Abstract
Background. Oral health is a significant public health issue; yet barriers to implementing the prenatal oral health guidelines into practice remain. This formative research aimed to identify key implementation science characteristics to inform the development of an eHealth application (app) to assist providers in implementing the prenatal oral health guidelines during prenatal visits. Method. Guided by the Consolidated Framework for Implementation Research, the clinic’s infrastructure, workflow, and contextual factors were assessed via clinic observation, technology assessment, prenatal provider interviews (n = 4), clinic staff interviews (n = 8), and two focus groups with oral health providers (n = 16). Results. System-level factors influencing future implementation were identified regarding structural characteristic, networks/communication, culture, external policy/incentives, relative advantage, complexity, design quality/packaging, knowledge/beliefs, and personal attributes. Discussion. Findings provided vital information and will directly inform the design and implementation of an eHealth app that aims to facilitate the translation of the interprofessional prenatal oral health guidelines into clinical prenatal oral health practices.
Keywords
Introduction
Oral health care remains a missed opportunity during pregnancy. A growing body of evidence supports a potential association between poor oral health and adverse pregnancy, birth, and childhood outcomes, including gestational diabetes (Hartnett et al., 2016; Hunt & Schuller, 2007), low birth weight (Corbella et al., 2016; Ide & Papapanou, 2013), preterm birth (Centers for Disease Control and Prevention, 2011; Ide & Papapanou, 2013), and early childhood caries (Finlayson, Gupta, & Ramos-Gomez, 2017; U.S. Department of Health and Human Services, 2011). Approximately 40% of women experience periodontal disease during pregnancy (Lieff et al., 2004). According to data from the 2015 Pregnancy Risk Assessment Monitoring System, 83.0% of U.S. women reported receiving prenatal care in the first trimester, but only 48.3% visited a dentist or dental clinic during their most recent pregnancy (Centers for Disease Control and Prevention, 2015).
Background
National guidelines, endorsed by both the American College of Obstetricians and Gynecologists and the American Dental Association, have been established for prenatal and oral health providers to promote oral health during pregnancy (Oral Health Care During Pregnancy Expert Workgroup, 2012). Specifically, providers are to assess, advise, refer, and coordinate care (Oral Health Care During Pregnancy Expert Workgroup, 2012). Although prenatal care is a “cornerstone of the health care system for pregnant women” (Kiely & Kogan, 1994) and serves as an opportune time to promote oral health (Boggess et al., 2011), a significant gap exists in translating this guidance into comprehensive and quality prenatal care. Previous research reveals that prenatal providers are generally not aware of the guidelines and do not perform the recommended behaviors, such as taking an oral health history from pregnant patients, visually inspecting pregnant patients’ mouths, referring pregnant patients to oral health providers, and collaborating with oral health providers on patient management and care (Morgan, Crall, Goldenberg, & Schulkin, 2009; Strafford, Shellhaas, & Hade, 2008; Vamos et al., 2015). Explanations cited for this practice gap include lack of information, training, time, and resources to address oral health issues, and difficulty finding an oral health provider to refer pregnant patients (Morgan et al., 2009; Strafford et al., 2008; Vamos et al., 2015).
eHealth technologies offer an innovative mechanism for improving health care processes, outcomes, and quality of care (Lewis, 1999; Renker & Tonkin, 2007; Richter et al., 2008; Thornberry et al., 2002; Wofford, Smith, & Miller, 2005). Providers often use eHealth technologies such as electronic medical records, electronic health records (EHR), personal health records, e-prescribing technology, and health information exchange to store and share relevant health data (National Alliance for Health Information Technology, 2008; Office of the National Coordinator for Health Information Technology, 2013). These eHealth technologies usually incorporate clinical decision support, which provides clinicians with knowledge and patient-specific information, intelligently filtered or presented at appropriate times. Clinical decision support systems have been found to successfully increase provider adherence to recommended treatment and referral guidelines and enhance the delivery of health care (De Angelis et al., 2016; Marasinghe, 2015; McCartney, 2006; Watkins, Wood, Schneider, & Clifford, 2015). eHealth applications (apps) are interactive, incorporate multiple learning strategies, and have greater potential to educate users compared with other methods of health promotion (Bennett, Switzer, Aguirre, Evans, & Barg, 2006).
