Assessing the Financial Sustainability of High-Fidelity and Virtual Reality Simulation for Nursing Education: A Retrospective Case Analysis.

To stimulate classroom discussion and collaboration amid the COVID-19 pandemic, increasingly creative pedological methods for nursing education are necessary. Traditionally, high-fidelity simulation has been the standard for nursing education, but the use of virtual reality simulation is increasing. One of the major evaluative measures of simulation clinical training is the cost associated with each modality. In this retrospective case analysis, budget impact analysis methods were employed to compare high-fidelity simulation with virtual reality simulation. The components of each simulation pedagogy were compared in categorized cost buckets. Overall, virtual reality simulation education was determined to require 22% less time than high-fidelity simulation education. The cost associated with the virtual reality simulation was found to be 40% less expensive than the high-fidelity simulation. Our results demonstrate that virtual reality simulation is a financially advantageous, resource conscious pedagogical option for nursing education.

Health benefits and economic advantages associated with increased utilization of a smoking cessation program.

Rationale, aim & objective: The goal of this study was to examine the health and economic impacts related to increased utilization of the Duke Smoking Cessation Program resulting from the addition of two relatively new referral methods - Best Practice Advisory and Population Outreach. Materials & methods: In a companion paper 'Comparison of Referral Methods into a Smoking Cessation Program', we report results from a retrospective, observational, comparative effectiveness study comparing the impact of three referral methods - Traditional Referral, Best Practice Advisory and Population Outreach on utilization of the Duke Smoking Cessation Program. In this paper we take the next step in this comparative assessment by developing a Markov model to estimate the improvement in health and economic outcomes when two referral methods - Best Practice Advisory and Population Outreach - are added to Traditional Referral. Data used in this analysis were collected from Duke Primary Care and Disadvantaged Care clinics over a 1-year period (1 October 2017-30 September 2018). Results: The addition of two new referral methods - Best Practice Advisory and Population Outreach - to Traditional Referral increased the utilization of the Duke Smoking Cessation Program in Primary Care clinics from 129 to 329 smokers and in Disadvantaged Care clinics from 206 to 401 smokers. The addition of these referral methods was estimated to result in 967 life-years gained, 408 discounted quality-adjusted life-years saved and total discounted lifetime direct healthcare cost savings of US$46,376,285. Conclusion: Health systems may achieve increased patient health and decreased healthcare costs by adding Best Practice Advisory and Population Outreach strategies to refer patients to smoking cessation services.

Comparison of referral methods into a smoking cessation program.

Rational, aims & objectives: The goal of this observational study was to compare three referral methods and determine which led to the highest utilization of the Duke Smoking Cessation Program (DSCP). Materials & methods: We conducted two assessments within the Duke health system: a 12-month assessment of Traditional Referral (a provider refers a patient during a patient visit) and Best Practice Advisory (BPA) (a provider refers a patient after responding to an alert within the electronic health record); and a 30-day assessment of Population Outreach (a list of smokers is generated through the electronic health record and patients are contacted directly). Results: Over the 12-month assessment, a total of 13,586 smokers were seen throughout health system clinics receiving services from the DSCP. During this period, the service utilization rate was significantly higher for Traditional Referral (3.8%) than for BPA (0.6%); p < 0.005. The 30-day pilot assessment of showed a service utilization rate for Population Outreach of 6.3%, significantly higher than Traditional Referral (3.8%); p < 0.005 and BPA (0.6%; p < 0.005). Conclusion: Population Outreach appears to be an effective referral method for increasing utilization of the DSCP.

"I'm Putting My Trust in Their Hands": A Qualitative Study of Patients' Views on Clinician Initial Communication About Lung Cancer Screening.

