Browsing by Author "Bosworth, Hayden B"

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    ItemOpen Access
    A Combined Patient and Provider Intervention for Management of Osteoarthritis in Veterans: A Randomized Clinical Trial.
    (Annals of internal medicine, 2016-01) Allen, Kelli D; Yancy, William S; Bosworth, Hayden B; Coffman, Cynthia J; Jeffreys, Amy S; Datta, Santanu K; McDuffie, Jennifer; Strauss, Jennifer L; Oddone, Eugene Z

    Background

    Management of osteoarthritis requires both medical and behavioral strategies, but some recommended therapies are underused.

    Objective

    To examine the effectiveness of a combined patient and provider intervention for improving osteoarthritis outcomes.

    Design

    Cluster randomized clinical trial with assignment to osteoarthritis intervention and usual care groups. (ClinicalTrials.gov: NCT01130740).

    Setting

    Department of Veterans Affairs Medical Center in Durham, North Carolina.

    Participants

    30 providers (clusters) and 300 outpatients with symptomatic hip or knee osteoarthritis.

    Intervention

    The telephone-based patient intervention focused on weight management, physical activity, and cognitive behavioral pain management. The provider intervention involved delivery of patient-specific osteoarthritis treatment recommendations to primary care providers through the electronic medical record.

    Measurements

    The primary outcome was total score on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at 12 months. Secondary outcomes were WOMAC function and pain subscale scores, physical performance (Short Physical Performance Battery), and depressive symptoms (Patient Health Questionnaire-8). Linear mixed models that were adjusted for clustering of providers assessed between-group differences in improvement in outcomes.

    Results

    At 12 months, WOMAC scores were 4.1 points lower (indicating improvement) in the osteoarthritis intervention group versus usual care (95% CI, -7.2 to -1.1 points; P = 0.009). WOMAC function subscale scores were 3.3 points lower in the intervention group (CI, -5.7 to -1.0 points; P = 0.005). WOMAC pain subscale scores (P = 0.126), physical performance, and depressive symptoms did not differ between groups. Although more patients in the osteoarthritis intervention group received provider referral for recommended osteoarthritis treatments, the numbers who received them did not differ.

    Limitation

    The study was conducted in a single Veterans Affairs medical center.

    Conclusion

    The combined patient and provider intervention resulted in modest improvement in self-reported physical function in patients with hip and knee osteoarthritis.

    Primary funding source

    Department of Veterans Affairs, Health Services Research and Development Service.
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    A Comparison of the effect of patient-specific vs. weight-based protocols to treat vaso-occlusive episodes (VOE) in the emergency department.
    (Academic emergency medicine : official journal of the Society for Academic Emergency Medicine, 2023-09) Tanabe, Paula; Ibemere, Stephanie; Pierce, Ava E; Freiermuth, Caroline E; Bosworth, Hayden B; Yang, Hongqui; Osunkwo, Ifeyinwa; Paxton, James H; Strouse, John J; Miller, Joseph; Paice, Judith A; Veeramreddy, Padmaja; Kavanagh, Patricia L; Wilkerson, R Gentry; Hughes, Robert; Barnhart, Huiman X

    Background

    Vaso-occlusive episodes (VOC) cause debilitating pain and are a common cause of emergency department (ED) visits, for people with sickle cell disease (SCD). Strategies for achieving optimal pain control vary widely despite evidence-based guidelines. We tested existing guidelines and hypothesized a patient-specific protocol (PSP) written by their SCD provider, may be more effective than weight-based (WB) dosing of parenteral opiate medication, in relieving pain.

    Methods

    Prospective, randomized controlled trial comparing a PSP versus WB protocol for patients presenting with VOC to six EDs. Patients were randomized to a PSP or WB protocol prior to an ED visit. SCD provider wrote their protocol and placed in the electronic health record for future ED visits with a VOC Exclusion criteria included: pre-existing PSP excluding parenteral opioid analgesia or out-patient use of buprenorphine or methadone, or highly suspected for COVID-19. Pain intensity scores, side effects and safety were obtained every 30 minutes for up to 6 hours post-ED bed placement. The primary outcome was change in pain intensity score from placement in an ED space to disposition or six hours.

    Results

    328 subjects were randomized, 104 participants enrolled (ED visit, target n=230) with complete data for 96 visits. The study was unable to reach the target sample size and stopped early due to the impact of COVID-19. We found no significant differences between groups in the primary outcome; patients randomized to a PSP had a shorter ED length of stay (p=.008); the prevalence of side effects was low in both groups. Subjects in both groups experienced both a clinically meaningful and statistically significant decrease in pain (27 mm on a 0-100 mm scale) CONCLUSIONS: We found a shorter ED length of stay for patients assigned to a PSP. Patients in both groups experienced good pain relief without significant side effects.
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    ItemOpen Access
    A feasibility study to develop and test a Spanish patient and provider intervention for managing osteoarthritis in Hispanic/Latino adults (PRIMO-Latino).
    (Pilot and feasibility studies, 2018-01) Corsino, Leonor; Coffman, Cynthia J; Stanwyck, Catherine; Oddone, Eugene Z; Bosworth, Hayden B; Chatterjee, Ranee; Jeffreys, Amy S; Dolor, Rowena J; Allen, Kelli D

    Background

    Arthritis affects approximately 50 million adults in the USA. Hispanics/Latinos have a higher prevalence of arthritis-attributed activity limitations primarily related to osteoarthritis (OA). Hispanic/Latinos are less likely to receive hip replacement independent of health care access, and they are less likely to receive knee replacement. There have been few interventions to improve OA treatment among the Hispanic/Latino population in the USA. In our study, we aimed to develop and test a telephone delivered culturally appropriate Spanish behavioral intervention for the management of OA in Hispanic/Latino adults.

