Clinic-based Intervention Research Articles

Community Health Workers Linking Clinics and Schools and Asthma Control

Childhood asthma is characterized by pervasive disparities, including 3-fold higher hospitalization rates and 7-fold higher death rates for Black children compared with White children. To address asthma disparities, one must intervene in all lived environments. To determine if a community health worker (CHW) intervention to connect the primary care, home, and school for low-income minoritized school-aged children with asthma and their caregivers improves asthma control. This study was a hybrid effectiveness/implementation trial using a 2 × 2 factorial, cluster randomized clinical trial design of 36 schools crossed with participant-level randomization into a clinic-based CHW intervention. The study was conducted from May 2018 to June 2022. The intervention took place in primary care offices, homes, and 36 West Philadelphia, Pennsylvania, public and charter schools. Children aged 5 to 13 years with uncontrolled asthma were recruited from local primary care practices. Asthma management, trigger remediation, and care coordination occurred in school, home, and primary care settings. Children were followed up for 12 months. The Yes We Can Children's Asthma Program, Open Airways For Schools Plus, and school-based asthma therapy were implemented. Improvement in asthma control, as measured by the Asthma Control Questionnaire, comparing the mean difference between groups 1 year after randomization with their baseline (difference in differences). Both primary care and school interventions were dramatically disrupted by the COVID-19 pandemic; therefore, stratified analyses were performed to assess per-protocol intervention efficacy before the pandemic disruptions. A total of 1875 participants were approached, 1248 were excluded, and 1 was withdrawn. The 626 analyzed study participants (mean [SD] age, 8.7 [2.4] years; 363 male [58%]) self-identified as Black race (96%) and non-Hispanic ethnicity (98%). Although all groups had statistically significant improvements in asthma control from baseline to 12 months (P- group: -0.46; 95% CI, -0.58 to -0.33; P+ group: -0.57; 95% CI, -0.74 to -0.44; S- group: -0.47; 95% CI, -0.58 to -0.35; S+ group: -0.59; 95% CI, -0.74 to -0.44), none of the difference-in-differences estimates from the primary prespecified models showed a clinically meaningful improvement in asthma control. Analysis from the prepandemic interval, however, demonstrated that children in the combined clinic-school intervention had a statistically significant improvement in asthma control scores compared with control (-0.79; 95% CI, -1.40 to -0.18). This randomized clinical trial provides preliminary evidence that connecting all lived environments for care of children can be accomplished through linkages with CHWs.

MHealth interventions to improve public knowledge of HPV-associated oropharyngeal cancer in the UK

In the United Kingdom (UK), the current prevalence rates of oropharyngeal cancer linked to human papillomavirus (HPV) are 6.29% and 2.04% in men and women, respectively. Over the years, the burden of this disease has increased in the UK, and this is mainly due to the rising prevalence of HPV infection in the UK. Research evidence has shown that over 70% of oropharyngeal cancers in the UK are linked to HPV. Oral sex is the major route of transmission of HPV, and over 63% of UK young adults are found to have a positive history of oral sex practice. However, only a minority of the UK population are aware of HPV-associated oropharyngeal cancer; this therefore calls for more public health efforts to increase awareness and knowledge on HPV-associated oropharyngeal cancer in the UK. While the use of technology-based, clinic-based, and community-based interventions have been employed to improve public awareness and knowledge on the role of HPV-associated oropharyngeal cancer, mobile health (mhealth) interventions have not been seriously explored despite existing robust evidence on the effective roles of mhealth in improving awareness and knowledge in diverse diseases. This article therefore calls for the adoption and use of mhealth interventions in educating the UK’s population on HPV-associated oropharyngeal cancer. The use of mhealth interventions in this regard is highly viable as its implementation closely aligns with the country’s National Health Service (NHS) commitment towards the digital transformation of the UK’s healthcare system.

Effects of an Intervention to Improve Evidence-Based Care for People With Diabetes and Cardiovascular Disease Across Sex, Race, and Ethnicity Subgroups: Insights From the COORDINATE-Diabetes Trial.