BACKGROUND: Lung cancer screening (LCS) using low-dose CT imaging is recommended for people at high risk of dying of lung cancer. Communication strategies for clinicians have been recommended, but their influence on patient-centered outcomes is unclear. RESEARCH QUESTION: How do patients experience communication and decision-making with clinicians when offered LCS? STUDY DESIGN AND METHODS: We performed semistructured interviews with 51 patients from three institutions with established LCS programs. We focused on communication domains such as information exchange, patient as person, and shared decision-making. Using conventional content analysis, we report on patients' assessment of information, reasons for (dis)satisfaction, distress, and role in the decision-making process. RESULTS: Participants recalled few specific harms or benefits of screening, but uniformly reported satisfaction with the amount of information provided. All participants reported that clinicians did not explicitly ask about their values and preferences and about one-half reported some distress in anticipation of screening results. Almost all participants were satisfied with their role in the decision-making process. Despite participants' reporting that they did not experience all aspect of shared decision-making as defined, they reported high levels of trust in clinicians, which may relate to their largely positive reactions to the LCS decision interaction through the patient as person domain of communication. INTERPRETATION: Although decision-making for lung cancer screening as currently practiced may not meet all criteria of high-quality communication, patients in our sample are satisfied with the process, and report high trust in clinicians. Patients may place greater importance on interpersonal aspects of communication rather than information exchange.

A Randomized Controlled Trial of an Integrated Alcohol Reduction Intervention in Patients With Hepatitis C Infection.

BACKGROUND AND AIMS: Hepatitis C virus (HCV) and alcohol use are patient risk factors for accelerated fibrosis progression, yet few randomized controlled trials have tested clinic-based alcohol interventions. APPROACH AND RESULTS: A total of 181 patients with HCV and qualifying alcohol screener scores at three liver center settings were randomly assigned to the following: (1) medical provider-delivered Screening, Brief Intervention, and Referral to Treatment (SBIRT), including motivational interviewing counseling and referral out for alcohol treatment (SBIRT-only), or (2) SBIRT plus 6 months of integrated colocated alcohol therapy (SBIRT + Alcohol Treatment). The timeline followback method was used to assess alcohol use at baseline and 3, 6, and 12 months. Coprimary outcomes were alcohol abstinence at 6 months and heavy drinking days between 6 and 12 months. Secondary outcomes included grams of alcohol consumed per week at 6 months. Mean therapy hours across 6 months were 8.8 for SBIRT-only and 10.1 for SBIRT + Alcohol Treatment participants. The proportion of participants exhibiting full alcohol abstinence increased from baseline to 3, 6, and 12 months in both treatment arms, but no significant differences were found between arms (baseline to 6 months, 7.1% to 20.5% for SBIRT-only; 4.2% to 23.3% for SBIRT + Alcohol Treatment; P = 0.70). Proportions of participants with any heavy drinking days decreased in both groups at 6 months but did not significantly differ between the SBIRT-only (87.5% to 26.7%) and SBIRT + Alcohol Treatment (85.7% to 42.1%) arms (P = 0.30). Although both arms reduced average grams of alcohol consumed per week from baseline to 6 and 12 months, between-treatment effects were not significant. CONCLUSIONS: Patients with current or prior HCV infection will engage in alcohol treatment when encouraged by liver medical providers. Liver clinics should consider implementing provider-delivered SBIRT and tailored alcohol treatment referrals as part of the standard of care.

An electronic family health history tool to identify and manage patients at increased risk for colorectal cancer: protocol for a randomized controlled trial.

BACKGROUND: Colorectal cancer is the fourth most commonly diagnosed cancer in the United States. Approximately 3-10% of the population has an increased risk for colorectal cancer due to family history and warrants more frequent or intensive screening. Yet, < 50% of that high-risk population receives guideline-concordant care. Systematic collection of family health history and decision support may improve guideline-concordant screening for patients at increased risk of colorectal cancer. We seek to test the effectiveness of a web-based, systematic family health history collection tool and decision support platform (MeTree) to improve risk assessment and appropriate management of colorectal cancer risk among patients in the Department of Veterans Affairs primary care practices. METHODS: In this ongoing randomized controlled trial, primary care providers at the Durham Veterans Affairs Health Care System and the Madison VA Medical Center are randomized to immediate intervention or wait-list control. Veterans are eligible if assigned to enrolled providers, have an upcoming primary care appointment, and have no conditions that would place them at increased risk for colorectal cancer (such as personal history, adenomatous polyps, or inflammatory bowel disease). Those with a recent lower endoscopy (e.g. colonoscopy, sigmoidoscopy) are excluded. Immediate intervention patients put their family health history information into a web-based platform, MeTree, which provides both patient- and provider-facing decision support reports. Wait-list control patients access MeTree 12 months post-consent. The primary outcome is the risk-concordant colorectal cancer screening referral rate obtained via chart review. Secondary outcomes include patient completion of risk management recommendations (e.g. colonoscopy) and referral for genetic consultation. We will also conduct an economic analysis and an assessment of providers' experience with MeTree clinical decision support recommendations to inform future implementation efforts if the intervention is found to be effective. DISCUSSION: This trial will assess the feasibility and effectiveness of patient-collected family health history linked to decision support to promote risk-appropriate screening in a large healthcare system such as the Department of Veterans Affairs. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02247336 . Registered on 25 September 2014.

