Are Virtual Complementary and Integrative Therapies as Effective as In-Person Therapies? Examining Patient-Reported Outcomes Among Veterans with Chronic Musculoskeletal Pain.

Background: Virtual complementary and integrative health (CIH) therapy availability increased during the COVID-19 pandemic, but little is known about effectiveness. We examined the perceived effectiveness of in-person and virtual CIH therapies for patients with chronic musculoskeletal pain who recently started using CIH therapies. Methods: The sample included Veterans (n = 1,091) with chronic musculoskeletal pain, identified in the Veterans Health Administration's electronic health record based on initiation of CIH therapy use, who responded to VA's Patient Complementary and Integrative Health Therapy Experience Survey during March, 2021, to August, 2022. Using multivariable models with self-guided virtual (apps or videos) delivery as the reference, we compared patient-reported outcomes (pain, mental health, fatigue, and general well-being) associated with any yoga, Tai Chi/Qigong, or meditation use delivered: (1) only in-person, (2) only virtually with a live provider, (3) only virtually self-guided, (4) virtually self-guided + virtually provider-guided, or (5) hybrid in-person + virtual (self-or provider-guided). Results: Under 10% of Veterans reported only in-person use; 54% used only virtual formats and 36% a hybrid of in-person and virtual. Forty-one percent reported improvement in general well-being, 40.6% in mental health, 37.1% in pain, and 22.7% in fatigue. Compared with Veterans using only self-guided virtual CIH therapies, Veterans using only in-person therapies were more likely to report improvement in fatigue (odds ratio [OR]: 1.8, confidence interval [CI]: 1.1-3.1) and general well-being (OR: 1.7, CI: 1.0-2.6). Conclusions: Many patients perceived health improvements from CIH therapies, with in-person users reporting more improvement in fatigue and well-being than those using virtual sessions and similar improvements in pain and mental health for in-person and hybrid users.

A qualitative study identifying implementation strategies using the i-PARIHS framework to increase access to pre-exposure prophylaxis at federally qualified health centers in Mississippi.

BACKGROUND: Mississippi (MS) experiences disproportionally high rates of new HIV infections and limited availability of pre-exposure prophylaxis (PrEP). Federally Qualified Health Centers (FQHCs) are poised to increase access to PrEP. However, little is known about the implementation strategies needed to successfully integrate PrEP services into FQHCs in MS. PURPOSE: The study had two objectives: identify barriers and facilitators to PrEP use and to develop tailored implementation strategies for FQHCs. METHODS: Semi-structured interviews were conducted with 19 staff and 17 PrEP-eligible patients in MS FQHCs between April 2021 and March 2022. The interview was guided by the integrated-Promoting Action on Research Implementation in Health Services (i-PARIHS) framework which covered PrEP facilitators and barriers. Interviews were coded according to the i-PARIHS domains of context, innovation, and recipients, followed by thematic analysis of these codes. Identified implementation strategies were presented to 9 FQHC staff for feedback. RESULTS: Data suggested that PrEP use at FQHCs is influenced by patient and clinic staff knowledge with higher levels of knowledge reflecting more PrEP use. Perceived side effects are the most significant barrier to PrEP use for patients, but participants also identified several other barriers including low HIV risk perception and untrained providers. Despite these barriers, patients also expressed a strong motivation to protect themselves, their partners, and their communities from HIV. Implementation strategies included education and provider training which were perceived as acceptable and appropriate. CONCLUSIONS: Though patients are motivated to increase protection against HIV, multiple barriers threaten uptake of PrEP within FQHCs in MS. Educating patients and providers, as well as training providers, are promising implementation strategies to overcome these barriers.

Tailoring opioid use prevention content for juvenile diversion programs with adolescents and their caregivers.