Based on principles of implementation science, it is critical to understand the clinical systems and structures to maximize the potential for an app to be adopted and integrated into current clinical workflow and processes. Thus, the purpose of this formative study was to identify key implementation science characteristics to inform the development of an eHealth app to assist providers in implementing the prenatal oral health guidelines during prenatal visits.
Method
Conceptual Framework
The Consolidated Framework for Implementation Research (CFIR) guided this formative study (Damschroder et al., 2009) and was used to (1) understand the clinical context, infrastructure, and workflow and (2) identify key characteristics to inform the development of the app and maximize the potential of adoption and use. The CFIR is a “meta-theoretical framework” that compiles and organizes known evidence-based constructs from existing implementation theories across the following system levels or “domains”: (1) inner setting, (2) outer setting, (3) intervention characteristics, (4) characteristics of individuals, and (5) process (Damschroder et al., 2009). The authors of CFIR suggest that researchers use only those constructs that are applicable and salient for the specific innovation, setting, and priority population under investigation. Subsequently, similar to the process used by previous studies employing this framework (Vamos et al., 2016; Vamos et al., 2017), domains and constructs of focus were identified through discussions held among the research team (Investigators and Scientific Advisory Board members) with multidisciplinary expertise (e.g., behavioral theory, implementation science, qualitative methodology, eHealth technology development, patient–provider communication, clinical practice), as well as preliminary discussion held with the clinic administration. As a result, constructs across four out of the five domains were identified to examine during this elicitation research (see Table 1). The process domain was excluded from this phase of the research as these constructs involve factors related to planning and reflecting on an intervention that has been actually implemented.
Brief Descriptions of the Domains Addressed in the Formative Study as Guided by the Consolidated Framework for Implementation Research (CFIR; Damschroder et al., 2009)
Sample and Procedures
This formative research was conducted with a federally qualified health center (FQHC). The FQHC has multiple clinic sites offering comprehensive services, including prenatal and oral health care. The University of South Florida’s Institutional Review Board approved all study procedures and provided ethical regulation and oversight of activities.
Interviews and Focus Groups
A series of interviews and focus groups were conducted with different stakeholder groups: (1) clinic staff, (2) prenatal providers, and (3) oral health providers. Interviews were conducted with eight clinic staff members, including administrators, health IT personnel, office staff, nurses, medical assistants, and a doula. Interviews were audio-recorded and lasted approximately 30 to 45 minutes. Sixty-minute interviews (n = 4) were conducted with prenatal care providers (nurse practitioners and midwives). Two 60-minute focus groups (n = 8 per group) were conducted with oral health care staff, including dentists, dental hygienists, and dental assistants (see Table 2).
Participant Demographics (N = 28)
NOTE: FQHC = federally qualified health center.
Data missing from one record.
Data collection instruments (interview and focus group guides) were developed based on the study’s research questions and the CFIR framework. A member of the organization’s administration team contacted potential participants to introduce the study. Following an agreement to participate, a member of the research team scheduled an interview or focus group where informed consent was obtained.
Technological Assessment
An interview with a health information officer for the FQHC yielded details about network infrastructure, availability of technology resources such as tablets and wireless printers, and operating systems in use. This information helped define the app’s technical requirements as well as potential obstacles that might hinder the app’s performance.
Clinic Observations
The research team assessed the clinical environment to understand how the app could fit within established processes and augment patient encounters. An observation protocol was used by the research team to collect information about patient visit times, patient–provider encounters, communication methods, the presence and delivery of health education information, and overall clinic workflow.
Data Analysis
Audio recordings from the clinic staff interviews were professionally transcribed verbatim and uploaded into ATLAS.ti. The audio recordings of the interviews and focus groups were transcribed by the research team and detailed notes were taken to abstract key data by thematic area.
A codebook was developed using a priori codes based on four CFIR domains. Two research staff members independently coded (1) one transcribed clinic interview, (2) notes from one oral health provider’s focus group, and (3) one prenatal provider interview. Coding discrepancies were discussed and resolved by the research staff. All remaining data were then coded by the two research staff members using the codebook and themes identified. Given the multiple data collection methods (interviews, focus groups, technology assessment, and clinic observations) and only the key interviews with clinic staff (i.e., administrators, health IT personnel, office staff, nurses, medical assistants, and a doula) being professionally transcribed, it is unknown whether data saturation was achieved. However, data redundancy, where key findings across data collection methods and participant stakeholder groups emerge were found (Guest, MacQueen, & Namey, 2012).