Results from the COORDINATE-Diabetes trial (Coordinating Cardiology Clinics Randomized Trial of Interventions to Improve Outcomes - Diabetes) demonstrated that a multifaceted, clinic-based intervention increased prescription of evidence-based medical therapies to participants with type 2 diabetes and atherosclerotic cardiovascular disease. This secondary analysis assessed whether intervention success was consistent across sex, race, and ethnicity. COORDINATE-Diabetes, a cluster randomized trial, recruited participants from 43 US cardiology clinics (20 randomized to intervention and 23 randomized to usual care). The primary outcome was the proportion of participants prescribed all 3 groups of evidence-based therapy (high-intensity statin, angiotensin-converting enzyme inhibitor/angiotensin receptor blocker, and sodium-glucose cotransporter-2 inhibitor or glucagon-like peptide 1 receptor agonist) at last trial assessment (6 to 12 months). In this prespecified analysis, mixed-effects logistic regression models were used to assess the outcome by self-reported sex, race, and ethnicity in the intervention and usual care groups, with adjustment for baseline characteristics, medications, comorbidities, and site location. Among 1045 participants with type 2 diabetes and atherosclerotic cardiovascular disease, the median age was 70 years, 32% were female, 16% were Black, and 9% were Hispanic. At the last trial assessment, there was an absolute increase in the proportion of participants prescribed all 3 groups of evidence-based therapy in women (36% versus 15%), Black participants (41% versus 18%), and Hispanic participants (46% versus 18%) with the intervention compared with usual care, with consistent benefit across sex (male versus female; Pinteraction=0.44), race (Black versus White; Pinteraction=0.59), and ethnicity (Hispanic versus Non-Hispanic; Pinteraction= 0.78). The COORDINATE-Diabetes intervention successfully improved delivery of evidence-based care, regardless of sex, race, or ethnicity. Widespread dissemination of this intervention could improve equitable health care quality, particularly among women and minority communities who are frequently underrepresented in clinical trials. URL: https://www.clinicaltrials.gov. Unique identifier: NCT03936660.

Supporting direct acting antiviral medication adherence and treatment completion in a sample of predominantly rural veterans with hepatitis C and substance use disorders

BackgroundClinic-based interventions are needed to promote successful direct acting antiviral (DAA) treatment for chronic hepatitis C virus (HCV) infection in patients with substance use disorders (SUDs) among rural Veterans.MethodsWe implemented a clinic-based intervention which used motivational interviewing (MI) techniques to promote medication adherence and treatment completion with 12 weeks of DAA treatment among rural Veterans with chronic HCV and SUDs. Patients received an MI session with a licensed psychologist at baseline and at each two-week follow-up visit during DAA treatment. Patients received $25 per study visit completed. Patients were to attend a laboratory visit 12 weeks after treatment completion to assess for sustained virologic response (SVR).ResultsOf the 20 participants who enrolled, 75% (n = 15) completed the planned 12-week course of treatment. Average adherence by pill count was 92% (SD = 3%). Overall SVR was 95% (19/20).ConclusionsWe demonstrated that a clinic-based intervention which incorporated frequent follow up visits and MI techniques was feasible and acceptable to a sample of predominantly rural Veterans with chronic HCV and SUDs.Clinical trial registrationRegistered at ClinicalTrials.gov (NCT 02823457) on July 1, 2016. https://clinicaltrials.gov.

Design and development of a mixed reality application for aphasia rehabilitation: The ICMR-MiRAR project

BACKGROUND: Aphasia is an impaired ability to use language for communication after a brain damage. The primary means of intervention for aphasia – Speech-Language therapy (SLT) – usually involves didactic interaction between the Speech-Language therapist and the client, often without regard to the real-life environments in which the communication occurs. The provision of SLT in natural environments is beyond the scope of the conventional, clinic-based intervention setups. Using the technological advances, the Mixed Reality in Aphasia Rehabilitation (MiRAR) aims to make persons with aphasia (PwA) use their language in an ecologically valid and meaningful manner in natural communication contexts. AIM: This report aims to delineate the design and development of a Mixed Reality environment (MR: i.e., augmented + virtual realities (i.e., AR + VR)) to provide social communicative intervention for PwA. METHODS: We describe the concept and provide the details of the development and deployment of a communication-based mixed reality application for PwA in the Indian context. For this purpose, we generated 20 distinct communication scenarios and their scripts. These scenarios were implemented into the Mixed Reality environment with the help of a hired technical team. RESULTS: The 20 scenarios were successfully developed and deployed into the Mixed Reality environment for the purpose of communication intervention for PwA. The program consists of a web-based admin panel (for SLPs) and a Mixed Reality application (for the PwA). CONCLUSIONS: The MiRAR program is expected to foster the delivery of speech-language therapy in a meaningful, controlled and simulated environments by the SLPs, thus alleviating the practical restraints of conventional clinical setups. The clinical trial of this intervention program is planned in the next phase of this ongoing project.