INTRODUCTION: Opioid use (OU) skyrockets as youth transition into young adulthood, indicating adolescence is a critical time for prevention. The juvenile legal system (JLS) presents an ideal setting for OU prevention, as it is the single largest referral source for youth outpatient OU treatment, after self-referral. However, no OU prevention programs have been developed for youth in JLS diversion programs or their families. The current formative study established specific OU prevention needs and preferences of families in JLS programs, to guide future tailored prevention efforts. METHODS: We interviewed 21 adolescents with substance use and 20 of their caregivers referred by a JLS diversion program in the northeastern United States to explore their OU-related knowledge, personal experiences, motivations, and behavioral skills. We used a deductive qualitative analysis approach wherein data were analyzed using an a priori coding framework based on the Information Motivation Behavioral Skills model. RESULTS: Caregivers knew more about OU than youth, several of whom misidentified both opiates and non-opiates. Few participants reported a history of personal OU, though many knew of others' OU. Participants perceived several potential motivations for OU: mental health problems, relationships, life stressors, difficulty accessing preferred substances, and experimentation. Though often unfamiliar with the symptoms, participants were eager to learn skills to identify and manage a suspected overdose. CONCLUSIONS: Youth involved in a JLS diversion program and their caregivers were open to and eager for tailored opioid use prevention content to help them reduce risks. We discuss implications for OU prevention and intervention program development.

Who's in control? Situating expertise, (mis)trust, and power among the Latine/Hispanic community in COVID-19's liminal moments.

BACKGROUND: Research has established the disproportionate impact of COVID-19 on Black, Indigenous, and People of color (BIPOC) communities, and the barriers to vaccine trust and access among these populations. Focusing on perceptions of safety, access, and trustworthiness, studies often attach barriers to community-members, and discuss vaccines as if developed from an objective perspective, or "view from nowhere" (Haraway). OBJECTIVE: We sought to follow Haraway's concept of "situated knowledges," whereby no one truth exists, and information is understood within its context, to understand the exertions of expertise surrounding vaccines. We focused on perceptions of power among a BIPOC community during a relatively unexamined moment, wherein the status of the pandemic and steps to prevent it were particularly uncertain. METHODS: We report the findings of ten focus groups conducted among members of Rhode Island's Latine/Hispanic communities between December 2021 and May 2022. We called this time COVID-19's liminal moment because vaccines were distributed, mandates were lifted, vaccine efficacy was doubted, and new strains spread. We translated, transcribed, and analyzed focus groups using thematic analysis. RESULTS: Community-member (n = 65) perceptions of control aligned with three key themes: (1) no power is capable of controlling COVID-19, (2) we are the objects of scientific and political powers, and (3) we, as individuals and communities, can control COVID-19 through our decisions and actions. CONCLUSIONS: By centering the perspectives of a minoritized community, we situated the scientific knowledge produced about COVID-19 within the realities of imperfect interventions, uncontrollable situations, and medical power-exertions. We argue that medical knowledge should not be assumed implicitly trustworthy, or even capable, but instead seen as one of many products of human labor within human systems. Trust and trustworthiness must be mutually negotiated between experts, contexts, and communities through communication, empowerment, and justice.

Mindfulness-Based Stress Reduction Health Insurance Coverage: If, How, and When? An Integrated Knowledge Translation (iKT) Delphi Key Informant Analysis.

Objectives: Hundreds of trials have evaluated Mindfulness-Based Stress Reduction (MBSR), but in the United States, it is generally not covered by health insurance. Consequently, the aims were to identify the following: (1) key questions to make decisions about if, how, and when MBSR should be covered by health insurance; (2a) barriers and (2b) facilitators to understand and resolve for MBSR to be covered by health insurance; and (3) highest priority evidence needed to inform health insurance coverage decisions. Methods: Key informants (n = 26) included health insurers, healthcare administrators, policymakers, clinicians, MBSR instructors, and MBSR students. An initial pool of items related to the study aims was generated through qualitative interviews. Through the Delphi process, participants rated, discussed, and re-rated each item's relevance. Items were required to reach a consensus of ≥ 80% agreement to be retained for final inclusion. Results: Of the original 149 items, 42 (28.2%) met the ≥ 80% agreement criterion and were retained for final inclusion. The most highly rated items informing whether MBSR should be covered by health insurance included research demonstrating that MBSR works and that it is not harmful. The most highly rated barriers to coverage were that MBSR is not a medical treatment and patient barriers to attendance. Highly rated facilitators included the potential of MBSR to address common mental health and psychosomatic problems. Finally, understanding what conditions are effectively treated with MBSR and the impact of MBSR on stress were rated as the highest priority evidence needed to inform health insurance coverage decisions. Conclusions: Findings highlight priorities for future research and policy efforts to advance health insurance coverage of MBSR in the United States. Supplementary Information: The online version contains supplementary material available at 10.1007/s12671-024-02366-x.

