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Abstract
Introduction Assertive Community Treatment (ACT), which was developed in the 1970s in the USA, is a programme that supports people with severe mental illness living in the community through a multidisciplinary team, individual care and outreach approach. It is widely known that ACT effectively decreases hospital stays and improves Global Assessment of Functioning scores. In Japan, empirical studies on ACT were conducted in the late 2000s. Through the introduction of the standardised programme and domestic network, its implementation nationwide was anticipated. However, to date, the implementation of ACT is limited. There has been no comprehensive research in Japan on what inhibits and promotes the implementation of ACT in community mental health settings. Therefore, in this study, we aimed to systematically and comprehensively investigate the factors influencing the implementation of ACT in Japan using implementation research.
Methods and analysis A qualitative study will be conducted using semistructured interviews with key stakeholders in the ACT team. Interviews will be conducted face-to-face or online, using an interview guide. The inclusion criteria are present and past ACT teams. Recruitment will be in two steps. A preinterview questionnaire will be sent to the members of the Community Mental Health Outreach Association regarding their basic characteristics and fidelity to the ACT model, and purposive sampling will be performed based on it. The Consolidated Framework for Implementation Research will be used to collect and analyse the interview data according to the qualitative content analysis, with reference to the fidelity category, because this will help to find influencing factors by identifying constructs that appear to distinguish between high-fidelity and low-fidelity teams.
Ethics and dissemination This study has been approved by the Tokyo Medical University Ethics Approval Committee (approval number: T2022-0175). The findings will be shared via peer-reviewed journal publications and presentations to policymakers and service users.
- Implementation Science
- MENTAL HEALTH
- Health Services
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STRENGTHS AND LIMITATIONS OF THIS STUDY
The Consolidated Framework for Implementation Research (CFIR) will promote a systematic and comprehensive investigation of factors affecting the implementation of this intervention and contribute to generalisation of the results.
Analysing data from both the high-fidelity and low-fidelity teams will help to clarify both facilitating and inhibiting factors.
Assertive Community Treatment (ACT) teams/ex-ACT teams belonging to the Community Mental Health Outreach Association will be recruited, so teams that have withdrawn from the association may be missed.
Introduction
In Japan, the government has been working to transition from a hospital-centred mental care system to a community-based mental care system. The reform has started with the governmental scheme of the mental healthcare system, ‘Vision for the Reform of Mental Health and Medical Welfare’, launched in 2004,1 followed by various strategies, such as the functional differentiation of psychiatric hospital beds and the promotion of comprehensive community care in municipalities, towards the integration of medical and welfare care. However, at present in Japan, sufficient community-care services are not available for all patients with severe mental illness. There are also still cases of hospital admission of psychiatric patients owing to the lack of social support.
Development and evidence of Assertive Community Treatment (ACT)
In the 1970s, the ACT programme, a multidisciplinary team-based outreach approach, was developed based on case management in the USA.2 3 This programme supports people with severe mental illness living in the community2 3 and is widely implemented in the USA and countries in Western Europe. In the background of this development, there has been an increasing need for an enhanced risk management system in the community under the deinstitutionalisation movement.4 Various lines of evidence have demonstrated the effectiveness of ACT, such as the Cochrane Review published in 2017, showing a reduction in hospital stays and an improvement in Global Assessment of Functioning (GAF) scores in individuals with severe mental illness during a 2-year period.5
Evidence practice gap of ACT in Japan
Japan has the largest number of psychiatric beds in the world6 due to a rapid increase in the number of psychiatric beds, mainly in private hospitals, resulting from the frequent involuntary admission of psychiatric patients and the enactment of a discriminatory ordinance towards psychiatric wards by the Ministry of Health, Labour and Welfare (MHLW).7 Consequently, welfare support in the community for people with severe mental illness is insufficient, and they often require frequent or lengthy hospitalisations. The ACT programme was introduced in Japan as a research project in 20018 and the standardised programme for Japanese setting (ACT-J standards V.3.0) was developed.9 An empirical study was conducted in Ichikawa City, Chiba Prefecture comparing ACT and the usual hospital-based rehabilitation programme for people with severe psychiatric disorders.10 The study indicates the potentially promising effects on reducing hospitalisation days, although multivariate analysis adjusting for baseline variables did not demonstrate a significant difference in this outcome between the groups.