Results
Overview
Data from the clinical workflow, technology assessment, interviews, and focus groups are presented below by CFIR domain and corresponding themes with supporting quotes presented in Table 3.
Themes and Supporting Quotes by Consolidated Framework for Implementation Research (CFIR) Domain
Inner Setting
Structural Characteristics
Figure 1 illustrates the findings from the clinic observation, including how a patient navigates and interacts with clinic staff. In general, a patient checks in at the main registration desk, which processes documentation and appointments for all services at the clinic. The patient completes paper forms, and then a medical assistant calls the patient back to take vital signs and/or collect a urine specimen. Finally, the patient is brought into another room to see the prenatal provider. This describes a visit for a returning prenatal care patient, which lasts 15 to 20 minutes on average.

Clinical Workflow
During a new patient visit, the patient also visits with a licensed practical nurse who provides printed health education materials. In addition, women are encouraged to attend a prenatal class offered once a week by a doula, where oral health information is provided by a dental hygienist. New patient visits last 2 to 3 hours on average.
Networks and Communication
Three themes emerged throughout the data with regard to networks and communications: patient education and communication, organizational and internal communication, and external communication.
Patient education and communication
Doulas were identified as the primary individuals providing health education. Other staff providing information to patients included nurses and nurse midwives. Overwhelmingly, participants identified the provision of “one-on-one” education with patients as an area for improvement.
Organizational and internal communication
Organizational communication focuses on the methods in which policy changes or information are conveyed from the organization’s management to the providers and staff. The most common methods of organizational communication were paper memos and e-mail. Internal communication describes methods of documentation and communication across departments. Participants’ discussions often included the concept of “ownership” of documentation and patient education. For example, medical assistants reported that the documentation and education are the providers’ responsibility, while their responsibility is limited to taking vital signs. Additional discussions included the referral process across departments, specifically from the women’s department to the dental department. Participants mentioned a wide range of referral methods, including physically walking the patient to the dental area to schedule an appointment. Furthermore, although patient records are shared between the two departments, some participants explained that they are not always able to access certain screens within the patient’s EHR or are unable to understand the terminology.
External communication
This theme included the referral process and information communicated with external providers, hospitals, or organizations. The referral process was described as having designated staff person responsible for scheduling “most” of the patients’ appointments with outside organizations.
Culture
Most participants believed that the norms and values of their organizational culture were conducive to implementing innovative processes. Participants discussed how their organization is often perceived as being a leader in testing and implementing health care innovations. Participants also described the organization as “family-like,” indicating a sense of belonging and a desire to provide quality health care services to patients.
Outer Setting
External Policy and Incentives
Importantly, participants who held management and leadership roles discussed how their organization’s designation (FQHC) can affect policy, regulations, and other performance requirements. With regard to incentives, one participant discussed how a new technological intervention that could help the organization adhere to meaningful use guidelines would motivate them to adopt a new intervention.
Intervention Characteristics
Relative Advantage
Participants discussed their perception regarding how an app could help address oral health during prenatal visits and how it might affect the current standard of practice. Several advantages were noted for a technological intervention, including enhanced patient–provider communication and efficiency with processes, especially through standardized questions and scripts. Similarly, a technological intervention that had the potential to reduce wait times and improve clinic flow would be advantageous. Additionally, participants thought that an app that allows them to document, track processes and referrals, and stay organized with the overall elements of a patient visit would be advantageous at both the individual and organizational levels.
In contrast, some participants reported that a technological intervention hosted on another device outside the existing computer system may not be viewed favorably. In addition, some participants reported that technology had the potential to add more time and negatively affect visit efficiency.
Complexity
Several factors related to the perceived difficulty of using the technology were mentioned, emphasizing the need for an app to be user-friendly. Participants also explained that the app should not cover complex oral health issues considering that the main user group is prenatal care providers, and this may be beyond their specialty. Similarly, participants felt that the app should not be diagnostic but should promote oral health, congruent with prenatal providers’ knowledge and comfort by focusing on identifying potential issues to be referred to an oral health provider. It was also suggested that the app could serve as a patient education tool and may need to function and present information in a manner that patients could understand.
Design Quality and Packaging
Participants reflected how best to design the technology, including having minimum steps but with options for expanded access to resources and information if needed. Participants also discussed how the inclusion of pictures could serve the dual purpose of helping providers in their assessments and being used as a patient education resource. Participants also discussed packaging the intervention on a device that would be viewed as professional and credible. Specifically, the device needed to be viewed as an important tool in the health care process and capture the patient’s attention.