    Methods

    We conducted a feasibility study in an academic health center and local community in Durham, North Carolina. We enrolled self-identified Spanish speaking overweight/obese adults (≥ 18) with OA of the knee and/or hip under the care of a primary health care provider. The 12-month patient intervention focused on physical activity, weight management, and cognitive behavioral pain management skills. The patient intervention was delivered via telephone with calls scheduled twice per month for the first 6 months, then monthly for the last 6 months (18 sessions). The one-time provider intervention included delivery of patient-specific OA treatment recommendations, based on patients' baseline data and published guidelines. The primary measures were metrics of feasibility, including recruitment and intervention delivery. We also assessed pain, stiffness, and function using the Spanish-Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).

    Results

    A total of 1879 participants were identified for potential enrollment. Of those, 1864 did not meet inclusion criteria, were not able to be reached or refused. Fifteen participants enrolled in the intervention. The mean number of phone calls completed was 14.7. Eighty percent completed more than 16 calls. The mean WOMAC baseline score (SD) was 39 (20); mean improvement in WOMAC scores between baseline and 12 months, among 11 participants who completed the study, was - 13.27 [95% CI, - 25.09 to - 1.46] points.

    Conclusion

    Recruitment of Hispanics/Latinos, continues to be a major challenge. A Spanish-based telephone delivering lifestyle intervention for OA management in Hispanic/Latino adults is feasible to deliver and may lead to improved OA symptoms. Future research is needed to further test the feasibility and effectiveness of this type of intervention in this segment of the population.

    Trial registration

    NCT01782417.
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    ItemOpen Access
    A health literacy pilot intervention to improve medication adherence using Meducation® technology.
    (Patient education and counseling, 2014-05) Zullig, Leah L; McCant, Felicia; Melnyk, S Dee; Danus, Susanne; Bosworth, Hayden B

    Objective

    To determine whether antihypertensive medication adherence could improve using a Meducation® technology health literacy intervention.

    Methods

    We conducted a six-month feasibility study among patients with cardiovascular disease (CVD) risk factors receiving care from hospital-based primary care clinics. All patients received a personalized Meducation® calendar listing CVD-related medications. We evaluated changes in medication adherence and clinical outcomes at six months.

    Results

    There was a 42% enrollment rate (n=23). Forty percent had low health literacy, defined as less than 9th grade reading level. At three months, self-reported medication adherence improved. At six months, medication possession ratio improved 3.2%. Also, at six months there were decreases in patients' average systolic blood pressure (0.5 mmHg), diastolic blood pressure (1.5 mmHg), and body weight (3.6 pounds) (p>0.05).

    Conclusions

    A health literacy intervention may be a feasible mechanism to improve cardiovascular-related medication adherence and outcomes.

    Practice implications

    Health literacy interventions may improve adherence while requiring relatively few resources to implement.
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    ItemOpen Access
    A multilevel mHealth intervention boosts adherence to hydroxyurea in individuals with sickle cell disease.
    (Blood advances, 2023-09) Hankins, Jane S; Brambilla, Donald; Potter, Michael B; Kutlar, Abdullah; Gibson, Robert; King, Allison A; Baumann, Ana A; Melvin, Cathy; Gordeuk, Victor R; Hsu, Lewis L; Nwosu, Chinonyelum; Porter, Jerlym S; Alberts, Nicole M; Badawy, Sherif M; Simon, Jena; Glassberg, Jeffrey A; Lottenberg, Richard; DiMartino, Lisa; Jacobs, Sara; Fernandez, Maria E; Bosworth, Hayden B; Klesges, Lisa M; Shah, Nirmish
    Hydroxyurea reduces sickle cell disease (SCD) complications, but medication adherence is low. We tested two mobile health (mHealth) interventions targeting determinants of low adherence among patients (InCharge Health) and low prescribing among providers (HU Toolbox) in a multi-center non-randomized trial of individuals with SCD ages 15-45. We compared the percentage of days covered (PDC), labs, healthcare utilization, and self-reported pain over 24 weeks of intervention and 12 weeks post-study with a 24-week pre-intervention interval. We enrolled 293 patients (51% male; median age 27.5 years, 86.8% HbSS/HbSβ0-thalassemia). The mean change in PDC among 235 evaluable subjects increased (39.7% to 56.0%; p<0.001) and sustained (39.7% to 51.4%, p<0.001). Mean HbF increased (10.95% to 12.78%; p=0.03). Self-reported pain frequency fell (3.54 to 3.35 events/year; p=0.041). InCharge Health was used >or=1 day by 199 of 235 participants (84.7% implementation; median usage: 17% study days; IQR: 4.8-45.8%). For individuals with >or=1 baseline admission for pain, admissions per 24 weeks declined from baseline through 24 weeks (1.97 to 1.48 events/patient, p=0.0045) and weeks 25-36 (1.25 events/patient, p=0.0015). PDC increased with app use(p<0.001), with the greatest effect in those with private insurance (p=0.0078), in older subjects (p=0.033), and those with lower pain interference (p=0.0012). Of the 89 providers (49 hematologists, 36 advanced care providers, four unreported), only 11.2% used HU Toolbox >or=1/month on average. This use did not affect change in PDC. Tailoring mHealth solutions to address barriers to hydroxyurea adherence has the potential to improve adherence and provide clinical benefits. A definitive randomized study is warranted.
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    ItemOpen Access
    A protocol to evaluate the efficacy, perceptions, and cost of a cholesterol packaging approach to improve medication adherence.
    (Contemporary clinical trials, 2014-09) Zullig, Leah L; Pathman, Joshua; Melnyk, S Dee; Brown, Jamie N; Sanders, Linda L; Koropchak, Celine; Howard, Teresa; Danus, Susanne; McCant, Felicia; Bosworth, Hayden B