Measuring Patient-Reported Use and Outcomes From Complementary and Integrative Health Therapies: Development of the Complementary and Integrative Health Therapy Patient Experience Survey.

Background: Assessing the use and effectiveness of complementary and integrative health (CIH) therapies via survey can be complicated given CIH therapies are used in various locations and formats, the dosing required to have an effect is unclear, the potential health and well-being outcomes are many, and describing CIH therapies can be challenging. Few surveys assessing CIH therapy use and effectiveness exist, and none sufficiently reflect these complexities. Objective: In a large-scale Veterans Health Administration (VA) quality improvement effort, we developed the "Complementary and Integrative Health Therapy Patient Experience Survey", a longitudinal, electronic patient self-administered survey to comprehensively assess CIH therapy use and outcomes. Methods: We obtained guidance from the literature, subject matter experts, and Veteran patients who used CIH therapies in designing the survey. As a validity check, we completed cognitive testing and interviews with those patients. We conducted the survey (March 2021-April 2023), inviting 15,608 Veterans with chronic musculoskeletal pain with a recent CIH appointment or referral identified in VA electronic medical records (EMR) to participate. As a second validity check, we compared VA EMR data and patient self-reports of CIH therapy utilization a month after survey initiation and again at survey conclusion. Results: The 64-item, electronic survey assesses CIH dosing (amount and timing), delivery format and location, provider location, and payor. It also assesses 7 patient-reported outcomes (pain, global mental health, global physical health, depression, quality of life, stress, and meaning/purpose in life), and 3 potential mediators (perceived health competency, healthcare engagement, and self-efficacy for managing diseases). The survey took 17 minutes on average to complete and had a baseline response rate of 45.3%. We found high degrees of concordance between self-reported and EMR data for all therapies except meditation. Conclusions: Validly assessing patient-reported CIH therapy use and outcomes is complex, but possible.

The education of experience: Mixed methods evidence demonstrates the benefit of multiparity.

PROBLEM: Existing quantitative data is conflicting concerning whether multiparous birthing parents (individuals with an older child(ren)) experience an easier postpartum transition compared to primiparous birthing parents (first time parents). AIM: This convergent mixed methods study leverages the depth of qualitative inquiry to seek a clearer understanding of the way in which acquired parenting experience contributes to observed quantitative differences in outcomes between parity groups. This work can serve as a first step in planning for supportive interventions that effectively address the postpartum needs of both parity groups. METHODS: Thirty birthing parents (43.3% multiparous; 46.7% racial minorities) completed measures of postpartum functioning, perceived stress, anxiety symptoms, and depression symptoms as well as an interview inquiring about factors impacting postpartum functioning. Scores on postpartum functioning and emotional wellbeing were compared between parity groups, and these findings were merged with the qualitative data on firsthand parenting experience to clarify how acquired experience impacts functioning and emotional wellbeing during the postpartum transition. FINDINGS: Primiparous parents reported significantly: worse postpartum functioning, higher perceived stress, higher levels of depression symptoms, and higher levels of anxiety symptoms. Participants' qualitative report of how acquired parenting experience impacts wellbeing suggests that experience grants parents skills, knowledge, and the opportunity to disconfirm maladaptive cognitions about parenting which allows for increased comfort and confidence in the parental role. CONCLUSIONS: The practical and psychological resources gained from acquiring parenting experience during one's first postpartum period appear to be brought forward into subsequent pregnancies and protect against threats to functioning and emotional wellbeing.

A Hybrid Type 1 trial of a multi-component mHealth intervention to improve post-hospital transitions of care for patients with serious mental illness: Study protocol.

