StressNCT04970771
Solving Wellness: An Initiative to Enhance Canadian Healthcare Provider Wellness
A study testing Solving Wellness platform in people with Stress and Burnout, Professional, run by Hopital Montfort at 1 site in Canada.
Trial summary
Given the high incidence of burnout, depression, and suicidal ideation among Canadian healthcare providers (HCPs), there is an urgent need to support wellness through strengthening peer networks and engaging key stakeholders. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress, Burnout, Professional, Burnout
- What is being tested?
- Solving Wellness platform
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteCanada
- Study dates
- 31 Mar 2022to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Participant Inclusion Criteria Healthcare providers who are
- aged 18 years or older
- physicians, residents, medical students, nurses, and allied health professionals of various specialties at the Montfort Hospital and will also be open to Canadian medical professionals (physicians, residents, medical students, nurses, and allied health professionals).
Participant exclusion criteria: Healthcare providers who have previously enrolled as a member of Solving Wellness prior to project start.
Stakeholder staff inclusion criteria:
Employees who are
- aged 18 years or older; and
- whose roles provide them with direct knowledge of topics relating to physician wellness at the Montfort Hospital and of the interventions implemented during the study period (e.g., senior physicians, experts on physician wellness, health system decision makers, mental health experts, health care service managers, nurse managers, ICU managers, medical site lead, directors or department heads).
Stakeholder staff exclusion criteria: Any employees who are involved in the project design and execution (ie. advisory circle members or research team members)
Trial locations and contacts
1 site in 1 country.
About this study
Given the high incidence of burnout, depression, and suicidal ideation among Canadian healthcare providers (HCPs), there is an urgent need to support wellness through strengthening peer networks and engaging key stakeholders. This project will explore the capacity of digital tools to educate HCPs and enable them to support their mental health. The investigators will evaluate specific research questions: Are HCPs more aware of their wellness needs? Did burnout and stress decrease? Do HCPs feel more supported by their peers? The overarching objective is to contribute towards a culture prioritizing HCP wellbeing. The investigators hope to achieve this through two outcome-oriented objectives: 1) to create resources to promote HCP wellbeing and 2) to foster a web-based HCP community. This initiative integrates big data tools, interactive online content, and the Solving Healthcare podcast to improve HCP wellness. It is anticipated that HCPs will become more aware of their wellness needs, and once they are able to identify strategies to live healthier work lives, cultural changes will take place, leading to a new attitude surrounding HCP mental health. To complete these objectives, resources will be drawn from the HELP-MD physician database and an advisory circle, and will be disseminated via a web platform and the widely known Solving Healthcare podcast. The project's significance stems from the changes it will incite in both individuals and health care institutions, inspiring long term changes in workplace culture and teaching the next generation that a balanced work life is attainable.
- Conditions
- Stress, Burnout, Professional, Burnout
- Being tested
- Solving Wellness platform
- Keywords
- Mental Health, Healthcare Providers, Digital Tools, Wellness Resources
- Medical subject headings
- Burnout, Professional, Burnout, Psychological, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Solving Wellness platformBehavioural
Interactive wellness resources available include a wide range of curated content and resources including fitness and yoga classes, cooking classes, webinars on sleep and various mental health topics including resilience, stress management, relationships and mindfulness, and resources including e-books, videos and guided meditations. Online discussion groups will foster awareness for specific issues and allow casual discussion. A curated collection of links to additional resources including the Solving Healthcare podcast will also be provided.
| Study group | Role | What they receive |
|---|---|---|
| Solving Wellness Platform Group | Experimental | Participants will receive a 1-year membership to the Solving Wellness virtual platform containing interactive wellness resources. Receives: Behavioral: Solving Wellness platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in healthcare provider burnout
As measured by the administration of the Maslach Burnout Inventory (MBI) at Months 1 and 12 of the intervention phase. The MBI is a 22 question survey which evaluates 3 subscales; emotional exhaustion, depersonalization and reduced personal accomplishment. Each question is rated from 1 to 5, where 1 is strongly disagree and 5 is strongly agree. A high score on the emotional exhaustion subscale (27+) coupled with a high score on the depersonalization scale (10+) indicates that the individual may be experiencing 1+ symptoms of burnout.
Measured: 12 months
Reduction in healthcare provider stress
As measured by the administration of the Perceived Stress Scale (PSS) at Months 1 and 12 of the intervention phase. The PSS consists of 10 questions, answered on a scale of 0-4 depending on the frequency of which the behavior is observed, with 0 indicating "never" and 4 indicating "very often". Overall, a score of 0 indicates low stress, while a score of 40 indicates an individual with high perceived stress levels.
Measured: 12 months
Increase in perceived peer support
A pre/post intervention staff questionnaire will measure this outcome quantitatively through the inclusion of questions relating to the degree of perceived peer support , and measured qualitatively by thematic analysis of post-intervention focus group discussions with study participants and staff stakeholders.
Measured: 12 months
Increased awareness of personal wellness needs
A pre/post intervention staff questionnaire will measure this outcome quantitatively through the inclusion of questions relating to the degree that wellness is considered daily, and measured qualitatively by thematic analysis of post-intervention focus group discussions with study participants and staff stakeholders.