A Novel Mental Health Curriculum Pilot for Pediatric Cardiology Fellows: Preparing the Subspecialist to Expand the Team.

Mental health (MH) is an important, yet understudied area of care for patients with congenital heart disease (CHD). Pediatric subspecialty fellows believe MH should be within their scope of practice, but few feel confident in their ability to appropriately screen, evaluate, manage, and make treatment referrals for youth with CHD and concurrent MH concerns. A 6-session, didactic-based curriculum was designed by an interprofessional team of experts. It was administered to pediatric cardiology fellows over 9months during two academic years. Topics included the following: Introduction to MH and CHD, MH Screening and Clinic-Based Interventions, Psychopharmacology, Delirium, Trauma-Informed Care, and Adult CHD and Transitional Care. An investigator-designed survey was developed to assess fellow comfort with MH knowledge, screening, and treatment recommendation domains. Twenty-three fellows participated with 14 completing the pre-post survey (58% participation, 11/17 in year 1, 3/6 in year 2). Most participants were in their first year of training (9/14, 57%). Overall, fellow comfort with MH topics increased significantly (mean score 2.89 ± 0.46 vs. 3.4 ± 0.4, p = 0.0005), with improved comfort in the MH knowledge (p = 0.003) and treatment recommendation domains (p = 0.001). A didactic-based MH curriculum improves the comfort of pediatric cardiology fellows to address the MH concerns of their patients. The topics in this curriculum will continue to be refined over time and could be generalized to training programs, both nationally and across pediatric specialties, to improve MH care for high-risk populations.

Evaluating A Multicomponent Chronic Disease Management Pilot Intervention among Korean Patients with Hypertension and Diabetes.

A local clinic-based chronic disease management intervention including care planning, education about disease management, monitoring, and evaluation of the achievement of objects was introduced in Korea in 2019. We evaluated the effect of the intervention on medication adherence in patients with hypertension and diabetes. In 2019, a one-year retrospective case-control group study design was performed using data from the National Health Insurance Service in Korea. Propensity score matching was used to control for selection bias. Medication adherence, calculated by medication possession rate, was the dependent variable. We conducted multivariate logistic regression analyses to examine the association between participation in the intervention and medication adherence, adjusting for covariates. A control group was set as a reference for participation in the full/partial component intervention. The proportions of participants in the full component intervention in the experimental group were 43.2% and 42.6% for patients with hypertension or diabetes, respectively. Both these groups tended to be more medication adherent than their counterparts (hypertension OR: 1.23, 95% CI 1.03-1.45, diabetes OR: 1.64, 95% CI: 1.24-2.17). Institutionalizing a comprehensive chronic disease management program using multidisciplinary teams in the primary care context is crucial. Also, it is necessary to refine reimbursement payment systems.

How Can Large Language Models Enable Better Socially Assistive Human-Robot Interaction: A Brief Survey

Socially assistive robots (SARs) have shown great success in providing personalized cognitive-affective support for user populations with special needs such as older adults, children with autism spectrum disorder (ASD), and individuals with mental health challenges. The large body of work on SAR demonstrates its potential to provide at-home support that complements clinic-based interventions delivered by mental health professionals, making these interventions more effective and accessible. However, there are still several major technical challenges that hinder SAR-mediated interactions and interventions from reaching human-level social intelligence and efficacy. With the recent advances in large language models (LLMs), there is an increased potential for novel applications within the field of SAR that can significantly expand the current capabilities of SARs. However, incorporating LLMs introduces new risks and ethical concerns that have not yet been encountered, and must be carefully be addressed to safely deploy these more advanced systems. In this work, we aim to conduct a brief survey on the use of LLMs in SAR technologies, and discuss the potentials and risks of applying LLMs to the following three major technical challenges of SAR: 1) natural language dialog; 2) multimodal understanding; 3) LLMs as robot policies.

