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Table 1 Evaluation plan for the PULSAR Specialist Care study

From: The PULSAR Specialist Care protocol: a stepped-wedge cluster randomized control trial of a training intervention for community mental health teams in recovery-oriented practice

  Sub-study name Evaluation
design
Unit of analysis Number Number at each time point Number in each cluster at each time point Detectable differences
Primary outcome, QPR Secondary outcome, WEMWBS Secondary outcome, INSPIRE
cRCT (quantitative data) Stream 1 (primary analysis) cross-sectional cRCT (complete step-wedge) Consumers (mail-out) 756 252 at baseline
252 at step 1
252 at step 2
18 6.34 (medium effect) NA NA
Stream 2 pre- and post-intervention (incomplete step-wedge) Consumers (interviews) 252 (stream 1 subset) 63 at baseline
126 at step 1
63 at step 2
9 7.68 (medium effect) 4.80 (medium effect) 7.72 (medium effect)
Stream 3 longitudinal, (same participant, 12-mths apart pre- and post-intervention) Consumers with diagnosis of psychosis (interviews) 88 (stream 2 subset) 44 at baseline & step 1
44 at step 1 & step 2
6–7 10.94 (medium-large effect) 6.84 (medium-large effect) 11.28 (medium-large effect)
Nested Qualitative study
(qualitative data)
Consumers
Staff
20–24
20–24
10–12 at step 1
10–12 at step 2
Nested sub-study examining qualitative data collected in study interviews and focus groups
Nested Process evaluation
(both quantitative & qualitative data)
Consumers & staff The process evaluation assesses a specific set of qualitative, quantitative and documentary data relating to each cluster.
  1. Notes. The primary analysis examines the primary outcome– the Questionnaire about the Process of Recovery (QPR) - collected in the two-step stepped-wedge cluster randomized controlled trial (cRCT). A subset of consumers in the cRCT participate in study interviews where secondary outcomes measuring well-being, service satisfaction and health economic impact are collected In a yet another subset in the cRCT, longitudinal data are collected via interviews that are 12 months apart from consumers with a diagnosis of a psychotic disorder. Qualitative and process evaluation sub-studies are nested within the overarching cRCT and include information from consumers and staff.