    Purpose

    Elevated low-density lipoprotein cholesterol (LDL-C) is a major modifiable risk factor for cardiovascular disease (CVD), a leading cause of death in the United States. Despite clinical practice guidelines aimed at facilitating LDL-C control, many Veterans do not achieve guideline-recommended LDL-C levels.

    Methods

    We describe a study focused on VA healthcare system users at risk for CVD (i.e., LDL-C level >130 mg/dl and/or <80% cholesterol pill refill adherence in the last 12 months). We are conducting a two and a half year randomized controlled trial (i.e., intervention administered over 12 months) among Veterans with uncontrolled cholesterol receiving care at select VA-affiliated primary care clinics in North Carolina. We anticipate enrolling 250 diverse patients (10% women; 40% African American). Patients are randomized to an educational control group or intervention group. Intervention group participants' medication is provided in special blister packaging labeled for daily use that includes reminders; MeadWestvaco Corporation's pre-filled DosePak® contains standard doses of statins in accordance with the existing prescriptions.

    Conclusions

    Pre-filled blister packaging may provide an inexpensive solution to improve medication adherence. Our study enrolls a diverse sample and provides information about whether an adherence packaging intervention can: 1) improve medication adherence; 2) improve patients' LDL-C levels; 3) be well received by patients and providers; and 4) provide a cost effective solution to improve medication adherence.
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    ItemOpen Access
    A qualitative study of facilitators of medication adherence in systemic lupus erythematosus: Perspectives from rheumatology providers/staff and patients.
    (Lupus, 2024-01) Herndon, Shannon; Corneli, Amy; Dombeck, Carrie; Swezey, Teresa; Clowse, Megan Eb; Rogers, Jennifer L; Criscione-Schreiber, Lisa G; Sadun, Rebecca E; Doss, Jayanth; Eudy, Amanda M; Bosworth, Hayden B; Sun, Kai

    Objective

    Systemic lupus erythematosus (SLE) disproportionately affects patients from racial and ethnic minority groups. Medication adherence is lower among these patient populations, and nonadherence is associated with worse health outcomes. We aimed to identify factors that enable adherence to immunosuppressive medications among patients with SLE from racial and ethnic minority groups.

    Methods

    Using a qualitative descriptive study design, we conducted in-depth interviews with purposefully selected (1) patients with SLE from racial and ethnic minority groups who were taking immunosuppressants and (2) lupus providers and staff. We focused on adherence facilitators, asking patients to describe approaches supporting adherence and for overcoming common adherence challenges and providers and staff to describe actions they can take to foster patient adherence. We used applied thematic analysis and categorized themes using the Capability, Opportunity, Motivation, Behavior (COM-B) model.

    Results

    We interviewed 12 patients (4 adherent and 8 nonadherent based on medication possession ratio) and 12 providers and staff. Although each patient described a unique set of facilitators, patients most often described social support, physical well-being, reminders, and ability to acquire medications as facilitators. Providers also commonly mentioned reminders and easy medication access as facilitators as well as patient education/communication and empowerment.

    Conclusion

    Using an established behavioral change model, we categorized a breadth of adherence facilitators within each domain of the COM-B model while highlighting patients' individual approaches. Our findings suggest that an optimal adherence intervention may require a multi-modal and individually tailored approach including components from each behavioral domain-ensuring medication access (Capability) and utilizing reminders and social support (Opportunity), while coupled with internal motivation through improved communication and empowerment (Motivation).
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    ItemOpen Access
    A Quantitative Framework for Medication Non-Adherence: Integrating Patient Treatment Expectations and Preferences.
    (Patient preference and adherence, 2023-01) Muiruri, Charles; van den Broek-Altenburg, Eline M; Bosworth, Hayden B; Cené, Crystal W; Gonzalez, Juan Marcos

    Introduction

    Medication non-adherence remains a significant challenge in healthcare, impacting treatment outcomes and the overall effectiveness of medical interventions. This article introduces a novel approach to understanding and predicting medication non-adherence by integrating patient beliefs, efficacy expectations, and perceived costs. Existing theoretical models often fall short in quantifying the impact of barrier removal on medication adherence and struggle to address cases where patients consciously choose not to follow prescribed medication regimens. In response to these limitations, this study presents an empirical framework that seeks to provide a quantifiable model for both individual and population-level prediction of non-adherence under different scenarios.