BACKGROUND: The transition from acute (e.g., psychiatric hospitalization) to outpatient care is associated with increased risk for rehospitalization, treatment disengagement, and suicide among people with serious mental illness (SMI). Mobile interventions (i.e., mHealth) have the potential to increase monitoring and improve coping post-acute care for this population. This protocol paper describes a Hybrid Type 1 effectiveness-implementation study, in which a randomized controlled trial will be conducted to determine the effectiveness of a multi-component mHealth intervention (tFOCUS) for improving outcomes for adults with SMI transitioning from acute to outpatient care. METHODS: Adults meeting criteria for schizophrenia-spectrum or major mood disorders (n = 180) will be recruited from a psychiatric hospital and randomized to treatment-as-usual (TAU) plus standard discharge planning and aftercare (CHECK-IN) or TAU plus tFOCUS. tFOCUS is a 12-week intervention, consisting of: (a) a patient-facing mHealth smartphone app with daily self-assessment prompts and targeted coping strategies; (b) a clinician-facing web dashboard; and, (c) mHealth aftercare advisors, who will conduct brief post-hospital clinical calls with patients (e.g., safety concerns, treatment engagement) and encourage app use. Follow-ups will be conducted at 6-, 12-, and 24-weeks post-discharge to assess primary and secondary outcomes, as well as target mechanisms. We also will assess barriers and facilitators to future implementation of tFOCUS via qualitative interviews of stakeholders and input from a Community Advisory Board throughout the project. CONCLUSIONS: Information gathered during this project, in combination with successful study outcomes, will inform a potential tFOCUS intervention scale-up across a range of psychiatric hospitals and healthcare systems. CLINICALTRIALS: govregistration: NCT05703412.

Social, Structural, Behavioral, and Clinical Barriers Influencing Pre-exposure Prophylaxis (PrEP) Use Among Young Black Men Who Have Sex with Men in the South: A Qualitative Update to a 2016 Study.

Antiretroviral pre-exposure prophylaxis (PrEP) is highly effective in preventing HIV. Despite its promise, PrEP use is low, especially among young Black men who have sex with men (YBMSM). The prevalence of HIV in Mississippi (MS) is among the highest in the United States, with the bulk of new infections occurring amongst YBMSM living in Jackson, MS. We recruited 20 PrEP-eligible YBMSM and 10 clinic staff from MS health clinics between October 2021 and April 2022. Data were collected remotely using in-depth interviews and a brief survey, which lasted approximately 45-60 min. Interview content included PrEP knowledge/experiences, HIV risk perception, and PrEP use barriers and facilitators. Qualitative data were coded then organized using NVivo. Using thematic analysis methodology, data were assessed for current barriers to PrEP use. An array of barriers were identified by participants. Barriers included structural factors (cost of PrEP, lack of discreet clinics, time commitment, competing interests); social factors (unaware of HIV risk, stigma and homophobia, fear that partners would find out about PrEP use, not knowing anyone on PrEP); behavioral factors (sexual risk factors, denial, less priority for prevention vs treatment); and clinical factors (misunderstood side effects, fear PrEP won't work). Significant barriers to PrEP use among YBMSM stem from structural, social, behavioral, and clinical factors. These results will inform intervention efforts tailored to mitigate barriers and improve PrEP uptake among YBMSM in the southern United States.

Engaging patients in antimicrobial stewardship: co-designed educational tool to improve periprocedural care through de-implementation of guideline-discordant antimicrobial use.

Effective de-implementation models often include replacement of an ineffective practice with an alternative. We co-developed patient education materials as a replacement strategy for inappropriate post-procedural antibiotics in cardiac device procedures. Lessons learned and developed materials may be used to promote infection prevention in other periprocedural settings.

Costs of Implementing Electronic Context Factor Assessments and Patient-reported Outcomes in Pain Clinic Settings.

