Implementation of Community Health Worker Support for Tobacco Cessation: A Mixed-Methods Study.

Objective: Adults with serious mental illness have high tobacco use disorder rates and underutilization of first-line tobacco cessation pharmacotherapy. In a randomized trial, participants offered community health worker (CHW) support and primary care provider (PCP) education had higher tobacco abstinence rates at two years, partly through increased tobacco cessation pharmacotherapy initiation. This study determined the association between participant-CHW engagement and tobacco abstinence outcomes. Methods: This was a secondary, mixed-methods analysis of 196 participants in the trial's intervention arm. Effects of CHW visit number and duration, CHW co-led smoking cessation group sessions attended, and CHW-attended PCP visit number on tobacco use disorder pharmacotherapy initiation and tobacco abstinence were modeled using logistic regression. Interviews with 12 CHWs, 16 participants, and 17 PCPs were analyzed thematically. Results: Year-two tobacco abstinence was associated with CHW visit number (OR=1.85, 95% CI=[1.29, 2.66]) and duration (OR=1.85, 95% CI=[1.33, 2.58]) and number of groups attended (OR=1.51, 95% CI=[1.00, 2.28]); effects on pharmacotherapy initiation were similar. 1-3 CHW visits per month over two years was optimal for achieving abstinence. Interviews identified engagement facilitators, including CHWs establishing trust, providing goal accountability, skills reinforcement, and assistance overcoming barriers to treatment access and adherence related to social determinants of health and illness factors. Robust training and supervision facilitated CHW effectiveness. Barriers included PCPs' and care teams' limited understanding of the CHW role. Conclusions: Feasible CHW engagement was associated with tobacco abstinence in adults with serious mental illness. CHW implementation may benefit from promoting CHW training and integration within clinical teams.

A Pragmatic Cluster-Randomized Trial of Provider Education and Community Health Worker Support for Tobacco Cessation.

OBJECTIVE: Individuals with serious mental illness have a high prevalence of tobacco use disorder and related early mortality but underutilize smoking cessation medication. The authors determined whether clinician-delivered education to primary care providers regarding safety, efficacy, and importance of cessation medication (provider education [PE]) alone or combined with community health worker (CHW) support would increase tobacco abstinence in this population, compared with usual care. METHODS: All adult current tobacco smokers receiving psychiatric rehabilitation for serious mental illness through two community agencies in Greater Boston were eligible, regardless of readiness to quit smoking. Primary care clinics were cluster randomized to PE or usual care, with a nested, participant-level randomization to CHW or no CHW in PE-assigned clinics. The primary outcome was blindly assessed, biochemically verified tobacco abstinence at year 2. RESULTS: Overall, 1,010 eligible participants were enrolled. PE was delivered to providers in 53 of 55 assigned clinics; 220 of 336 CHW-assigned participants consented to CHW support. Year 2 abstinence rates were significantly higher among participants assigned to PE+CHW versus usual care (12% vs. 5%; adjusted odds ratio [AOR]=2.40, 95% confidence interval [CI]=1.20-4.79) or PE alone (12% vs. 7%; AOR=1.84, 95% CI=1.04-3.24). No effect of PE alone on abstinence was detected. Compared with participants assigned to usual care, those assigned to PE+CHW had greater odds of varenicline use (OR=2.77, 95% CI=1.61-4.75), which was associated with higher year 2 abstinence (OR=1.97, 95% CI=1.16-3.33). CONCLUSIONS: Combined PE and CHW tobacco cessation support increased tobacco abstinence rates among adults with serious mental illness.

Study protocol for a phase II, double-blind, randomised controlled trial of cannabidiol (CBD) compared with placebo for reduction of brain neuroinflammation in adults with chronic low back pain.

