A phase 3 randomised double-blind placebo-controlled trial of mirtazapine as a pharmacotherapy for methamphetamine use disorder: a study protocol for the Tina Trial.

BACKGROUND: There are no approved pharmacotherapies for methamphetamine use disorder. Two preliminary phase 2 randomised controlled trials have found mirtazapine, a tetracyclic antidepressant, to be effective in reducing methamphetamine use. The proposed Tina Trial is the first phase 3 placebo-controlled randomised trial to examine the effectiveness and safety of mirtazapine as an outpatient pharmacotherapy for methamphetamine use disorder. METHODS: This is a multi-site phase 3 randomised, double-blind, placebo-controlled parallel trial. Participants are randomly allocated (1:1) to receive either mirtazapine (30 mg/day for 12 weeks) or matched placebo, delivered as a take-home medication. The target population is 340 people aged 18-65 years who have moderate to severe methamphetamine use disorder. The trial is being conducted through outpatient alcohol and other drug treatment clinics in Australia. The primary outcome is measured as self-reported days of methamphetamine use in the past 4 weeks at week 12. Secondary outcomes are methamphetamine-negative oral fluid samples, depressive symptoms, sleep quality, HIV risk behaviour and quality of life. Other outcomes include safety (adverse events), tolerability, and health service use. Medication adherence is being monitored using MEMS® Smart Caps fitted to medication bottles. DISCUSSION: This trial will provide information on the safety and effectiveness of mirtazapine as a pharmacotherapy for methamphetamine use disorder when delivered as an outpatient medication in routine clinical practice. If found to be safe and effective, this trial will support an application for methamphetamine use disorder to be included as a therapeutic indication for the prescription of mirtazapine. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry ACTRN12622000235707. Registered on February 9, 2022.

Feasibility and preliminary results of a call centre delivered continuing care intervention following residential alcohol and other drug treatment.

INTRODUCTION: To help reduce relapse rates following alcohol and other drug (AOD) treatment, continuing care interventions have been recommended. Previous continuing care interventions have incorporated telephone and face-to-face sessions to help promote participant engagement. The study was conducted as a randomised controlled feasibility study and examined a call centre delivered continuing care intervention for people leaving residential rehabilitation services. METHODS: Participants were attending AOD residential treatment services in NSW, Australia (N = 154). Participants were randomised to either 12- or 4-sessions of continuing care. Follow up assessments were completed at 6-months. The primary outcomes were demand and implementation. Secondary outcomes were AOD use, mental health and physical health at 6-months. RESULTS: Interest in continuing care was high, with 93% of participants approached reporting an interest in being involved. Of the participants who completed the consent and baseline procedures, 29% of people were contacted post residential treatment and randomised. For those people randomised, the average number of sessions completed was 2.78 (SD = 1.65) for the 4-session arm and 4.81 (SD = 4.46) for the 12-session arm. Fidelity to the treatment manual was high. Both treatment arms showed higher complete abstinence at 6-months compared to baseline (12-session OR 28.57 [2.3, 353.8]; 4-session OR 28.11 [3.6, 221.2]). DISCUSSION AND CONCLUSIONS: A major challenge associated with the call centre approach was re-engaging participants once they left the residential facility and delivering the planned dose of treatment. Further work is required to promote greater uptake of these protocols once people leave residential treatment.

A Qualitative Study Exploring the Benefits and Challenges of Implementing Client Centred Care (CCC) in an Alcohol and Other Drug Treatment Service.

Objective: Client centered care (CCC) is strongly advocated for improving the quality of health care. The aim of the current study was to explore client and staff perspectives of a new model of CCC implemented in a residential alcohol and other drug (AOD) treatment service. Specifically, the study aimed to (i) describe the defining features of CCC, and (ii) describe the benefits and challenges of implementing CCC at the service. Methods: Participants were 18 clients and eight staff who took part in focus groups and interviews. Thematic analysis of four client focus groups and eight staff individual interviews was conducted. Results: Staff identified the defining features of CCC as flexible, comprehensive, open-minded, and inclusive. Clients and staff shared predominantly positive views on the CCC model. Shared themes included the challenge of balancing flexibility and structure, and delivering comprehensive and individualized care within the limits of staff knowledge, skills, and resources. Conclusions: Results suggest that implementing CCC across an AOD treatment setting has clear benefits to staff and clients, along with challenges that require careful consideration and planning. Future research should evaluate the effectiveness of providing guidelines that address many of the challenges associated with implementing CCC.

Health literacy and healthcare service utilisation in the 12-months prior to entry into residential alcohol and other drug treatment.