BACKGROUND: The Healing Encounters and Attitudes Lists (HEALs) patient-reported measures, consisting of 6 separate context factor questionnaires, predict patients' pain improvements. Our Patient-centered Outcomes Research Initiative-funded implementation project demonstrated success in using HEAL data during clinic consultations to enhance patient engagement, improve patient outcomes, and reduce opioid prescribing. OBJECTIVE: We aimed to determine the resources needed for additional sites to implement HEAL to improve pain care treatment. RESEARCH DESIGN: An observational study from March 1 to November 30, 2021, assessing implementation cost data from invoices, time and salary requirements for clinic personnel training, estimates of non-site-based costs, and one-time resource development costs. SUBJECTS: Unique patients eligible to complete a HEAL survey (N=24,018) and 74 clinic personnel. MEASURES: The Stages of Implementation Completion guided documentation of preimplementation, implementation, and sustainment activities of HEAL pain clinic operations. These informed the calculations of the costs of implementation. RESULTS: The total time for HEAL implementation is 7 months: preimplementation and implementation phases (4 mo) and sustainment (3 mo). One hour of HEAL implementation involving a future clinical site consisting of 2 attending physicians, 1 midlevel provider, 1 nurse manager, 1 nurse, 1 radiology technician, 2 medical assistants, and 1 front desk staff will cost $572. A 10-minute time increment for all clinic staff is $95. Total implementation costs based on hourly rates over 7 months, including non-site-based costs of consultations, materials, and technology development costs, is $28,287. CONCLUSIONS: Documenting our implementation costs clarifies the resources needed for additional new sites to implement HEAL to measure pain care quality and to engage patients and clinic personnel.

Embracing dynamic public health policy impacts in infectious diseases responses: leveraging implementation science to improve practice.

Rationale: The host-pathogen relationship is inherently dynamic and constantly evolving. Applying an implementation science lens to policy evaluation suggests that policy impacts are variable depending upon key implementation outcomes (feasibility, acceptability, appropriateness costs) and conditions and contexts. COVID-19 case study: Experiences with non-pharmaceutical interventions (NPIs) including masking, testing, and social distancing/business and school closures during the COVID-19 pandemic response highlight the importance of considering public health policy impacts through an implementation science lens of constantly evolving contexts, conditions, evidence, and public perceptions. As implementation outcomes (feasibility, acceptability) changed, the effectiveness of these interventions changed thereby altering public health policy impact. Sustainment of behavioral change may be a key factor determining the duration of effectiveness and ultimate impact of pandemic policy recommendations, particularly for interventions that require ongoing compliance at the level of the individual. Practical framework for assessing and evaluating pandemic policy: Updating public health policy recommendations as more data and alternative interventions become available is the evidence-based policy approach and grounded in principles of implementation science and dynamic sustainability. Achieving the ideal of real-time policy updates requires improvements in public health data collection and analysis infrastructure and a shift in public health messaging to incorporate uncertainty and the necessity of ongoing changes. In this review, the Dynamic Infectious Diseases Public Health Response Framework is presented as a model with a practical tool for iteratively incorporating implementation outcomes into public health policy design with the aim of sustaining benefits and identifying when policies are no longer functioning as intended and need to be adapted or de-implemented. Conclusions and implications: Real-time decision making requires sensitivity to conditions on the ground and adaptation of interventions at all levels. When asking about the public health effectiveness and impact of non-pharmaceutical interventions, the focus should be on when, how, and for how long they can achieve public health impact. In the future, rather than focusing on models of public health intervention effectiveness that assume static impacts, policy impacts should be considered as dynamic with ongoing re-evaluation as conditions change to meet the ongoing needs of the ultimate end-user of the intervention: the public.

Developing and testing a COVID-19 vaccination acceptance intervention: A pragmatic trial comparing vaccine acceptance intervention vs usual care - Rationale, methods, and implementation.

