Risk Communication After Health Care Exposures: An Experimental Vignette Survey With Patients.

Purpose. We investigated how health care systems should communicate with patients about possible exposures to blood-borne pathogens that may have occurred during their care. Our goal was to determine how best to communicate uncertain risk information in a way that would minimize harm to patients, maintain their trust, and encourage patients to seek follow-up treatment. Methods. Participants (N = 1103) were randomized to receive one of six vignette surveys; 997 (98.4%) responded. All vignettes described the same event, but differed by risk level and recommendations (lower risk v. higher risk) and by communication mode (telephone, letter, social media). We measured participants' perceived risk of blood-borne infection, trust in the health care system, and shared decision making about next clinical steps. Open-ended questions were analyzed using grounded thematic analysis. Results. When the vignette requested patients to undergo testing and practice certain health behaviors (higher risk), participants' likelihood of seeking follow-up testing for blood-borne pathogens and their understanding of health issues increased. Perceived trust was unaffected by risk level or communication processes. Qualitative data indicated a desire for telephone communication from providers known to the patient. Limitations. It is not clear whether higher risk language or objective risk levels in vignettes motivated patients' behavioral intentions. Conclusion. Using higher risk language when disclosing large-scale adverse events increased participants' willingness to seek follow-up care. Implications. Health care organizations' disclosures should focus on the next steps to take after health care exposures. This communication should involve helping patients to understand their personal health issues better, make them feel that they know which steps to take following the receipt of this information, and encouraging them to seek follow-up infectious disease testing in order to better take care of themselves.

From implementation to sustainment: A large-scale adverse event disclosure support program generated through embedded research in the Veterans Health Administration.

In 2008, the Veterans Health Administration published a groundbreaking policy on disclosing large-scale adverse events to patients in order to promote transparent communication in cases where harm may not be obvious or even certain. Without embedded research, the evidence on whether or not implementation of this policy was generating more harm than good among Veteran patients was unknown. Through an embedded research-operations partnership, we conducted four research projects that led to the development of an evidence-based large-scale disclosure toolkit and disclosure support program, and its implementation across VA healthcare. Guided by the Consolidated Framework for Implementation Research, we identified specific activities corresponding to planning, engaging, executing, reflecting and evaluating phases in the process of implementation. These activities included planning with operational leaders to establish a shared research agenda; engaging with stakeholders to discuss early results, establishing buy-in of our efforts and receiving feedback; joining existing operational teams to execute the toolkit implementation; partnering with clinical operations to evaluate the toolkit during real-time disclosures; and redesigning the toolkit to meet stakeholders' needs. Critical lessons learned for implementation success included a need for stakeholder collaboration and engagement, an organizational culture involving a strong belief in evidence, a willingness to embed researchers in clinical operation activities, allowing for testing and evaluation of innovative practices, and researchers open to constructive feedback. At the conclusion of the research, VA operations worked with the researchers to continue to support efforts to spread, scale-up and sustain toolkit use across the VA healthcare system, with the final goal to establish long-term sustainability.

Evaluating the implementation of a national disclosure policy for large-scale adverse events in an integrated health care system: identification of gaps and successes.

BACKGROUND: Many healthcare organizations have developed disclosure policies for large-scale adverse events, including the Veterans Health Administration (VA). This study evaluated VA's national large-scale disclosure policy and identifies gaps and successes in its implementation. METHODS: Semi-structured qualitative interviews were conducted with leaders, hospital employees, and patients at nine sites to elicit their perceptions of recent large-scale adverse events notifications and the national disclosure policy. Data were coded using the constructs of the Consolidated Framework for Implementation Research (CFIR). RESULTS: We conducted 97 interviews. Insights included how to handle the communication of large-scale disclosures through multiple levels of a large healthcare organization and manage ongoing communications about the event with employees. Of the 5 CFIR constructs and 26 sub-constructs assessed, seven were prominent in interviews. Leaders and employees specifically mentioned key problem areas involving 1) networks and communications during disclosure, 2) organizational culture, 3) engagement of external change agents during disclosure, and 4) a need for reflecting on and evaluating the policy implementation and disclosure itself. Patients shared 5) preferences for personal outreach by phone in place of the current use of certified letters. All interviewees discussed 6) issues with execution and 7) costs of the disclosure. CONCLUSIONS: CFIR analysis reveals key problem areas that need to be addresses during disclosure, including: timely communication patterns throughout the organization, establishing a supportive culture prior to implementation, using patient-approved, effective communications strategies during disclosures; providing follow-up support for employees and patients, and sharing lessons learned.