    Methods

    We present an empirical framework that includes a health production function, specifically applied to antihypertensive medications nonadherence. Data collection involved a pilot study that utilized a double-bound contingent-belief (DBCB) questionnaire. Through this questionnaire, participants could express how efficacy and side effects were affected by controlled levels of non-adherence, allowing for the estimation of sensitivity in health outcomes and costs.

    Results

    Parameters derived from the DBCB questionnaire revealed that on average, patients with hypertension anticipated that treatment efficacy was less sensitive to non-adherence than side effects. Our derived health production function suggests that patients may strategically manage adherence to minimize side effects, without compromising efficacy. Patients' inclination to manage medication intake is closely linked to the relative importance they assign to treatment efficacy and side effects. Model outcomes indicate that patients opt for full adherence when efficacy outweighs side effects. Our findings also indicated an association between income and patient expectations regarding the health of antihypertensive medications.

    Conclusion

    Our framework represents a pioneering effort to quantitatively link non-adherence to patient preferences. Preliminary results from our pilot study of patients with hypertension suggest that the framework offers a viable alternative for evaluating the potential impact of interventions on treatment adherence.
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    ItemOpen Access
    A randomized controlled trial comparing two vaso-occlusive episode (VOE) protocols in sickle cell disease (SCD).
    (American journal of hematology, 2018-02) Tanabe, Paula; Silva, Susan; Bosworth, Hayden B; Crawford, Regina; Paice, Judith A; Richardson, Lynne D; Miller, Christopher N; Glassberg, Jeffrey
    Limited evidence guides opioid dosing strategies for acute Sickle Cell (SCD) pain. We compared two National Heart, Lung and Blood (NHBLI) recommended opioid dosing strategies (weight-based vs. patient-specific) for ED treatment of acute vaso-occlusive episodes (VOE). A prospective randomized controlled trial (RCT) was conducted in two ED's. Adults ≥ 21 years of age with SCD disease were eligible. Among the 155 eligible patients, 106 consented and 52 had eligible visits. Patients were pre-enrolled in the outpatient setting and randomized to one of two opioid dosing strategies for a future ED visit. ED providers accessed protocols through the electronic medical record. Change in pain score (0-100 mm VAS) from arrival to ED disposition, as well as side effects were assessed. 52 patients (median age was 27 years, 42% were female, and 89% black) had one or more ED visits for a VOE (total of 126 ED study visits, up to 5 visits/patient were included). Participants randomized to the patient-specific protocol experienced a mean reduction in pain score that was 16.6 points greater than patients randomized to the weight-based group (mean difference 95% CI = 11.3 to 21.9, P = 0.03). Naloxone was not required for either protocol and nausea and/or vomiting was observed less often in the patient-specific protocol (25.8% vs 59.4%, P = 0.0001). The hospital admission rate for VOE was lower for patients in the patient-specific protocol (40.3% vs 57.8% P = 0.05). NHLBI guideline-based analgesia with patient-specific opioid dosing resulted in greater improvements in the pain experience compared to a weight-based strategy, without increased side effects.
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    ItemOpen Access
    A randomized controlled trial to evaluate the effectiveness of CouPLES: a spouse-assisted lifestyle change intervention to improve low-density lipoprotein cholesterol.
    (Preventive medicine, 2013-01) Voils, Corrine I; Coffman, Cynthia J; Yancy, William S; Weinberger, Morris; Jeffreys, Amy S; Datta, Santanu; Kovac, Stacey; McKenzie, Jamiyla; Smith, Rose; Bosworth, Hayden B

    Objective

    This randomized controlled trial evaluated the effectiveness of a telephone-delivered, spouse-assisted lifestyle intervention to reduce patient LDL-C.

    Method

    From 2007 to 2010, 255 outpatients with LDL-C>76 mg/dL and their spouses from the Durham Veterans Affairs Medical Center were randomized to intervention or usual care. The intervention comprised nine monthly goal-setting telephone calls to patients and support planning calls to spouses. Outcomes were assessed at 11 months.

    Results

    Patients were 95% male and 65% White. LDL-C did not differ between groups (mean difference = 2.3 mg/dL, 95% CI = -3.6, 8.3, p = 0.44), nor did the odds of meeting goal LDL-C (OR = 0.95, 95% CI = 0.6, 1.7; p = 0.87). Intakes of calories (p = 0.03), total fat (p = 0.02), and saturated fat (p = 0.02) were lower for the intervention group. Cholesterol and fiber intake did not differ between groups (p = 0.11 and 0.26, respectively). The estimated rate of moderate intensity physical activity per week was 20% higher in the intervention group (IRR = 1.2, 95% CI = 1.0, 1.5, p = 0.06). Most participants did not experience a change in cholesterol medication usage during the study period in the intervention (71.7%) and usual care (78.9%) groups.

