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. 2021 Aug 4;16(1):77.
doi: 10.1186/s13012-021-01146-8.

Implementing work-related Mental health guidelines in general PRacticE (IMPRovE): a protocol for a hybrid III parallel cluster randomised controlled trial

Danielle Mazza  1 , Samantha Chakraborty  2 , Vera Camões-Costa  2 , Justin Kenardy  3 , Bianca Brijnath  4   5 , Duncan Mortimer  6 , Joanne Enticott  7 , Michael Kidd  8 , Lyndal Trevena  9 , Sharon Reid  9 , Alex Collie  10
Affiliations

Implementing work-related Mental health guidelines in general PRacticE (IMPRovE): a protocol for a hybrid III parallel cluster randomised controlled trial

Danielle Mazza et al. Implement Sci. .

Abstract

Background: The Clinical Guideline for the Diagnosis and Management of Work-related Mental Health Conditions in General Practice (the Guideline) was published in 2019. The objective of this trial is to implement the Guideline in general practice.

Trial design: Implementing work-related Mental health conditions in general PRacticE is a hybrid III, parallel cluster randomised controlled trial undertaken in Australia. Its primary aim is to assess the effectiveness of a complex intervention on the implementation of the Guideline in general practice. Secondary aims are to assess patient health and work outcomes, to evaluate the cost-effectiveness of the trial, and to develop a plan for sustainability.

Methods: A total of 86 GP clusters will be randomly allocated either to the intervention arm, where they will receive a complex intervention comprising academic detailing, enrolment in a community of practice and resources, or to the control arm, where they will not receive the intervention. GP guideline concordance will be assessed at baseline and 9 months using virtual simulated patient scenarios. Patients who meet the eligibility criteria (>18years, employed, and receiving care from a participating GP for a suspected or confirmed work-related mental health condition) will be invited to complete surveys about their health and work participation and provide access to their health service use data. Data on health service use and work participation compensation claim data will be combined with measures of guideline concordance and patient outcomes to inform an economic evaluation. A realist evaluation will be conducted to inform the development of a plan for sustainability.

Results: We anticipate that GPs who receive the intervention will have higher guideline concordance than GPs in the control group. We also anticipate that higher concordance will translate to better health and return-to-work outcomes for patients, as well as cost-savings to society.

Conclusions: The trial builds on a body of work defining the role of GPs in compensable injury, exploring their concerns, and developing evidence-based guidelines to address them. Implementation of these guidelines has the potential to deliver improvements in GP care, patient health, and return-to-work outcomes.

Trial registration: ACTRN12620001163998 , November 2020.

Keywords: General practice; Guideline implementation; Hybrid III trial; Integrated Knowledge Translation; Mental health; Work.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Theoretical basis for the IMPRovE intervention based on Prochaska and DiClemente Transtheoretical Model of Change [18]
Fig. 2
Fig. 2
CONSORT flowchart for the IMPRovE trial design and outcomes. *Patient numbers calculated assuming 25% of GPs will drop out of study. **GP guideline concordance calculated assuming 25% of GPs will drop out of the study
See this image and copyright information in PMC

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