INTRODUCTION: Chronic pain is a debilitating medical problem that is difficult to treat. Neuroinflammatory pathways have emerged as a potential therapeutic target, as preclinical studies have demonstrated that glial cells and neuroglial interactions play a role in the establishment and maintenance of pain. Recently, we used positron emission tomography (PET) to demonstrate increased levels of 18 kDa translocator protein (TSPO) binding, a marker of glial activation, in patients with chronic low back pain (cLBP). Cannabidiol (CBD) is a glial inhibitor in animal models, but studies have not assessed whether CBD reduces neuroinflammation in humans. The principal aim of this trial is to evaluate whether CBD, compared with placebo, affects neuroinflammation, as measured by TSPO levels. METHODS AND ANALYSIS: This is a double-blind, randomised, placebo-controlled, phase II clinical trial. Eighty adults (aged 18-75) with cLBP for >6 months will be randomised to either an FDA-approved CBD medication (Epidiolex) or matching placebo for 4 weeks using a dose-escalation design. All participants will undergo integrated PET/MRI at baseline and after 4 weeks of treatment to evaluate neuroinflammation using [11C]PBR28, a second-generation radioligand for TSPO. Our primary hypothesis is that participants randomised to CBD will demonstrate larger reductions in thalamic [11C]PBR28 signal compared with those receiving placebo. We will also assess the effect of CBD on (1) [11C]PBR28 signal from limbic regions, which our prior work has linked to depressive symptoms and (2) striatal activation in response to a reward task. Additionally, we will evaluate self-report measures of cLBP intensity and bothersomeness, depression and quality of life at baseline and 4 weeks. ETHICS AND DISSEMINATION: This protocol is approved by the Massachusetts General Brigham Human Research Committee (protocol number: 2021P002617) and FDA (IND number: 143861) and registered with ClinicalTrials.gov. Results will be published in peer-reviewed journals and presented at conferences. TRIAL REGISTRATION NUMBER: NCT05066308; ClinicalTrials.gov.

Facilitating Smoking Cessation in Primary Care Settings.

The Psychiatric Consultation Service at Massachusetts General Hospital sees medical and surgical inpatients with comorbid psychiatric symptoms and conditions. During their twice-weekly rounds, Dr Stern and other members of the Consultation Service discuss diagnosis and management of hospitalized patients with complex medical or surgical problems who also demonstrate psychiatric symptoms or conditions. These discussions have given rise to rounds reports that will prove useful for clinicians practicing at the interface of medicine and psychiatry.

Understanding engagement behaviors and rapport building in tobacco cessation telephone counseling: An analysis of audio-recorded counseling calls.

INTRODUCTION: Though telephone counseling is a modality commonly used to promote health behavior change, including tobacco cessation, specific counselor and participant behaviors that indicate engagement and therapeutic alliance remain poorly characterized in the literature. We sought to explore smokers' and counselors' engagement and rapport-building behaviors in telephone counseling for smoking cessation and patterns of these behaviors by smokers' psychiatric symptoms. METHODS: The study team transcribed, audio-recorded tobacco cessation counseling calls for the presence of engagement and rapport-building behaviors among recently hospitalized participants enrolled in a smoking cessation randomized controlled trial (RCT). The study used baseline data from the RCT to explore frequencies of counselors' and smokers' behaviors among smokers who had reported more (vs. fewer) symptoms of depression (PHQ8 ≥ 10) or anxiety (GAD7 ≥ 10) at study entry. RESULTS: Participants (n = 37) were mostly female (23/37), White (26/37), with a median age of 58. At study entry while hospitalized, moderate-to-severe symptoms of depression (18/37) and anxiety (22/37) were common. Participant-led engagement behaviors included referencing past quit attempts, asking questions, elaborating response to yes/no questions, expressing commitment to behavior change, and assigning importance to nonautomated calls. Counselor-led behaviors included building off prior interaction, empathy, normalizing challenges, reframing and summarizing, validating achievements, and expressing shared experience. Both participants and counselors engaged via general discussion and humor. Participant-led engagement behaviors appeared more often in call transcripts among patients with higher baseline depression and anxiety symptoms compared to those with lower symptom scores. CONCLUSIONS: This study classified participant-led, counselor-led, and shared engagement behaviors during tobacco cessation counseling calls. Increased engagement via telephone counseling may be important for individuals with psychiatric symptoms identified at the start of treatment.

Integrated Smoking Cessation for Smokers With Serious Mental Illness: Protocol for a Convergent Mixed Methods Implementation Evaluation Study.