    Conclusion

    This intervention might be an adjunct to usual primary care to improve adherence to lifestyle behaviors.
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    ItemOpen Access
    A re-conceptualization of access for 21st century healthcare.
    (Journal of general internal medicine, 2011-11) Fortney, John C; Burgess, James F; Bosworth, Hayden B; Booth, Brenda M; Kaboli, Peter J
    Many e-health technologies are available to promote virtual patient-provider communication outside the context of face-to-face clinical encounters. Current digital communication modalities include cell phones, smartphones, interactive voice response, text messages, e-mails, clinic-based interactive video, home-based web-cams, mobile smartphone two-way cameras, personal monitoring devices, kiosks, dashboards, personal health records, web-based portals, social networking sites, secure chat rooms, and on-line forums. Improvements in digital access could drastically diminish the geographical, temporal, and cultural access problems faced by many patients. Conversely, a growing digital divide could create greater access disparities for some populations. As the paradigm of healthcare delivery evolves towards greater reliance on non-encounter-based digital communications between patients and their care teams, it is critical that our theoretical conceptualization of access undergoes a concurrent paradigm shift to make it more relevant for the digital age. The traditional conceptualizations and indicators of access are not well adapted to measure access to health services that are delivered digitally outside the context of face-to-face encounters with providers. This paper provides an overview of digital "encounterless" utilization, discusses the weaknesses of traditional conceptual frameworks of access, presents a new access framework, provides recommendations for how to measure access in the new framework, and discusses future directions for research on access.
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    ItemOpen Access
    A renewed Medication Adherence Alliance call to action: harnessing momentum to address medication nonadherence in the United States.
    (Patient preference and adherence, 2016-01) Zullig, Leah L; Granger, Bradi B; Bosworth, Hayden B

    The problem

    Nonadherence to prescription medications is a common and costly problem with multiple contributing factors, spanning the dimensions of individual behavior change, psychology, medicine, and health policy, among others. Addressing the problem of medication nonadherence requires strategic input from key experts in a number of fields.

    Meeting of experts

    The Medication Adherence Alliance is a group of key experts, predominately from the US, in the field of medication nonadherence. Members include representatives from consumer advocacy groups, community health providers, nonprofit groups, the academic community, decision-making government officials, and industry. In 2015, the Medication Adherence Alliance convened to review the current landscape of medication adherence. The group then established three working groups that will develop recommendations for shifting toward solutions-oriented science.

    Commentary of expert opinion

    From the perspective of the Medication Adherence Alliance, the objective of this commentary is to describe changes in the US landscape of medication adherence, framing the evolving field in the context of a recent think tank meeting of experts in the field of medication adherence.
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    ItemOpen Access
    A Tailored SMS Text Message-Based Intervention to Facilitate Patient Access to Referred Community-Based Social Needs Resources: Protocol for a Pilot Feasibility and Acceptability Study.
    (JMIR research protocols, 2022-10) Lian, Tyler; Reid, Hadley; Rader, Abigail; Dewitt-Feldman, Sarah; Hezarkhani, Elmira; Gu, Elizabeth; Scott, Malik; Scott, Malik; Kutzer, Kate; Sandhu, Sahil; Crowder, Carolyn; Ito, Kristin; Eisenson, Howard; Bettger, Janet Prvu; Shaw, Ryan J; Lewinski, Allison A; Ming, David Y; Bosworth, Hayden B; Zullig, Leah L; Batch, Bryan C; Drake, Connor

    Background

    Health care providers are increasingly screening patients for unmet social needs (eg, food, housing, transportation, and social isolation) and referring patients to relevant community-based resources and social services. Patients' connection to referred services is often low, however, suggesting the need for additional support to facilitate engagement with resources. SMS text messaging presents an opportunity to address barriers related to contacting resources in an accessible, scalable, and low-cost manner.

    Objective

    In this multi-methods pilot study, we aim to develop an automated SMS text message-based intervention to promote patient connection to referred social needs resources within 2 weeks of the initial referral and to evaluate its feasibility and patient acceptability. This protocol describes the intervention, conceptual underpinnings, study design, and evaluation plan to provide a detailed illustration of how SMS technology can complement current social needs screening and referral practice patterns without disrupting care.

    Methods

    For this pilot prospective cohort study, this SMS text message-based intervention augments an existing social needs screening, referral, and navigation program at a federally qualified health center. Patients who received at least one referral for any identified unmet social need are sent 2 rounds of SMS messages over 2 weeks. The first round consists of 5-10 messages that deliver descriptions of and contact information for the referred resources. The second round consists of 2 messages that offer a brief reminder to contact the resources. Participants will evaluate the intervention via a survey and a semistructured interview, informed by an adapted technology acceptance model. Rapid qualitative and thematic analysis will be used to extract themes from the responses. Primary outcomes are implementation feasibility and patient acceptability. Secondary outcomes relate to intervention effectiveness: self-reported attempt to connect and successful connection to referred resources 2 weeks after the initial referral encounter.

    Results

    The study received regulatory approval in May 2021, and we anticipate enrolling 15-20 participants for this initial pilot.

    Conclusions

    This protocol presents detailed implementation methods about a novel automated SMS intervention for social care integration within primary care. By sharing the study protocol early, we intend to facilitate the development and adoption of similar tools across different clinical settings, as more health care providers seek to address the unmet social needs of patients. Study findings will provide practical insights into the design and implementation of SMS text message-based interventions to improve social and medical care coordination.