In 2009, the MHLW started discussing official legislation of ACT and care management with the mental health and welfare committee.11 In the same year, a domestic network, ‘The Association for Community Mental Health Outreach’, was launched to promote the dissemination and implementation of ACT throughout Japan. Following these events, ACT teams were established in various regions.12 They were featured as change makers to enhance the transition from hospital-centred care to a community-based mental healthcare system. However, the number of ACT teams in Japan remains only about 40, less than 3.4% of the number of teams needed based on a population-estimating study.13
Factors affecting the implementation of ACT
Evidence is limited regarding the factors affecting the implementation of ACT. In 2018, Bergmark conducted a qualitative study on the implementation process of ACT in Sweden, using the Framework for Community Mental Health Services, to identify factors that promote and inhibit ACT implementation. The facilitating factors were careful preparation, characteristics of the team members and the effort by the team leader and steering group.14 The inhibiting factors were the involved authorities having conflicting goals and mismatches between the characteristics of the ACT model and traditions and regulations of the organisation.14 In 2019, Odden investigated team members’ perceptions of ACT after its implementation in Norway. The study demonstrated that members found some parts of the ACT model difficult to implement, and it was challenging to find efficient ways to collaborate with current health and social services.15 Regarding Japan, Aikawa discussed the factors associated with the practice of psychiatric outreach intervention based on the current medical care system and pointed out ethical dilemmas on informed consent, overtreatment, the protection of privacy and resource allocation in mental healthcare.16 Thus, the implementation of ACT is influenced by different factors on different levels. However, these factors have not been analysed comprehensively. Therefore, the purpose of this study is to identify factors on multiple levels that prevent the sufficient implementation of ACT despite its proven effectiveness, and the factors that will promote its implementation. Furthermore, we aim to suggest future implications to Japanese community mental health.
Our challenge using implementation research
We will attempt to fulfil our above purpose using implementation research. Implementation research is an area of research that investigates methods to quickly apply evidence obtained through research to health policies and activities in practice. Theories, models and frameworks (TMFs) used in implementation research provide a systematic structure for developing, managing and evaluating interventions by linking research objectives, designs, measures and implementation strategies.17 Various TMFs are devised for different purposes. In this study, we will use the Consolidated Framework for Implementation Research (CFIR), which is the framework established to identify multilevel factors affecting the implementation of targeted interventions.18
Aims of the study
We aim to comprehensively and systematically identify factors influencing the implementation of ACT using CFIR. We define the ACT-J standards V.3.09 12 as a targeted, evidence-based intervention in this study.
Methods and analysis
A qualitative study using semistructured interviews with key stakeholders, such as the team leader and psychiatrist in ACT teams, will be conducted. Teams that began implementing the ACT and are continuing, suspended or have already discontinued its implementation will be included. Facilities that are preparing to implement the ACT, are implementing other outreach interventions only, or are only collaborating with ACT teams will be excluded. Interview-based data will be collected and analysed using CFIR. This framework consists of 39 constructs organised into the following five domains: intervention characteristics, outer setting, inner setting, characteristics of the individuals and process.18 Such multilevel constructs are designed to enable effective implementation and can be used to identify how evidence-based intervention works across multiple contexts.18
Preinterview questionnaires
Recruitment will be performed in two steps. The first step is a preinterview questionnaire to screen teams that meet our inclusion criteria, and the second step is purposive sampling. Preinterview questionnaires will be sent to the Community Mental Health Outreach Association, which is a network mainly consisting of 40 facilities, including present and past ACT teams, facilities preparing for ACT implementation, and facilities that are collaborating with ACT teams. Information on the basic characteristics of the team and their fidelity to the ACT will be collected through the questionnaires (table 1). In implementation studies, fidelity is known as an important implementation outcome, which is known to be a key intermediate outcome associated with the service system or clinical outcomes in treatment effectiveness and quality of care research.19 A previous review demonstrated that intensive case management models with high fidelity to the original team organisation of the ACT model are effective for reducing time in hospital.5 20 The fidelity items are chosen based on the ACT-J standards V.3.0 at the staff and team structure section, such as small caseload; team approach; psychiatrist on staff; nurse on staff, and service content section, such as services based on the community.9 This is because these items are regarded as the minimum requirement of ACT in Japan.
