- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05677997
Evaluating the Impact of Resource Navigators to Support LTC and RH Staff During and Beyond COVID-19
Evaluating the Impact of Resource Navigators to Support Long-term Care and Retirement Home Staff During and Beyond COVID-19
The goal of this clinical trial is to test how well resource navigators help long-term care and retirement home staff access the various health and wellness resources available to them and the effects that this has on their health and wellness overall. The main questions it aims to answer are:
- How does one-on-one support from a resource navigator affect the wellness of long-term care and retirement home staff, including burnout, vaccination status, and COVID-19 infection? Researchers will compare participants in the intervention group (where participants are paired with a resource navigator) and the control group (where participants are not paired with a resource navigator) to see the impact access to a resource navigator has on wellness (primary outcome), burnout, knowledge of, access to and use of wellness resources, knowledge/alignment with provincial public health guidelines related to SARS-CoV-2 vaccine outcomes, SARS-CoV-2 infection, hospitalization, and death (secondary outcomes).
Hypothesis: Researchers anticipate that those in the intervention group (have access to a resource navigator) will report a higher positive change in wellness between baseline and 6 months.
Study Overview
Status
Intervention / Treatment
Detailed Description
In response to the increased stress and workload of the COVID-19 pandemic response for long term care home (LTCH) and retirement home (RH) staff, the Knowledge Translation Program (KTP) at St. Michaels Hospital launched efforts to support this population. Via in-depth discussions and surveys, >200 personal support workers (PSWs) were canvassed to identify their needs during the pandemic. Four areas of need were identified, which included supports for:
- Wellness, burnout and mental health
- Infection Prevention and Control (IPAC)
- Wraparound resources (e.g., access to food banks, caring for a family member with COVID-19) and
- Vaccine information
Additionally, using the Theoretical Domains Framework, the KTP identified the following barriers that impact PSWs' and/or other long-term care and retirement home staff's ability to navigate the pandemic [1]:
- lack of knowledge of available resources
- perceptions of identity within the long-term care home context, resource challenges (e.g., lack of occupational health programs), and * impact of social influences on beliefs (e.g., family and peer perceptions of vaccine efficacy and safety).
These barriers were mapped to corresponding implementation strategies via the Behaviour Change Wheel framework to identify education and enablement (e.g., supporting individuals' own self-efficacy) as interventions to mitigate the identified barriers.[1] Utility of these interventions was confirmed by long-term care home staff partners who believed routine check in calls would reduce social isolation and support PSWs and other long-term care staff to find and use available resources to address their needs.[1]
Through funding from the COVID-19 Immunity Task Force (CITF), the Ontario Ministry of Labour Training and Skills Development (MOLTSD) and the Canadian Immunization Research Network (CIRN), the KTP developed educational resources compiled in a single online repository for long-term care home staff on optimizing infection prevention and control (IPAC) [2-5] in long-term care home, promoting wellness and preventing burnout [6, 7] providing 'wraparound' [8 ,9] resource supports to individuals (e.g., access to food banks, resources on self-isolation, caring for a family member with COVID-19), and addressing SARS-CoV-2 vaccine [10-12] myths and questions (via infographics and town halls created in partnership with OPSWA).[13, 14]
However, currently long-term care and retirement home staff access these resources passively and many do not have the capacity or skills to implement the resources effectively.
A navigator is the missing link to putting these resources into practice.
Through this clinical trial, the researchers aim to answer the following research question:
What is the impact of tailored 1:1 support from a resource navigator and educational resources (intervention arm) compared to educational resources only (control arm) on the wellness of long-term care and retirement home staff (primary outcome), burnout, knowledge of, access to and use of wellness resources, SARS-CoV- 2 vaccination status, self-reported SARS-CoV-2 infection and hospitalization (secondary outcomes).
To achieve the study aim, the researchers will:
- Conduct a trial, which will randomize PSWs and other support service staff to receive 6 months of tailored 1:1 support from a resource navigator and educational resources (intervention arm) versus educational resources only (control arm) to navigate the pandemic.
- Evaluate the impact of the intervention on PSW's and other support service staff's wellness (primary outcome), burnout, knowledge of, access to and use of wellness resources, alignment of provincial public health guidelines related to SARS-CoV-2 vaccine outcomes, SARS-CoV-2 infection, hospitalization, and death (secondary outcomes).
- Conduct a process evaluation to assess quality and delivery of the study intervention.
This study will take place in Long-Term Care and Retirement Homes in Ontario. Each month, participants in the intervention arm will receive a PDF package by email from a research staff member, which will include wellness, burnout and mental health resources (e.g., how to use the free, self-referral Centre for Addiction and Mental Health service [6]; tips on reducing/preventing burnout [9]), SARS-CoV-2 vaccine infographics [10], a wraparound [8] resource package, and IPAC [5] tips/guidance. Participants that indicated they would like a print copy of the resources in the pre-screening survey will be provided a copy via mail. Participants will also receive two hours (2, 1-hour sessions) of navigation support sessions from the resource navigator (by phone/zoom) per month for six months (Total 12, 1-hour sessions). While the resource navigator will not directly provide counselling or mental health supports, they will serve as a liaison to link the PSWs and other support service staff (where applicable) to these supports. The resource navigators will hold a degree or diploma in social services/work, psychology or a related field and have at least 2 years of experience in these sectors.
