Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000636954
Ethics application status
Approved
Date submitted
27/05/2020
Date registered
29/05/2020
Date last updated
9/12/2020
Date data sharing statement initially provided
29/05/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
COACHING FOR COVID-19: A Pilot Study Investigating the Effectiveness of Coaching on Psychological Outcomes in Hospital-Based Senior Doctors
Scientific title
COACHING FOR COVID-19: A Pilot Study Investigating the Effectiveness of Coaching on Psychological Outcomes in Hospital-Based Senior Doctors
Secondary ID [1] 301363 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psychological distress 317597 0
Wellbeing 317598 0
Condition category
Condition code
Mental Health 315676 315676 0 0
Depression
Mental Health 315677 315677 0 0
Anxiety
Mental Health 315678 315678 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Coaching will be undertaken via the Zoom video platform and will be scheduled to suit participants’ commitments and workloads. Zoom coaching sessions will be conducted using a password protected online connection. Participants will book their appointments through Capstan Partner’s online booking system. Coaching will be available from 0730 to 1900 Monday to Thursday and 0730 to 1700 on Fridays. Weekend sessions will be available on request. Allocation of participants to coaches will be based on participant and coach availability. In most circumstances it is expected that the schedules of multiple coaches will match with participants, and coaches will be randomly allocated. Within ten days of participants and coaches being assigned, coaches will contact participants to conduct a half-hour introductory meeting to focus on creating the relationship, building rapport, and responding to any questions from participants.

The professional coaches administering the program are screened and selected against stringent criteria for appropriate accredited coach-specific training, have many years of coaching experience, knowledge of professional services and/or experience coaching in the healthcare industry, and agree to adhere to the coaching community’s International Coach Federation Code of Ethics.The International Coaching Federation is the leading global organisation dedicated to advancing the coaching profession by setting high standards, providing independent certification and building a worldwide network of trained coaching professionals.

The first coaching session will be a 1-hour session to begin the process of reflection, goal setting, and solution-focussed thinking. Participants will then have five 30-minute sessions at three-week intervals with their coach. Participants will be given the option of completing non-mandatory guided reflections between coaching sessions that will be sent via email. These reflections will ask participants to reflect on their previous coaching session and any insights they gained, and ask them to think about what they would like to explore in their next session. The reflections may be used to guide the coaching sessions and will not be collected for analysis. Coaching sessions will be unscripted, and participants will self-direct the coaching session themes. Coaches will be required to record the themes participants explore in a predetermined rubric, including COVID-19 related issues.

It is likely the coaching session will generally be structured as follows:
a. Debrief, actions the participants have taken, supporting progress and accountability
b. Planning and goal setting
c. Designing sustainable actions
d. Optimising accountability to next steps
e. Conclusion and wrap-up

Coaches will demonstrate active listening, powerful questioning, direct communication skills, and develop the participants self-awareness to facilitate learning, behaviour change, and meaningful outcomes. Coaches and participants will receive each other’s name, work contact email and mobile phone number.

Regular audits to ensure coaching programs are being conducted to meet project timelines and outcomes, are to be documented, communicated, tracked and followed-up in real time by the project team. Coaches are required to attend two group coaching supervision meetings at one-third and two-thirds of the way through the program.
Intervention code [1] 317678 0
Treatment: Other
Intervention code [2] 317698 0
Lifestyle
Intervention code [3] 317699 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323922 0
Psychological distress, as measured by the 21-item Depression Anxiety Stress Scale (DASS-21), in a cohort of Senior Doctors at Liverpool Hospital through the implementation of a one-on-one virtual coaching program during the COVID-19 pandemic.
Timepoint [1] 323922 0
Baseline, 1-week post program (primary timepoint), and 3-months post program
Secondary outcome [1] 383340 0
Well-being in senior doctors as measured by the WHO-5
Timepoint [1] 383340 0
Baseline, 1-week post program, and 3-months post program
Secondary outcome [2] 383341 0
Flourishing as measured by the Flourishing scale (Diener et al., 2010).
Timepoint [2] 383341 0
Baseline, 1-week post program, and 3-months post program
Secondary outcome [3] 383342 0
Solution-focused thinking as measured by the Solution-focused inventory (Grant et al., 2012)
Timepoint [3] 383342 0
Baseline, 1-week post program, and 3-months post program
Secondary outcome [4] 383343 0
Work performance in senior doctor as measured by presenteeism (WHO-HPQ).
Timepoint [4] 383343 0
Baseline, 1-week post program, and 3-months post program
Secondary outcome [5] 383351 0
Work performance in senior doctor as measured by a two-item absenteeism measure that asks participants to identify the number of sick day they have taken in the last 28 days, and the number of those sick days that were due to mental health or emotional problems.
Timepoint [5] 383351 0
Baseline, 1-week post program, and 3-months post program
Secondary outcome [6] 383352 0
Work performance in senior doctor as measured by a previously used two item scale on medical error (Shanafelt et al., 2010).
Timepoint [6] 383352 0
Baseline, 1-week post program, and 3-months post program
Secondary outcome [7] 389775 0
Acceptability and feasibility (composite outcome) of administering a coaching program during the COVID-19 pandemic as measured by a study-specific questionnaire .
Timepoint [7] 389775 0
1-week post program.

Eligibility
Key inclusion criteria
To be eligible for inclusion:
- Doctors must be Staff Specialists or Visiting Medical Officers employed at a minimum of 0.4 FTE, and/or a Head of Department at participating hospitals
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Staff ineligible for inclusion:
- Junior Medical Officers and other health employees
- General practitioners
- Doctors not employed by the participating hospital
- Doctors employed less than 0.4 FTE at the participating hospital

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
23/07/2020
Actual
23/07/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
35
Accrual to date
29
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 18184 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 18185 0
Campbelltown Hospital - Campbelltown
Recruitment postcode(s) [1] 32239 0
2170 - Liverpool
Recruitment postcode(s) [2] 32240 0
2560 - Campbelltown

Funding & Sponsors
Funding source category [1] 305804 0
Hospital
Name [1] 305804 0
Liverpool Hospital
Country [1] 305804 0
Australia
Primary sponsor type
Government body
Name
South Western Sydney Local Health District
Address
Locked Bag 7103 Liverpool BC NSW 1871
Country
Australia
Secondary sponsor category [1] 306243 0
None
Name [1] 306243 0
n/a
Address [1] 306243 0
n/a
Country [1] 306243 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306075 0
South Western Sydney Local Health District HREC
Ethics committee address [1] 306075 0
Ethics committee country [1] 306075 0
Australia
Date submitted for ethics approval [1] 306075 0
25/05/2020
Approval date [1] 306075 0
10/07/2020
Ethics approval number [1] 306075 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 102610 0
Dr Sarah Dalton
Address 102610 0
Capstan Partners
4/62A Aubin St Neutral Bay NSW 2089
Country 102610 0
Australia
Phone 102610 0
+61 400374747
Fax 102610 0
Email 102610 0
sarah.dalton@health.nsw.gov.au
Contact person for public queries
Name 102611 0
Rita Holland
Address 102611 0
Capstan Partners
4/62A Aubin St Neutral Bay NSW 2089
Country 102611 0
Australia
Phone 102611 0
+61 413599009
Fax 102611 0
Email 102611 0
rita.holland@capstan.com.au
Contact person for scientific queries
Name 102612 0
Samuel Harvey
Address 102612 0
Black Dog Institute
Hospital Road
Randwick NSW 2031
Country 102612 0
Australia
Phone 102612 0
+61 02 9382 4517
Fax 102612 0
Email 102612 0
s.harvey@unsw.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.