Literature Collection

BACKGROUND: Black women are significantly more likely to experience severe maternal morbidity and are 3 times as likely to die from pregnancy-related causes compared to White women. Using a strengths-based wellness approach within an integrated supportive care program provided by a community doula could offer pragmatic solutions for Black maternal disparities. The Protective Assets Reinforced with Integrated Care and Technology (PARITY) program consists of a wellness technology platform, including informational links to wellness content and reinforcing motivational SMS text messages, as well as community-based doula support delivered both in person and through the technology platform to improve Black maternal wellness. OBJECTIVE: This pilot randomized controlled trial (RCT) and mixed methods evaluation aims to (1) determine the feasibility and acceptability of the PARITY intervention; (2) investigate the preliminary efficacy of the PARITY intervention on clinical outcomes (maternal blood pressure, gestational weight gain, and cesarean birth); and (3) investigate changes to wellness behavioral outcomes (nutrition, physical activity, sleep, and health care adherence) and empowered strengths (self-efficacy, social support, motivation, resilience, problem-solving, and self-regulation) in the intervention group compared to a control group. METHODS: A 2-arm RCT and mixed methods evaluation will be conducted. Overall, 60 Black pregnant individuals will be randomized in a ratio of 1:1 to either the intervention or informational control group. Participants in the intervention group will receive access to the technology platform over a 12-week period that ends before birth. Intervention participants will be assigned a doula interventionist, who will meet with them 4 times during the intervention. All participants (intervention and control) will receive a referral for a birth doula at no cost, printed materials about having a healthy pregnancy, and community resources. Feasibility and acceptability will be assessed at the end of the program. Measures will be obtained at baseline (20-28 weeks), the 36th week of pregnancy, birth, and 6-12 weeks post partum. Summary statistics and distribution plots will be used to describe measured variables at each time point. A generalized linear mixed model with a shared random component will be used to analyze the effects of PARITY on clinical, wellness behavioral, and empowered strength outcomes, including baseline nutrition, physical activity, and sleep measures as covariates. For significant effects, post hoc contrasts will be adjusted using the Holm method to maintain comparison-wise error at or <.05. Missing data will be addressed using a pattern-mixture model. RESULTS: The National Institute of Nursing Research funded this pilot RCT. Recruitment, enrollment, and data collection are ongoing, and the estimated study completion date is October 2024. CONCLUSIONS: The expected results of this study will provide the feasibility and preliminary efficacy of the PARITY intervention, to be used in a larger trial with a 12-month PARITY program intervention. TRIAL REGISTRATION: ClinicalTrials.gov NCT05802615; https://clinicaltrials.gov/study/NCT05802615. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/58580.

INTRODUCTION: Depressive disorders in adolescents are highly prevalent and debilitating and are a risk factor for self-harm and death by suicide. In the context of recovery from the COVID-19 pandemic, strained healthcare resources are compounded by an increased demand for treatment services for adolescents with depression. The objective of this study protocol is to delineate the proposed economic evaluation of an integrated care pathway for depression in adolescents within the Care for Adolescents who Received Information 'Bout Outcomes, 2nd iteration (CARIBOU-2) non-randomised, cluster-controlled trial. METHODS AND ANALYSIS: Two economic evaluations of the CARIBOU-2 trial (n=300) will be conducted-a cost-effectiveness analysis and a cost-utility analysis. In the cost-effectiveness analysis, we will examine the primary clinical outcome of the trial, change in the Mood and Feelings Questionnaire total score. In the cost-utility analysis, the clinical outcome will be quality-adjusted life-years, a generic measure of health burden. Data on the resources and respective costs required to deliver the intervention will be collected by the research team. Data on resource use post-intervention will be obtained from a mix of administrative data holdings and self-report; relevant unit costs will be obtained from existing data sources. The outcome of both economic evaluations will be the incremental cost-effectiveness ratio. Relevant sensitivity analyses will be undertaken, and cost-effectiveness acceptability curves will be produced to characterise any sources of uncertainty in the analysis. Equity considerations will also be examined, where relevant. ETHICS AND DISSEMINATION: Ethical approval for the larger CARIBOU-2 trial, including the economic evaluation, has been obtained by the Centre for Addiction and Mental Health as well as site-level ethics boards (019/2021; Centre for Addiction and Mental Health). All participants will provide informed consent for their data to be analysed and reported. The results of the main trial and the economic evaluation will be submitted for publication in a peer-reviewed journal and shared with relevant policy makers across Canada. TRIAL REGISTRATION NUMBER: NCT05142683.

With overdose deaths increasing, improving access to harm reduction and low barrier substance use disorder treatment is more important than ever. The Community Care in Reach(®) model uses a mobile unit to bring both harm reduction and clinical care for addiction to people experiencing barriers to office-based care. These mobile units provide many resources and services to people who use drugs, including safer consumption supplies, naloxone, medication for substance use disorder treatment, and a wide range of primary and preventative care. This protocol outlines the evaluation plan for the Community in Care(®) model in MA, USA. Using the RE-AIM framework, this evaluation will assess how mobile services engage new and underserved communities in addiction services and primary and preventative care.