In the control arm, participants will receive the monthly educational resources only.
Both intervention and control arms will complete a baseline survey, exit survey (at 6 months), and interview if selected to participate.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5B 1W8
- St. Michaels Hospital,
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- A fulltime or part-time employee aged 18 years and older identified as a Long-Term Care and Retirement Home staff (PSW's and other support service staff in those in nutrition, housekeeping and laundry)
- Work in an Ontario Long-term care or retirement home;
- Comfortable speaking and reading English; and
- Access to and willingness to use email for study communications
Exclusion Criteria:
- Do not identify as or are not employed as a PSW and other support service staff;
- Do not work in an Ontario long-term care or retirement home;
- Uncomfortable speaking or reading English; and
- Do not have access to or unwillingness to use email for study communications
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
Receiving monthly resources only
|
|
|
Experimental: Intervention Group
Receiving sessions with a resource navigator 2x a month, and monthly resources.
|
Sessions to go through goals, problem areas, areas they want to improve.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of Change in Wellness
Time Frame: Baseline, and 6 months.
|
Participant wellness will be assessed using the Personal Wellbeing Score.
Survey includes 5 questions and will be scored on a scale from 0 to 16, where 16 is the worst outcome, or poorest level of wellness.
For ONS4 life satisfaction, worthwhile and happiness scores, responses 9-10 are grouped as Very high, 7-8 as High, 5-6 as Medium and 0-4 as Low.
For anxiety scores, responses 6-10 are grouped as High, 4-5 as Medium, 2-3 as Low and 0-1 as Very low.
|
Baseline, and 6 months.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of Change in Level of Burnout
Time Frame: Baseline, and 6 months.
|
Burnout will be assessed with the 22-item Maslach Burnout Inventory for Medical Personnel.
The questionnaire has three main areas which are to be scored independently: emotional exhaustion, on a scale of 0 to 54, where 54 is the worse outcome (highest level of emotional exhaustion); depersonalization, on a scale of 0 to 30, where 30 is the worst outcome (highest level of depersonalization); and low sense of personal accomplishment, on a scale of 0 to 48, where 0 is the worst outcome (lowest sense of personal accomplishment).
|
Baseline, and 6 months.
|
|
Rate of Changes in knowledge, access to and use of wellness supports,
Time Frame: Baseline, and 6 months.
|
There are five individual surveys assessing changes to participants' knowledge, access to, and use of wellness supports.
|
Baseline, and 6 months.
|
|
Rate Changes in number of participants with COVID-19 vaccination, number of participants with COVID infection and hospitalization, over time
Time Frame: Baseline, and 6 months.
|
Via participants' Ontario Health Insurance Plan (OHIP) number, we will link to the ICES provincial administrative database to obtain participants' vaccine status, and rates of SARS-CoV-2 infection, hospitalization and death.
|
Baseline, and 6 months.
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Michie S, van Stralen MM, West R. The behaviour change wheel: a new method for characterising and designing behaviour change interventions. Implement Sci. 2011 Apr 23;6:42. doi: 10.1186/1748-5908-6-42.
- Rios P, Radhakrishnan A, Thomas SM, Darvesh N, Straus SE, Tricco AC. Preventing respiratory illness in older adults aged 60 years and above living in long-term care. MedRxiv. 2020; 1-25. https://doi.org/10.1101/2020.03.19.20039081
- Rios P, Radhakrishnan A, Williams C, Ramkissoon N, Pham B, Cormack GV, Grossman MR, Muller MP, Straus SE, Tricco AC. Preventing the transmission of COVID-19 and other coronaviruses in older adults aged 60 years and above living in long-term care: a rapid review. Syst Rev. 2020 Sep 25;9(1):218. doi: 10.1186/s13643-020-01486-4.
- IPAC+ Self-Assessment for Long-term Care Facilities (LTCHs) and Retirement Homes (RHs). https://ipac.knowledgetranslation.ca/. Accessed 2021 Feb 18.
- IPAC+ Resource Library. Regional Geriatric Program of Toronto. https://www.rgptoronto.ca/resources/ipac+/. Updated 2021.
- Mental Health and COVID-19. Centre for Addiction and Mental Health (CAMH). https://www.camh.ca/en/health-info/mental-health-and-covid-19/information-for-professionals. Published 2020.
- Mental Health Supports. Wellness HUB Support for Congregate Living Centres. https://wellness-hub.ca/tag/mental-health-supports/. Published 2021.
- Wraparound Resources Package. Wellness Hub. https://wellness-hub.ca/res/wraparound-resources-package/. Published 2021.
- Caregiver Resources. The Ontario Caregiver Organization. https://ontariocaregiver.ca/resources-education/caregiver-resources/#caring-for-yourself. Published 2021.
- What you need to know about getting the COVID-19 vaccine. Wellness Hub. https://wellness-hub.ca/res/what-you-need-to-know-about-getting-the-covid-19-vaccine/. Published 2021.