Are current screening protocols for chronic hepatitis B virus infection adequate?

Chronic hepatitis B virus (HBV) infection screening usually includes only HBV surface antigen (HBsAg) testing; HBV core and surface antibody (anti-HBc, anti-HBs) assays, indicating resolved infection and immunity, are not routinely performed. Yet, serum HBV DNA is measurable in approximately 10% of HBsAg-negative/anti-HBc-positive cases, representing occult HBV infection (OBI). Patient blood samples from 2 Veterans Affairs medical center look-back investigations were screened for HBV infection using HBsAg enzyme immunoassays. Supplementary testing included anti-HBc and anti-HBs enzyme immunoassays. For anti-HBc-positive samples, HBV DNA testing was performed. Background OBI prevalence was further estimated at these 2 facilities based on HBV serology testing results from 1999-2012. Finally, a literature review was performed to determine OBI prevalence in the published literature. Of 1887 HBsAg-negative cohort patients, 98 (5.2%) were anti-HBc positive/anti-HBs negative; and 175 (9.3%), anti-HBc positive/anti-HBs positive. Six of 273 were HBV DNA positive, representing 0.3% of the total tested and 2.2% who were anti-HBc positive/anti-HBs negative or anti-HBc positive/anti-HBs positive. Among 32,229 general population veterans at these 2 sites who had any HBV testing, 4/108 (3.7%) were HBV DNA positive, none of whom were part of the cohort. In 129 publications with HBsAg-negative patients, 1817/1,209,426 (0.15%) had OBI. However, excluding blood bank studies with greater than 1000 patients, the OBI rate increased to 1800/17,893 (10%). OBI is not rare and has implications for transmission and disease detection. HBsAg testing alone is insufficient for detecting all chronic HBV infections. These findings may impact blood donation, patient HBV screening, follow-up protocols for patients assumed to have cleared the infection, and initiation of immunosuppression in patients with distant or undetected HBV.

Intended and unintended effects of large-scale adverse event disclosure: a controlled before-after analysis of five large-scale notifications.

BACKGROUND AND OBJECTIVE: How patients respond to being notified of a large-scale adverse event (LSAE), such as improper sterilisation of medical equipment that exposes them to bloodborne pathogens, is not well known. The objective of this study was to determine, using administrative data, the intended and unintended consequences of patient notification following a LSAE. METHODS: We examined five LSAEs where patients may have been inadvertently exposed to hepatitis C virus (HCV), HIV, and hepatitis B virus (HBV). A total of 9638 cases were identified at five Department of Veteran Affairs (VA) medical facilities between 2009 and 2012. We identified controls at the same facility prior to the exposure period and at neighbouring facilities (n=45,274). Difference-in-differences models were used with Veterans Health Administration (VHA) and Medicare data to examine infectious disease testing rates and subsequent utilisation patterns. RESULTS: Receipt of a LSAE notification was associated with a 73.2, 76.8 and 77.1 adjusted percentage point increase for HCV, HIV and HBV testing, respectively (all p<0.001). Compared with white patients, African-American patients were significantly less likely to return to VHA for follow-up testing. Patients exposed to a dental LSAE reduced their use of preventive and restorative dental care over the subsequent year, but they eventually came back to VHA for dental services 18-months post exposure. CONCLUSIONS: The majority of patients notified of a LSAE responded by getting tested for HCV, HIV and HBV, although there remains room for improvement. Potential exposure to a LSAE was associated with increased odds of subsequently using non-VA facilities, but the size and timing of the shift depended on the type of care.

Building strong research partnerships between public health and researchers: a VA case study.