BACKGROUND: Tobacco smoking is associated with significant morbidity and premature mortality in individuals with serious mental illness. A 2-year pragmatic clinical trial (PCORI PCS-1504-30472) that enrolled 1100 individuals with serious mental illness in the greater Boston area was conducted to test 2 interventions for tobacco cessation for individuals with serious mental illness: (1) academic detailing, which delivers education to primary care providers and highlights first-line pharmacotherapy for smoking cessation, and (2) provision of community health worker support to smoker participants. Implementing and scaling this intervention in other settings will require the systematic identification of barriers and facilitators, as well as the identification of relevant subgroups, effective and unique components, and setting-specific factors. OBJECTIVE: This protocol outlines the proposed mixed methods evaluation of the pragmatic clinical trial to (1) identify barriers and facilitators to effective implementation of the interventions, (2) examine group differences among primary care physicians, and (3) identify barriers that stakeholders such as clinical, payor, and policy leaders would anticipate to impact the implementation of effective components of the intervention. METHODS: Qualitative interviews will be conducted with all study community health workers and selected smoker participants, primary care providers, and other stakeholders. Measures of performance and engagement will guide purposive sampling. The Consolidated Framework for Implementation Research will guide qualitative data collection and analysis in accordance with the following framework approach: (1) familiarization, (2) identifying a thematic framework, (3) indexing, (4) charting, and (5) mapping and interpretation. Joint display analyses will be constructed to analyze and draw conclusions across the quantitative and qualitative data. RESULTS: The 3-year cluster-randomized trial has concluded, and the analysis of primary outcomes is underway. Results from the pragmatic trial and this mixed methods implementation evaluation will be used to help disseminate, scale, and expand a systems intervention. CONCLUSIONS: The results of this mixed methods implementation evaluation will inform strategies for dissemination and solutions to potential barriers to the implementation of interventions from a smoking cessation trial for individuals with serious mental illness. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/25390.

A Qualitative Study of the Impact of COVID-19 on Smoking Behavior for Participants in a Post-Hospitalization Smoking Cessation Trial.

(1) Background: COVID-19 has substantially altered individual environments and behaviors. We aim to explore the impact of COVID-19 on the smoking behavior of individuals trying to quit tobacco. (2) Methods: This study presents a qualitative analysis of individual interviews focused on perceived impacts of the COVID-19 pandemic on tobacco use among 39 participants in the Helping HAND 4 (HH4) post-hospitalization smoking cessation trial (NCT03603496). (3) Results: Emergent impacts of COVID-19 included change in routine, isolation, employment changes, and financial challenges; these in turn were associated with boredom, altered cravings and triggers, and increased stress. The availability of effective coping mechanisms instead of smoking to deal with stress heavily influenced subsequent smoking behavior. These results were triangulated with the Transactional Model of Stress, providing a framework to elucidate connections between factors such as perceived control, self-efficacy, and dispositional coping style, and highlighting potential areas for intervention. (4) Conclusions: Results suggest that stress during the COVID-19 pandemic may undermine effective coping skills among individuals enrolled in a post-hospitalization smoking cessation trial. Strengthening effective coping skills (e.g., minimizing the use of tobacco as a default stress response) and increasing perceived control and self-efficacy are promising intervention targets.

For Homeless People with Serious Mental Illness, Can a State Transitional Shelter Promote Racial Equity in Housing Outcomes?

OBJECTIVE: To examine the role of race, sex, arrest history, and psychiatric diagnoses in duration of shelter tenure and housing outcomes for patients in transitional shelters. METHODS: The authors performed a three-year retrospective chart review of Massachusetts Department of Mental Health (DMH) records for individuals residing in three DMH transitional homeless shelters from 2013 to 2015. RESULTS: Race was not predictive of length of stay, initial disposition, or housing status at three to five-year follow-up. Arrest history negatively predicted initial housing placement, and diagnosis of substance use disorder predicted homelessness at follow-up. There were no differences by race in arrest history or diagnosis of substance use disorder. CONCLUSIONS: Race was not a factor in duration of shelter tenure, or in securing or maintaining housing following shelter stay. Arrest history and lifetime substance use disorder were associated with more negative outcomes following transitional shelter stay.