Mhealth interventions to improve public knowledge of HPV-associated oral cancer in the UK

In the UK, the age-standardised incidence rates of cancers of the ‘oropharynx’and ‘lip and oral cavity’ are ‘2.6%’ and ‘4.9%’ respectively.These indicate a significant oral cancer burden. These are attributable tonumerous risk factors; the major risk factors include tobacco use, alcoholconsumption, and exposure to oral HPV infection. Though, significantsuccess in reducing the prevalence of most of the major risk factorshas been recorded, exposure to HPV infection still remains a majordriver of oral cancer prevalence in the UK. HPV-associated oropharyngealcancer prevalence in men and women is 6.29 and 2.04%, respectively,while prevalence for HPV-associated oral cavity cancer in menand women is 11.7 and 6.95%, respectively; and it is projected to overtakecervical cancer by the year 2025. This is mainly due to exposure tooral HPV infection through oral sex practice as over 63% of UK youngadults are found to have a history of oral sex practice. Only a minorityof the UK population is aware of HPV-associated oral cancer whichcalls for more public health efforts to increase knowledge on the role ofHPV in oral cancer. While the use of technology-based, clinic-based,and community-based interventions has been employed to improvepublic knowledge on the role of HPV in oral cancer development, technology-based interventions have not been adequately explored. Mhealthapplication-based interventions have been previously employed toimprove knowledge and behavioural change in diverse chronic diseases.Hence, our recommendation on the adoption of Mhealth application-based intervention strategy in the education of the UK’s populationon HPV-associated oral cancer is highly desirable as it closelyaligns with the country’s National Health Service (NHS) commitmenttowards the digital transformation of the healthcare system.

Abstract PO2-12-03: Home-based Resistance Exercise Improves Fatigue and Functional Strength in Female Breast Cancer Survivors Post Chemotherapy

Abstract Introduction: Chemotherapy is associated with an increase in fatigue and loss of strength in female breast cancer (BCa) survivors. Strength training has been found to reverse these effects, however, the COVID pandemic added a complexity to clinic-based exercise intervention. The purpose of this study is to determine if a home-based resistance exercise program can attenuate these debilitating effects in a cohort of breast cancer survivors that have recently completed chemotherapy. Methods: Ten BCa survivors who completed chemotherapy within the previous 6 months were recruited to participate in a 12-week home-based resistance exercise proof of concept study. Exercise was performed 3 times per week, supervised via Zoom. Participants completed 2-3 sets of upper body and lower body exercises to volitional fatigue. Self-reported fatigue was measured using the respective subscale from the EORTC QLQ-C30. Strength was measured using hand grip dynamometry and isometric leg strength. Physical function was measured using the 6-minute walk test. Assessments were completed at baseline and end of study. As a comparison, age matched controls (AMCs) were recruited to complete cross-sectional analysis of each of these variables. A one-way analysis variance was done with Tukey’s post hoc test. Significance was set at p< 0.05. Results: BCa survivors were 46.4 ± 12.5 years old with a BMI of 28.11 ± 5.25. AMCs were 50.3 ±13.3 years old with a BMI of 30.8 ± 5.8. There was no significant difference in patient characteristics. A significant difference in self-reported fatigue was found between groups (F=18.52; p< 0.0001). Post hoc analysis found significant difference in fatigue between BCa survivors at baseline (48 ± 23) and the age matched controls (p< 0.0001). Exercise was able to significantly reduce fatigue in BCa survivors (21 ± 15; p=0.003) to levels not significantly different to AMCs (3.3 ± 7.5). A significant difference was also observed between groups for right-hand grip strength (F= 4.923; p=0.015) and left-hand grip strength (F=8.685, p=0.001). Post hoc analysis found a significant increase in right hand grip strength in the BCa survivor group following the intervention (p=0.012). Left hand grip strength was found to be significantly lower at baseline than AMCs (p=0.048). Left hand grip strength was significantly increased in BCa survivors at end of study (p< 0.001). Finally, a significant difference was observed between groups for isometric leg strength (F= 3.699; p=0.038). Post hoc analysis found a significant difference in leg strength in the BCa survivor group following intervention (pre: 105.9 ± 50.6 N-M; post: 158.4 ± 13.2 N-M; p=0.030) which was 16.5% higher than AMCs (127.4 ± 36.5 N-M). No significant difference was found in 6-minute walk distance. However, there was a 21% increase in the distance walked for BCa survivors after interventions (pre: 441.2 ± 66.5m; post: 501.4 ± 123m), identical to distances walked by AMCs (501.4 ± 90.8m). Conclusion: The results of our study suggest that a virtually supervised resistance exercise program can attenuate the negative effects of chemotherapy in BCa survivors to levels similar to their peers that never had breast cancer. Further research using powered sample sizes is needed to validate these results. Citation Format: Taylor Moncrief, Crisann Moon, Angela Gonzalez, Allison Stepanenko, Tiffany Cortes, Darpan Patel. Home-based Resistance Exercise Improves Fatigue and Functional Strength in Female Breast Cancer Survivors Post Chemotherapy [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO2-12-03.