    International registered report identifier (irrid)

    DERR1-10.2196/37316.
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    A telehealth-delivered intervention to extend the veteran HIV treatment cascade for cardiovascular disease prevention: V-EXTRA-CVD study protocol for a randomized controlled trial.
    (HIV research & clinical practice, 2023-12) Musoke, Lewis; Bosworth, Hayden B; Dickson, Christina; Gentry, Pamela; Strawbridge, Elizabeth; Subramaniam, Soumya; Gierisch, Jennifer; Smith, Valerie; Woolson, Sandra; Pura, John; Amutuhaire, Willington; Naggie, Susanna; Schexnayder, Julie; Hall, Karen; Longenecker, Chris T; Harris, Nadine M; Rogers, Chantrice; Van Epps, Puja; for V-EXTRA-CVD Group
    Background: Veterans living with HIV have up to twice the risk of atherosclerotic cardiovascular disease (ASCVD) compared to those without HIV.Objective: Our study seeks to test a non-physician led virtual self-management implementation strategy to reduce ASCVD risk among people living with HIV (PWH). We aim to conduct a randomized control trial among PWH (n = 300) with a diagnosis of hypertension (HTN) who are enrolled in Veterans Health Administration (VHA) clinics, on suppressive antiretroviral therapy (ART), randomized 1:1 to intervention vs. education control for a 12-month duration.Methods: Using human centered design approach, we have adapted a previous 5-component telehealth focused, non-physician led intervention to a Veteran population. The education control arm receives enhanced education in addition to usual care. The primary outcome is 6 mmHg reduction in systolic BP over 12-month in the intervention arm compared to the control arm. The secondary outcome is a 12-month difference in non-HDL cholesterol. While each component of our intervention has an evidence base, they have not been tested together in an HIV context.Conclusion: The proposed multicomponent intervention has the potential to improve cardiovascular outcomes in PWH using novel virtual care methods in a patient centered care approach.
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    A time-series analysis of the relation between unemployment rate and hospital admission for acute myocardial infarction and stroke in Brazil over more than a decade.
    (International journal of cardiology, 2016-12) Katz, Marcelo; Bosworth, Hayden B; Lopes, Renato D; Dupre, Matthew E; Morita, Fernando; Pereira, Carolina; Franco, Fabio GM; Prado, Rogerio R; Pesaro, Antonio E; Wajngarten, Mauricio

    Background

    The effect of socioeconomic stressors on the incidence of cardiovascular disease (CVD) is currently open to debate. Using time-series analysis, our study aimed to evaluate the relationship between unemployment rate and hospital admission for acute myocardial infarction (AMI) and stroke in Brazil over a recent 11-year span.

    Methods and results

    Data on monthly hospital admissions for AMI and stroke from March 2002 to December 2013 were extracted from the Brazilian Public Health System Database. The monthly unemployment rate was obtained from the Brazilian Institute for Applied Economic Research, during the same period. The autoregressive integrated moving average (ARIMA) model was used to test the association of temporal series. Statistical significance was set at p<0.05. From March 2002 to December 2013, 778,263 admissions for AMI and 1,581,675 for stroke were recorded. During this time period, the unemployment rate decreased from 12.9% in 2002 to 4.3% in 2013, while admissions due to AMI and stroke increased. However, the adjusted ARIMA model showed a positive association between the unemployment rate and admissions for AMI but not for stroke (estimate coefficient=2.81±0.93; p=0.003 and estimate coefficient=2.40±4.34; p=0.58, respectively).

    Conclusions

    From 2002 to 2013, hospital admissions for AMI and stroke increased, whereas the unemployment rate decreased. However, the adjusted ARIMA model showed a positive association between unemployment rate and admissions due to AMI but not for stroke. Further studies are warranted to validate our findings and to better explore the mechanisms by which socioeconomic stressors, such as unemployment, might impact on the incidence of CVD.
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    Accelerating Implementation of Virtual Care in an Integrated Health Care System: Future Research and Operations Priorities.
    (Journal of general internal medicine, 2021-08) Lewinski, Allison A; Sullivan, Caitlin; Allen, Kelli D; Crowley, Matthew J; Gierisch, Jennifer M; Goldstein, Karen M; Gray, Kaileigh; Hastings, Susan N; Jackson, George L; McCant, Felicia; Shapiro, Abigail; Tucker, Matthew; Turvey, Carolyn; Zullig, Leah L; Bosworth, Hayden B

    Background

    Virtual care is critical to Veterans Health Administration (VHA) efforts to expand veterans' access to care. Health care policies such as the Veterans Access, Choice, and Accountability (CHOICE) Act and the Maintaining Internal Systems and Strengthening Integrated Outside Networks (MISSION) Act impact how the VHA provides care. Research on ways to refine virtual care delivery models to meet the needs of veterans, clinicians, and VHA stakeholders is needed.

    Objective

    Given the importance of virtual approaches for increasing access to high-quality VHA care, in December 2019, we convened a Think Tank, Accelerating Implementation of Virtual Care in VHA Practice, to consider challenges to virtual care research and practice across the VHA, discuss novel approaches to using and evaluating virtual care, assess perspectives on virtual care, and develop priorities to enhance virtual care in the VHA.

