Solving Wellness: An Initiative to Enhance Canadian Healthcare Provider Wellness

December 5, 2023 updated by: Hopital Montfort
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
53

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1K0T1
        • Montfort Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Solving Wellness Platform Group
Participants will receive a 1-year membership to the Solving Wellness virtual platform containing interactive wellness resources.
Behavioral: Solving Wellness platform
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
12 months
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.
12 months
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.
12 months
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.
12 months
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hopital Montfort

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kwadwo Kyeremanteng, MD, The Ottawa Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 31, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 12, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 21, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 6, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 21-22-06-011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

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