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      The PULSAR primary care protocol: a stepped-wedge cluster randomized controlled trial to test a training intervention for general practitioners in recovery-oriented practice to optimize personal recovery in adult patients

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          Abstract

          Background

          General practitioners (GPs) in Australia play a central role in the delivery of mental health care. This article describes the PULSAR (Principles Unite Local Services Assisting Recovery) Primary Care protocol, a novel mixed methods evaluation of a training intervention for GPs in recovery-oriented practice. The aim of the intervention is to optimize personal recovery in patients consulting study GPs for mental health issues.

          Methods

          The intervention mixed methods design involves a stepped-wedge cluster randomized controlled trial testing the outcomes of training in recovery-oriented practice, together with an embedded qualitative study to identify the contextual enablers and challenges to implementing recovery-oriented practice. The project is conducted in Victoria, Australia between 2013 and 2017. Eighteen general practices and community health centers are randomly allocated to one of two steps (nine months apart) to start an intervention comprising GP training in the delivery of recovery-oriented practice. Data collection consists of cross-sectional surveys collected from patients of participating GPs at baseline, and again at the end of Steps 1 and 2. The primary outcome is improvement in personal recovery using responses to the Questionnaire about the Process of Recovery. Secondary outcomes are improvements in patient-rated measures of personal recovery and wellbeing, and of the recovery-oriented practice they have received, using the INSPIRE questionnaire, the Warwick-Edinburgh Mental Well-being Scale, and the Kessler Psychological Distress Scale. Participant data will be analyzed in the group that the cluster was assigned to at each study time point. Another per-protocol dataset will contain all data time-stamped according to the date of intervention received at each cluster site. Qualitative interviews with GPs and patients at three and nine months post-training will investigate experiences and challenges related to implementing recovery-oriented practice in primary care.

          Discussion

          Recovery-oriented practice is gaining increasing prominence in mental health service delivery and the outcomes of such an approach within the primary care sector for the first time will be evaluated in this project. If findings are positive, the intervention has the potential to extend recovery-oriented practice to GPs throughout the community.

          Trial registration

          Australian and New Zealand Clinical Trial Registry ( ACTRN12614001312639). Registered: 8 August 2014.

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          Most cited references36

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          Designing and conduction mixed methods research

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            Systematic review of stepped wedge cluster randomized trials shows that design is particularly used to evaluate interventions during routine implementation.

            To describe the application of the stepped wedge cluster randomized controlled trial (CRCT) design. Systematic review. We searched Medline, Embase, PsycINFO, HMIC, CINAHL, Cochrane Library, Web of Knowledge, and Current Controlled Trials Register for articles published up to January 2010. Stepped wedge CRCTs from all fields of research were included. Two authors independently reviewed and extracted data from the studies. Twenty-five studies were included in the review. Motivations for using the design included ethical, logistical, financial, social, and political acceptability and methodological reasons. Most studies were evaluating an intervention during routine implementation. For most of the included studies, there was also a belief or empirical evidence suggesting that the intervention would do more good than harm. There was variation in data analysis methods and insufficient quality of reporting. The stepped wedge CRCT design has been mainly used for evaluating interventions during routine implementation, particularly for interventions that have been shown to be effective in more controlled research settings, or where there is lack of evidence of effectiveness but there is a strong belief that they will do more good than harm. There is need for consistent data analysis and reporting. Copyright © 2011 Elsevier Inc. All rights reserved.
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              A Guide for applying a revised version of the PARIHS framework for implementation

              Background Based on a critical synthesis of literature on use of the Promoting Action on Research Implementation in Health Services (PARIHS) framework, revisions and a companion Guide were developed by a group of researchers independent of the original PARIHS team. The purpose of the Guide is to enhance and optimize efforts of researchers using PARIHS in implementation trials and evaluations. Methods Authors used a planned, structured process to organize and synthesize critiques, discussions, and potential recommendations for refinements of the PARIHS framework arising from a systematic review. Using a templated form, each author independently recorded key components for each reviewed paper; that is, study definitions, perceived strengths/limitations of PARIHS, other observations regarding key issues and recommendations regarding needed refinements. After reaching consensus on these key components, the authors summarized the information and developed the Guide. Results A number of revisions, perceived as consistent with the PARIHS framework's general nature and intent, are proposed. The related Guide is composed of a set of reference tools, provided in Additional files. Its core content is built upon the basic elements of PARIHS and current implementation science. Conclusions We invite researchers using PARIHS for targeted evidence-based practice (EBP) implementations with a strong task-orientation to use this Guide as a companion and to apply the revised framework prospectively and comprehensively. Researchers also are encouraged to evaluate its use relative to perceived strengths and issues. Such evaluations and critical reflections regarding PARIHS and our Guide could thereby promote the framework's continued evolution.
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                Author and article information

                Contributors
                joanne.enticott@monash.edu
                frances.shawyer@monash.edu
                lbrophy@unimelb.edu.au
                grant.russell@monash.edu
                ellie.fossey@monash.edu
                brett.inder@monash.edu
                danielle.mazza@monash.edu
                shiva.vasi@monash.edu
                penelopejune.weller@rmit.edu.au
                Elisabeth.WilsonEvered@vu.edu.au
                vrinda.edan@monash.edu
                graham.meadows@monash.edu
                Journal
                BMC Psychiatry
                BMC Psychiatry
                BMC Psychiatry
                BioMed Central (London )
                1471-244X
                20 December 2016
                20 December 2016
                2016
                : 16
                : 451
                Affiliations
                [1 ]Southern Synergy, Department of Psychiatry, Monash University, 126 Cleeland St, Dandenong, VIC Australia
                [2 ]Royal District Nursing Service Institute, 31 Alma Rd, St Kilda, VIC Australia
                [3 ]Mind Australia, Heidelberg, VIC Australia
                [4 ]Melbourne School of Population and Global Health, University of Melbourne, Parkville, VIC Australia
                [5 ]School of Primary Health Care, Monash University, Notting Hill Campus, Victoria, Australia
                [6 ]Southern Academic Primary Care Research Unit, Monash University, Notting Hill, Victoria, Australia
                [7 ]School of Primary Health Care, Monash University Peninsula Campus, Frankston, VIC Australia
                [8 ]Department of Econometrics and Business Statistics, Monash University, Melbourne, VIC Australia
                [9 ]Graduate School of Business and Law, RMIT University, Melbourne, VIC Australia
                [10 ]College of Business, Victoria University, Melbourne, VIC Australia
                [11 ]Monash Health, Melbourne, VIC Australia
                Article
                1153
                10.1186/s12888-016-1153-6
                5168875
                27998277
                9f7075b1-721c-4a61-933a-2a07b58a242b
                © The Author(s). 2016

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 16 November 2016
                : 1 December 2016
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/501100004752, State Government of Victoria;
                Award ID: MIRF 18
                Award Recipient :
                Categories
                Study Protocol
                Custom metadata
                © The Author(s) 2016

                Clinical Psychology & Psychiatry
                recovery,recovery-oriented practice,primary care,general practitioners,mental health,psychiatry,training,randomized controlled trial (rct),complex intervention

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