We are in a new era of partner-based implementation research, and we need clear strategies for how to navigate this new era. Drawing on principles from community-based participatory research, the Clinical Public Health group of the Department of Veterans Affairs and the HIV/Hepatitis Quality Enhancement Research Initiative (HHQUERI) forged a longstanding partnership that has improved the care of Veterans with Human Immunodeficiency Virus (HIV) and Hepatitis C Virus. An exemplar HIV testing project epitomizes this partnership and is discussed in terms of the lessons learned as a result of our high level of collaboration around design, analysis, implementation, and dissemination across projects over the past several years. Lessons learned through this partnered testing program involve respecting different time horizons among the partners, identifying relevant research questions for both parties, designing flexible studies, engaging all partners throughout the research, and placing an emphasis on relationship building at all times. These lessons and strategies can benefit others conducting partner-based research both within the Veterans Health Administration (VA) and in other integrated healthcare systems.

Improving healthcare systems' disclosures of large-scale adverse events: a Department of Veterans Affairs leadership, policymaker, research and stakeholder partnership.

BACKGROUND: The Department of Veterans Affairs (VA) mandates disclosure of large-scale adverse events to patients, even if risk of harm is not clearly present. Concerns about past disclosures warranted further examination of the impact of this policy. OBJECTIVE: Through a collaborative partnership between VA leaders, policymakers, researchers and stakeholders, the objective was to empirically identify critical aspects of disclosure processes as a first step towards improving future disclosures. DESIGN: Semi-structured interviews were conducted with participants at nine VA facilities where recent disclosures took place. PARTICIPANTS: Ninety-seven stakeholders participated in the interviews: 38 employees, 28 leaders (from facilities, regions and national offices), 27 Veteran patients and family members, and four congressional staff members. APPROACH: Facility and regional leaders were interviewed by telephone, followed by a two-day site visit where employees, patients and family members were interviewed face-to-face. National leaders and congressional staff also completed telephone interviews. Interviews were analyzed using rapid qualitative assessment processes. Themes were mapped to the stages of the Crisis and Emergency Risk Communication model: pre-crisis, initial event, maintenance, resolution and evaluation. KEY RESULTS: Many areas for improvement during disclosure were identified, such as preparing facilities better (pre-crisis), creating rapid communications, modifying disclosure language, addressing perceptions of harm, reducing complexity, and seeking assistance from others (initial event), managing communication with other stakeholders (maintenance), minimizing effects on staff and improving trust (resolution), and addressing facilities' needs (evaluation). CONCLUSIONS: Through the partnership, five recommendations to improve disclosures during each stage of communication have been widely disseminated throughout the VA using non-academic strategies. Some improvements have been made; other recommendations will be addressed through implementation of a large-scale adverse event disclosure toolkit. These toolkit strategies will enable leaders to provide timely and transparent information to patients and families, while reducing the burden on employees and the healthcare system during these events.

Association between facility characteristics and the process of care delivered to patients with hepatitis C virus infection.

BACKGROUND: Available data suggest problems in the process of care provided to patients with chronic hepatitis C (HCV). However, the solutions to these problems are less obvious. Healthcare facility factors are potentially modifiable and may enhance process quality in HCV treatment. METHODS: We evaluated the relationship between the process of HCV care and facility factors including number of weekly half-day HCV clinics per 1,000 HCV patients, HCV-specific quality-improvement initiatives, and administrative service of the HCV clinic (gastroenterology, infectious disease, primary care) for a cohort of 34,258 patients who sought care in 126 Veterans Affairs facilities during 2003-2006. We measured HCV care on the basis of 23 HCV-specific process measures capturing pretreatment (seven measures), preventive and/or comorbid (seven measures), and treatment and treatment monitoring care (nine measures). RESULTS: Patients seen at a facility with >8 half-day clinics were 52 % more likely to receive overall indicated care (OR 1.52, 95 % CI 1.13-2.05). Patients seen at a facility with >3 HCV quality improvement initiatives were more likely to receive better preventive and/or comorbid care (OR 1.32, 95 % CI 1.00-1.74). Compared with patients in facilities with no dedicated HCV clinic, patients at facilities with gastroenterology-based clinics received better pretreatment care (OR 1.36, 95 % CI 1.01-1.85) and more antiviral treatment (OR 1.45, 95 % CI 1.06-1.97) whereas those at facilities with infectious disease-based or primary care-based clinics received better preventive and/or comorbid care (OR 1.59, 95 % CI 1.06-2.39 and 1.84, 95 % CI 1.21-2.79 respectively). CONCLUSION: Several facility factors affected the process of HCV care. These factors may serve as targets for quality-improvement efforts.

