OT Directed Services in Long-term Care in Ontario

NCT05527028 | Unknown

• 1 other identifier: 001
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Aging

Outcome Measures

Primary Outcomes (1)

• Modified Bathel Index (MBI)

  The MBI is a measure of activities of daily living, which shows the degree of independence of a patient from any assistance. It covers 10 domains of functioning (activities): bowel control, bladder control, as well as help with grooming, toilet use, feeding, transfers, walking, dressing, climbing stairs, and bathing. The scoring for the MBI is out of 100. A higher score indicates a greater degree of independence.

  eight weeks (between July 1st and August 26th, 2022)

Secondary Outcomes (1)

• EuroQoL-5D

  Eight weeks between July 1st and August 26th, 2022

Study Arms (2)

Control group

PLACEBO COMPARATOR

Both groups will receive the standard care provided at the long-term care home. The intervention group will receive the addition of directed occupational therapy intervention provided by student occupational therapists for up to 30 minutes, five days a week. At present, no decisive evidence exists that this intervention being tested will be superior to the standard of care.

Other: Occupational Therapy Services

Intervention Group

EXPERIMENTAL

Both groups will receive the standard care provided at the long-term care home. The intervention group will receive the addition of directed occupational therapy intervention provided by student occupational therapists for up to 30 minutes, five days a week. At present, no decisive evidence exists that this intervention being tested will be superior to the standard of care.

Other: Occupational Therapy Services

Interventions

Occupational Therapy Services OTHER

Investigators will complete an initial assessment based on a thorough chart review and observation of the participants activities of daily living during week one. 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 of OT 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.

Control group; Intervention Group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Residents eligible for the trial must comply with all the following at randomization:
• Current admission to St. Joseph's Villa as a long-term care resident.
• An Activities of Daily Living (ADL) Self-Performance Hierarchy Scale of 4 out of 6 or lower. Higher scores indicate greater decline (progressive loss) in ADL performance.
• ADL Long Form score of 22 out of 28 or lower. Higher scores indicate more dependence in ADL.
• Cognitive Performance Scale (CPS) score between 0-3 out of 6 within the last three months. Higher scores indicate more severe cognitive impairment.
• Individuals can respond or have a caregiver who is able to respond to the EuroQoL-5D Health Questionnaire.
• Individuals or their proxy are willing to provide consent to participate.

You may not qualify if:

• \. Residents with a Change in Health, End-Stage Disease and Signs and Symptoms (CHESS) score of equal to 4 or greater on their last assessment, completed within the last three months. This assessment completed for all residents by nursing staff every three months. Higher scores indicate higher levels of medical complexity and are associated with adverse outcomes

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

McMaster University, School of Rehabilitation Science

Dundas, Ontario, L8S 4K1, Canada

RECRUITING

Study Officials

• Laurie Perrett

  McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laurie Perrett

CONTACT

289-426-0854; perrettl@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be blinded to participant group allocation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Clinical Education, Occupational Therapy

Model Details: Pilot study for single site trial.

Study Record Dates

• First Submitted: February 18, 2022
• First Posted: September 2, 2022
• Study Start: July 1, 2022
• Primary Completion: September 30, 2023
• Study Completion: January 31, 2024
• Last Updated: March 10, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The data will become available in August, 2022

Locations

CA (1)