Patient Experience and Predictors of Improvement in a Group Behavioral and Educational Intervention for Individuals With Diabetes and Serious Mental Illness: Mixed Methods Case Study.

BACKGROUND: In a previous study, participation in a 16-week reverse integrated care and group behavioral and educational intervention for individuals with diabetes and serious mental illness was associated with improved glycemic control (hemoglobin A1c) and BMI. To inform future implementation efforts, more information about the effective components of the intervention is needed. OBJECTIVE: The goal of this study is to identify the aspects of the intervention participants reported to be helpful and to evaluate the predictors of outcomes. METHODS: This study involved qualitative evaluation and post hoc quantitative analysis of a previous intervention. Qualitative data were collected using semistructured interviews with 69% (24/35) of the individuals who attended 1 or more group sessions and 35% (9/26) of the individuals who consented but attended no sessions. Quantitative mixed effects modeling was performed to test whether improved diabetes knowledge, diet, and exercise or higher group attendance predicted improved hemoglobin A1c and BMI. These interview and modeling outcomes were combined using a mixed methods case study framework and integrated thematically. RESULTS: In qualitative interviews, participants identified the application of health-related knowledge gained to real-world situations, accountability for goals, positive reinforcement and group support, and increased confidence in prioritizing health goals as factors contributing to the success of the behavioral intervention. Improved knowledge of diabetes was associated with reduced BMI (ß=-1.27, SD 0.40; P=.003). No quantitative variables examined were significantly associated with improved hemoglobin A1c levels. CONCLUSIONS: In this mixed methods analysis of predictors of success in a behavioral diabetes management program, group participants highlighted the value of positive reinforcement and group support, accountability for goals set, and real-world application of health-related knowledge gained. Improved diabetes knowledge was associated with weight loss.

Developing a Sound Body: Open Trial Results of a Group Healthy Lifestyle Intervention for Young Adults with Psychosis.

The mortality disparity for persons with schizophrenia spectrum disorders (SSDs) due to cardiovascular disease is a devastating problem. Many risk factors are present in young adults with psychosis that may be ameliorated with lifestyle interventions. Sixteen participants with SSDs enrolled in an 11-week open trial of a novel lifestyle intervention comprised of group high intensity interval training exercise and health and wellness education. The aims were to evaluate (1) feasibility and (2) impact on sedentary behavior, physical activity, nutritional knowledge, physiological outcomes, and psychological well-being at end of intervention and 11-week follow-up. Attendance rates were 70% or higher for both intervention components and participants reported increased learning about healthy eating and exercise habits. Moderate to large effect sizes were observed for physical activity and sedentary behavior with sustained improvements in sedentary behavior at follow-up. Meaningful changes were not observed in other domains.

Disparities in Care: The Role of Race on the Utilization of Physical Restraints in the Emergency Setting.

OBJECTIVE: Race-based bias in health care occurs at organizational, structural, and clinical levels and impacts emergency medical care. Limited literature exists on the role of race on patient restraint in the emergency setting. This study sought to examine the role of race in physical restraint in an emergency department (ED) at a major academic medical center. METHODS: Retrospective chart analysis was performed, querying all adult ED visits over a 2-year period (2016-2018) at Massachusetts General Hospital. The associations between race and restraint and selected covariates (sex, insurance, age, diagnosis, homelessness, violence) were analyzed. RESULTS: Of the 195,092 unique ED visits by 120,469 individuals over the selected period, 2,658 (1.4%) involved application of a physical restraint by health care providers. There was a significant effect of race on restraint (p < 0.0001). The risk ratio (RR) for Asian patients compared to white patients was 0.71 (95% confidence interval [CI] = 0.55 to 0.92, p = 0.009). The RR for Black patients compared to white patients was 1.22 (95% CI = 1.05 to 1.40, p = 0.007). Visits with patients having characteristics of male sex, public or no insurance, younger age, diagnoses pertaining to substance use, diagnoses pertaining to psychotic or bipolar disorders, current homelessness, and a history of violence were more likely to result in physical restraint. CONCLUSIONS: There was a significant effect of race on restraint that remained when controlling for sex, insurance, age, diagnosis, homelessness, and history of violence, all of which additionally conferred independent effects on risk. These results warrant a careful examination of current practices and potential biases in utilization of restraint in emergency settings.

