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

Abstract

BackgroundRecovery features strongly in Australian mental health policy; however, evidence is limited for the efficacy of recovery-oriented practice at the service level. This paper describes the Principles Unite Local Services Assisting Recovery (PULSAR) Specialist Care trial protocol for a recovery-oriented practice training intervention delivered to specialist mental health services staff. The primary aim is to evaluate whether adult consumers accessing services where staff have received the intervention report superior recovery outcomes compared to adult consumers accessing services where staff have not yet received the intervention. A qualitative sub-study aims to examine staff and consumer views on implementing recovery-oriented practice. A process evaluation sub-study aims to articulate important explanatory variables affecting the interventions rollout and outcomes.MethodsThe mixed methods design incorporates a two-step stepped-wedge cluster randomized controlled trial (cRCT) examining cross-sectional data from three phases, and nested qualitative and process evaluation sub-studies. Participating specialist mental health care services in Melbourne, Victoria are divided into 14 clusters with half randomly allocated to receive the staff training in year one and half in year two. Research participants are consumers aged 18–75 years who attended the cluster within a previous three-month period either at baseline, 12 (step 1) or 24 months (step 2). In the two nested sub-studies, participation extends to cluster staff. The primary outcome is the Questionnaire about the Process of Recovery collected from 756 consumers (252 each at baseline, step 1, step 2). Secondary and other outcomes measuring well-being, service satisfaction and health economic impact are collected from a subset of 252 consumers (63 at baseline; 126 at step 1; 63 at step 2) via interviews. Interview-based longitudinal data are also collected 12 months apart from 88 consumers with a psychotic disorder diagnosis (44 at baseline, step 1; 44 at step 1, step 2). cRCT data will be analyzed using multilevel mixed-effects modelling to account for clustering and some repeated measures, supplemented by thematic analysis of qualitative interview data. The process evaluation will draw on qualitative, quantitative and documentary data.DiscussionFindings will provide an evidence-base for the continued transformation of Australian mental health service frameworks toward recovery.Trial RegistrationAustralian and New Zealand Clinical Trial Registry: ACTRN12614000957695. Date registered: 8 September 2014.

REFOCUS-PULSAR Recovery-Oriented Practice Training in Adult Primary Mental Health Care: Exploratory Findings Including From a Pretest–Posttest Evaluation

“…This was a well-resourced project and we used many flexible strategies to support the engagement and recruitment efforts of GPs as described in the protocol paper. Nevertheless, the requirement for GPs to recruit patients for the trial, despite significant financial and practical support from project staff ( 19 ), was for the most part not something they were equipped to do effectively. Compounding this problem was the cross-sectional design.…”

“…To enable data analysis in the context of low response rates, the design was adjusted after the completion of participant recruitment as a pre- and post- intervention design by collapsing data from the three data collection points. In line with the original design ( 18 ) and with similar argument for this as set out in the specialist study design ( 15 , 19 ), the study employed cross-sectional data from different, anonymous, patient samples. We acknowledge this as an intrinsically inferior design to that planned and so frame the findings as exploratory ( 20 ).…”

“…The decision to amend the analysis design was made following the recommendation by the Research Module Committee at the end of data collection, and was confirmed by the Steering Committee and Principal investigator (GM). All adaptations to the study protocol were approved by the appropriate Module Committee governing the relevant aspect of the project [see “Study Leadership” section in protocol ( 19 )], received ethics' committee approval ( 18 ), were communicated to and endorsed by the funding body.…”

“…We refer to people who experience mental illness and engage with services as “consumers” ( 15 , 19 ) but in the Primary Care project described in this paper, the term “patient” will be used as more representative of regular usage in this context. The broader PULSAR research program was enhanced by consumer involvement from the outset (VE) and an overarching principle that all consumer data collection was overseen by consumer researchers.…”

“…The broader PULSAR research program was enhanced by consumer involvement from the outset (VE) and an overarching principle that all consumer data collection was overseen by consumer researchers. Study components were co-designed with a consumer academic (VE) and the involvement of the PULSAR Lived Experience Advisory Panel [LEAP; see Leadership structure ( 19 )]. The GP training was delivered by mental health clinicians, including experienced trainers from the study team, with co-delivery by consumer trainers.…”