Expanded HIV testing in the US Department of Veterans Affairs, 2009-2011.

OBJECTIVES: We measured HIV testing and seropositivity among veterans in Veterans Affairs (VA) care for calendar years 2009 through 2011 and analyzed 2011 results by patient demographics. METHODS: We performed a repeated-measures cross-sectional study using standardized electronic data extraction from the VA electronic health records for all veterans with at least 1 outpatient visit during 2009 through 2011. We analyzed testing rates and seropositivity by demographic characteristics for 2011. RESULTS: Of veterans with an outpatient visit, 20.0% had an HIV test in 2011, compared with 9.2% in 2009. Documented HIV testing rates were highest in women and Blacks. Of confirmed positive test results, 67.0% were in outpatients older than 50 years. Seropositivity was highest among men aged 30 to 49 years, women aged 50 to 69 years, and Black outpatients of both genders. Implementation of an electronic clinical reminder was associated with higher testing rates. CONCLUSIONS: The significant effect of an electronic clinical reminder suggests that such decision support tools can substantially increase testing rates. The frequency of positive test results in older individuals suggests the need for additional work to define optimum approaches to HIV testing in this population.

Hepatocellular carcinoma screening practices in the Department of Veterans Affairs: findings from a national facility survey.

BACKGROUND: Previous studies suggest low rates of hepatocellular carcinoma (HCC) screening in clinical practice. There is little information on the provider- and healthcare-facility-related factors that explain the use of HCC screening. AIMS: We used data from the 2007 Survey to Assess Hepatitis C Care in Veterans Health Administration that collected information regarding the care of patients with hepatitis C virus (HCV) from 138 of 140 Veterans Administration healthcare facilities nationwide. METHODS: All providers caring for veterans with HCV were invited to respond. In addition, each facility was asked to identify a lead HCV clinician to respond to facility-specific questions. Our outcome was a response concordant with HCC screening guidelines [HCC screening in patients with cirrhosis or in patients with chronic hepatitis B virus (HBV), and screening every 6 or 12 months]. RESULTS: A total of 268 providers responded (98 % facility participation rate). Of these, 190 respondents (70.9 %) reported recommending HCC screening with guideline-concordant risk groups and frequency. Providers reporting guideline-concordant HCC screening practices were significantly more likely to have expertise in liver disease (MD, gastroenterologists or hepatologists), routinely screen for varices, prescribe HCV treatment, and refer or manage patients with liver transplant. The availability of HCC-specific treatments on site was the main facility factor associated with guideline-concordant HCC screening. CONCLUSIONS: Self-reported rates of guideline-concordant HCC screening are considerably higher than those seen in routine VA practice. Provider expertise in liver disease and the perceived availability of HCC treatment including transplantation in the local facility are important factors driving self-reported HCC screening practices.

Significant reductions in drinking following brief alcohol treatment provided in a hepatitis C clinic.

BACKGROUND: Although the hepatitis C virus (HCV) alone increases the risk of cirrhosis, alcohol use is thought to act synergistically with HCV to significantly hasten the development of fibrosis. OBJECTIVE: The authors assessed the impact of brief medical counseling or integrated-care approaches to lessen or eliminate alcohol use in these vulnerable patients. METHOD: This retrospective study describes the effect of brief alcohol treatment delivered in a hepatitis clinic on drinking outcomes and antiviral treatment eligibility: 47 heavy-drinking chronic hepatitis C patients received a brief intervention performed by medical clinicians, with follow-up by a psychiatric nurse-specialist. RESULTS: At the last follow-up, 62% of patients reported >50% drinking reduction; these included 36% who achieved abstinence. Only 6% of patients were excluded from antiviral therapy. DISCUSSION: Brief treatment addressing heavy drinking delivered by hepatitis clinicians with psychiatric-specialist follow-up was associated with abstinence or a significant reduction in alcohol consumption in over 50% of patients.

Antibody response to hepatitis B vaccine in substance use disorder patients.

