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Table 2 Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) diagram illustrating the design and timescales of the IGLOo cluster-RCT pilot

From: Protocol for a pilot cluster randomised controlled trial of a multicomponent sustainable return to work IGLOo intervention

Time point

Enrolment

Allocation

Baseline

3-month follow-up

6-month follow up

9-month follow-up

End of intervention (12-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

 Leader e-learning (P1)

  

x

     

 Worker and manager toolkits (P2&3)

  

x

x

x

x

x

 

 Worker telephone coaching

  

x

x

x

   

 Control group—usual practice

  

x

x

x

x

x

 

Assessments

 Organisational sickness policy

x

       

 Organisational sickness report data

x

       

 Feasibility outcomes (recruitment)

  

x

     

 Feasibility outcomes (retention, compliance)

      

x

x

 Process evaluation

x

 

x

x

x

x

x

x

 Intervention resource used

       

x

 Economic evaluation

x

 

x

x

x

x

x

x

 Organisation-wide survey

 

x

     

x

Phase 1 leader measures

 Timepoint

  

Baseline

1 month

    

 Sick leave and RTW policy and practice

  

x

     

 Intervention readiness

  

x

x

    

 Autonomy

  

x

     

 Demands

  

x

     

 Communication about mental health resources

  

x

x

    

 Demographics

  

x

     

 Intervention acceptability

   

x

    

 Intentions to apply learning

   

x

    

 Transfer of learning

   

x

    

 Intention to take part in phase 2

   

x

    

 Integration of intervention

   

x

    

Measures for worker on long-term sick leave

 Demographics

  

x

     

 Days off sick

  

x

x**

x**

x**

x**

 

 Mental health

  

x

x

x

x

x

 

 Quality of life

  

x

x

x

x

x

 

 Healthcare resource used

  

x

x

x

x

x

 

 RTW self-efficacy

  

x

x

x

x

x

 

 Workplace support and communication

  

x

x

x

x

x

 

 Work adjustments

  

x

x

x

x

x

 

 Readiness to stay at work

   

x*

x*

x*

x*

 

 Job autonomy

   

x*

x*

x*

x*

 

 Job crafting

   

x*

x*

x*

x*

 

 Job satisfaction and intention to quit

   

x*

x*

x*

x*

 

Manager measures

 Demographics

  

x

     

 Mental health management experience

  

x

     

 RTW management experience

  

x

   

x

 

 Work adjustments

   

x*

x*

x*

x*

 

 Work demands

  

x

   

x

 

 Autonomy

  

x

   

x

 

 Confidence managing sick leave and RTW

  

x

x

x

x

x

 

 RTW competency

   

x*

x*

x*

x*

 

 RTW competency (post- RTW)

   

x**

x**

x**

x**

 
  1. Key: x** = measures administered until employee returns to work; x* = measures administered once employee has returned to work; 1 month = measures administered at 1-month follow-up