one and again at week
eight. The assessors will be blinded to the resident's allocation group. Student
investigators will not have access to the baseline data. They will only be provided the names
of the resident who have been randomized to the intervention group to receive occupational
therapy services.
3.4 INTERVENTION The student investigators will complete an initial OT assessment based on a
thorough chart review and observation of the participants self-care routine (bathing,
dressing, grooming, toileting, eating and mobility) during week one of their eight-week
placement clinical placement. Next, the student OTs will conduct an initial assessment using
the Canadian Model of Occupational Performance Measure (COPM). Then, based on goals
identified by the resident, the student occupational therapists will share their findings
based on their chart review, observation of resident performance, and information gathered
during the initial assessment with members of the care team.
Next, in collaboration with the resident and the team, the student OT will establish
resident-centered goals and develop a targeted intervention plan to address performance
issues identified by residents in areas of daily living. The resident will receive
approximately 30 minutes a day of direct student OT service delivery. Additional intervention
may be delivered through an indirect, collaborative, or consultative service delivery model.
Students will use a workload measurement tool to track the amount of time and types of
intervention provided to these residents. The intervention will be delivered by two pairs
student occupational therapy students under the direction of a registered OT. Student OTs
will have access to Point Click Care and will document daily and will be required to document
indirect and non-direct time for each resident.
3.5 USUAL CARE
Those residents allocated to the control group will continue to receive usual care. Usual
care is defined as an average of four hours of direct care from nurses and personal support
workers. Direct care hands-on care that includes personal care, such as feeding, bathing,
dressing, and other medical/therapeutic tasks (Ontario Ministry of Long-Term Care, 2020). All
residents will continue to have access to 24-hour nursing and personal care in addition to
access to all usual programming, including recreation and physiotherapy services.