The objectives of this study were to assess the prevalence of prognostic factors previously known to be associated with poor antibody response to hepatitis B vaccination in a sample of veterans presenting for substance use disorders treatment at a Veterans Health Administration (VA) Medical Center, assess vaccination response, and identify markers for poor response in this population. Results indicated that most participants had multiple prognostic factors previously known to be associated with poor antibody response including male gender, age over 40, smoking, and obesity. The rate of seroconversion in this sample was 51.9%. This is substantially lower than seen in healthy adults. Alcohol dependence was the only significant independent negative predictor of seroconversion in this sample. Substance use disorders treatment providers who are considering adding hepatitis B vaccination services to their clinics should be aware that the antibody response to the hepatitis B vaccination is inconsistent and that patients with particular demographic characteristics may be at heightened risk of poor antibody response.

Outcomes of a Hepatitis C screening program at a large urban VA medical center.

GOALS: To determine the outcomes of implementing clinical care guidelines for Hepatitis C screening, evaluation, and treatment in a large urban Veterans Affairs Medical Center. BACKGROUND: Little information exists regarding the actual outcomes of institutional screening programs for Hepatitis C. STUDY: Retrospective review of all patients tested for Hepatitis C at the Minneapolis Veterans Affairs Medical Center from January 1, 2000 to December 31, 2001. Logistic regression was used to determine factors related to successful referral and treatment. RESULTS: During this period 36,422 unique patients were screened for Hepatitis C virus (HCV) risk factors, resulting in 12,485 HCV enzyme-linked immunoassay antibody tests. HCV antibodies were positive in 681 (5.4%) patients and 520 (4.2%) were HCV-RNA-positive. Of HCV-RNA-positive patients, 430 (83%) were referred, 382 (73%) attended the Hepatitis clinic, and 232 (44.6%) received liver biopsies. Patients referred had significantly fewer comorbidities, known marital status, and greater prior clinic attendance than those not referred. Overall, 124 patients with established fibrosis received antiviral therapy (32% of patients attending clinic or 24% of viremic cohort). White race, fewer major medical problems, and age less than 60 years predicted antiviral treatment. Sustained virologic response occurred in 46 (37%) of treated patients (9% of the viremic cohort). Patients with a sustained virologic response include 17 patients with stage 3 to 4 fibrosis. CONCLUSIONS: This screening and referral program resulted in 73% of HCV-RNA-positive patients attending a specialty Hepatitis C clinic and 24% of those most likely to benefit received antiviral therapy. Measures to increase referral, engagement in care, and antiviral treatment are needed.

Integrating hepatitis prevention services into a substance use disorder clinic.

The Healthy Liver Program, established at the Minneapolis Veterans Affairs Medical Center Substance Use Disorder Clinic, provides screening for exposure to hepatitis infections, a group education class, and an individual nursing appointment to review screening results, give vaccinations for hepatitis A and hepatitis B, and make referrals to the hepatitis clinic as appropriate. A patient chart audit was completed 11 months after the establishment of the Healthy Liver Program. The attendance rate for the educational group and individual feedback sessions was 66.9%, with 94.1% of attendees accepting recommended hepatitis A and/or hepatitis B vaccinations. All patients with chronic hepatitis C who attended the Healthy Liver Program received a referral for evaluation in the hepatitis clinic, as compared with only 50% of patients with chronic hepatitis C who were identified before the establishment of the program. The importance of providing comprehensive educational sessions and recommendations for how patients with substance use disorders can access hepatitis screening, vaccination, and treatment resources are stressed.

Integrated psychiatric/medical care in a chronic hepatitis C clinic: effect on antiviral treatment evaluation and outcomes.

OBJECTIVES: Psychiatric and substance use disorders are common in hepatitis C patients and represent barriers to antiviral treatment. We evaluated the effect of integrating psychiatric and medical care on evaluation for and initiation of antiviral treatment in a cohort of 184 patients with chronic hepatitis C. METHODS: Integrated care consisted of screening for psychiatric problems with Alcohol Use Disorders Identification Test-Consumption (AUDIT-C), Beck Depression Inventory (BDI), Urine Drug Screen (UDS), and Primary Care Posttraumatic Stress Disorder (PC-PTSD) screens, referral based on specified cutoff scores to an established mental health (MH) provider, to a colocated psychiatric clinical nurse specialist (PCNS), or both. Data were collected retrospectively by chart review. RESULTS: Most patients (149/184, 81.0%) had at least one positive screen, 25.5% had a positive UDS. Among patients with positive screens, 38.3% had established MH providers, 47.0% had no MH provider and were referred to the PCNS, and 15.0% refused any psychiatric referral. Patients receiving integrated care with a colocated PCNS were significantly more likely to complete evaluation for and start antiviral treatment than other patients with positive screens, and at a rate similar to that of patients with negative screens. Patients with positive screens followed by any MH provider had significantly greater adherence to antiviral therapy than patients without positive screens. CONCLUSION: An integrated MH and medical approach was associated with rates of antiviral therapy recommendation and initiation similar to patients without risks for psychiatric or substance use problems. MH care was associated with improved adherence to antiviral therapy. Integrated care offers promise as an approach for addressing psychiatric comorbidity in this traditionally difficult to treat population.