Measured: 12 months
Increased ability to apply wellness practices to daily life
A pre/post intervention staff questionnaire will measure this outcome quantitatively through the inclusion of questions relating to the degree that wellness is considered daily, and qualitatively measured by thematic analysis of post-intervention focus group discussions with study participants and staff stakeholders.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start31 Mar 2022
- Primary completion30 Apr 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Montfort
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kwadwo Kyeremanteng, MD, Principal investigator, The Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04970771
- Sponsor's protocol ID
- 21-22-06-011
- Status last verified
- Dec 2023
- First submitted
- 12 Jul 2021
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Solving Wellness: An Initiative to Enhance Canadian Healthcare Provider Wellness
- ClinicalTrials.gov ID
- NCT04970771
- Acronym / sponsor ID
- 21-22-06-011
- Conditions
- Stress, Burnout, Professional, Burnout
- Keywords
- Mental Health, Healthcare Providers, Digital Tools, Wellness Resources
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Hopital MontfortUniversity, hospital or other
- Study start
- 31 Mar 2022 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 21 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Given the high incidence of burnout, depression, and suicidal ideation among Canadian healthcare providers (HCPs), there is an urgent need to support wellness through strengthening peer networks and engaging key stakeholders. This project will explore the capacity of digital tools to educate HCPs and enable them to support their mental health. The investigators will evaluate specific research questions: Are HCPs more aware of their wellness needs? Did burnout and stress decrease? Do HCPs feel more supported by their peers? The overarching objective is to contribute towards a culture prioritizing HCP wellbeing. The investigators hope to achieve this through two outcome-oriented objectives: 1) to create resources to promote HCP wellbeing and 2) to foster a web-based HCP community. This initiative integrates big data tools, interactive online content, and the Solving Healthcare podcast to improve HCP wellness. It is anticipated that HCPs will become more aware of their wellness needs, and once they are able to identify strategies to live healthier work lives, cultural changes will take place, leading to a new attitude surrounding HCP mental health. To complete these objectives, resources will be drawn from the HELP-MD physician database and an advisory circle, and will be disseminated via a web platform and the widely known Solving Healthcare podcast. The project's significance stems from the changes it will incite in both individuals and health care institutions, inspiring long term changes in workplace culture and teaching the next generation that a balanced work life is attainable.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Solving Wellness Platform Group | Experimental | Behavioral: Solving Wellness platformParticipants will receive a 1-year membership to the Solving Wellness virtual platform containing interactive wellness resources. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Solving Wellness platformInteractive wellness resources available include a wide range of curated content and resources including fitness and yoga classes, cooking classes, webinars on sleep and various mental health topics including resilience, stress management, relationships and mindfulness, and resources including e-books, videos and guided meditations. Online discussion groups will foster awareness for specific issues and allow casual discussion. A curated collection of links to additional resources including the Solving Healthcare podcast will also be provided. | Behavioural | Solving Wellness Platform Group |
Primary outcome
Reduction in healthcare provider burnout
Time frame: 12 months
As measured by the administration of the Maslach Burnout Inventory (MBI) at Months 1 and 12 of the intervention phase. The MBI is a 22 question survey which evaluates 3 subscales; emotional exhaustion, depersonalization and reduced personal accomplishment. Each question is rated from 1 to 5, where 1 is strongly disagree and 5 is strongly agree. A high score on the emotional exhaustion subscale (27+) coupled with a high score on the depersonalization scale (10+) indicates that the individual may be experiencing 1+ symptoms of burnout.
Reduction in healthcare provider stress
Time frame: 12 months
As measured by the administration of the Perceived Stress Scale (PSS) at Months 1 and 12 of the intervention phase. The PSS consists of 10 questions, answered on a scale of 0-4 depending on the frequency of which the behavior is observed, with 0 indicating "never" and 4 indicating "very often". Overall, a score of 0 indicates low stress, while a score of 40 indicates an individual with high perceived stress levels.
Increase in perceived peer support
Time frame: 12 months
A pre/post intervention staff questionnaire will measure this outcome quantitatively through the inclusion of questions relating to the degree of perceived peer support , and measured qualitatively by thematic analysis of post-intervention focus group discussions with study participants and staff stakeholders.
Increased awareness of personal wellness needs
Time frame: 12 months
A pre/post intervention staff questionnaire will measure this outcome quantitatively through the inclusion of questions relating to the degree that wellness is considered daily, and measured qualitatively by thematic analysis of post-intervention focus group discussions with study participants and staff stakeholders.
Increased ability to apply wellness practices to daily life
Time frame: 12 months
A pre/post intervention staff questionnaire will measure this outcome quantitatively through the inclusion of questions relating to the degree that wellness is considered daily, and qualitatively measured by thematic analysis of post-intervention focus group discussions with study participants and staff stakeholders.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kwadwo Kyeremanteng, MD principal investigator
The Ottawa Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Solving Wellness platform in people with Stress and Burnout, Professional, run by Hopital Montfort at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in healthcare provider burnout (time frame: 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2023.