Data Collection
psychotic disorders
CORONAVIRUS, BLIND
The timeline in Supplementary file 2 shows the intervals between fidelity measurements in the experimental arm. The official start of the implementation period was 6 months after the baseline fidelity measurements, with the first follow-up measurements 6 months later and then every 6th month throughout the trial. Fidelity assessments in the control arm were only performed at baseline and 24 months. When measuring fidelity at baseline and 12 months, the assessors visited the clinical sites. However, because of the coronavirus pandemic, we had to employ a digital video conference platform for some of the measurements at 18 months, and all of the measurements at 24 months.At each site, two researchers measured fidelity by conducting structured interviews with leaders, clinicians, and resource persons, and by examining written material such as procedures and information leaflets. They performed 2–5 separate interviews of 1–1.5 h length. Usually the head of department was interviewed individually, whereas those in other participant categories were interviewed in groups of 2–6 persons. Verbal informed consent was obtained from all participants prior to the interviews. The two fidelity assessors first scored all items independently and then resolved any discrepancies to reach a consensus score for each item. Where clusters consisted of subunits with differing clinical approaches and patient populations, their average scores were recorded. The two experimental sites that were merged to a single cluster were scored separately throughout the trial, and their average scores were calculated at each time point as the cluster scores. We solely assessed the sites’ practice towards patients with psychotic disorders and their relatives. At each time point, we also recorded the percentage of patients with psychotic disorders that had received or were receiving FPE, based on administrative data. When calculating these percentages, the denominator only included patients currently receiving treatment at the clinical unit.The assessors, and the pairing of them, varied across both sites and time points. None of the five researchers who assessed fidelity throughout the trial were employees of the clinical sites in the study. At each time point, the fidelity assessors prepared a detailed report for the respective site to complement the scores. Scores and reports were made available to the sites in the experimental arm, but not to the sites in the control arm, to reduce the influence of fidelity assessments on their practice during the implementation period. Due to obvious changes in the practice and organisation of experimental sites, and the fact that researchers provided implementation support, it was impossible to blind the assessments.