Browsing by Subject "Ambulatory Care Facilities"
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Item Open Access A cross-site, comparative effectiveness study of an integrated HIV and substance use treatment program.(AIDS Patient Care STDS, 2010-10) Proeschold-Bell, Rae Jean; Heine, Amy; Pence, Brian Wells; McAdam, Keith; Quinlivan, Evelyn ByrdCo-occurrence of HIV and substance abuse is associated with poor outcomes for HIV-related health and substance use. Integration of substance use and medical care holds promise for HIV patients, yet few integrated treatment models have been reported. Most of the reported models lack data on treatment outcomes in diverse settings. This study examined the substance use outcomes of an integrated treatment model for patients with both HIV and substance use at three different clinics. Sites differed by type and degree of integration, with one integrated academic medical center, one co-located academic medical center, and one co-located community health center. Participants (n=286) received integrated substance use and HIV treatment for 12 months and were interviewed at 6-month intervals. We used linear generalized estimating equation regression analysis to examine changes in Addiction Severity Index (ASI) alcohol and drug severity scores. To test whether our treatment was differentially effective across sites, we compared a full model including site by time point interaction terms to a reduced model including only site fixed effects. Alcohol severity scores decreased significantly at 6 and 12 months. Drug severity scores decreased significantly at 12 months. Once baseline severity variation was incorporated into the model, there was no evidence of variation in alcohol or drug score changes by site. Substance use outcomes did not differ by age, gender, income, or race. This integrated treatment model offers an option for treating diverse patients with HIV and substance use in a variety of clinic settings. Studies with control groups are needed to confirm these findings.Item Open Access At-Home Versus In-Clinic INR Monitoring: A Cost-Utility Analysis from The Home INR Study (THINRS).(Journal of general internal medicine, 2016-09) Phibbs, Ciaran S; Love, Sean R; Jacobson, Alan K; Edson, Robert; Su, Pon; Uyeda, Lauren; Matchar, David B; writing for the THINRS Executive Committee and Site InvestigatorsBackground
Effective management of patients using warfarin is resource-intensive, requiring frequent in-clinic testing of the international normalized ratio (INR). Patient self-testing (PST) using portable at-home INR monitoring devices has emerged as a convenient alternative. As revealed by The Home INR Study (THINRS), event rates for PST were not significantly different from those for in-clinic high-quality anticoagulation management (HQACM), and a cumulative gain in quality of life was observed for patients undergoing PST.Objective
To perform a cost-utility analysis of weekly PST versus monthly HQACM and to examine the sensitivity of these results to testing frequency.Patients/interventions
In this study, 2922 patients taking warfarin for atrial fibrillation or mechanical heart valve, and who demonstrated PST competence, were randomized to either weekly PST (n = 1465) or monthly in-clinic testing (n = 1457). In a sub-study, 234 additional patients were randomized to PST once every 4 weeks (n = 116) or PST twice weekly (n = 118). The endpoints were quality of life (measured by the Health Utilities Index), health care utilization, and costs over 2 years of follow-up.Results
PST and HQACM participants were similar with regard to gender, age, and CHADS2 score. The total cost per patient over 2 years of follow-up was $32,484 for HQACM and $33,460 for weekly PST, representing a difference of $976. The incremental cost per quality-adjusted life year gained with PST once weekly was $5566 (95 % CI, -$11,490 to $25,142). The incremental cost-effectiveness ratio (ICER) was sensitive to testing frequency: weekly PST dominated PST twice weekly and once every 4 weeks. Compared to HQACM, weekly PST was associated with statistically significant and clinically meaningful improvements in quality of life. The ICER for weekly PST versus HQACM was well within accepted standards for cost-effectiveness, and was preferred over more or less frequent PST. These results were robust to sensitivity analyses of key assumptions.Conclusion
Weekly PST is a cost-effective alternative to monthly HQACM and a preferred testing frequency compared to twice weekly or monthly PST.Item Open Access Diagnostic performance of short portable mental status questionnaire for screening dementia among patients attending cognitive assessment clinics in Singapore.(Annals of the Academy of Medicine, Singapore, 2013-07) Malhotra, Chetna; Chan, Angelique; Matchar, David; Seow, Dennis; Chuo, Adeline; Do, Young KyungIntroduction
