Table 1.
Evaluation plan for the PULSAR Specialist Care study
| 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. | |||||||
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.