Negative clinic experiences as a barrier to care for people with HIV and their impact on patient preferences for intervention support: a qualitative study in Cape Town, South Africa

ABSTRACT We conducted qualitative research among people with HIV (PWH) and care providers in Cape Town, South Africa to understand the impact of negative clinic experiences on adherence and support preferences. In-depth interviews were conducted with 41 patients with an unsuppressed viral load or a treatment gap, and focus group discussions with physicians, nurses, counselors, and community health workers. Questions addressed treatment history and adherence barriers, then participants evaluated evidence-based adherence interventions for potential scale up. Inductive analysis examined care experiences and corresponding preference for intervention options. More than half of PWH described negative experiences during clinic visits, including mistreatment by staff and clinic administration issues, and these statements were corroborated by providers. Those with negative experiences in care stated that fear of mistreatment led to nonadherence. Most patients with negative experiences preferred peer support groups or check-in texts to clinic-based interventions. We found that PWH’s negative clinic experiences were a primary reason behind nonadherence and influenced preferences for support mechanisms. These findings emphasize the importance of HIV treatment adherence interventions at multiple levels both in and outside of the clinic, and providing more comprehensive training to providers to better serve PWH in adherence counseling, especially those who are most vulnerable..

Therapy Dogs in the Dialysis Clinic: A Qualitative Study Examining Hemodialysis Patients’ Attitudes Toward an Animal-Assisted Intervention

ABSTRACT Hemodialysis (HD) is a burdensome clinical process that demands frequent and long visits to the clinic every week indefinitely, yet strict adherence to its regimen is paramount to overall health and wellbeing. Effective approaches are needed to not only reduce patients’ rates of missed treatments but also ease the overall burden and stress associated with long-term HD use. The purpose of this qualitative study was to explore HD patients’ attitudes toward a clinic-based animal-assisted intervention (AAI) to build an understanding of its perceived fit within this novel setting, as well as how this intervention could improve their treatment adherence. Patients from four outpatient clinics engaged in one-on-one, in-depth semi-structured interviews that were audio-recorded and transcribed verbatim. Within a framework of iterative thematic analysis, the Matrix Method was utilized in combination with line-by-line coding to thematically analyze data. A total of 20 patients (age M = 57, SD = 7.93) participated. Results are reflected in four main themes: (1) The dread and suffering of endless treatment; (2) Yearning for the presence of therapy dogs at the clinic; (3) Therapy dogs can aid in the internal battle of treatment adherence; (4) The logistics of incorporating therapy dogs into HD care routine. Participants’ narratives collectively illustrate the perceived value of AAI in the HD clinic setting. This study improves not only our understanding of how HD patients perceive clinic-based therapy-dog visits but also offers helpful insights for implementing this intervention in future research. Incorporating therapy dogs into HD patients’ healthcare routine may offer an innovative approach to improving patient outcomes, and the results of this study are a compelling prompt to empirically investigate the role of AAI in HD treatment adherence.

Effect of clinic-based and telemonitored home-based intervention on pain intensity, functioning and quality of life in patients with knee osteoarthritis

Introduction and aim. The study assessed and compared the effects of clinic-based and telemonitored home-based interventions on pain intensity, functioning and quality of life in patients with knee osteoarthritis (KOA). Material and methods. Forty-two patients were recruited purposely and randomly allocated into clinic-based (CBG) and telemonitored home-based group (THG) equally. The CBG and THG received isometric exercises to strengthen the quadriceps and hamstring muscles using theraband. THG received the exercise at home they were monitored on phone thrice in a week, while the CBG did the exercise in the hospital. The subjects performed four sets of eight repetitions three days in a week for eight weeks. Pain intensity, functioning and health related quality of life (HRQoL) were assessed at pretreatment, 6th and 8th week of intervention. Data was analyzed with descriptive and inferential statistics. Alpha level was set at 0.05. Results. There was a significant reduction (p<0.001) among pre-treatment, 6th and 8th week intervention in pain intensity, functional pain intensity and quality of life of CBG and THG. CBG showed significant reduction (p<0.001) in pain intensity, function and increase in HRQoL than THG at 8th week. Conclusion. Clinic-based and telemonitored home-based interventions were both effective in the management of KOA but clinic-based intervention was better than telemonitored home-based intervention.