The Short Portable Mental Status Questionnaire (SPMSQ) is a brief cognitive screening instrument, which is easy to use by a healthcare worker with little training. However, the validity of this instrument has not been established in Singapore. Thus, the primary aim of this study was to determine the diagnostic performance of SPMSQ for screening dementia among patients attending outpatient cognitive assessment clinics and to assess whether the appropriate cut-off score varies by patient's age and education. A secondary aim of the study was to map the SPMSQ scores with Mini-Mental State Examination (MMSE) scores.Materials and methods
SPMSQ and MMSE were administered by a trained interviewer to 127 patients visiting outpatient cognitive assessment clinics at the Singapore General Hospital, Changi General Hospital and Tan Tock Seng Hospital. The geriatricians at these clinics then diagnosed these patients with dementia or no dementia (reference standard). Sensitivity and specificity of SPMSQ with different cut-off points (number of errors) were calculated and compared to the reference standard using the Receiver Operator Characteristic (ROC) analysis. Correlation coefficient was also calculated between MMSE and SPMSQ scores.Results
Based on the ROC analysis and a balance of sensitivity and specificity, the appropriate cut-off for SPMSQ was found to be 5 or more errors (sensitivity 78%, specificity 75%). The cut-off varied by education, but not by patient's age. There was a high correlation between SPMSQ and MMSE scores (r = 0.814, P <0.0001).Conclusion
Despite the advantage of being a brief screening instrument for dementia, the use of SPMSQ is limited by its low sensitivity and specificity, especially among patients with less than 6 years of education.Item Open Access eConsults' Impact on Care Access and Wait Times in Rheumatology.(Journal of clinical rheumatology : practical reports on rheumatic & musculoskeletal diseases, 2022-04) Malcolm, Elizabeth J; Brandon, Zachary; Wilson, Lauren E; Shoup, John Paul; King, Heather A; Lewinski, Allison; Greiner, Melissa A; Malone, Shauna; Miller, Julie; Keenan, Robert T; Tarrant, Teresa K; Phinney, Donna; Cho, Alex; Bosworth, Hayden B; Shah, KevinBackground/objective
A growing number of health systems have implemented eConsults to improve access to specialty advice, but few studies have described their use in rheumatology or impact on visit wait times. We evaluated the uptake of an eConsult program and its impact on wait times for in-person rheumatology visits.Methods
In this quality improvement project, we analyzed electronic health record data from 4 intervention clinics and 4 comparison clinics, 12 months before and after implementation of an eConsult program. We compared median wait time for rheumatology appointments using a pre-post difference-in-differences analysis and quantile regression, adjusting for patient age, race, sex, clinic pair, and primary insurance payer. We also interviewed 11 primary care providers from the intervention clinics and conducted a rheumatology provider focus group (n = 4) to elucidate experiences with the program.Results
Rheumatologists recommended management in primary care or referral to another specialty for 41% of eConsults, reducing initial demand for in-person visits. The median wait times dropped in the intervention and the comparison clinics (42 and 25 days, respectively). Intervention clinic median wait time dropped 17 days more than comparison clinics, and this was nonstatistically significant (p = 0.089). eConsults fit provider care tasks best for triage or initial workup for diagnosis, and less well when tests required interpretation, or when back and forth communication was needed to manage the patient's condition.Conclusions
Implementation of eConsults for rheumatology was associated with reduced wait times for rheumatology appointments and supported primary care providers in the triage and workup for a substantial portion of patients.Item Open Access Healthcare utilization and cost trajectories post-stroke: role of caregiver and stroke factors.(BMC health services research, 2018-11-22) Tyagi, Shilpa; Koh, Gerald Choon-Huat; Nan, Luo; Tan, Kelvin Bryan; Hoenig, Helen; Matchar, David B; Yoong, Joanne; Finkelstein, Eric A; Lee, Kim En; Venketasubramanian, N; Menon, Edward; Chan, Kin Ming; De Silva, Deidre Anne; Yap, Philip; Tan, Boon Yeow; Chew, Effie; Young, Sherry H; Ng, Yee Sien; Tu, Tian Ming; Ang, Yan Hoon; Kong, Keng Hee; Singh, Rajinder; Merchant, Reshma A; Chang, Hui Meng; Yeo, Tseng Tsai; Ning, Chou; Cheong, Angela; Ng, Yu Li; Tan, Chuen SengBackground