INTRODUCTION: Health literacy refers to an individual's capacity to gather, process and understand health information, make appropriate health decisions, and engage adequately with healthcare services. Inadequate health literacy has been linked to an increase in acute healthcare utilisation. Research suggests that people living with substance use disorders also access acute healthcare services at high rates. The study investigates whether overall health literacy is related to this population's use of general healthcare services. METHODS: A total of 568 participants were recruited from residential substance use treatment services located in NSW, Australia, as part of a randomised controlled trial; the Continuing Care Project. All participants completed a face-to face baseline questionnaire, which included the Health Literacy Questionnaire; a measure of multidimensional health literacy. Latent profile analysis was used to examine health literacy profiles, with multinominal regression analysis examining if healthcare service utilisation was related to these profiles. RESULTS: Three profiles of health literacy were identified and termed lowest (n = 86, 15.1%), moderate (n = 338, 59.5%) and highest health literacy (n = 144, 25.4%). The sample accessed both primary and acute healthcare services at high rates. When controlling for demographic variables, there were no significant differences identified between health literacy profiles and service use. DISCUSSION/CONCLUSIONS: This study was the first to use a multidimensional health literacy tool to examine health literacy and general healthcare service utilisation for people attending residential substance use disorder treatment. This population access high levels of healthcare services, however the role that health literacy may play in helping reduce acute healthcare use requires further investigation.

Predictors of consent and engagement to participate in telephone delivered continuing care following specialist residential alcohol and other drug treatment.

INTRODUCTION AND AIMS: Although continuing care programs have been shown to improve alcohol and other drug (AOD) treatment outcomes, uptake of continuing care has been low. The current study aimed to determine predictors of participants' who both re-confirmed consent to engage in telephone-based continuing care and commenced continuing care once they left residential AOD treatment. These participants had initially consented to partake in continuing care during the course of their residential stay. METHODS: Participants were 391 individuals (232 males, 59% and 158 females, 40%) accessing therapeutic communities for AOD treatment provided by The Australian Salvation Army and We Help Ourselves (WHOS). Measures at baseline, collected during residential treatment, included demographics, primary substance of concern, abstinence goal, refusal self-efficacy, cravings for substances, mental health diagnoses, psychological distress, quality of life and feelings of loneliness. All measures were used as predictor variables to determine characteristics of participants who re-confirmed consent to engage in continuing care and commenced continuing care following residential AOD treatment. RESULTS: Completing residential treatment, being unmarried, and higher levels of loneliness predicted re-confirmation of consent to participate in continuing care following discharge from residential treatment. Participants who were Aboriginal and/or Torres Strait Islander were less likely to provide re-confirmation of consent. Participants were more likely to commence continuing care if they completed residential treatment, were older, and had longer years of substance use. CONCLUSIONS: Tailoring continuing care programs to reach a broader array of individuals such as Indigenous populations and persons who exit treatment services early is needed to ensure these programs can reach all individuals who might need them.

Health literacy of people living with mental illness or substance use disorders: A systematic review.

AIM: Health literacy is one's ability to use cognitive and social skills to access, understand and appraise health information. Despite poor health outcomes of people living with mental illness there is limited research assessing their health literacy. This systematic review aims to synthesise research on health literacy rates, conceptualizations, and outcomes of people living with mental illness, including substance use disorders. This will provide insights into how health literacy might be targeted to reduce these health inequities. METHODS: A search of published literature in multiple databases up until February 2019 was conducted. One reviewer screened the titles, abstracts and keywords of identified publications and the eligibility of all full-text publications were assessed for inclusion along with a second reviewer. Both reviewers independently rated the quality of the included studies. RESULTS: Fourteen studies were included in the review. Rates and measures of health literacy varied. Low health literacy and health literacy weaknesses were identified. There is a lack of research on the relationship between health literacy and other outcomes, particularly health service engagement. CONCLUSION: The review highlights the high rates of low health literacy within this population compared with general populations. Most studies used a functional health literacy measure, despite its limitations, with only a few using multidimensional measures. Overall, there is limited research examining the impact that this populations health literacy has on their recovery and how it affects them over time. The review emphasizes the importance of practitioners assessing and targeting health literacy needs when working with this population.

Correction to: Study protocol the Continuing Care Project: a randomised controlled trial of a continuing care telephone intervention following residential substance dependence treatment.

It was highlighted that in the original article [1] author Amanda Baker was erroneously omitted from the authorship during the copy editing stage.

Study protocol the Continuing Care Project: a randomised controlled trial of a continuing care telephone intervention following residential substance dependence treatment.

