https://orcid.org/0000-0001-7726-1186
Abstract
We developed a Project ECHO® module to offer prenatal providers training on engaging in shared decision-making about hepatitis C virus (HCV) treatment during pregnancy. In this pilot program, the ECHO module addressing HCV during pregnancy and the potential benefits of treatment was associated with increases in self-efficacy scores among participants.
INTRODUCTION
Hepatitis C virus (HCV) prevalence has risen in the United States in recent years due to the opioid epidemic; HCV now affects 1%–4% of pregnant people, with national data suggesting a 10-fold rise in HCV among pregnant people from 2000 to 2019 [1, 2]. In addition to a 6%–7% risk of perinatal transmission of HCV to neonates, HCV during pregnancy is associated with maternal and obstetric sequelae, including fetal growth restriction and intrahepatic cholestasis of pregnancy [1, 2]. While HCV is a target for elimination, pregnant individuals have been largely excluded from research and treatment programs [3]. Signs of progress toward more inclusion of pregnant patients include recommendations for universal HCV screening with each pregnancy [4], clinical trials evaluating the safety and efficacy of direct-acting antiviral (DAA) treatment in pregnancy (STORC trial NCT#05140941; IMPAACT 2041) [5], and current national guidance that states “treatment can be considered during pregnancy on an individual basis after a patient-physician discussion about the potential risks and benefits” [6]. Prior qualitative data demonstrated that patients want more discussion about possible treatment during pregnancy, but providers feel they lack the knowledge and training to have these discussions [7].
To address this gap among prenatal care providers, we leveraged existing Extension for Community Health Outcomes (ECHO)–Chicago telehealth infrastructure, based on the Project ECHO® model, to design a module to offer prenatal care providers specific knowledge about HCV in pregnancy. Originally created to combat preventable deaths from HCV, the evidence-based Project ECHO® model builds primary care capacity through workforce development to support healthy communities. Using video-conferencing technology, education through ECHO modules includes didactic and case-based learning which was molded after medical rounds on the wards [8].
METHODS
Content experts within the fields of infectious diseases, pediatrics, hepatology, maternal–fetal medicine, and bioethics met for a series of planning meetings with members of ECHO-Chicago. Discussions involved a review of prior qualitative data, selection of HCV-related topics to include in an ECHO module, who the target audience should be for a pilot study, and when it should occur. The result of the planning meetings was the development of a curriculum on the topics deemed most relevant to an audience of prenatal care providers. The format of the curriculum was eight 1-hour subject matter expert-led sessions with 20–30 minutes of didactic content and the balance of time used for group discussion of anonymized cases solicited from participants. All sessions were conducted using a virtual platform. Participants were asked to bring cases representing the full spectrum of clinical management of HCV during pregnancy, including patients who received HCV treatment during pregnancy, after pregnancy, or were never treated. Approximately 1–2 cases were discussed per session; participants who presented cases were asked to complete a form with clinical details prior to the case, and participants typically presented 1 case each over the course of the module.
Participants were recruited from local groups who participated in prior ECHO-Chicago trainings, prenatal providers in local and regional practices, and a national listserv maintained by ECHO-Chicago. Recruitment strategies focused on individuals who provide prenatal care, including to people with HCV, but were not targeted to specific specialty types or geographic regions. Participants were not compensated for their enrollment in the module. Participants were administered a survey pre- and post-training to assess various metrics of self-efficacy in having discussions of topics relevant to HCV in pregnancy and childhood. A 7-point Likert scale was used ranging from 0 = no skill at all, 4 = average among my peers, 7 = expert, teach others. Changes in self-efficacy scores from pre- to post-testing were evaluated as absolute improvement and compared using the Wilcoxon sign rank test for paired data. Prior work by ECHO-Chicago has demonstrated a 10% improvement (absolute improvement of 0.7 points) to represent a clinically meaningful improvement in competence [9]. This project was deemed exempt by the University of Chicago Institutional Review Board.
RESULTS
The ECHO pilot modules for HCV during pregnancy were conducted from May through June 2023 and included 8 modules on the following topics: screening for viral hepatitis; pathophysiology/clinical presentations of HCV; staging fibrosis in HCV and co-management (ie, management jointly between a subspecialist and primary care clinician) strategies; treatment of HCV in the non-pregnant population; harm reduction in the perinatal population; key clinical considerations in managing HCV in the pregnant population; HCV management in pregnancy: a shared decision-making model; HCV screening in the newborn and treatment options for children. As part of the ECHO model, each session included cases presented by attendees for interactive discussion with the content experts (Supplementary Table 1). Nineteen providers (14 physicians, 3 nurse practitioners, and 2 physician assistants) participated in the ECHO sessions and 14 completed the pre- and post-surveys. They represented 20 clinical sites from 13 organizations (8 from Chicagoland, 2 from rural Illinois, 1 from central Illinois, and 2 from outside Illinois). Participants included clinicians from family medicine (10), obstetrics and gynecology (6; including 2 maternal–fetal medicine), and pediatrics (3); among those who completed surveys, 8 were from family medicine, 5 from obstetrics and gynecology, and 1 from pediatrics.