    Methods

    We used a participatory approach to develop potential priorities for virtual care research and activities at the VHA. We refined these priorities through force-ranked prioritization and group discussion, and developed solutions for selected priorities.

    Results

    Think Tank attendees (n = 18) consisted of VHA stakeholders, including operations partners (e.g., Office of Rural Health, Office of Nursing Services, Health Services Research and Development), clinicians (e.g., physicians, nurses, psychologists, physician assistants), and health services researchers. We identified an initial list of fifteen potential priorities and narrowed these down to four. The four priorities were (1) scaling evidence-based practices, (2) centralizing virtual care, (3) creating high-value care within the VHA with virtual care, and (4) identifying appropriate patients for virtual care.

    Conclusion

    Our Think Tank took an important step in setting a partnered research agenda to optimize the use of virtual care within the VHA. We brought together research and operations stakeholders and identified possibilities, partnerships, and potential solutions for virtual care.
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    ItemOpen Access
    Adaptive intervention design in mobile health: Intervention design and development in the Cell Phone Intervention for You trial.
    (Clin Trials, 2015-12) Lin, Pao-Hwa; Intille, Stephen; Bennett, Gary; Bosworth, Hayden B; Corsino, Leonor; Voils, Corrine; Grambow, Steven; Lazenka, Tony; Batch, Bryan C; Tyson, Crystal; Svetkey, Laura P
    BACKGROUND/AIMS: The obesity epidemic has spread to young adults, and obesity is a significant risk factor for cardiovascular disease. The prominence and increasing functionality of mobile phones may provide an opportunity to deliver longitudinal and scalable weight management interventions in young adults. The aim of this article is to describe the design and development of the intervention tested in the Cell Phone Intervention for You study and to highlight the importance of adaptive intervention design that made it possible. The Cell Phone Intervention for You study was a National Heart, Lung, and Blood Institute-sponsored, controlled, 24-month randomized clinical trial comparing two active interventions to a usual-care control group. Participants were 365 overweight or obese (body mass index≥25 kg/m2) young adults. METHODS: Both active interventions were designed based on social cognitive theory and incorporated techniques for behavioral self-management and motivational enhancement. Initial intervention development occurred during a 1-year formative phase utilizing focus groups and iterative, participatory design. During the intervention testing, adaptive intervention design, where an intervention is updated or extended throughout a trial while assuring the delivery of exactly the same intervention to each cohort, was employed. The adaptive intervention design strategy distributed technical work and allowed introduction of novel components in phases intended to help promote and sustain participant engagement. Adaptive intervention design was made possible by exploiting the mobile phone's remote data capabilities so that adoption of particular application components could be continuously monitored and components subsequently added or updated remotely. RESULTS: The cell phone intervention was delivered almost entirely via cell phone and was always-present, proactive, and interactive-providing passive and active reminders, frequent opportunities for knowledge dissemination, and multiple tools for self-tracking and receiving tailored feedback. The intervention changed over 2 years to promote and sustain engagement. The personal coaching intervention, alternatively, was primarily personal coaching with trained coaches based on a proven intervention, enhanced with a mobile application, but where all interactions with the technology were participant-initiated. CONCLUSION: The complexity and length of the technology-based randomized clinical trial created challenges in engagement and technology adaptation, which were generally discovered using novel remote monitoring technology and addressed using the adaptive intervention design. Investigators should plan to develop tools and procedures that explicitly support continuous remote monitoring of interventions to support adaptive intervention design in long-term, technology-based studies, as well as developing the interventions themselves.
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    Addressing barriers to optimal oral anticoagulation use and persistence among patients with atrial fibrillation: Proceedings, Washington, DC, December 3-4, 2012.
    (American heart journal, 2014-09) Hess, Paul L; Mirro, Michael J; Diener, Hans-Christoph; Eikelboom, John W; Al-Khatib, Sana M; Hylek, Elaine M; Bosworth, Hayden B; Gersh, Bernard J; Singer, Daniel E; Flaker, Greg; Mega, Jessica L; Peterson, Eric D; Rumsfeld, John S; Steinberg, Benjamin A; Kakkar, Ajay K; Califf, Robert M; Granger, Christopher B; Atrial Fibrillation Think-Tank Participants
    Approximately half of patients with atrial fibrillation and with risk factors for stroke are not treated with oral anticoagulation (OAC), whether it be with vitamin K antagonists (VKAs) or novel OACs (NOACs); and of those treated, many discontinue treatment. Leaders from academia, government, industry, and professional societies convened in Washington, DC, on December 3-4, 2012, to identify barriers to optimal OAC use and adherence and to generate potential solutions. Participants identified a broad range of barriers, including knowledge gaps about stroke risk and the relative risks and benefits of anticoagulant therapies; lack of awareness regarding the potential use of NOAC agents for VKA-unsuitable patients; lack of recognition of expanded eligibility for OAC; lack of availability of reversal agents and the difficulty of anticoagulant effect monitoring for the NOACs; concerns with the bleeding risk of anticoagulant therapy, especially with the NOACs and particularly in the setting of dual antiplatelet therapy; suboptimal time in therapeutic range for VKA; and costs and insurance coverage. Proposed solutions were to define reasons for oral anticoagulant underuse classified in ways that can guide intervention and improve use, to increase awareness of stroke risk as well as the benefits and risks of OAC use via educational initiatives and feedback mechanisms, to better define the role of VKA in the current therapeutic era including eligibility and ineligibility for different anticoagulant therapies, to identify NOAC reversal agents and monitoring strategies and make knowledge regarding their use publicly available, to minimize the duration of dual antiplatelet therapy and concomitant OAC where possible, to improve time in therapeutic range for VKA, to leverage observational data sets to refine understanding of OAC use and outcomes in general practice, and to better align health system incentives.
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    Addressing Diabetes and Poorly Controlled Hypertension: Pragmatic mHealth Self-Management Intervention.
    (Journal of medical Internet research, 2019-04) Lewinski, Allison A; Patel, Uptal D; Diamantidis, Clarissa J; Oakes, Megan; Baloch, Khaula; Crowley, Matthew J; Wilson, Jonathan; Pendergast, Jane; Biola, Holly; Boulware, L Ebony; Bosworth, Hayden B