The Hepatitis C-Alcohol Reduction Treatment (Hep ART) intervention: Study protocol of a multi-center randomized controlled trial.

INTRODUCTION: Among patients with hepatitis C virus (HCV) infection, alcohol synergistically increases the risk of cirrhosis, hepatocellular carcinoma, and death. Randomized controlled trials of integrated models of HCV-alcohol treatment have been recommended but only performed in patients with severe alcohol use disorders. OBJECTIVES: This pragmatic randomized controlled trial seeks to compare clinical effectiveness and cost-effectiveness of integrated alcohol treatment compared to enhanced treatment as usual (TAU) on alcohol consumption and economic outcomes among patients ever infected with HCV. METHODS: Patients recruited from three liver centers who had current or prior chronic HCV and qualifying alcohol screener scores were randomly assigned to enhanced TAU or the Hepatitis C-Alcohol Reduction Treatment (Hep ART) intervention. All patients received enhanced TAU, consisting of a patient-administered alcohol screener and care from medical providers who were trained in Screening, Brief Intervention and Referral to Treatment (SBIRT), including brief motivational interviewing counseling. The Hep ART intervention combined enhanced TAU with up to six months of integrated co-located individual and/or group therapy that provided motivational, cognitive, and behavioral strategies to reduce alcohol consumption. The Timeline Followback (TLFB) Method was used to evaluate alcohol use at baseline, 3, 6, and 12 months. Primary outcomes are alcohol abstinence and fewer heavy drinking days, and for the cost-effectiveness analysis, measures included grams of alcohol consumed. DISCUSSION: This study will determine whether Hep ART, a six-month integrated alcohol treatment, compared to enhanced TAU, is both clinically effective and cost-effective in patients with a history of comorbid HCV and alcohol use.

Measuring sustainability of a grassroots program in a large integrated health care delivery system: the Warrior to Soul Mate Program.

INTRODUCTION: Veterans experience many physical and psychosocial adjustment problems that challenge personal relationships and social functioning and successful social reintegration. The Warrior to Soul Mate (W2SM) program uses a structured curriculum [i.e., the Practical Application of Intimate Relationships Skills (PAIRS)] to address veterans' interpersonal needs by teaching participants effective interpersonal skills. Veterans who attended the W2SM program reported lower anxiety levels, improvements in marital alterations and satisfaction, and increased intimacy, cohesion, and affection. Therefore, sustaining the W2SM program can have long-term positive effects for veterans, families, and the greater society. The purpose of this paper is to describe the sustainability of the W2SM program. METHODS: The Model of Community-based Program Sustainability conceptually guided the evaluation. Twenty-three VA hospitals in the U.S. that offer W2SM programs completed a self-report survey to measure sustainability. RESULTS: The highest scoring sustainability elements were "Demonstrating program results" (M=5.82, SD=1.23), "Staff involvement and integration" (M= 5.79, SD= 1.34), and "Program responsivity" (M=4.39, SD= 1.16); the lowest scoring element was "Strategic funding" (M=2.78, SD=1.75). Statistically significant associations were found between the global middle-range program results and three sustainability elements: leadership competence (r = .472, p = .023), effective collaboration (r = .470, p = .024), and strategic funding (r = .507, p = .014). DISCUSSION: Efforts to sustain programs should focus on leaders planning for sustainability at the onset of program implementation, collaborators must be involved in program design, implementation and evaluation, and long-term funding sources must be secured to support program operations and continuation.

