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A meta-analysis indicated no observed heterogeneity between practices of the intervention effect on 6-month prolonged abstinence (Cochrane's Q = 15.84, P = 0.99; I-squared = 0.0%).
All practices of the intervention groups (A: pathway developers, B: users) were located in the Marburg region, Germany, whereas the practices of the control group (C) were situated in a neighbouring town.
GPs, GP trainees, and nurse practitioners of general practices of the intervention arm receive a two hours lasting interactive training on the diagnosis and pharmacological management of HF by a cardiologist and GP with expertise in HF.
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Participating therapists are required to attend a one-day training course involving review of both intervention manuals and practice of the intervention techniques with feedback from senior psychologists/psychiatrists.
The approach used, an adaptation of Community Parent Education (COPE), provided for individual application to each family and child regardless of age, clinician modeling of the intervention, and parent-clinician role play practice of the intervention as applied to each child.
Training involved interactive lectures, role plays and mock sessions aimed at practice of the intervention protocol, and were conducted by the study cardiologist-PI, the behaviorist-co-PI, and the clinical research nutritionist, who also provided ongoing supervision.
Five key components of potential difference can be identified: 1) theory (for aetiology, diagnosis and treatment); 2) the rationale offered for how the treatment is expected to work; 3) the practice of the intervention; 4) the implied or assumed causal pathway for change; 5) the desired outcome of treatment.
'There is a lot of cross-over between the two...we already seemed to be doing a lot of it anyway.' (Practice 1, GP) In all but one of the practices administration of the intervention was delegated to the practice nurses.
Participating GPs and practice nurses of the intervention practices will be instructed how to carry out the study protocol and will receive a handbook.
Model validity reflects the concordance between the trial study design and "state of the art" practice for the intervention under investigation [ 4].
Practice nurses of the intervention group will receive SMS training.
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