Organizational change in management of hepatitis C: evaluation of a CME program.

INTRODUCTION: Effective treatment regimens exist for the hepatitis C virus (HCV); however, clinicians are often resistant to evaluation or treatment of patients with alcohol or substance abuse problems. We describe a continuing medical education (CME) program for clinicians in a nationwide health care system, with emphasis on current treatment practices, multispecialty collaboration, and organizational change. METHODS: Quantitative measures were used to assess changes in knowledge and treatment confidence, and site-specific organizational changes were qualitatively evaluated. The CME program included a preassessment of current HCV knowledge and care; a 2-day preceptorship; and follow-up with coaching calls at 1, 3, and 6 months. Program attendees included 54 medical and mental health providers from 28 Veterans Affairs Medical Centers. RESULTS: Knowledge following the CME program increased significantly. In 93% of the sites, there were organizational changes such as HCV support group-initiated group education, in-service training, improvement in patient notification or scheduling processes, hiring of new clinical staff, development of a business plans, and discussions about changes with administration. Of all sites, 15 (54%) changed existing antiviral treatment protocols, 18 (64%) established collaborative relationships, and almost half (13/28) established regular use of depression and alcohol use screening tools. Major barriers to change included lack of administrative support or resources (or both) and difficulty collaborating with mental health colleagues. DISCUSSION: This multifaceted CME program with follow-up coaching calls significantly increased individual knowledge and confidence scores and resulted in improved clinic processes and structures. Organizational change was facilitated by the development of an action plan. The major change agent was a nurse; the primary deterrent was an administrator.

Spectrum of disease in U.S. veteran patients with hepatitis C.

OBJECTIVE: Hepatitis C virus (HCV) infection is more prevalent in U.S. veterans attending Veterans Affairs Medical Centers than in the general population. The purpose of this study was to examine the risk factors, psychiatric and substance abuse conditions, and severity of liver disease in veterans with HCV. METHODS: The medical records and liver biopsies of 206 consecutive patients with HCV attending a multidisciplinary medical/psychiatric chronic hepatitis clinic and who met eligibility criteria for interferon alpha-2b therapy were reviewed. RESULTS: The mean age was 46.5+/-6.8 yr and 77% were Vietnam-era veterans. Risk factors included i.v. drug use (64%), blood transfusion (15%), and cocaine use (9%), and were unknown in 12%. The average estimated duration of disease was 24+/-7.6 yr. A history of alcohol abuse or dependence was identified in 80% of patients. Psychiatric illnesses were present in 60%, the most common being depression and posttraumatic stress disorder. Overall, 89% of patients had documented psychiatric and/or substance abuse diagnoses. Severe fibrosis (stages 3-4) was present in 32% and severe inflammation (grades 2-3) was present in 71% of biopsies. Psychiatric and substance abuse diagnoses did not correlate with severity of liver disease. A total of 145 patients (71%) were prescribed interferon-based treatment. The overall virological sustained response rates were 16% after interferon monotherapy and 28% after interferon/ribavirin therapy. Reasons for not receiving interferon therapy included minimal fibrosis on liver biopsy (37 patients [18%]), worsening medical conditions (nine [4%]), and worsening psychiatric and substance abuse problems (14 [7%]). CONCLUSIONS: Advanced fibrosis is common in this cohort of veteran patients with chronic hepatitis C, and the overwhelming majority of these patients have psychiatric and/or substance abuse diagnoses. Despite these comorbidities, the majority received interferon therapies in the context of a multidisciplinary clinic. These data emphasize the importance of hepatitis C care that includes linkage of medical care and psychiatric services.