Correction to: Comparative effectiveness of post-discharge strategies for hospitalized smokers: Study protocol for the Helping HAND 4 randomized controlled trial.

An amendment to this paper has been published and can be accessed via the original article.

Improved Glycemic Control in Adults With Serious Mental Illness and Diabetes With a Behavioral and Educational Intervention.

OBJECTIVE: The purpose of this study was to evaluate a 16-week, reverse-integrated care (bringing primary care interventions/services into the psychiatric setting) behavioral and educational group intervention for individuals with serious mental illness and diabetes. METHODS: The primary outcome was change in glycated hemoglobin (HbA1c). Secondary outcomes included body mass index (BMI), blood pressure, lipid levels, physical activity, diabetes knowledge, and self-care. RESULTS: Thirty-five participants attended at least one group and were included in a modified intent-to-treat analysis. From baseline to week 16, HbA1c improved, from 7.5±1.6 to 7.1±1.4, p=0.01, and BMI improved, from 33.3±3.8 to 32.9±4.1, p<0.001, as did measures of diabetes knowledge and self-care. One-year follow-up in a subset of participants showed no evidence of rebound in HbA1c. CONCLUSIONS: This 16-week behavioral and educational group intervention resulted in improvements in glycemic control, BMI, diabetes knowledge, and self-care. The results warrant larger-scale, controlled trial testing of this intervention to improve diabetes-related health outcomes in those with serious mental illness.

Comparative effectiveness of post-discharge strategies for hospitalized smokers: Study protocol for the Helping HAND 4 randomized controlled trial.

BACKGROUND: Tobacco smoking remains the leading preventable cause of death in the US. A hospital admission provides smokers with a unique opportunity to stop smoking because it requires temporary tobacco abstinence while illness may enhance motivation to quit. Hospital interventions must continue post-discharge to increase tobacco abstinence long-term, but how best to accomplish this remains unclear. Building on two previous randomized controlled trials, each of which tested smoking cessation interventions that began in hospital and continued after discharge, this trial compares two interventions that provide sustained smoking cessation treatment after hospital discharge with the goal of improving long-term smoking cessation rates among hospitalized smokers. METHODS/DESIGN: Helping HAND 4 is a three-site randomized controlled trial that compares the effectiveness of two active interventions for producing validated past 7-day tobacco abstinence 6 months after hospital discharge. Smokers who are admitted to three hospitals receive a standard in-hospital smoking intervention, and those who plan to quit smoking after discharge are recruited and randomly assigned to two interventions that begin at discharge, Personalized Tobacco Care Management (PTCM) or Quitline eReferral. Each lasts 3 months. At discharge, PTCM provides 8 weeks of free nicotine replacement (NRT; a participant's choice of patch, gum, lozenge, or a combination) and then proactive smoking cessation support using an automated communication platform and live contact with a tobacco treatment specialist who is based in the health care system. In the eReferral condition, a direct referral is made from the hospital electronic health record to a community-based resource, the state's telephone quitline. The quitline provides up to 8 weeks of free NRT and offers behavioral support via a series of phone calls from a trained coach. Outcomes are assessed at 1, 3, and 6 months after discharge. The study hypothesis is that PTCM will produce higher quit rates than eReferral. DISCUSSION: Helping HAND 4 is a pragmatic trial that aims to evaluate interventions in real-world conditions. This project will give hospital systems critical evidence-based tools for meeting National Hospital Quality Measures for tobacco treatment and maximizing their ability to improve cessation rates and overall health for the millions of smokers hospitalized annually in the US. TRIAL REGISTRATION: Prospectively registered prior to start of enrollment at Clinicaltrials.gov, NCT03603496 (July 27, 2018). https://register.clinicaltrials.gov/prs/app/action/SelectProtocol?sid=S00084MJ&selectaction=Edit&uid=U00002G7&ts=2&cx=ff0oxn.