Implementation findings from a hybrid III implementation-effectiveness trial of the Diabetes Prevention Program (DPP) in the Veterans Health Administration (VHA).

BACKGROUND: The Diabetes Prevention Program (DPP) is an effective lifestyle intervention to reduce incidence of type 2 diabetes. However, there are gaps in knowledge about how to implement DPP. The aim of this study was to evaluate implementation of DPP via assessment of a clinical demonstration in the Veterans Health Administration (VHA). METHODS: A 12-month pragmatic clinical trial compared weight outcomes between the Veterans Affairs Diabetes Prevention Program (VA-DPP) and the usual care MOVE!® weight management program (MOVE!). Eligible participants had a body mass index (BMI) ≥30 kg/m2 (or BMI ≥ 25 kg/m2 with one obesity-related condition), prediabetes (glycosylated hemoglobin (HbA1c) 5.7-6.5% or fasting plasma glucose (FPG) 100-125 mg/dL), lived within 60 min of their VA site, and had not participated in a weight management program within the last year. Established evaluation and implementation frameworks were used to guide the implementation evaluation. Implementation barriers and facilitators, delivery fidelity, participant satisfaction, and implementation costs were assessed. Using micro-costing methods, costs for assessment of eligibility and scheduling and maintaining adherence per participant, as well as cost of delivery per session, were also assessed. RESULTS: Several barriers and facilitators to Reach, Adoption, Implementation, Effectiveness and Maintenance were identified; barriers related to Reach were the largest challenge encountered by site teams. Fidelity was higher for VA-DPP delivery compared to MOVE! for five of seven domains assessed. Participant satisfaction was high in both programs, but higher in VA-DPP for most items. Based on micro-costing methods, cost of assessment for eligibility was $68/individual assessed, cost of scheduling and maintaining adherence was $328/participant, and cost of delivery was $101/session. CONCLUSIONS: Multi-faceted strategies are needed to reach targeted participants and successfully implement DPP. Costs for assessing patients for eligibility need to be carefully considered while still maximizing reach to the targeted population.

Diabetes Prevention Program Translation in the Veterans Health Administration.

INTRODUCTION: This clinical demonstration trial compared the effectiveness of the Veterans Affairs Diabetes Prevention Program (VA-DPP) with an evidence-based usual care weight management program (MOVE!®) in the Veterans Health Administration health system. DESIGN: Prospective, pragmatic, non-randomized comparative effectiveness study of two behavioral weight management interventions. SETTING/PARTICIPANTS: Obese/overweight Veterans with prediabetes were recruited from three geographically diverse VA sites between 2012 and 2014. INTERVENTION: VA-DPP included 22 group-based intensive lifestyle change sessions. MAIN OUTCOME MEASURES: Weight change at 6 and 12 months, hemoglobin A1c (HbA1c) at 12 months, and VA health expenditure changes at 15 months were assessed using VA electronic health record and claims data. Between- and within-group comparisons for weight and HbA1c were done using linear mixed-effects models controlling for age, gender, race/ethnicity, baseline outcome values, and site. Analyses were conducted in 2015-2016. RESULTS: A total of 387 participants enrolled (273 VA-DPP, 114 MOVE!). More VA-DPP participants completed at least one (73.3% VA-DPP vs 57.5% MOVE! p=0.002); four (57.5% VA-DPP vs 42.5% MOVE!, p=0.007); and eight or more sessions (42.5% VA-DPP vs 31% MOVE!, p=0.035). Weight loss from baseline was significant at both 6 (p<0.001) and 12 months (p<0.001) for VA-DPP participants, but only significant at 6 months for MOVE! participants (p=0.004). Between groups, there were significant differences in 6-month weight loss (-4.1 kg VA-DPP vs -1.9 kg MOVE!, p<0.001), but not 12-month weight loss (-3.4 kg VA-DPP vs -2.0 kg MOVE!, p=0.16). There were no significant differences in HbA1c change or outpatient, inpatient, and total VA expenditures. CONCLUSIONS: VA-DPP participants had higher participation rates and weight loss at 6 months, but similar weight, HbA1c, and health expenditures at 12 months compared to MOVE! PARTICIPANTS: Features of VA-DPP may help enhance the capability of MOVE! to reach a larger proportion of the served population and promote individual-level weight maintenance.