Primary Care and Community-Based Partnerships to Enhance HPV Vaccine Delivery.

With growing vaccination misinformation and mistrust, strategies to improve vaccination communication across community-based settings are needed. The Rural Adolescent Vaccine Enterprise (RAVE), a 5-year (2018-2022) stepped-wedge cluster randomized study, tested a clinic-based practice facilitation intervention designed to improve HPV vaccination. An exploratory aim sought to explore the use of partnerships between primary care clinics and a community partner of their choosing, to implement a social marketing campaign related to HPV immunization. We assessed perceptions about the value and success of the partnership, and barriers and facilitators to its implementation using a 29-item community partner survey, key informant interviews, and field notes from practice facilitators. Of the initial 45 clinics participating in RAVE, 9 were unable to either start or complete the study, and 36 participants (80.0%) were actively engaged. Of these, 16/36 clinics (44.4%) reported establishing successful partnerships, 10 reported attempting to develop partnerships (27.8%), and another 10 reported not developing a partnership (27.8%), which were often caused by the COVID-19 pandemic. The most common partnership was with public health departments at 27.3%. Other partnerships involved libraries, school districts, and local businesses. More than half (63.7%) reported that creating messages regarding getting HPV vaccination was moderately to very challenging. Just under half reported (45.5%) that messaging was hard because of a lack of understanding about the seriousness of diseases caused by HPV, parents being against vaccines because of safety concerns, and religious values that result in a lack of openness to HPV vaccines. Community partners' health priorities changed as a result of RAVE, with 80% prioritizing childhood immunizations as a result of the RAVE partnership. Community groups want to partner with primary care organizations to serve their patients and populations. More research is needed on how best to bring these groups together.

A Brief Digital Screening and Intervention Tool for Parental and Adolescent Tobacco and Electronic Cigarette Use in Pediatric Medical Care in Canada: Protocol for a Pilot Randomized Controlled Trial.

Though rates of tobacco smoking have decreased consistently over the past 3 decades, cigarette use remains the top preventable cause of premature death in North America. The Clinical Effort Against Secondhand Smoke Exposure (CEASE) is a medical clinic-based intervention that systematically screens parents for tobacco use and offers them direct access to evidence-based smoking cessation services. While the effectiveness of CEASE for parents who smoke has already been demonstrated in the United States, the CEASE model has not yet been tested in Canada, among parents who use e-cigarettes, or among adolescents who use cigarettes and e-cigarettes. We aim to demonstrate the feasibility and evaluate the preliminary effectiveness of the CEASE program for parental smoking cessation and its adapted version for adolescent smoking cessation and adolescent and parental vaping cessation. We will approach parents or guardians of children aged between 0 and 17 years, as well as adolescent patients aged between 14 and 17 years, from a tertiary care pediatric hospital in Montreal, Quebec, Canada, for participation in this single-blinded, pilot randomized controlled trial. Eligible participants are those who report using tobacco cigarettes or e-cigarettes at least once in the last 7 days and present to an outpatient pediatric clinic for a scheduled appointment. Our recruitment target is 100 participants: 50 parents or guardians of children aged 17 years or younger, and 50 adolescents aged between 14 and 17 years. The feasibility of implementation of the CEASE model will be measured by recruitment and retention rates for all 4 participant groups (stratified as follows: parents who use cigarettes, parents who use e-cigarettes exclusively, adolescents who use cigarettes, and adolescents who use e-cigarettes exclusively). Parent and adolescent participants within each group are randomized to the intervention and control groups using a 1:1 ratio through a computer-generated randomization list. Preliminary effectiveness outcomes include self-reported smoking and e-cigarette cessation, use of cessation resources, changes in smoking and e-cigarette use, motivation to quit, and quit attempts among participants. Participants complete electronic questionnaires on a tablet in the clinic at baseline as well as electronic follow-up questionnaires at 1, 3, and 6 months. Individuals reporting successful quit attempts are invited to provide a urine sample for cotinine testing to biochemically confirm quit. Analyses include descriptive statistics as well as exploratory trajectory analyses of smoking, e-cigarette use, and motivation to quit. Research activities began in June 2022. Participant enrollment and data collection began in February 2023 and are expected to be completed in 15 months. There is a strong need for effective and cost-effective smoking and vaping cessation interventions for parents and adolescents. If successful, this study will help inform the preparation of a fully powered randomized controlled trial of CEASE in Canada in these populations. Clinicaltrials.gov NCT05366790; https://www.clinicaltrials.gov/study/NCT05366790. DERR1-10.2196/47978.

