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Table 3 Process indicators, data collection method

From: Evaluating a multimodal, clinical and work-directed intervention (RTW-PIA) to support sustainable return to work among employees with mental disorders: study protocol of a multicentre, randomised controlled trial

Process indicators

Level

Operationalisation

Data collection method

Fidelity

Adherence to the intervention manual and intervention delivery of Module B

IG-TP

Statements (ratings, yes/no)

Reasons

Suggestions for manual improvement

Evaluation sheets (Module B)

Focus groups

Dose delivered

The extent to which each Module´s component (A-C) of RTW-PIA was actually delivered according to the intervention plan

IG-TP,

IG

Number, date, and duration of every module´s sessions

Participant-related documentation sheet

Technical log file (Module C)

Dose received

IG

Dose-response

Participant-related documentation sheet

Needs-oriented evaluation sheet (Module A)

Reach

Actual proportion of participation in each Module (A-C) of the RTW-PIA intervention

IG

Characteristics of SC

Characteristics of study participants

Drop-out and reasons

Participant-related documentation sheet

Satisfaction I

Study participant´s satisfaction with RTW-PIA Modules (A-C) and the overall intervention

IG,

Qualitative

sub-sample

Satisfaction rate

Quality rate

Experiences

Online surveys (T1-T3)

Post-Interview

Technical log file (Module C)

Satisfaction II

Treatment provider´s satisfaction with RTW-PIA implementation

IG-TP

Experiences

Focus groups

Context I

Contextual factors and history that have an impact on the effectiveness of the intervention

Qualitative

sub-sample

Description of barriers

Description of facilitators

Pre-Interview

Post-Interview

Context II

Contextual factors and history that have an impact on the effectiveness of the intervention

IG-TP

Description of barriers

Description of facilitators

Focus groups

Recruitment

Procedures used to approach and attract patients; number of invited patients; reasons for non-participation

SC

Description of approaches

Logbook

Weekly recruitment sheet

Focus groups

Anonymous non-response questionnaires

  1. Abbreviations: IG Intervention group, IG-TP Intervention group-treatment providers, SC Study centre. For further information regarding time of measurements (T1-T3), please see Flow Chart (Fig. 1) or study schedule of interventions and assessments (Table 2)