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Table 1 Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) diagram illustrating the design and timescales of the pilot PROWORK RCT

From: Protocol for a feasibility randomised controlled study of a multicomponent intervention to promote a sustainable return to work of workers on long-term sick leave — PROWORK: PROmoting a Sustainable and Healthy Return to WORK

TIMEPOINT

Enrolment

Allocation

Baseline

(0 month)

2-month follow-up

End of intervention (4-month)

End of study

ENROLMENT

 Organisation recruitment

x

     

 Eligibility screen

x

     

 Organisation informed consent

x

     

 Allocation

 

x

    

 Manager informed consent

  

x

   

 Worker informed consent

  

x

   

INTERVENTION

 Worker and manager RTW toolkit

  

X

X

X

 

 Worker coaching sessions

  

X

X

  

 Manager training webinar

  

X

   

 Control group - usual practice

  

X

X

X

 

ASSESSMENTS

 Organisational sickness policy data

X

     

 Organisational sickness report data

  

X

   

 Feasibility outcomes (recruitment)

  

X

   

 Feasibility outcomes (retention, compliance)

    

X

X

 Process evaluation

X

 

X

X

X

X

 Intervention resource used

     

X

 Economic evaluation

X

 

X

X

X

X

Worker measures

 Demographics

  

X

   

 Days of sick leave

  

X

X

X

 

 Mental health

  

X

X

X

 

 Quality of life

  

X

X

X

 

 Healthcare resource used

  

X

X

X

 

 Return to work measures

  

X

X

X

 

 Workplace support and communication

  

X

X

X

 

 Work outcomes

  

X

X

X

 

 Intention to use toolkit

  

X

X

  

 Manager RTW actions

   

X

X

X

 Interviews

     

X

Employer measures

 Demographics

  

X

   

 Mental health management experience

  

X

   

 RTW management experience

  

X

   

 RTW support for worker

    

X

X

 Interviews

     

X