Preinterview questionnaire
Sampling
A total of 40 interviews are planned from 20 teams. For the purpose of capturing different experiences and perspectives, maximum variation sampling will be used as the purposive sampling method. Regarding the teams that meet the inclusion criteria, the main areas of focus will be management organisation type and fidelity (high or low), and one or two out of available combinations will be chosen. Criteria for high-fidelity are as follows: (1) the caseload of each team is less than 10 patients, (2) the team’s activities are based within the community, (3) the team consists of multidisciplinary members, (4) a psychiatrist is included in the team, (5) a nurse is included in the team and (6) ACT implementation status is ‘ongoing’. In order to be considered high fidelity, all six criteria must be met. We presume that the teams classified as low fidelity will be either teams that used to implement ACT but intentionally shifted their style to other outreach intervention for some reason or teams that intend to implement ACT but whose fidelity remains low.
Semistructured interviews
Interview guides have been drafted based on CFIR. They consist of open-ended questions covering each domain (the process and the context within which ACT is implemented) and probing questions associated with each construct for identifying barriers and facilitators. We excluded the individual characteristics domain from the interview guides owing to advice received from the developer of CFIR.18 The draft of the interview guide was amended after pilot interviews. Example of probing questions associated with the corresponding CFIR constructs are listed. The revised interview guides are shown in online supplemental file 1. When we use the interview guide, we will use table 2 as the checklist to make sure all the constructs of CFIR are covered.
Supplemental material
Example of probing questions associated with the corresponding CFIR constructs
Interviews will be conducted by MY (MA, RN, CP), either face-to-face or online via Zoom (Zoom Video Communications, San Jose, California, USA). MH (DPH, MD, principal investigator) or JI (PhD, MD) will also attend the interviews. MY and JI are specialists in psychiatric outreach services. MH is a psychiatrist and the implementation science researcher.
The interviews will last 60–90 min. During the actual interviews, we will first introduce the purpose of the interview. To consider potential effects on the participants’ emotional aspects, it will be explained that participants can refuse to answer any of the items that they are not comfortable answering. We will obtain verbal and written consent for participation from each participant.
After obtaining the participant’s permission, we will audio record the interview. In the end, the interviewers and the participating researcher will briefly review the interview and discuss their concerns. A gift card of 5000 yen will be given to each interviewee as compensation for the interview. A transcript of the audio recordings will be created, with the names of teams and participants removed. Researchers will check the accuracy of the transcripts by comparing them to the audio recorded data. Unclear statements and statements that threaten participant anonymity will be checked and revised with the interviewee or researchers who attended the interview.