It is essential to study post-stroke healthcare utilization trajectories from a stroke patient caregiver dyadic perspective to improve healthcare delivery, practices and eventually improve long-term outcomes for stroke patients. However, literature addressing this area is currently limited. Addressing this gap, our study described the trajectory of healthcare service utilization by stroke patients and associated costs over 1-year post-stroke and examined the association with caregiver identity and clinical stroke factors.Methods
Patient and caregiver variables were obtained from a prospective cohort, while healthcare data was obtained from the national claims database. Generalized estimating equation approach was used to get the population average estimates of healthcare utilization and cost trend across 4 quarters post-stroke.Results
Five hundred ninety-two stroke patient and caregiver dyads were available for current analysis. The highest utilization occurred in the first quarter post-stroke across all service types and decreased with time. The incidence rate ratio (IRR) of hospitalization decreased by 51, 40, 11 and 1% for patients having spouse, sibling, child and others as caregivers respectively when compared with not having a caregiver (p = 0.017). Disability level modified the specialist outpatient clinic usage trajectory with increasing difference between mildly and severely disabled sub-groups across quarters. Stroke type and severity modified the primary care cost trajectory with expected cost estimates differing across second to fourth quarters for moderately-severe ischemic (IRR: 1.67, 1.74, 1.64; p = 0.003), moderately-severe non-ischemic (IRR: 1.61, 3.15, 2.44; p = 0.001) and severe non-ischemic (IRR: 2.18, 4.92, 4.77; p = 0.032) subgroups respectively, compared to first quarter.Conclusion
Highlighting the quarterly variations, we reported distinct utilization trajectories across subgroups based on clinical characteristics. Caregiver availability reducing hospitalization supports revisiting caregiver's role as potential hidden workforce, incentivizing their efforts by designing socially inclusive bundled payment models for post-acute stroke care and adopting family-centered clinical care practices.Item Open Access Home blood pressure management and improved blood pressure control: results from a randomized controlled trial.(Archives of internal medicine, 2011-07) Bosworth, Hayden B; Powers, Benjamin J; Olsen, Maren K; McCant, Felicia; Grubber, Janet; Smith, Valerie; Gentry, Pamela W; Rose, Cynthia; Van Houtven, Courtney; Wang, Virginia; Goldstein, Mary K; Oddone, Eugene ZBackground
To determine which of 3 interventions was most effective in improving blood pressure (BP) control, we performed a 4-arm randomized trial with 18-month follow-up at the primary care clinics at a Veterans Affairs Medical Center.Methods
Eligible patients were randomized to either usual care or 1 of 3 telephone-based intervention groups: (1) nurse-administered behavioral management, (2) nurse- and physician-administered medication management, or (3) a combination of both. Of the 1551 eligible patients, 593 individuals were randomized; 48% were African American. The intervention telephone calls were triggered based on home BP values transmitted via telemonitoring devices. Behavioral management involved promotion of health behaviors. Medication management involved adjustment of medications by a study physician and nurse based on hypertension treatment guidelines.Results
The primary outcome was change in BP control measured at 6-month intervals over 18 months. Both the behavioral management and medication management alone showed significant improvements at 12 months-12.8% (95% confidence interval [CI], 1.6%-24.1%) and 12.5% (95% CI, 1.3%-23.6%), respectively-but not at 18 months. In subgroup analyses, among those with poor baseline BP control, systolic BP decreased in the combined intervention group by 14.8 mm Hg (95% CI, -21.8 to -7.8 mm Hg) at 12 months and 8.0 mm Hg (95% CI, -15.5 to -0.5 mm Hg) at 18 months, relative to usual care.Conclusions
Overall intervention effects were moderate, but among individuals with poor BP control at baseline, the effects were larger. This study indicates the importance of identifying individuals most likely to benefit from potentially resource intensive programs.Trial registration
clinicaltrials.gov Identifier: NCT00237692.Item Open Access Implementation of an Intensive Telehealth Intervention for Rural Patients with Clinic-Refractory Diabetes.(Journal of general internal medicine, 2022-09) Kobe, Elizabeth A; Lewinski, Allison A; Jeffreys, Amy S; Smith, Valerie A; Coffman, Cynthia J; Danus, Susanne M; Sidoli, Elisabeth; Greck, Beth D; Horne, Leanne; Saxon, David R; Shook, Susan; Aguirre, Lina E; Esquibel, Mary G; Evenson, Clarene; Elizagaray, Christopher; Nelson, Vivian; Zeek, Amanda; Weppner, William G; Scodellaro, Stephanie; Perdew, Cassie J; Jackson, George L; Steinhauser, Karen; Bosworth, Hayden B; Edelman, David; Crowley, Matthew JBackground