In the pre-survey, participants had low to moderate ratings of self-efficacy (average 3.0), ranging from a low of 2.2 in “Ability to discuss and manage the timing of HCV treatment in a pregnant person” to a high of 4.4 in “Ability to identify pregnant patients who should be screened for HCV.” Mean self-efficacy varied by domain (Figure 1). In the post-survey, participants reported dramatic increases in all areas (average 5.2, increase of 2.2; all P-values <0.05) with the largest in the following areas: “Ability to discuss and manage timing of HCV treatment in a pregnant person” (average 5.1, increase of 3); “Ability to educate clinic staff about pregnant HCV patients” (average 5.3, increase of 2.8); and “Ability to identify suitable pregnant candidates for treatment for HCV” (average 5.2, increase of 2.7). Figure 2 demonstrates the increase in self-efficacy across each domain. All respondents reported clinically meaningful improvements in their ability to address HCV in a preconception, pregnant, postpartum, or neonatal population. In addition, in pre-survey assessment, 50% of participants reported that >50% of their eligible patients had been screened for HCV; after completion of the 8-week course, 76% of participants reported that >50% of their eligible participants had been screened.
Mean pre- and post-testing assessments of self-efficacy scores for HCV care during pregnancy.
Increase in self-efficacy scores after participation in the ECHO module about HCV care during pregnancy.
DISCUSSION
In settings where access to specialist care is a challenge, telehealth modules such as those offered by ECHO have been used to effectively coach primary care providers to treat HCV [10]. This pilot trial of an ECHO module focused on the management and potential treatment of HCV during pregnancy, as well as screening and treatment in children, resulted in significant increases in self-efficacy scores across all relevant domains. On this small scale, this project suggested the ECHO model may be a successful strategy to train clinicians about HCV care in pregnant people; future work must explore the wider dissemination and implementation of this module to reach more clinicians and the development of related modules for other specialty areas.
The conversation surrounding HCV elimination has been renewed with the Biden-Harris administration proposing a 5-year program with funding to expand all aspects of testing, treatment, and surveillance of HCV [11]. Included within this proposal was a specific focus on those at greatest risk of HCV infection, such as reproductive age women. Recent studies have documented how young women have experienced multifold increases in HCV infection, with a parallel increase in the number of infants with perinatal HCV exposure [12]. Although current HCV screening recommendations include testing with each pregnancy, real-world studies demonstrate many patients are not receiving it [13]. For those who are tested, referral for postpartum treatment can be low; even when referrals do occur, many barriers to completion of postpartum treatment exist [3]. Yet to facilitate elimination efforts, treatment must closely follow testing for all patients, including those who are pregnant. Treatment during pregnancy offers several advantages, including patients who are already being seen frequently, higher patient engagement, and the potential benefit of reducing or eliminating the risk of perinatal transmission [3]. While evidence on HCV treatment during pregnancy is still limited, the standard of care is rapidly changing. Without official guidance for the treatment of HCV during pregnancy, a minority of providers have undertaken “off-label” treatment with no major adverse events [14]. With 1 prior pilot study completed and 2 currently underway with the pan-genotype DAAs (STORC trial NCT#05140941; IMPAACT 2041), a plan for scaling up pregnancy treatment must include broad outreach to engage and empower prenatal providers to screen for and potentially treat HCV in their practices [5]. This ECHO module could be used to expedite those efforts.
It is important to acknowledge the limitations of our results. This pilot study included a highly motivated group who shared first-hand experiences of the impact of HCV infection on their patients and were uniquely motivated to learn about HCV treatment during pregnancy. Not all providers are likely to be as activated to adopt a new area of clinical management, and providers may not perceive their population to be at risk for HCV. Prior survey data show that prenatal providers are heavily influenced by professional society and Centers for Disease Control and Prevention (CDC) guidelines [15]. As more data demonstrating the efficacy and safety of HCV treatment during pregnancy emerge, professional society and CDC recommendations may be updated to prioritize this option, which we anticipate may increase providers’ interest in the type of training. This training package could be distributed broadly to support providers who are discussing the initiation of therapy and enable expanded treatment during pregnancy. Future work is needed to understand whether the improvements in self-efficacy seen here translate to clinically meaningful improvements in HCV-related linkages to care, testing, treatment, and assessment of sustained virologic response for pregnant and postpartum people.
Supplementary Data
Supplementary materials are available at the Journal of The Pediatric Infectious Diseases Society online (http://jpids.oxfordjournals.org).
Notes
Financial support. This work was supported by the CDC Contract 200-2022-15052 (75D30122C15052) for the grant “Towards elimination of hepatitis C: A focus on pregnancy and exposed infants” (PI Jhaveri).
Potential conflicts of interest. RJ: serves on Advisory Board for Gilead, Seqirus, Sanofi and AstraZeneca; receives research support from GSK; receives royalties from UptoDate. All other authors: No reported conflicts.
Supplement sponsorship. This article appears as part of the supplement “Viral Hepatitis Elimination in Infants, Children, and Pregnant Women,” sponsored by Gilead Sciences.