Analysis
We plan to perform qualitative content analysis.21 The data will be analysed in accordance with previous studies.22–24 In the process of data interpretation, we will refer to the fidelity category of the teams because it will help to find influencing factors by identifying constructs that appear to distinguish between the high-fidelity and low-fidelity teams.24 25 If the direction of influence of a factor that many high-fidelity teams refer to is diametrically opposite to that of the low-fidelity teams, this can be considered a common and important influencing factor for ACT. MY and MH will be the coders. AY-S and JI will supervise the analysis process. The analysis will be performed in the following four steps. Before analysing the data, all researchers will carefully study the content of the data. First, a codebook will be created using data from the first two teams. For each relevant transcript section, a corresponding CFIR construct will be deduced and labelled by each independent coder. The section will be open-coded and tagged if an adaptable code is unclear. Researchers will collate, discuss and integrate the results of the two coders and temporarily define each construct in this study’s context. Second, the remaining transcripts will be coded. Coders will independently code each transcript according to the definitions in the codebook. For each team, the results of the codes will be compared, discussed and integrated into a summary note together with the constructs of the CFIR. The codebook will be supplemented and revised along with the analysis. Third, the data will be analysed using the qualitative data software package NVivo V.14 software (QSR International, Melbourne, Australia) to identify similar descriptions in each construct without being missed and included in the summary note. Sections that cannot be coded using existing constructs will be coded inductively, in which researchers will create a new construct. Lastly, researchers and ACT team members will refer to the summary notes and discuss and conclude on facilitating and inhibiting factors.
Study period
The project is expected to be carried out from July 2023 to March 2026, including recruitment, interview, analysis and paper drafting. Online supplemental file 2 outlines the study period and timeline of each process. The first interview was conducted on 14 October 2023. The analysis is expected to be finished on 30 September 2025.
Supplemental material
Patient and public involvement
The patients and the public were not involved in the design of this protocol.
Ethics and dissemination
The Tokyo Medical University Ethics Approval Committee has approved this study protocol (study approval number: T2022-0175). Considering the small number of ACT clinicians in Japan, it is important to account for the anonymity of the interviewees. We will tackle this issue in four ways, as follows. First, we will remove the teams’ and interviewees’ names from the transcripts. Second, we will check and revise statements in the transcripts that threaten the anonymity of the interviewee who attended the interview. Third, when we draft manuscripts, we will anonymise the team and interviewees by labelling quotes based on the team (alphabetically anonymised), the fidelity category (high-fidelity/ low-fidelity), and the respondent (numerically anonymised). We will not disclose any other information regarding the quoted respondents. Lastly, when we obtain verbal and written consent for participation from participants, we will explain the risk of identification based on their comments due to the small number of ACT teams, and these strategies to tackle this issue. Participation in this study will be voluntary, and interviews will be administered only to those who consent verbally and in writing.
Dissemination of the study findings
Our report will comply with the standards for reporting qualitative research.26 We will share the results of this research through publications in peer-reviewed journals and presentations and panel discussions with the service-users, academia, policymakers and clinicians at scientific conferences.
Ethics statements
Patient consent for publication
Acknowledgments
We are grateful to the interviewees who will dedicate their time to our interviews and share their valuable experiences. We also want to thank the National Center Consortium in Implementation Science for Health Equity (N-EQUITY) for guidance on implementation research.
Supplementary materials
Supplementary Data
This web only file has been produced by the BMJ Publishing Group from an electronic file supplied by the author(s) and has not been edited for content.
Footnotes
Contributors MH and MY conceived the study. MY, MH, JI and AY-S contributed significantly to the study design. MH drafted the paper. MH, MY, JI and AY-S revised the paper critically for important intellectual content. All authors approved the final version of the manuscript. All authors have agreed to be in charge of every aspect of the work and have ensured that questions associated with the accuracy or integrity of every part of the work will be thoroughly examined and resolved. MH is the guarantor.
Funding This work is funded by the Ministry of Education, Culture, Sports, Science and Technology (KAKENHI grant numbers 20K18897 and 24K13325) to MH. The funding agency has no role in the design and administration of the research; data collection, management, analysis, or interpretation of the data; draft, review or approval of the manuscript; or decision to submit to the journal for publication.
Competing interests None declared.
Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting or dissemination plans of this research.
Provenance and peer review Not commissioned; externally peer reviewed.
Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.