A novel opt-in vs opt-out approach to referral-based treatment of tobacco use in Veterans Affairs (VA) primary care clinics: A provider-level randomized controlled trial protocol.

To determine whether an opt-out approach is effective for referral to treatment for tobacco use, we designed a clinical reminder for nurses in a primary care setting that provides a referral for patients who smoke cigarettes. We will use a two-arm, cluster-randomized design to assign nurses at the VA New York Harbor Healthcare System to test which mode of referral (opt-in vs opt-out) is more effective. All patients will be referred to evidence-based treatment for tobacco cessation including counseling from the New York State Quitline, and VetsQuit, a text messaging-based system for tobacco cessation counseling. We will measure patient engagement with the referral both in the short and long term to determine if referral modality had an impact on tobacco cessation treatment. We will also measure nurse engagement with the referral before, during, and after the implementation of the reminder to determine whether an opt-out approach is cost effective at the health system level. At the conclusion of this project, we expect to have developed and tested an opt-out system for increasing tobacco cessation treatment for Veterans in VA primary care and to have a thorough understanding of factors associated with implementation. Trial Registration:Clinicaltrials.govIdentifierNCT03477435.

A behavioral economic intervention to increase psychiatrist adherence to tobacco treatment guidelines: a provider-randomized study protocol.

BACKGROUND: People with a psychiatric diagnosis smoke at high rates, yet are rarely treated for tobacco use. Health care systems often use a 'no treatment' default for tobacco, such that providers must actively choose (opt-in) to treat their patients who express interest in quitting. Default bias theory suggests that opt-in systems may reinforce the status quo to not treat tobacco use in psychiatry. We aim to conduct a pilot study testing an opt-out system for implementing a 3A's (ask, advise, assist) tobacco treatment model in outpatient psychiatry. METHODS: We will use a mixed-methods, cluster-randomized study design. We will implement a tobacco use clinical reminder for outpatient psychiatrists at the VA New York Harbor Healthcare System. Psychiatrists (N = 20) will be randomized 1:1 to one of two groups: (1) Opt-In Treatment Approach: Psychiatrists will receive a reminder that encourages them to offer cessation medications and referral to cessation counseling; or (2) Opt-Out Treatment Approach: Psychiatrists will receive a clinical reminder that includes a standing cessation medication order and a referral to cessation counseling that will automatically generate unless the provider cancels. Prior to implementation of the reminders, we will hold a 1-hour training on tobacco treatment for psychiatrists in both arms. We will use VA administrative data to calculate the study's primary outcomes: 1) the percent of smokers prescribed a cessation medication and 2) the percent of smokers referred to counseling. During the intervention period, we will also conduct post-visit surveys with a cluster sample of 400 patients (20 per psychiatrist) to assess psychiatrist fidelity to the 3 A's approach and patient perceptions of the opt-out system. At six months, we will survey the clustered patient sample again to evaluate the study's secondary outcomes: 1) patient use of cessation treatment in the prior 6 months and 2) self-reported 7-day abstinence at 6 months. At the end of the intervention period, we will conduct semi-structured interviews with 12-14 psychiatrists asking about their perceptions of the opt-out approach. DISCUSSION: This study will produce important data on the potential of opt-out systems to overcome barriers in implementing tobacco use treatment in outpatient psychiatry. TRIAL REGISTRATION: Clinicaltrials.gov Identifier NCT04071795 (registered August 28, 2019). https://www.clinicaltrials.gov/ct2/show/NCT04071795.

Development of a 5As-based technology-assisted weight management intervention for veterans in primary care.

BACKGROUND: Obesity is a worldwide epidemic, and its prevalence is higher among Veterans in the United States. Based on our prior research, primary care teams at a Veterans Affairs (VA) hospital do not feel well-equipped to deliver effective weight management counseling and often lack sufficient time. Further, effective and intensive lifestyle-based weight management programs (e.g. VA MOVE! program) are underutilized despite implementation of systematic screening and referral at all VA sites. The 5As behavior change model (Assess, Advise, Agree, Assist, Arrange) is endorsed by the United States Preventive Service Task Force for use in counseling patients about weight management in primary care and reimbursed by Medicare. In this paper, we describe the iterative development of a technology-assisted intervention designed to provide primary care-based 5As counseling within Patient-Centered Medical Homes without overburdening providers/healthcare teams. METHODS: Thematic analyses of prior formative work (focus groups with patients [n = 54] and key informant interviews with staff [n = 25]) helped to create a technology-assisted, health coaching intervention called Goals for Eating and Moving (GEM). To further develop the intervention, we then conducted two rounds of testing with previous formative study participants (n = 5 for Round 1, n = 5 for Round 2). Each session included usability testing of prototypes of the online GEM tool, pilot testing of 5As counseling by a Health Coach, and a post-session open-ended interview. RESULTS: Three main themes emerged from usability data analyses: participants' emotional responses, tool language, and health literacy. Findings from both rounds of usability testing, pilot testing, as well as the open-ended interview data, were used to finalize protocols for the full intervention in the clinic setting to be conducted with Version 3 of the GEM tool. CONCLUSIONS: The use of qualitative research methods and user-centered design approaches enabled timely detection of salient issues to make iterative improvements to the intervention. Future studies will determine whether this intervention can increase enrollment in intensive weight management programs and promote clinically meaningful weight loss in both Veterans and in other patient populations and health systems.