Characteristics of Individuals
Knowledge and Beliefs About the Intervention
Although participants were asked to share their attitudes and beliefs related to a potential prenatal oral health app, most focused on the topic of oral health rather than the use of technology. Prenatal providers stated that oral health is not their specialty and there could be limitations within their abilities to address oral health. These sentiments were echoed by the oral health providers, who unanimously agreed that prenatal care providers are not trained in oral health care and should not diagnose oral health conditions. However, they should be able to perform a brief visual assessment, discuss oral health, and refer patients to an oral health provider. Oral health providers believed that prenatal providers would need resources to help them incorporate such care into their routine practice. This need was further corroborated by prenatal providers, as they often reflected on the fact that they did not learn anything dental in school.
Nonetheless, both groups of participants could identify specific information that should be known among prenatal care providers as reflected in the prenatal oral health guidance, including common oral health issues during pregnancy, the adverse effects of poor oral health on pregnancy and birth, and patients’ oral health care history. In terms of skills related to oral health care, prenatal providers were divided on whether they should look in the mouth. One prenatal provider participant mentioned that she would prefer to “delegate [some tasks] off to someone [another clinical team member]” and not perform any type of oral health assessment, only reviewing the oral health documentation and reinforcing educational messages.
Personal Attributes
Participants discussed their own abilities to implement a potential technological intervention to address oral health among pregnant patients. Participants believed that most clinic staff are comfortable with technology, although a technology learning curve among some staff was identified to be a potential barrier to adoption. Additionally, participants believed that there may be a difference between new and experienced employees in terms of intervention adoption. One participant discussed how experienced staff may have greater motivation and competence to adopt a technology intervention because they are more invested in their patients and have developed stronger patient–provider relationships.
Discussion
This study aimed to gather critical formative research to inform the development of an eHealth application to assist prenatal providers in adhering to prenatal oral health guidelines. As guided by CFIR, data from the technology assessment, clinic observations, interviews, and focus groups were triangulated to identify various contextual factors and considerations that will directly inform the development and implementation of this health promotion intervention.
Key processes and observations were documented during the clinical workflow assessment. Specifically, patient education, internal/organization, and external communication were identified as potential areas for future improvement.
Although the initial intended users of an app were prenatal providers, findings identified other opportunities where the intervention could be used by other clinical staff and patients. Furthermore, the culture of the organization was thought to be conducive to testing and implementing new processes, with a sense of being “family-like,” where there is desire to provide good health care services. Since various types of health care professionals are interrelated and integral to the clinic workflow, intervention designs should support the activities of all clinical staff who engage in health promotion activities (Campbell, Guappone, Sittig, Dykstra, & Ash, 2009). Subsequently, research should explore how an eHealth app that is designed to assist prenatal providers in implementing the oral health guidelines into routine prenatal care visits may integrate and coordinate with other health promotion activities, such as those delivered via prenatal care education classes.
With regard to clinical service delivery, participants discussed a sense of documentation “ownership,” with certain staff having the responsibility for eliciting and recording information. There was also a perceived limitation on the sharing and use of the EHR between departments, with some staff unable to view or understand records. Lack of interoperability among EHRs is a perceived major barrier to meaningful use of the systems. An application has the capacity to not only improve patient–provider communication but also improve communication between and within the clinic system. Therefore, technological interventions should consider how to improve interoperability among different systems and improve the ability to share clinical data between medical entities (Meigs & Solomon, 2016).
Several characteristics of the intervention were identified by participants as being advantageous. Participants believed that such an intervention could potentially improve patient–provider communication and positively affect efficiency with regard to time and documentation. Research has shown that technology can improve patient–provider communication by identifying clinical discussion points and empowering patients to take a more active role in their own care (Mirkovic et al., 2016). It was thought that the app could also have the potential to facilitate the adherence to meaningful use guidelines and provide motivation for use given this accountability requirement. On the other hand, such an intervention could negatively affect health care delivery by adding another device to the clinical system if not fully integrated during development efforts.