    Background

    Patients with diabetes and poorly controlled hypertension are at increased risk for adverse renal and cardiovascular outcomes. Identifying these patients early and addressing modifiable risk factors is central to delaying renal complications such as diabetic kidney disease. Mobile health (mHealth), a relatively inexpensive and easily scalable technology, can facilitate patient-centered care and promote engagement in self-management, particularly for patients of lower socioeconomic status. Thus, mHealth may be a cost-effective way to deliver self-management education and support.

    Objective

    This feasibility study aimed to build a population management program by identifying patients with diabetes and poorly controlled hypertension who were at risk for adverse renal outcomes and evaluate a multifactorial intervention to address medication self-management. We recruited patients from a federally qualified health center (FQHC) in an underserved, diverse county in the southeastern United States.

    Methods

    Patients were identified via electronic health record. Inclusion criteria were age between 18 and 75 years, diagnosis of type 2 diabetes, poorly controlled hypertension over the last 12 months (mean clinic systolic blood pressure [SBP] ≥140 mm Hg and/or diastolic blood pressure [DBP] ≥90 mm Hg), access to a mobile phone, and ability to receive text messages and emails. The intervention consisted of monthly telephone calls for 6 months by a case manager and weekly, one-way informational text messages. Engagement was defined as the number of phone calls completed during the intervention; individuals who completed 4 or more calls were considered engaged. The primary outcome was change in SBP at the conclusion of the intervention.

    Results

    Of the 141 patients enrolled, 84.0% (118/141) of patients completed 1 or more phone calls and had follow-up SBP measurements for analysis. These patients were on average 56.9 years of age, predominately female (73/118, 61.9%), and nonwhite by self-report (103/118, 87.3%). The proportion of participants with poor baseline SBP control (50/118, 42.4%) did not change significantly at study completion (53/118, 44.9%) (P=.64). Participants who completed 4 or more phone calls (98/118, 83.1%) did not experience a statistically significant decrease in SBP when compared to those who completed fewer calls.

    Conclusion

    We did not reduce uncontrolled hypertension even among the more highly engaged. However, 83% of a predominately minority and low-income population completed at least 67% of the multimodal mHealth intervention. Findings suggest that combining an automated electronic health record system to identify at-risk patients with a tailored mHealth protocol can provide education to this population. While this intervention was insufficient to effect behavioral change resulting in better hypertension control, it does suggest that this FQHC population will engage in low-cost population health applications with a potentially promising impact.

    Trial registration

    ClinicalTrials.gov NCT02418091; https://clinicaltrials.gov/ct2/show/NCT02418091 (Archived by WebCite at http://www.webcitation.org/76RBvacVU).
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    Addressing Hypertension Outcomes Using Telehealth and Population Health Managers: Adaptations and Implementation Considerations.
    (Current hypertension reports, 2022-08) Drake, Connor; Lewinski, Allison A; Rader, Abigail; Schexnayder, Julie; Bosworth, Hayden B; Goldstein, Karen M; Gierisch, Jennifer; White-Clark, Courtney; McCant, Felicia; Zullig, Leah L

    Purpose of review

    There is a growing evidence base describing population health approaches to improve blood pressure control. We reviewed emerging trends in hypertension population health management and present implementation considerations from an intervention called Team-supported, Electronic health record-leveraged, Active Management (TEAM). By doing so, we highlight the role of population health managers, practitioners who use population level data and to proactively engage at-risk patients, in improving blood pressure control.

    Recent findings

    Within a population health paradigm, we discuss telehealth-delivered approaches to equitably improve hypertension care delivery. Additionally, we explore implementation considerations and complementary features of team-based, telehealth-delivered, population health management. By leveraging the unique role and expertise of a population health manager as core member of team-based telehealth, health systems can implement a cost-effective and scalable intervention that addresses multi-level barriers to hypertension care delivery. We describe the literature of telehealth-based population health management for patients with hypertension. Using the TEAM intervention as a case study, we then present implementation considerations and intervention adaptations to integrate a population health manager within the health care team and effectively manage hypertension for a defined patient population. We emphasize practical considerations to inform implementation, scaling, and sustainability. We highlight future research directions to advance the field and support translational efforts in diverse clinical and community contexts.