- February 2nd, 2021 OPSWA Town Hall #2: COVID vaccine questions answered. Knowledge Translation Program. https://www.youtube.com/watch?v=UCzRgtbHFFQ&t=517s. Published 2021 Mar 31.
- March 23rd, 2021 OPSWA Town Hall #3: Get you COVID vaccine questions answered. Knowledge Translation Program. https://www.youtube.com/watch?v=hNrNsTXKGT8&t=3s. Published 2021 Mar 26.
- Knowledge Translation Program. COVID-19 Knowledge Translation. https://knowledgetranslation.net/expertise/covid-19/. Updated 2021.
- COVID-19 Immunity Task Force. Pan-Canadian studies investigate why COVID-19 has been devastating to long-term care facility residents and staff.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Occupational Stress
- Burnout, Psychological
- Behavioral Symptoms
- Respiratory Tract Infections
- Infections
- RNA Virus Infections
- Virus Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Pneumonia, Viral
- Pneumonia
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- Stress, Psychological
- Occupational Diseases
- Behavior
- Treatment Adherence and Compliance
- Health Behavior
- Personal Satisfaction
- Treatment Refusal
- COVID-19
- Caregiver Burden
- Burnout, Professional
- Psychological Well-Being
- Vaccination Refusal
- Investigative Techniques
- Methods
Other Study ID Numbers
- 22-026
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on COVID-19
-
PfizerActive, not recruitingCOVID-19 | Coronavirus Disease 2019 (COVID-19) | COVID-19 Infection | COVID-19 Vaccines | SARS-CoV-2 Infection, COVID19 | COVID-19 Vaccination | SARS-CoV-2 Infection, COVID-19 | COVID-19 (Coronavirus Disease 2019) | COVID-19 SARS-CoV-2 InfectionUnited States
-
Shanghai Public Health Clinical CenterNot yet recruiting
-
Duke UniversityNational Institute on Minority Health and Health Disparities (NIMHD)Completed
-
Eggensberger OHGBavarian Health and Food Safety Authority (LGL)RecruitingPost COVID-19 Condition | Post COVID-19 | Post COVID-19 Syndrome | Long COVID-19 Syndrome | Post COVID-19 Condition (PCC)Germany
-
PfizerRecruitingRespiratory Tract Diseases | COVID-19 | Pneumonia | Lung Diseases | Coronavirus Disease 2019 | Coronavirus Disease 2019 (COVID-19) | COVID-19 Infection | Upper Respiratory Tract Infections | Respiratory Tract Infection | COVID-19 (Coronavirus Disease 2019) | COVID-19 SARS-CoV-2 InfectionBelgium
-
ModeX Therapeutics, An OPKO Health CompanyRecruitingCOVID -19 | COVID-19 (Prevention)United States
-
Lawson Research Institute of St. Joseph'sCanadian Institutes of Health Research (CIHR); Western University, CanadaRecruitingFatigue | Post-COVID-19 Syndrome | Post COVID-19 Condition | Post-COVID Syndrome | Long COVID-19 | Long-COVID | Post-COVID ConditionCanada
-
University of Roma La SapienzaQueen Mary University of London; Università degli studi di Roma Foro Italico; Bios Prevention SrlCompletedPost Acute Sequelae of COVID-19 | Post COVID-19 Condition | Long-COVID | Chronic COVID-19 SyndromeItaly
-
Yang I. PachankisActive, not recruitingCOVID-19 Respiratory Infection | COVID-19 Stress Syndrome | COVID-19 Vaccine Adverse Reaction | COVID-19-Associated Thromboembolism | COVID-19 Post-Intensive Care Syndrome | COVID-19-Associated StrokeChina
-
Indonesia UniversityRecruitingPost-COVID-19 Syndrome | Long COVID | Post COVID-19 Condition | Post-COVID Syndrome | Long COVID-19Indonesia
Clinical Trials on Intervention
-
Biolux Research Holdings, Inc.TerminatedOrthodontic Tooth MovementCanada
-
Nottingham Trent UniversityUnknownOverweight and ObesityUnited Kingdom
-
University of Southern DenmarkTrygFonden, DenmarkUnknownObesity | Overweight | Metabolic Syndrome | ChildrenDenmark
-
University of California, San FranciscoNational Cancer Institute (NCI)CompletedColorectal Carcinoma | Healthy Subject | Health Status UnknownUnited States
-
University of FloridaCompletedSensitivityUnited States
-
Ohio State University Comprehensive Cancer CenterCompleted
-
Mayo ClinicNational Cancer Institute (NCI)WithdrawnCancer Survivor | Peripheral Sensory Neuropathy
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI)CompletedStage 0a Bladder Cancer AJCC v8 | Stage 0is Bladder Cancer AJCC v8 | Stage I Bladder Cancer AJCC v8United States
-
Vanderbilt UniversityCompletedMath Learning Disability | Reading Learning DisabilityUnited States
-
Universidad de ExtremaduraDiputación Provincial de BadajozRecruitingHealth Education | Gamification in Health EducationSpain