Pilot Test of Mopati, a Multi-Level Adherence Intervention for People Living with HIV and Their Treatment Partners in Botswana

BackgroundLow-cost, scalable strategies are necessary to reach the UNAIDS 2030 target of ending HIV as a public health threat. Use of treatment partners, informal caregivers selected by people living with HIV to support antiretroviral therapy adherence, is one such strategy that is included in many countries’ HIV guidelines, including Botswana, a country with high HIV prevalence.MethodFrom June 2021 to June 2022, we pilot tested a clinic-based treatment partner intervention (“Mopati”), including standardized language for providers to guide patients on treatment partner selection and workshops to train treatment partners on providing non-directive support to patients using a non-confrontational, non-judgmental approach. Sixty unsuppressed patients (30 per clinic) and 45 treatment partners (17 intervention, 28 control) were recruited from an intervention–control clinic matched-pair in Gaborone, Botswana.ResultsMopati had medium-to-large effects on increasing patients’ adherence, adherence self-efficacy, intrinsic adherence motivation, and perceived non-directive support from treatment partners, and decreasing treatment partner caregiver burden. Aggregate viral suppression rates significantly increased in the intervention (vs. control) clinic. Qualitative data from 14 clinic staff, 21 patients, and 16 treatment partners indicated that Mopati was viewed as effective. Providers said the guidance empowered them to be proactive in communicating about adherence; most reported using the guidance.ConclusionThis study shows preliminary support for the use of treatment partners in HIV care, and further evidence for interventions that leverage patients’ existing support. This research can inform ways to improve adherence to HIV treatment as well as the treatment of HIV-related comorbid conditions in lower-resource settings.Trial RegistrationClinicalTrials.gov Identifier: NCT04796610.

Home- versus clinic-based exercise intervention in patients with heart failure (EXIT-HF trial): a pragmatic randomized controlled trial

Abstract Background The limited accessibility partially explains the low uptake of cardiac rehabilitation (ExCR) for heart failure (HF). Home-based programs might address those obstacles but few data from randomized trials are available. Purpose To compare the effectiveness of a home-based versus clinic-based ExCR intervention in HF patients. Methods Single-center, single-blind, parallel groups, non-inferiority pragmatic randomized control trial (1:1 and after COVID-19 2:1 home- vs clinic-based). Adult HF patients referred to our cardiac rehabilitation (CR) unit were randomized to either a clinic-based (24 supervised sessions at a CR unit of a tertiary hospital over 12 weeks) or home-based (4 supervised ExT sessions to familiarize with the training protocol and the remaining sessions continued at home) over 12 weeks. Exercise training protocol consisted of a combination of endurance (at 60%-80% of peak oxygen uptake [VO2peak] and resistance training (elastic bands). The primary endpoint was the change in VO2peak at the end of the 12-week program. Secondary outcomes included adherence (>80% of sessions attendance) and change of Minnesota Living with HF Questionnaire (MLHFQ) scores. Results 120 patients (mean age 64±11 years; 64% men) were randomized: 44 to clinic- and to 76 home-based intervention. 41% had an ischemic cardiomyopathy, 27% had an ICD/CRT, the mean LVEF was 36±11% (62% had LVEF <40%), 73% were on NYHA class II, and the median NT-proBNP was 361 [IQR 170-1008] ng/mL. Intervention groups were well balanced, including basal VO2peak that was similar between groups (17.8±4.8 vs 18.1±5.2 mL/min/Kg; p=0.75). Adherence was similar between groups (87.5% vs 82.5%; p=0.50). At week 12, on average, patients increased VO2 peak by 0.9±2.5 mL/min/Kg compared to baseline (p<0.001). No significant differences were found between clinic- and home-based interventions (p=0.25). Consistently, the MLHFQ total score decreased significantly overall (-10.3±1.7 points; p<0.001), with no significant differences between groups (p=0.91). The drop-out rate was 14% and 17% in clinic- and home-based groups, respectively. Conclusions The clinical impact of home-based CR program on peakVO2 and health-related quality of life of HF patients was similar to a standard supervised clinic-based one. Our data support the home-based program as an effective alternative way of delivering CR in HF.