Implementation of Lung Cancer Screening in the Veterans Health Administration.

Importance: The US Preventive Services Task Force recommends annual lung cancer screening (LCS) with low-dose computed tomography for current and former heavy smokers aged 55 to 80 years. There is little published experience regarding implementing this recommendation in clinical practice. Objectives: To describe organizational- and patient-level experiences with implementing an LCS program in selected Veterans Health Administration (VHA) hospitals and to estimate the number of VHA patients who may be candidates for LCS. Design, Setting, and Participants: This clinical demonstration project was conducted at 8 academic VHA hospitals among 93 033 primary care patients who were assessed on screening criteria; 2106 patients underwent LCS between July 1, 2013, and June 30, 2015. Interventions: Implementation Guide and support, full-time LCS coordinators, electronic tools, tracking database, patient education materials, and radiologic and nodule follow-up guidelines. Main Outcomes and Measures: Description of implementation processes; percentages of patients who agreed to undergo LCS, had positive findings on results of low-dose computed tomographic scans (nodules to be tracked or suspicious findings), were found to have lung cancer, or had incidental findings; and estimated number of VHA patients who met the criteria for LCS. Results: Of the 4246 patients who met the criteria for LCS, 2452 (57.7%) agreed to undergo screening and 2106 (2028 men and 78 women; mean [SD] age, 64.9 [5.1] years) underwent LCS. Wide variation in processes and patient experiences occurred among the 8 sites. Of the 2106 patients screened, 1257 (59.7%) had nodules; 1184 of these patients (56.2%) required tracking, 42 (2.0%) required further evaluation but the findings were not cancer, and 31 (1.5%) had lung cancer. A variety of incidental findings, such as emphysema, other pulmonary abnormalities, and coronary artery calcification, were noted on the scans of 857 patients (40.7%). Conclusions and Relevance: It is estimated that nearly 900 000 of a population of 6.7 million VHA patients met the criteria for LCS. Implementation of LCS in the VHA will likely lead to large numbers of patients eligible for LCS and will require substantial clinical effort for both patients and staff.

Patient, Provider, and Combined Interventions for Managing Osteoarthritis in Primary Care: A Cluster Randomized Trial.

BACKGROUND: A single-site study showed that a combined patient and provider intervention improved outcomes for patients with knee osteoarthritis, but it did not assess separate effects of the interventions. OBJECTIVE: To examine whether patient-based, provider-based, and patient-provider interventions improve osteoarthritis outcomes. DESIGN: Cluster randomized trial with assignment to patient, provider, and patient-provider interventions or usual care. (ClinicalTrials.gov: NCT01435109). SETTING: 10 Duke University Health System community-based primary care clinics. PARTICIPANTS: 537 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 electronic delivery of patient-specific osteoarthritis treatment recommendations to providers. MEASUREMENTS: The primary outcome was the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score at 12 months. Secondary outcomes were objective physical function (Short Physical Performance Battery) and depressive symptoms (Patient Health Questionnaire). Linear mixed models assessed the difference in improvement among groups. RESULTS: No difference was observed in WOMAC score changes from baseline to 12 months in the patient (-1.5 [95% CI, -5.1 to 2.0]; P = 0.40), provider (2.5 [CI, -0.9 to 5.9]; P = 0.152), or patient-provider (-0.7 [CI, -4.2 to 2.8]; P = 0.69) intervention groups compared with usual care. All groups had improvements in WOMAC scores at 12 months (range, -3.7 to -7.7). In addition, no differences were seen in objective physical function or depressive symptoms at 12 months in any of the intervention groups compared with usual care. LIMITATIONS: The study involved 1 health care network. Data on provider referrals were not collected. CONCLUSION: Contrary to a previous study of a combined patient and provider intervention for osteoarthritis in a Department of Veterans Affairs medical center, this study found no statistically significant improvements in the osteoarthritis intervention groups compared with usual care. PRIMARY FUNDING SOURCE: National Institute of Arthritis and Musculoskeletal and Skin Diseases.