Issues related to the design, packaging, and complexity were also of concern to participants. Participants prefer a user-friendly application that requires minimum steps to use, includes pictures to guide prenatal providers’ assessments, and serves as a patient education tool. Other interventions that simplify prenatal providers’ efforts to screen and counsel their patients about behavioral risks through cueing (e.g., suggested counseling statements) have encouraged providers to consistently and effectively discuss specific health topics with their patients (Humphreys, Tsoh, Kohn, & Gerbert, 2011; Tsoh, Kohn, & Gerbert, 2010). In addition, participants noted the importance of having this application focus on general oral health promotion rather than serving as a complex oral health diagnostic tool, given prenatal providers’ lack of specialization in oral health care (Curtis, Silk, & Savageau, 2013; George et al., 2012). Participants also desired an app that could be adaptable to their clinic-specific processes and patient population. In addition, given that this organization provides comprehensive and integrated health care services, participants believed that the application should be flexible enough to be used within and across staff roles, departments, and clinical sites.
Participants also discussed several factors related to characteristics of the individuals that need to be considered in the application design. Most participants believed that prenatal providers have limited knowledge, skills, and training on oral health issues, but should be able to educate patients on the importance of oral health during pregnancy. Other attributes were identified at the clinic level, including the ability of this organization to implement new processes and technological innovations. In addition, it was noted that most staff were comfortable with technology but may need additional training and/or may be resistant to a process change.
Several limitations must be noted when considering these findings. This study was completed at one community-based organization, and the clinics were predominantly located in rural areas. Thus, the needs of the providers, clinical staff, and patients may differ from those in other geographic areas and in private practices. Also, the prenatal providers were all nurse practitioners or nurse midwives and therefore may not be representative of views held by other prenatal care providers with medical or osteopathic training. In addition, this organization was unique in that within many of their clinic sites, medical and dental services were provided, making referral and access to dental services more accessible. Furthermore, oral health education is offered by a dental hygienist to patients during their group prenatal care class. As a result, participants may take this into consideration when providing their input into the design of the app. Additionally, given that the clinic staff interviews (n = 8) were professional transcribed, whereas the audio recordings of the interviews and focus groups with the prenatal (n = 4) and oral health providers (n = 16) were not transcribed but the research team took detailed notes to abstract key data, intercoder reliability was not able to be established for this elicitation research. Moreover, although this formative research included diverse clinic participant roles, including patients in future research will be essential to understand from their perspective how best to foster patient–provider communication, patient engagement, and shared decision making.
Nonetheless, there are several strengths to this study, including being guided by consumer-driven, theoretically based principles and processes. Although the initial phase of this intervention is intended for use by prenatal care providers, multiple perspectives were initially gathered by interviewing diverse staff roles (e.g., oral health providers, clinic staff, and administration). Such input will ensure easy adaptability and modifications in future iterations of the technology. Furthermore, this app serves to bridge practice behaviors between two historically distinct disciplines—prenatal and oral health care—and facilitate the implementation of interprofessional practice guidelines. Additionally, the research was conducted by a multidisciplinary team of behavioral scientists in public health and a small business company (technology), with consultation by a national advisory board with comprehensive expertise (i.e., prenatal care, oral health care, maternal and child oral-systemic health, health literacy, and patient—provider communication). Such collaborations ensure that the design and implementation of this intervention are evidence-based and adhere to clinical practice considerations.
Conclusion
This formative, theoretical-based and consumer-driven research provided vital information needed prior to the development of an innovative eHealth application via multiple methods. Findings will directly inform the design and implementation of an eHealth application that aims to facilitate the translation of the interprofessional prenatal oral health guidelines into clinical practice. Specifically, the implementation science characteristics identified in this study can assist in not only guiding the design and components of the intervention but also providing a rich understanding of the complex context that may influence the adoption and experiences of the end users. Additionally, future research should consider and pretest the developed eHealth application in other clinical settings and contexts to assess the broader usability and feasibility capabilities. Last, future research will also need to explore patients’ perspectives, such as the acceptability and satisfaction with regard to how this eHealth application may facilitate patient–provider communication on a topic that is predominantly absent during prenatal care visits. This study also presents an example of a unique multidisciplinary academic–small business partnership while adhering to community-based and implementation science principles, with the ultimate goal of improving quality of care.
Footnotes
Authors’ Note:
Tom Jacobs is now at Trifoia, Eugene, OR, USA. We are extremely grateful for the time, participation, and collaboration provided by the community clinic’s administration and staff in this research. This work was supported by the National Institute of Dental and Craniofacial Research of the National Institutes of Health (Award Number R41DE023723). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
