COVID-19 Clinical Trial
Official title:
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.
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: 1. Wellness, burnout and mental health 2. Infection Prevention and Control (IPAC) 3. Wraparound resources (e.g., access to food banks, caring for a family member with COVID-19) and 4. 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: 1. 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. 2. 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). 3. 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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Withdrawn |
NCT06065033 -
Exercise Interventions in Post-acute Sequelae of Covid-19
|
N/A | |
Completed |
NCT06267534 -
Mindfulness-based Mobile Applications Program
|
N/A | |
Completed |
NCT05047601 -
A Study of a Potential Oral Treatment to Prevent COVID-19 in Adults Who Are Exposed to Household Member(s) With a Confirmed Symptomatic COVID-19 Infection
|
Phase 2/Phase 3 | |
Recruiting |
NCT04481633 -
Efficacy of Pre-exposure Treatment With Hydroxy-Chloroquine on the Risk and Severity of COVID-19 Infection
|
N/A | |
Recruiting |
NCT05323760 -
Functional Capacity in Patients Post Mild COVID-19
|
N/A | |
Completed |
NCT04537949 -
A Trial Investigating the Safety and Effects of One BNT162 Vaccine Against COVID-19 in Healthy Adults
|
Phase 1/Phase 2 | |
Completed |
NCT04612972 -
Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) to Prevent COVID-19 in Healthy Adult Population In Peru Healthy Adult Population In Peru
|
Phase 3 | |
Recruiting |
NCT05494424 -
Cognitive Rehabilitation in Post-COVID-19 Condition
|
N/A | |
Active, not recruiting |
NCT06039449 -
A Study to Investigate the Prevention of COVID-19 withVYD222 in Adults With Immune Compromise and in Participants Aged 12 Years or Older Who Are at Risk of Exposure to SARS-CoV-2
|
Phase 3 | |
Enrolling by invitation |
NCT05589376 -
You and Me Healthy
|
||
Completed |
NCT05158816 -
Extracorporal Membrane Oxygenation for Critically Ill Patients With COVID-19
|
||
Recruiting |
NCT04341506 -
Non-contact ECG Sensor System for COVID19
|
||
Completed |
NCT04512079 -
FREEDOM COVID-19 Anticoagulation Strategy
|
Phase 4 | |
Completed |
NCT04384445 -
Zofin (Organicell Flow) for Patients With COVID-19
|
Phase 1/Phase 2 | |
Completed |
NCT05975060 -
A Study to Evaluate the Safety and Immunogenicity of an (Omicron Subvariant) COVID-19 Vaccine Booster Dose in Previously Vaccinated Participants and Unvaccinated Participants.
|
Phase 2/Phase 3 | |
Active, not recruiting |
NCT05542862 -
Booster Study of SpikoGen COVID-19 Vaccine
|
Phase 3 | |
Withdrawn |
NCT05621967 -
Phonation Therapy to Improve Symptoms and Lung Physiology in Patients Referred for Pulmonary Rehabilitation
|
N/A | |
Terminated |
NCT05487040 -
A Study to Measure the Amount of Study Medicine in Blood in Adult Participants With COVID-19 and Severe Kidney Disease
|
Phase 1 | |
Terminated |
NCT04498273 -
COVID-19 Positive Outpatient Thrombosis Prevention in Adults Aged 40-80
|
Phase 3 | |
Active, not recruiting |
NCT06033560 -
The Effect of Non-invasive Respiratory Support on Outcome and Its Risks in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2)-Related Hypoxemic Respiratory Failure
|