A Combined Patient and Provider Intervention for Management of Osteoarthritis in Veterans: A Randomized Clinical Trial.

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.

Group Versus Individual Physical Therapy for Veterans With Knee Osteoarthritis: Randomized Clinical Trial.

BACKGROUND: Efficient approaches are needed for delivering nonpharmacological interventions for management of knee osteoarthritis (OA). OBJECTIVE: This trial compared group-based versus individual physical therapy interventions for management of knee OA. DESIGN AND METHODS: Three hundred twenty patients with knee OA at the VA Medical Center in Durham, North Carolina, (mean age=60 years, 88% male, 58% nonwhite) were randomly assigned to receive either the group intervention (group physical therapy; six 1-hour sessions, typically 8 participants per group) or the individual intervention (individual physical therapy; two 1-hour sessions). Both programs included instruction in home exercise, joint protection techniques, and individual physical therapist evaluation. The primary outcome measure was the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC; range=0-96, higher scores indicate worse symptoms), measured at baseline, 12 weeks, and 24 weeks. The secondary outcome measure was the Short Physical Performance Battery (SPPB; range=0-12, higher scores indicate better performance), measured at baseline and 12 weeks. Linear mixed models assessed the difference in WOMAC scores between arms. RESULTS: At 12 weeks, WOMAC scores were 2.7 points lower in the group physical therapy arm compared with the individual physical therapy arm (95% confidence interval [CI]=-5.9, 0.5; P=.10), indicating no between-group difference. At 24 weeks, WOMAC scores were 1.3 points lower in the group physical therapy arm compared with the individual physical therapy arm (95% CI=-4.6, 2.0; P=.44), indicating no significant between-group difference. At 12 weeks, SPPB scores were 0.1 points lower in the group physical therapy arm compared with the individual physical therapy arm (95% CI=-0.5, 0.2; P=.53), indicating no difference between groups. LIMITATIONS: This study was conducted in one VA medical center. Outcome assessors were blinded, but participants and physical therapists were not blinded. CONCLUSIONS: Group physical therapy was not more effective than individual physical therapy for primary and secondary study outcomes. Either group physical therapy or individual physical therapy may be a reasonable delivery model for health care systems to consider.

Cost and Utility Analysis of a Store-and-Forward Teledermatology Referral System: A Randomized Clinical Trial.

IMPORTANCE: The costs and utility of teledermatology are important features of implementation. Such an analysis requires a description of the perspective of the entity that will bear the cost. OBJECTIVE: To assess the costs and utility of a store-and-forward teledermatology referral process compared with a conventional referral process from the perspectives of the Department of Veterans Affairs (VA) and society. DESIGN, SETTING, AND PARTICIPANTS: Three hundred ninety-one randomized participants were referred from remote sites of primary care to the dermatology services of 2 VA medical facilities for ambulatory skin conditions from December 2008 through June 2010, and follow-up was completed in March 2011. The time trade-off utility measures and costs were collected during a 9-month period among participants in a 2-site parallel group randomized clinical trial. The perspectives of the VA and society were evaluated. The multiple imputation procedure or weighted means were used for missing data elements. Data were analyzed from January to July 2014. INTERVENTIONS: Referrals were managed using store-and-forward teledermatology or a conventional text-based referral process. MAIN OUTCOMES AND MEASURES: Total costs from the perspectives of the VA and society incurred during the 9-month follow-up were used to derive per-participant costs. Utility, using the time trade-off method, was the measure of effectiveness. RESULTS: From the VA perspective, the total cost for conventional referrals was $66 145 (minimum, $58 697; maximum, $71 635), or $338 (SD, $291) per participant (196 participants); the total cost for teledermatology referrals was $59 917 (mimimum, $51 794; maximum, $70 398), or $308 (SD, $298) per participant (195 participants). The $30 difference in per-participant cost was not statistically significant (95% CI, -$79 to $20). From the societal perspective, the total cost for conventional referrals was $106 194 (minimum, $98 746; maximum, $111 684), or $542 (SD, $403) per participant (196 participants); the total cost for teledermatology referrals was $89 523 (minimum, $81 400; maximum, $100 400) or $460 (SD, $428) per participant. This $82 difference in per-participant cost was statistically significant (95% CI, -$12 to -$152). From baseline to the 9-month follow-up, the time trade-off utility value improved by 0.02 in the conventional referral group and 0.03 in the teledermatology group. This difference was not statistically significant (P = .50). CONCLUSIONS AND RELEVANCE: Compared with conventional referrals, store-and-forward teledermatology referrals were performed at a comparable cost (VA perspective) or at a lower cost (societal perspective) with no evidence of a difference in utility as measured by the time trade-off method. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00488293.