BACKGROUND: A priority area in the field of substance dependence treatment is reducing the rates of relapse. Previous research has demonstrated that telephone delivered continuing care interventions are both clinically and cost effective when delivered as a component of outpatient treatment. This protocol describes a NSW Health funded study that assesses the effectiveness of delivering a telephone delivered continuing care intervention for people leaving residential substance treatment in Australia. METHODS/DESIGN: All participants will be attending residential alcohol and other drug treatment provided by The Salvation Army or We Help Ourselves. The study will be conducted as a randomised controlled trial, where participants will be randomised to one of three treatment arms. The treatment arms will be: (i) 12-session continuing care telephone intervention; (ii) 4-session continuing care telephone intervention, or (iii) continuing care plan only. Baseline assessment batteries and development of the participants' continuing care plan will be completed prior to participants being randomised to a treatment condition. Research staff blind to the treatment condition will complete follow-up assessments with participants at 3-months and 6-months after they have been discharged from their residential service. DISCUSSION: This study will provide comprehensive data on the effect of delivering the continuing care intervention for people exiting residential alcohol and other drug treatment. If shown to be effective, this intervention can be disseminated to improve the rates of relapse among people leaving residential alcohol and other drug treatment. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, ACTRN12618001231235. Registered on 23rd July 2018. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=375621&isReview=true.

The relationship between patient-centered care and outcomes in specialist drug and alcohol treatment: A systematic literature review.

Background: Patient-centered care is strongly advocated as a key for improving the quality of healthcare. Research examining the impact of patient-centered care in healthcare has concluded that there are demonstrable albeit inconsistent relationships between patient experience, quality of care, and healthcare outcomes. Knowledge of the impact of patient-centered care in the treatment of substance use disorder is limited. The aim of this review was to assess relationships between indicators of patient-centered care (satisfaction and patient-reported experience measures) and patient outcomes (substance use, psychological wellbeing, and service use) among people attending treatment for substance use disorder. Methods: A systematic electronic literature search of a range of databases was conducted with variations of the search terms 'patient-centered care', 'substance use disorders', and residential or community specialist 'treatment'. The populations, interventions and outcomes were summarized and described according to the PRISMA statement. Results: A total of 25 articles were identified, of which only five included a patient-centered indicator other than satisfaction. Indicators of patient-centered care showed a generally positive association with improved outcomes, particularly between satisfaction with treatment and substance use. Nonetheless, mixed and contradictory results were not uncommon, more so for psychological wellbeing outcomes. Conclusions: There were demonstrable relationships between patient-centered indicators and outcomes for people receiving treatment for substance use disorder. However, conclusions are limited due to underrepresentation of patient-reported experience measures. Further research in the area is needed involving comparisons of patient centered indicators with outcomes and use of patient-reported experience measures together with satisfaction. Registration number: CRD42018092829.

Health literacy in people living with mental illness: A latent profile analysis.

Health literacy comprises cognitive and social skills that enable people to understand health information and maintain good health. Research examining the health literacy of people living with mental illness is scarce. The aim of the present study was to identify distinct subgroups of health literacy in individuals attending mental health treatment and determine if profiles and health literacy levels differ from other populations accessing healthcare services and on health characteristics. Participants (N = 325) were attending Neami National Australia services. Participants completed the multidimensional Health Literacy Questionnaire. Latent profile analysis was conducted to identify health literacy profiles. Participants reported lowest health literacy scores in appraising health information, navigating the healthcare system, and finding good health information. Three health literacy profiles were identified; low (20.4%), moderate (61.3%), and high (18.3%). Compared to the other populations (i.e. private hospital patients, men with prostate cancer, older individuals with diabetes, general population, people attending substance dependence treatment), the current sample tended to have lower health literacy scores. The findings highlight the need to increase overall health literacy and consider an individualised approach to enhance specific health literacy domains.

Health literacy in substance use disorder treatment: A latent profile analysis.

INTRODUCTION AND AIMS: Health literacy refers to the degree to which people can access and understand health information, as well as communicate their health needs to service providers. Whilst health literacy is increasingly being examined within general community samples, there is limited research focused on substance use disorders where the need for health literacy is likely to be high. The aim of this study was to examine the health literacy profiles of people attending substance use disorder treatment and to examine how these profiles were related to measures of quality of life, mental health, and physical health. DESIGN AND METHODS: Participants were attending specialist non-government substance use disorder treatment across New South Wales, Queensland, and the Australia Capital Territory, Australia (N = 298). Participants completed the Health Literacy Questionnaire, a multi-dimensional measure of health literacy. Latent profile analysis was conducted to identify profiles of health literacy within the sample. RESULTS: Three distinct health literacy profiles were identified, and termed low (24.2%), moderate (62.8%) and high health literacy (13.1%). Participants with lower levels of health literacy had lower levels of social support in their home environment outside of treatment, as well as lower levels of quality of life, higher levels of psychological distress, and poorer mental health. There was no difference between the three profiles on measures of physical health. DISCUSSION AND CONCLUSION: The current study found that low to moderate health literacy levels were common for those attending residential substance abuse treatment. Participants with lower health literacy tended to have poorer quality of life and mental health. Future research should examine strategies to improve health literacy amongst people attending alcohol and other drug treatment. It may also be useful for service providers to consider ways to minimise the impact of low health literacy on the health needs and outcomes of this vulnerable population.