Rural patients with type 2 diabetes (T2D) may experience poor glycemic control due to limited access to T2D specialty care and self-management support. Telehealth can facilitate delivery of comprehensive T2D care to rural patients, but implementation in clinical practice is challenging.Objective
To examine the implementation of Advanced Comprehensive Diabetes Care (ACDC), an evidence-based, comprehensive telehealth intervention for clinic-refractory, uncontrolled T2D. ACDC leverages existing Veterans Health Administration (VHA) Home Telehealth (HT) infrastructure, making delivery practical in rural areas.Design
Mixed-methods implementation study.Participants
230 patients with clinic-refractory, uncontrolled T2D.Intervention
ACDC bundles telemonitoring, self-management support, and specialist-guided medication management, and is delivered over 6 months using existing VHA HT clinical staffing/equipment. Patients may continue in a maintenance protocol after the initial 6-month intervention period.Main measures
Implementation was evaluated using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. The primary effectiveness outcome was hemoglobin A1c (HbA1c).Key results
From 2017 to 2020, ACDC was delivered to 230 patients across seven geographically diverse VHA sites; on average, patients were 59 years of age, 95% male, 80% white, and 14% Hispanic/Latinx. Patients completed an average of 10.1 of 12 scheduled encounters during the 6-month intervention period. Model-estimated mean baseline HbA1c was 9.56% and improved to 8.14% at 6 months (- 1.43%, 95% CI: - 1.64, - 1.21; P < .001). Benefits persisted at 12 (- 1.26%, 95% CI: - 1.48, - 1.05; P < .001) and 18 months (- 1.08%, 95% CI - 1.35, - 0.81; P < .001). Patients reported increased engagement in self-management and awareness of glycemic control, while clinicians and HT nurses reported a moderate workload increase. As of this submission, some sites have maintained delivery of ACDC for up to 4 years.Conclusions
When strategically designed to leverage existing infrastructure, comprehensive telehealth interventions can be implemented successfully, even in rural areas. ACDC produced sustained improvements in glycemic control in a previously refractory population.Item Open Access Implementing Health Related Social Needs Screening in an Outpatient Clinic.(Journal of primary care & community health, 2022-01) Nohria, Raman; Xiao, Nan; Guardado, Rubeen; Drainoni, Mari-Lynn; Smith, Cara; Nokes, Keith; Byhoff, ElenaIntroduction/objectives
Health-related social needs (HRSN) screening efforts have reported high rates of identified social needs. Little is known if efforts to conduct HRSN screening in resource-constrained federally-qualified health centers (FQHC) successfully captures a representative patient population.Methods
This cross-sectional study extracted EMR data from 2016 to 2020 for 4731 screened patients from 7 affiliated clinics of a FQHC. Unscreened patients were pulled as a random sample from the study period. A multivariable logistic regression was used to identify sociodemographic traits, chronic disease diagnoses and burden, and clinic visit type and frequency associated with being screened for HRSN.Results
BHC screened 4731 unique patients or <1% of the total clinic population. Screened patients had a median of 3.3 (±2.5) unmet HRSN. Medicaid patients had higher odds of being screened (aOR = 1.38, CI 1.19-1.61) relative to Medicare patients. The odds of being screened for social needs increased with more provider visits per year: compared to fewer than 1 visit per year, patients with 1 to 3 provider visits (aOR = 2.06, CI 1.73-2.32), 4 to 6 provider visits (aOR = 3.34, CI 2.89-3.87), and more than 6 provider visits (aOR = 5.16, CI 4.35-6.12) all had higher odds of social needs screening. Patients with a higher comorbid disease burden (>2 conditions, aOR = 2.80, CI 2.07-3.79) had higher odds of screening.Conclusions
Our findings demonstrate an increased likelihood to screen patients who visit outpatient services more often and have a higher comorbid disease burden. To meet state-level Medicaid requirements, resource-constrained FQHCs that implement clinic wide HRSN screening may be well served to identify a priori strategies to ensure representative and equitable screening across the patient population.Item Open Access Improving Timely Resident Follow-Up and Communication of Results in Ambulatory Clinics Utilizing a Web-Based Audit and Feedback Module.