Evaluating the implementation and sustainability of a program for enhancing veterans' intimate relationships.

The Warrior to Soul Mate (W2SM) program is a grassroots initiative on the part of Veterans Affairs chaplain services to provide relationship enhancement skills to veterans and significant others based on the Practical Application of Intimate Relationship Skills model. To examine the implementation and sustainability of the W2SM program, two online surveys were sent to each participating facility's W2SM leader. The first examined how individual W2SM events were conducted (100% response rate, 67 surveys) and the second assessed facility-level issues impacting program sustainability (100% response rate, 23 surveys). Four sites were selected for qualitative interviews based on levels of sustainability. In 2013, W2SM served 1,664 people including 847 veterans, incurring reasonable program costs when compared to other intensive Veterans Affairs services. However, there have been important systematic (e.g., contracting processes) and resource (e.g., time, concern over funding) challenges that are reflected in the wide range of predicted program sustainability.

Implementation and evaluation of the VA DPP clinical demonstration: protocol for a multi-site non-randomized hybrid effectiveness-implementation type III trial.

BACKGROUND: The Diabetes Prevention Program (DPP) study showed that lifestyle intervention resulted in a 58% reduction in incidence of type 2 diabetes among individuals with prediabetes. Additional large randomized controlled trials have confirmed these results, and long-term follow-up has shown sustained benefit 10-20 years after the interventions ended. Diabetes is a common and costly disease, especially among Veterans, and despite strong evidence supporting the feasibility of type 2 diabetes prevention, the DPP has not been widely implemented. The first aim of this study will evaluate implementation of the Veterans Affairs (VA) DPP in three VA medical centers. The second aim will assess weight and hemoglobin A1c (A1c) outcomes, and the third aim will determine the cost-effectiveness and budget impact of implementation of the VA DPP from a health system perspective. METHODS/DESIGN: This partnered multi-site non-randomized systematic assignment study will use a highly pragmatic hybrid effectiveness-implementation type III mixed methods study design. The implementation and administration of the VA DPP will be funded by clinical operations while the evaluation of the VA DPP will be funded by research grants. Seven hundred twenty eligible Veterans will be systematically assigned to the VA DPP clinical demonstration or the usual care VA MOVE!® weight management program. A multi-phase formative evaluation of the VA DPP implementation will be conducted. A theoretical program change model will be used to guide the implementation process and assess applicability and feasibility of the DPP for VA. The Consolidated Framework for Implementation Research (CFIR) will be used to guide qualitative data collection, analysis, and interpretation of barriers and facilitators to implementation. The RE-AIM framework will be used to assess Reach, Effectiveness, Adoption, Implementation, and Maintenance of the VA DPP. Twelve-month weight and A1c change will be evaluated for the VA DPP compared to the VA MOVE! PROGRAM: Mediation analyses will be conducted to identify whether program design differences impact outcomes. DISCUSSION: Findings from this pragmatic evaluation will be highly applicable to practitioners who are tasked with implementing the DPP in clinical settings. In addition, findings will determine the effectiveness and cost-effectiveness of the VA DPP in the Veteran population.

Randomized Trial of Telegenetics vs. In-Person Cancer Genetic Counseling: Cost, Patient Satisfaction and Attendance.