BACKGROUND: COVID-19 has resulted in significant disability and loss of life. COVID-19 vaccines effectively prevent severe illness, hospitalization, and death. Nevertheless, many people remain hesitant to accept vaccination. Veterans perceive healthcare providers (HCP) and staff as trusted vaccine information sources and thereby are well suited to initiate vaccine discussions. The overall objective of this study is to implement and test a virtual COVID-19 Vaccine Acceptance Intervention (VAI) training that is informed by motivational interviewing (MI) techniques. METHODS: The VAI training is being delivered to VA HCPs and staff within a Hybrid Type 2 pragmatic implementation-effectiveness trial using Implementation Facilitation as the implementation strategy. The implementation team includes external facilitators paired with VA Healthcare System (VAHCS)-level internal facilitators. The trial has three aims: 1) Examine the effectiveness of the VAI versus usual care on unvaccinated veterans' vaccination rates in a one-year cluster randomized controlled trial, with randomization at the level of VAHCS. 2) Determine factors associated with veterans' decisions to accept or decline primary COVID-19 vaccination, and better understand how these factors influence vaccination decisions, through survey and qualitative data; and 3) Use qualitative interviews with HCPs and staff from clinics with high and low vaccination rates to learn what was helpful and not helpful about the VAI and implementation strategies. CONCLUSION: This is the first multisite randomized controlled trial to test an MI-informed vaccine acceptance intervention to improve COVID-19 vaccine acceptance. Information gained can be used to inform healthcare systems' approaches to improve future vaccination and other public health campaigns. CLINICALTRIALS: gov Identifier: NCT05027464.

Considerations for PrEP Implementation at Federally Qualified Health Centers in Mississippi: Perspectives From Staff and Patients.

Pre-exposure prophylaxis (PrEP) uptake remains low in the southeastern United States ("the South"), likely owing to overlapping structural barriers, including the lack of nearby PrEP providers. Federally qualified health centers (FQHCs) are potential sites through which to expand PrEP availability in the South, and telemedicine is promising for these services. This study investigated considerations for PrEP implementation at FQHCs and the use of telemedicine through qualitative interviews with 19 FQHC staff and 17 PrEP-eligible patients in Mississippi. Results indicated that existing infrastructure and policies at FQHCs can support PrEP implementation and that additional needed resources include more education for providers and strategies to advertise PrEP services. Findings suggest that using telemedicine for PrEP can address some regional implementation barriers (e.g., transportation problems and confidentiality concerns) but may present new ones (e.g., concerns about patients performing home HIV/STI testing procedures). Results can inform future PrEP implementation efforts in the South.

Using a person-centered approach in clinical care for patients with complex chronic conditions: Perspectives from healthcare professionals caring for Veterans with COPD in the U.S. Veterans Health Administration's Whole Health System of Care.

BACKGROUND: The largest nationally integrated health system in the United States, the Veterans Health Administration (VHA), has been undergoing a transformation toward a Whole Health (WH) System of Care. WH Clinical Care, a component of this system, includes holistically assessing the Veteran's life context, identifying what really matters to the Veteran, collaboratively setting and monitoring personal health and well-being goals, and equipping the Veteran with access to conventional and complementary and integrative health resources. Implementation of WH Clinical Care has been challenging. Understanding healthcare professionals' perspectives on the value of and barriers and facilitators to practicing WH Clinical Care holds relevance for not only VHA's efforts but also other health systems, in the U.S. and internationally, that are engaged in person-centered care implementation. OBJECTIVES: We sought to understand perspectives of healthcare professionals at VHA on providing WH Clinical Care to Veterans with COPD, as a lens to understand the broader issue of WH Clinical Care for Veterans living with complex chronic conditions. DESIGN: We interviewed 25 healthcare professionals across disciplines and services at a VA Medical Center in 2020-2021, including primary care providers, pulmonologists, palliative care providers, and chaplains. Interview transcripts were analyzed using qualitative content analysis. KEY RESULTS: Each element of WH Clinical Care raised complex questions and/or concerns, including: (1) the appropriate depth/breadth of inquiry in person-centered assessment; (2) the rationale for elicitation of what really matters; (3) the feasibility and appropriate division of labor in personal health goal setting and planning; and (4) challenges related to referring Veterans to a broad spectrum of supportive services. CONCLUSIONS: Efforts to promote person-centered care must account for healthcare professionals' existing comfort with its elements, advocate for a team-based approach, and continue to grapple with the conflicting structural conditions and organizational imperatives.

Health disparities in orthopedic trauma: a qualitative study examining providers' perspectives on barriers to care and recovery outcomes.