(Journal of Graduate Medical Education, 2017-04) Boggan, Joel C; Swaminathan, Aparna; Thomas, Samantha; Simel, David L; Zaas, Aimee K; Bae, Jonathan GFailure to follow up and communicate test results to patients in outpatient settings may lead to diagnostic and therapeutic delays. Residents are less likely than attending physicians to report results to patients, and may face additional barriers to reporting, given competing clinical responsibilities.This study aimed to improve the rates of communicating test results to patients in resident ambulatory clinics.We performed an internal medicine, residency-wide, pre- and postintervention, quality improvement project using audit and feedback. Residents performed audits of ambulatory patients requiring laboratory or radiologic testing by means of a shared online interface. The intervention consisted of an educational module viewed with initial audits, development of a personalized improvement plan after Phase 1, and repeated real-time feedback of individual relative performance compared at clinic and program levels. Outcomes included results communicated within 14 days and prespecified "significant" results communicated within 72 hours.A total of 76 of 86 eligible residents (88%) reviewed 1713 individual ambulatory patients' charts in Phase 1, and 73 residents (85%) reviewed 1509 charts in Phase 2. Follow-up rates were higher in Phase 2 than Phase 1 for communicating results within 14 days and significant results within 72 hours (85% versus 78%, P < .001; and 82% versus 70%, P = .002, respectively). Communication of "significant" results was more likely to occur via telephone, compared with communication of nonsignificant results.Participation in a shared audit and feedback quality improvement project can improve rates of resident follow-up and communication of results, although communication gaps remained.Item Open Access Preferences of people living with HIV for differentiated care models in Kenya: A discrete choice experiment.(PloS one, 2021-01) Dommaraju, Sagar; Hagey, Jill; Odeny, Thomas A; Okaka, Sharon; Kadima, Julie; Bukusi, Elizabeth A; Cohen, Craig R; Kwena, Zachary; Eshun-Wilson, Ingrid; Geng, ElvinIntroduction
To improve retention on HIV treatment in Africa, public health programs are promoting a family of innovations to service delivery-referred to as "differentiated service delivery" (DSD) models-which seek to better meet the needs of both systems and patients by reducing unnecessary encounters, expanding access, and incorporating peers and patients in patient care. Data on the relative desirability of different models to target populations, which is currently sparse, can help guide prioritization of specific models during scale-up.Methods
We conducted a discrete choice experiment to assess patient preferences for various characteristics of treatment services. Clinically stable people living with HIV were recruited from an HIV clinic in Kisumu, Kenya. We selected seven attributes of DSD models drawn from literature review and previous qualitative work. We created a balanced and orthogonal design to identify main term effects. A total of ten choice tasks were solicited per respondent. We calculated relative utility (RU) for each attribute level, a numerical representation of the strength of patient preference. Data were analyzed using a Hierarchical Bayesian model via Sawtooth Software.Results
One hundred and four respondents (37.5% men, 41.1 years mean age) preferred receiving care at a health facility, compared with home-delivery or a community meeting point (RU = 69.3, -16.2, and -53.1, respectively; p << 0.05); receiving those services from clinicians and pharmacists-as opposed to lay health workers or peers (RU = 21.5, 5.9, -24.5; p < 0.05); and preferred an individual support system over a group support system (RU = 15.0 and 4.2; p < 0.05). Likewise, patients strongly preferred longer intervals between both clinical reviews (RU = 40.1 and -50.7 for 6- and 1-month spacing, respectively; p < 0.05) and between ART collections (RU = 33.6 and -49.5 for 6- and1-month spacing, respectively; p < 0.05).Conclusion
Although health systems find community- and peer-based DSD models attractive, clinically stable patients expressed a preference for facility-based care as long as clinical visits were extended to biannual. These data suggest that multi-month scripting and fast-track models best align with patient preferences, an insight which can help prioritize use of different DSD models in the region.Item Open Access Protocol for implementation of family health history collection and decision support into primary care using a computerized family health history system.