Telegenetics-genetic counseling via live videoconferencing-can improve access to cancer genetic counseling (CGC) in underserved areas, but studies on cancer telegenetics have not applied randomized methodology or assessed cost. We report cost, patient satisfaction and CGC attendance from a randomized trial comparing telegenetics with in-person CGC among individuals referred to CGC in four rural oncology clinics. Participants (n = 162) were randomized to receive CGC at their local oncology clinic in-person or via telegenetics. Cost analyses included telegenetics system; mileage; and personnel costs for genetic counselor, IT specialist, and clinic personnel. CGC attendance was tracked via study database. Patient satisfaction was assessed 1 week post-CGC via telephone survey using validated scales. Total costs were $106 per telegenetics patient and $244 per in-person patient. Patient satisfaction did not differ by group on either satisfaction scale. In-person patients were significantly more likely to attend CGC than telegenetics patients (89 vs. 79 %, p = 0.03), with bivariate analyses showing an association between lesser computer comfort and lower attendance rate (Chi-square = 5.49, p = 0.02). Our randomized trial of telegenetics vs. in-person counseling found that telegenetics cost less than in-person counseling, with high satisfaction among those who attended. This study provides support for future randomized trials comparing multiple service delivery models on longer-term psychosocial and behavioral outcomes.

Implementation of new clinical programs in the VHA healthcare system: the importance of early collaboration between clinical leadership and research.

Collaboration between policy, research, and clinical partners is crucial to achieving proven quality care. The Veterans Health Administration has expended great efforts towards fostering such collaborations. Through this, we have learned that an ideal collaboration involves partnership from the very beginning of a new clinical program, so that the program is designed in a way that ensures quality, validity, and puts into place the infrastructure necessary for a reliable evaluation. This paper will give an example of one such project, the Lung Cancer Screening Demonstration Project (LCSDP). We will outline the ways that clinical, policy, and research partners collaborated in design, planning, and implementation in order to create a sustainable model that could be rigorously evaluated for efficacy and fidelity. We will describe the use of the Donabedian quality matrix to determine the necessary characteristics of a quality program and the importance of the linkage with engineering, information technology, and clinical paradigms to connect the development of an on-the-ground clinical program with the evaluation goal of a learning healthcare organization. While the LCSDP is the example given here, these partnerships and suggestions are salient to any healthcare organization seeking to implement new scientifically proven care in a useful and reliable way.

Tailored Case Management for Diabetes and Hypertension (TEACH-DM) in a community population: study design and baseline sample characteristics.

BACKGROUND: Despite recognition of the benefits associated with well-controlled diabetes and hypertension, control remains suboptimal. Effective interventions for these conditions have been studied within academic settings, but interventions targeting both conditions have rarely been tested in community settings. We describe the design and baseline results of a trial evaluating a behavioral intervention among community patients with poorly-controlled diabetes and comorbid hypertension. METHODS: Tailored Case Management for Diabetes and Hypertension (TEACH-DM) is a 24-month randomized, controlled trial evaluating a telephone-delivered behavioral intervention for diabetes and hypertension versus attention control. The study recruited from nine community practices. The nurse-administered intervention targets 3 areas: 1) cultivation of healthful behaviors for diabetes and hypertension control; 2) provision of fundamentals to support attainment of healthful behaviors; and 3) identification and correction of patient-specific barriers to adopting healthful behaviors. Hemoglobin A1c and blood pressure measured at 6, 12, and 24 months are co-primary outcomes. Secondary outcomes include self-efficacy, self-reported medication adherence, exercise, and cost-effectiveness. RESULTS: Of 377 randomized patients, 193 were allocated to the intervention and 184 to attention control. The cohort is balanced in terms of gender, race, education level, and income. The cohort's mean baseline hemoglobin A1c and blood pressure are above goal, and mean baseline body mass index falls in the obese range. Baseline self-reported non-adherence is high for diabetes and hypertension medications. Trial results are pending. CONCLUSIONS: If effective, the TEACH-DM intervention's telephone-based delivery strategy and nurse administration make it well-suited for rapid implementation and broad dissemination in community settings.