Social workers involved in interdisciplinary orthopedic trauma care can benefit from the knowledge of providers' perspectives on healthcare disparities in this field. Using qualitative data from focus groups conducted on 79 orthopedic care providers at three Level 1 trauma centers, we assessed their perspectives on orthopedic trauma healthcare disparities and discussed potential solutions. Focus groups originally aimed to detect barriers and facilitators of the implementation of a trial of a live video mind-body intervention to aid in recovery in orthopedic trauma care settings (Toolkit for Optimal Recovery-TOR). We used the Socio-Ecological Model to analyze an emerging code of "health disparities" during data analysis to determine at which levels of care these disparities occurred. We identified factors related to health disparities in orthopedic trauma care and outcomes at the Individual (Education- comprehension, health-literacy; Language Barriers; Psychological Health- emotional distress, alcohol/drug use, learned helplessness; Physical Health- obesity, smoking; and Access to Technology), Relationship (Social Support Network), Community (Transportation and Employment Security), and Societal level (Access- safe/clean housing, insurance, mental health resources; Culture). We discuss the implications of the findings and provide recommendations to address these issues, with a specific focus on their relevance to the field of social work in health care.

Study protocol for a hybrid 1 effectiveness-implementation trial of Brief Skills Training in Affective and Interpersonal Regulation (Brief STAIR) and web-administered STAIR (webSTAIR) for posttraumatic stress disorder in integrated primary care.

BACKGROUND: Posttraumatic stress disorder (PTSD) disproportionally affects low-income, racial and ethnic minoritized communities, where prevalence is high, yet access to evidence-based treatments (EBTs) is low. As such, there is a need to identify effective, feasible, and scalable interventions for PTSD. Stepped care approaches that include brief, low-intensity treatments are one approach to improving access yet have not been developed for adults with PTSD. Our study aims to test the effectiveness of a step one PTSD treatment in primary care while gathering information on implementation to maximize sustainability in the setting. METHODS: This study will be conducted in integrated primary care in the largest safety net hospital in New England using a hybrid type 1 effectiveness-implementation design. Eligible trial participants are adult primary care patients who meet full or subthreshold criteria for PTSD. Interventions include Brief clinician-administered Skills Training in Affective and Interpersonal Regulation (Brief STAIR) versus web-administered STAIR (webSTAIR) during a 15-week active treatment period. Participants complete assessments at baseline (pre-treatment), 15 weeks (post-treatment), and 9 months (follow-up) post-randomization. We will assess feasibility and acceptability post-trial using surveys and interviews with patients, study therapists, and other key informants, and will assess the preliminary effectiveness of interventions in terms of PTSD symptom change and functioning. CONCLUSION: This study will provide evidence for the feasibility, acceptability, and preliminary effectiveness of brief, low-intensity interventions in safety net integrated primary care, with the aim of including these interventions in a future stepped care approach to PTSD treatment. CLINICAL TRIAL NUMBER: NCT04937504.

Formative evaluation prior to implementation of a brief treatment for posttraumatic stress disorder in primary care.

BACKGROUND: Successful implementation of evidence-based treatments (EBT) for posttraumatic stress disorder (PTSD) in primary care may address treatment access and quality gaps by providing care in novel and less stigmatized settings. Yet, PTSD treatments are largely unavailable in safety net primary care. We aimed to collect clinician stakeholder data on organizational, attitudinal, and contextual factors relevant to EBT implementation. METHODS: Our developmental formative evaluation was guided by the Consolidated Framework for Implementation Research (CFIR), including (a) surveys assessing implementation climate and attitudes towards EBTs and behavioral health integration and (b) semi-structured interviews to identify barriers and facilitators to implementation and need for augmentation. Participants were hospital employees (N = 22), including primary care physicians (n = 6), integrated behavioral health clinicians (n = 8), community wellness advocates (n = 3), and clinic leadership (n = 5). We report frequency and descriptives of survey data and findings from directed content analysis of interviews. We used a concurrent mixed-methods approach, integrating survey and interview data collected simultaneously using a joint display approach. A primary care community advisory board (CAB) helped to refine interview guides and interpret findings. RESULTS: Stakeholders described implementation determinants of the EBT related to the CFIR domains of intervention characteristics (relative advantage, adaptability), outer setting (patient needs and resources), inner setting (networks and communication, relative priority, leadership engagement, available resources), and individuals involved (knowledge and beliefs, cultural considerations). Stakeholders described strong attitudinal support (relative advantage), yet therapist time and capacity restraints are major PTSD treatment implementation barriers (available resources). Changes in hospital management were perceived as potentially allowing for greater access to behavioral health services, including EBTs. Patient engagement barriers such as stigma, mistrust, and care preferences were also noted (patient needs and resources). Recommendations included tailoring the intervention to meet existing workflows (adaptability), system alignment efforts focused on improving detection, referral, and care coordination processes (networks and communication), protecting clinician time for training and consultation (leadership engagement), and embedding a researcher in the practice (available resources). CONCLUSIONS: Our evaluation identified key CFIR determinants of implementation of PTSD treatments in safety net integrated primary care settings. Our project also demonstrates that successful implementation necessitates strong stakeholder engagement.