Group education sessions for women veterans who experienced sexual violence: Qualitative findings.

INTRODUCTION: The impact of sexual violence (SV) on mental health, self-care, and interpersonal relationships is profound and poses special challenges to health care delivery. Reproductive health care merits special attention because the care required may be linked to reminders of past abuse. We explored facilitators and barriers affecting the use of reproductive health services among women veterans with a history of SV. METHOD: Between June and September 2015, we conducted 2 focus groups and 3 general education sessions with 27 female veterans with a history of SV at 1 medical center. We analyzed transcripts according to applied thematic analysis and used Nvivo software for data management and retrieval. RESULTS: Three main themes emerged from the focus groups and education sessions. PARTICIPANTS: (a) expressed a desire for greater agency in relation to the control they have over their bodies and medical care; (b) described how posttraumatic stress symptoms are retriggered during medical care; and (c) expressed needs for additional education, peer and provider support within the medical system. DISCUSSION: For women with a history of SV, multiple individual and systemic barriers complicate how they utilize reproductive health services. Group education sessions were an effective mode of support, information and connection to other women within the Veterans Health Administration. (PsycINFO Database Record

Moving from theory to research to practice. Implementing an effective dyadic intervention to improve antiretroviral adherence for clinic patients.

There is a dearth of evidence on the relative efficacy of intervention modalities to improve and maintain patient adherence to antiretroviral medications. Although empiric findings from research on HIV/AIDS, other diseases, and chronic medical conditions consistently demonstrate that social support plays an important role in facilitating adherence, few HIV/AIDS interventions have directly targeted this factor. Ewart's social action theory emphasizes the role of social relationships in behavior change and provides a comprehensive and useful guide to the development of interventions for adherence. We describe the development, content, and testing of SMART Couples, an effective antiretroviral adherence intervention that is grounded in social action theory and designed to enhance social support for ART adherence. Finally, we discuss some of the challenges of translating findings from the randomized clinical trial of this intervention into clinical practice and offer recommendations for integration of lessons learned into ongoing clinical care.

Couple-focused support to improve HIV medication adherence: a randomized controlled trial.

OBJECTIVE: To assess the efficacy of a couple-based intervention to improve medication-taking behavior in a clinic population with demonstrated adherence problems. DESIGN: A randomized controlled trial (SMART Couples Study) conducted between August 2000 and January 2004. SETTING: Two HIV/AIDS outpatient clinics in New York City. PARTICIPANTS: Heterosexual and homosexual HIV-serodiscordant couples (n = 215) in which the HIV-seropositive partner had < 80% adherence at baseline. The sample was predominantly lower-income racial/ethnic minorities. INTERVENTION: Participants were randomly assigned to a four-session couple-focused adherence intervention or usual care. The intervention consisted of education about treatment and adherence, identifying adherence barriers, developing communication and problem-solving strategies, optimizing partner support, and building confidence for optimal adherence. OUTCOME MEASURES: Medication adherence at week 8 (2 weeks after the intervention) compared with baseline, assessed with a Medication Event Monitoring System cap. RESULTS: Intervention participants showed higher mean medication adherence at post-intervention when compared with controls whether adherence was defined as proportion of prescribed doses taken (76% versus 60%) or doses taken within specified time parameters (58% versus 35%). Also, participants in the intervention arm were significantly more likely to achieve high levels of adherence (> 80%, > 90%, or > 95%) when compared with controls. However, in most cases, effects diminished with time, as seen at follow-up at 3 and 6 months. CONCLUSION: The SMART Couples program significantly improved medication adherence over usual care, although the level of improved adherence, for many participants, was still suboptimal and the effect was attenuated over time.