(BMC Health Serv Res, 2011-10-11) Orlando, Lori A; Hauser, Elizabeth R; Christianson, Carol; Powell, Karen P; Buchanan, Adam H; Chesnut, Blair; Agbaje, Astrid B; Henrich, Vincent C; Ginsburg, GeoffreyBACKGROUND: The CDC's Family History Public Health Initiative encourages adoption and increase awareness of family health history. To meet these goals and develop a personalized medicine implementation science research agenda, the Genomedical Connection is using an implementation research (T3 research) framework to develop and integrate a self-administered computerized family history system with built-in decision support into 2 primary care clinics in North Carolina. METHODS/DESIGN: The family health history system collects a three generation family history on 48 conditions and provides decision support (pedigree and tabular family history, provider recommendation report and patient summary report) for 4 pilot conditions: breast cancer, ovarian cancer, colon cancer, and thrombosis. All adult English-speaking, non-adopted, patients scheduled for well-visits are invited to complete the family health system prior to their appointment. Decision support documents are entered into the medical record and available to provider's prior to the appointment. In order to optimize integration, components were piloted by stakeholders prior to and during implementation. Primary outcomes are change in appropriate testing for hereditary thrombophilia and screening for breast cancer, colon cancer, and ovarian cancer one year after study enrollment. Secondary outcomes include implementation measures related to the benefits and burdens of the family health system and its impact on clinic workflow, patients' risk perception, and intention to change health related behaviors. Outcomes are assessed through chart review, patient surveys at baseline and follow-up, and provider surveys. Clinical validity of the decision support is calculated by comparing its recommendations to those made by a genetic counselor reviewing the same pedigree; and clinical utility is demonstrated through reclassification rates and changes in appropriate screening (the primary outcome). DISCUSSION: This study integrates a computerized family health history system within the context of a routine well-visit appointment to overcome many of the existing barriers to collection and use of family history information by primary care providers. Results of the implementation process, its acceptability to patients and providers, modifications necessary to optimize the system, and impact on clinical care can serve to guide future implementation projects for both family history and other tools of personalized medicine, such as health risk assessments.Item Open Access Protocol for the "Implementation, adoption, and utility of family history in diverse care settings" study.(Implement Sci, 2015-11-24) Wu, R Ryanne; Myers, Rachel A; McCarty, Catherine A; Dimmock, David; Farrell, Michael; Cross, Deanna; Chinevere, Troy D; Ginsburg, Geoffrey S; Orlando, Lori A; Family Health History NetworkBACKGROUND: Risk assessment with a thorough family health history is recommended by numerous organizations and is now a required component of the annual physical for Medicare beneficiaries under the Affordable Care Act. However, there are several barriers to incorporating robust risk assessments into routine care. MeTree, a web-based patient-facing health risk assessment tool, was developed with the aim of overcoming these barriers. In order to better understand what factors will be instrumental for broader adoption of risk assessment programs like MeTree in clinical settings, we obtained funding to perform a type III hybrid implementation-effectiveness study in primary care clinics at five diverse healthcare systems. Here, we describe the study's protocol. METHODS/DESIGN: MeTree collects personal medical information and a three-generation family health history from patients on 98 conditions. Using algorithms built entirely from current clinical guidelines, it provides clinical decision support to providers and patients on 30 conditions. All adult patients with an upcoming well-visit appointment at one of the 20 intervention clinics are eligible to participate. Patient-oriented risk reports are provided in real time. Provider-oriented risk reports are uploaded to the electronic medical record for review at the time of the appointment. Implementation outcomes are enrollment rate of clinics, providers, and patients (enrolled vs approached) and their representativeness compared to the underlying population. Primary effectiveness outcomes are the percent of participants newly identified as being at increased risk for one of the clinical decision support conditions and the percent with appropriate risk-based screening. Secondary outcomes include percent change in those meeting goals for a healthy lifestyle (diet, exercise, and smoking). Outcomes are measured through electronic medical record data abstraction, patient surveys, and surveys/qualitative interviews of clinical staff. DISCUSSION: This study evaluates factors that are critical to successful implementation of a web-based risk assessment tool into routine clinical care in a variety of healthcare settings. The result will identify resource needs and potential barriers and solutions to implementation in each setting as well as an understanding potential effectiveness. TRIAL REGISTRATION: NCT01956773.