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Table 1 Summary of outcomes, measurements, data source and measurement time-points, and methods of analysis

From: Evaluation of a cross-sectoral care intervention for families with psychosocial burden: a study protocol of a controlled trial

Outcomes

Measurement

Data source

Measurement time-point

Data analysis

t1

t1

t2

Use of supportive services by families with psychosocial burden (primary outcome)

Online-survey

Families

x

x

x

Comparison of intervention & control group using generalized linear mixed models

Correctly identified families with psychosocial burden (secondary outcome, proximal)

Paper-pencil-questionnaire

Pediatricians

x

  

Information provision & motivation of families with psychosocial burden by the pediatrician (secondary outcome, proximal)

Online-survey

Families

x

x

x

Cost-effectiveness ration of the PATH-intervention (secondary outcome, distal)

Direct costs of the intervention, health insurance claim data

Association of Statutory Health Insurance Physicians Baden-Wuerttemberg, Statutory Health Insurance “AOK” Baden-Württemberg

Throughout the study.

Calculation of incremental cost-effectiveness ratios (ICERs)

Acceptance of the PATH-intervention (secondary outcome, distal)

Telephone interviews

Families with psychosocial burden, IG-pediatricians, ECI network members

Throughout the online-survey data collection phase.

Qualitative content structuring

Treatment fidelity

Video-assisted observations

IG-Pediatricians

The next preventive medical check-up (U4-U6) of a participating family with psychosocial burden.

Qualitative analysis (incl. Conversation analysis)

  1. Note: t1/ t2/ t3 = first/ second/ third measurement time-point; “U” = U-Untersuchung (preventive medical check-up for children aged 0-3 years)