Abstract 16805: A Mental Health Curriculum for Pediatric Cardiology Fellows: Increasing Preparedness of Pediatric Cardiologists to Meet the Needs of Patients at Increased Risk

Introduction: Mental health (MH) is an important yet understudied area of care for patients with congenital heart disease (CHD). It is known that children and adults with CHD have increased incidence of MH disorders when compared to their peers. MH disorders are not reliably identified in the pediatrics population at large, and many children who would benefit from treatment of MH conditions do not receive appropriate care. Pediatric subspecialty fellows feel MH should be within their scope, but few feel competent in their ability to appropriately screen and make treatment referrals. Research Question: Does a didactic-based MH curriculum improve the preparedness of pediatric cardiology fellows to identify and refer patients at need for MH care? Aims: Determine the comfort of pediatric cardiology fellows with MH knowledge, screening, and treatment recommendations, before and after a didactic- based curriculum. Methods: A 9 session didactic based curriculum was designed by a multi-disciplinary team of experts, administered over 9 months (September 2021 - June 2022 and September 2022 - June 2023). Topics included MH and CHD Overview, MH Screening and Clinic-Based Interventions, Psychopharmacology, Delirium, Substance Abuse, Trauma-Informed Care, and Adult CHD and Transitional Care. An investigator designed survey was developed to assess fellow comfort with MH knowledge, screening, and treatment recommendation domains, and was administered at the beginning and end of the curriculum in each academic year. Results: 24 fellows participated over 2 academic years, 14 completed the pre-post survey (11/17 in year 1, 3/6 in year 2). Most participants were in their first year of training (9/14, 57%). Overall, fellow comfort with MH topics increased significantly (mean score 2.89±0.46 vs. 3.4±0.4, p = 0.0005), with improved comfort in the MH knowledge and treatment recommendation domains (p = 0.003 and p = 0.001). Conclusion: A didactic based MH curriculum improves the comfort and preparedness of pediatric cardiology fellows to address MH concerns of their patients. This curriculum will continue to be refined in topics over time but could be generalized to training programs nationally and across pediatric specialties to improve MH care for high-risk patients.

Evaluating the acceptability, usability, and feasibility of a clinic-based genetic testing risk assessment intervention in Black women with breast cancer.

436 Background: Black women diagnosed with breast cancer utilize genetic counseling and testing services less often than White women despite these services having the potential to personalize medical management of breast cancer and identify family members for cascade testing. Lower rates of provider recommendations may be a driver of these disparities, as uptake does not appear to differ by race. The objective of this study was to evaluate the acceptability, usability, and feasibility of a clinic-based genetic risk assessment to facilitate provider recommendations for genetic testing in Black women diagnosed with breast cancer. Methods: A clinic-embedded, race-concordant, trained navigator administered a 15-minute screening tool based on National Comprehensive Cancer Network genetic testing criteria to English-speaking, Black women ≥18 and newly diagnosed with breast cancer. A copy of the results were given to the treating surgeon to facilitate consideration of genetic testing for the patient. However, the decision to recommend genetic testing was left to discretion of the surgeon. After enrollment completion, we conducted semi-structured interviews with a subsample of patients and surgeons who participated in the intervention to elicit their perspectives and experiences. We also used medical record data to determine if surgeons recommended genetic testing to participating patients, and if so, whether they completed it. Results: Between January 2022 and April 2023, 37 patients with a median age of 56.9 years (IQR 15.0-37.5) consented to participate. Surgeons recommended genetic testing to 25/37 patients and 5/37 additional patients were referred outside of this intervention (81.1% total). 12/37 patients (including those who were and were not recommended genetic testing) and 4/4 surgeons completed follow-up interviews. For clinician usability and acceptability, surgeons reported little to no negative impact on their clinic flow. While some found the intervention to be a helpful reminder, others shared it made no discernible impact on their practice, as they reported already incorporating a similar system into their clinic flow. For patient usability and acceptability, some patients found questions on the screening tool difficult to answer and expressed feeling overwhelmed at the time it was administered but the navigator was comforting, reassuring, and informative. Patients, surgeons, and the navigator recommended administering the screening tool prior to the initial appointment with the surgeon and ensuring follow up with patients regarding results. Conclusions: Participating patients and surgeons found this intervention to be feasible and acceptable. Usability challenges warrant further exploration into the logistics of the intervention, including timing, delivery, and medium.

“A Ray of Hope”: A Qualitative Study of Hemodialysis Patients' Attitudes Toward a Clinic-Based Animal-Assisted Intervention

“A Ray of Hope”: A Qualitative Study of Hemodialysis Patients' Attitudes Toward a Clinic-Based Animal-Assisted Intervention