A randomized trial of acceptance-based behavioral therapy to improve mental health outcomes for LGBTQ+ persons: Study protocol.

BACKGROUND: During the COVID-19 pandemic, public health measures limited social interactions as an effective and protective intervention for all. For many, however, this social isolation exacerbated mental health symptoms. People who identify as lesbian, gay, bisexual, transgender, and queer (LGBTQ+) were already at elevated risk of anxiety and depression, relative to cisgender and heterosexual populations, and pandemic-related social isolation likely heightened these disparities. In our prior work with sexual and gender minorities, we developed and established feasibility and acceptability of a novel acceptance-based behavioral therapy (ABBT) intervention for HIV treatment. ABBT showed promise in improving social support and reducing mental health symptoms. In the current study, we investigate the efficacy of ABBT, compared to a treatment-as-usual control condition, in a full-scale randomized controlled trial to improve social support for LGBTQ+ persons living with anxiety and depression. METHODS: Two hundred forty LGBTQ+ adults with anxiety and/or depressive symptoms will be recruited and equally randomized to receive: (a) the ABBT intervention, consisting of two 30-40 min sessions plus treatment-as-usual (TAU), or (b) TAU only. Primary outcomes are interviewer-assessed anxiety and depressive symptoms. Secondary outcomes are self-reported anxiety and depressive symptoms. Experiential avoidance and social support are hypothesized mediators and presence of an anxiety and/or depressive disorder is a hypothesized moderator. CONCLUSIONS: ABBT represents a novel, identify-affirming real-world approach to promoting social support as a means of improving mental health among individuals who identify as LGBTQ+. This study will contribute actionable data establishing the impact, mediational mechanisms, and effect modifiers of ABBT. CLINICALTRIALS: govregistration: NCT05540067.

Research and engagement considerations for alcohol use telehealth services within HIV care: a qualitative exploration in federally qualified health centers.

The prevalence of alcohol misuse is high among people with HIV (PWH); however, access to and utilization of evidence-based alcohol misuse interventions remain limited. Telehealth is one treatment approach with the potential for enhancing substance use disorder treatment utilization for PWH served by Federally Qualified Health Centers (FQHCs). However, questions remain regarding barriers to alcohol-focused telehealth service integration and telehealth research in FQHCs. This study employed qualitative methods, guided by the Dynamic Sustainability Framework, to evaluate barriers and cultural factors impacting FQHC telehealth integration. Eighteen qualitative interviews were completed with staff and leaders across four FQHCs. Interviews were analyzed using directed content analysis, and codes were organized into a priori and emergent themes. Key themes included the presence of common workflows for referring clients to substance use disorder treatment; existing research workflows and preferences for active project staff involvement; telehealth barriers including exacerbation of healthcare disparities and high provider turnover; and the importance of cultural humility and telehealth adaptations for sexual, gender, racial and ethnic minority clients. Findings from this study will inform the development of an alcohol-focused telehealth implementation strategy for a Hybrid Type 1 implementation effectiveness trial to enhance FQHC substance use disorder treatment.Trial registration: ClinicalTrials.gov identifier: NCT02563574..