2023 Volume 2 Issue 2 Pages 203-225
Objective: Continuous interprofessional support for women with gestational diabetes mellitus (GDM) is not standardized in Japan creating a gap in care. The purpose of this study was to assess the intention and perceived barriers to implementing an integrated GDM clinical care pathway that we developed towards resolving the GDM gaps in care in hospitals.
Methods: This study was a convergent parallel mixed methods design. Participants were health professionals who cared for women with GDM. The clinical care pathway was presented to the participants through an e-leaning format. A 41-item questionnaire was developed for the online survey and analyzed by descriptive statistics. Semi-structured interviews also provided participants' views about those same content areas. Framework analysis and content analysis were conducted for qualitative data.
Results: A total of 77 participants were recruited for the online survey and 19 participants for the semi-structured interviews. Most participants had positive intentions to implement the integrated GDM clinical care pathway. However, there were various potential barriers in terms of the feasibility of implementation, stemming from: a) the difficulty of implementation of the long-term clinical care pathway into hospitals, and collaboration with the local facilities; b) lack of time and resources as many issues take priority over GDM, and c) insufficient knowledge, skill, and self-confidence among nursing staff to implement the GDM clinical care pathway.
Conclusion: The intention to implement the GDM clinical care pathway was generally positive. However, potential barriers to implementation need to be addressed before implementing the pathway into hospitals.
Globally, gestational diabetes mellitus (GDM) has been increasing, with an incidence rate of approximately 5.8-12.9% (Zhu & Zhang, 2016). Similarly, in Japan, the percentage of pregnant women diagnosed with GDM is approximately 13% (Nobumoto et al., 2015). GDM causes various short term and long term adverse maternal and neonatal outcomes including: a higher risk of cesarean section, induction of labor, macrosomia, shoulder dystocia and large for gestational age (Farrar et al., 2016), increased risk of obesity compared with those born to healthy women (Kawasaki et al., 2018), high recurrence rate of GDM at the next pregnancy (Schwartz et al., 2015), seven times higher risk of developing type 2 diabetes mellitus than women without GDM (Bellamy et al., 2009), and an increased long-term risk for cardiac events (Kramer et al., 2019). However, there are successful evidenced-based interventions for pregnant women with GDM to reduce these risks.
In a synthesis of systematic reviews, Martis et al. (2018) found that lifestyle changes including healthy diet, physical activity and self-monitoring of blood glucose levels reduced the risk of macrosomia and reported the potential for improved health outcomes for women and their children. Miyazaki et al. (2017) reported in their overview that dietary and exercise interventions were effective in reducing glycemic load. Furthermore, in a systematic review, Tanase-Nakao et al. (2017) found that women with a history of GDM who breastfed for longer than 4-12 weeks postpartum had a reduced risk of type 2 diabetes compared to women with GDM who breastfed for shorter periods of time.
Given the complexity of lifestyle changes required to achieve these positive outcomes, support for women with GDM requires interprofessional collaboration among various specialists, including obstetricians, endocrinologists, nutritionists, pharmacists, nurses, and midwives. Furthermore, lifestyle changes require a continuous support system from the time of GDM diagnosis to long-term follow-up care after childbirth. However, according to a nationwide cross-sectional survey in Japan (Matsunaga et al., 2021a; Matsunaga et al., 2021b), there were various issues in achieving that type of GDM support. For example, the support for prevention of type 2 diabetes after GDM has not been standardized. In addition, Matsunaga et al. (2021a) identified numerous barriers constraining continuous support through interprofessional collaboration. It was noted that clinical care pathways could address these barriers.
Clinical care pathways are tools that promote the standardization of high-quality healthcare (Asmirajanti et al., 2018). They also enhance interprofessional collaboration in healthcare services by facilitating coordination, communication, and decision-making to achieve better healthcare outcomes (Asmirajanti et al., 2018; Scaria, 2016). In addition, a Cochrane systematic review (Rotter et al., 2012) reported that clinical care pathways could significantly reduce complications of disease in hospitals and improve patient health outcomes without negatively impacting costs.
Therefore, towards closing the gap of GDM support in Japan, we developed an integrated GDM clinical care pathway with the following characteristics: a) a comprehensive package of testing, treatment, and support from diagnosis of GDM through to postpartum follow-up, including type 2 diabetes prevention to strengthen continuous support and b) a format that promotes multidisciplinary professionals working together towards a common goal.
Thus, the overarching goal of this study was to evaluate the integrated GDM clinical care pathway at the development stage, using a mixed methods approach. The rationale for such an approach was that this is a feasibility study, designed to develop the integrated GDM clinical care pathway within complex hospital settings. Therefore, a more nuanced understanding of the implications of such settings was essential. Mixed methods research draws meta-inference by combining quantitative and qualitative data collection and analysis to yield a deeper and more subtle understanding which takes context more fully into account. Thus, more valid insights can potentially be gained than with a single approach (Creswell & Plano Clark, 2017). Moreover, Curry et al., (2013) state that within health sciences, mixed methods are especially useful in navigating the difficulties in obtaining the viewpoints of key stakeholders, such as patients, providers, and organizations.
Purpose and Research QuestionsThe purposes of this study were to assess whether and why health professionals: (a) intend to implement the integrated GDM clinical care pathway, and (b) judge the clinical care pathway as acceptable, appropriate, and feasible. Furthermore, this study aimed to identify barriers that health professionals perceived in implementing the integrated GDM clinical care pathway into their hospitals.
Our mixed methods research questions were as follows:
The results of this study could help to inform both the content development of the integrated GDM clinical care pathway and the implementation strategies for development.
This study was conducted as a convergent mixed methods design, combining online surveys (quantitative [QUAN]) with semi-structured interviews (qualitative [QUAL]). In such a design, qualitative and quantitative data are collected simultaneously, separately analyzed, and finally merged (Creswell & Plano Clark, 2017). A convergent mixed method design has been used to achieve the research purpose of the study. This requires a comprehensive understanding, which can only be achieved by converging, comparing, and corroborating quantitative and qualitative data, yielding a deeper understanding of the research questions than would be possible through separate analyses of the two forms of data. This study is part of a larger pre-post, mixed-method feasibility study of E-learning for health professionals toward the implementation of the integrated GDM clinical care pathway.
Research Participants and RecruitmentParticipants consisted of medical and health professionals who were engaged in the care of women with GDM within hospital settings in Japan. Inclusion criteria included at least two years of experience as a professional and at least one year at the hospital where they were currently working. Participants were individually recruited for the online survey and the semi-structured interview by a) an invitation letter to the target hospitals throughout Japan that were chosen via a purposive sampling method; b) e-mail invitations from the principal investigator, and c) snowball sampling. The participants for the quantitative data and those for the qualitative data were recruited separately. However, the same participants were able to take part in both the online survey and the semi-structured interview, making subject overlap possible.
Sample Size Online survey [QUAN]As this study was part of the larger pre-post, mixed-method feasibility study, the sample size of the online survey was realistically set at approximately 40 each for (a) nursing staff (nurses and midwives), and (b) other health professionals (obstetricians, endocrinologists, pediatricians, nutritionists, pharmacists, and other health professionals). This sample size was calculated using GPower, a software tool for power analysis, as follows: in each group, a priori power analysis was conducted using t-test, means, difference between two dependent means (matched pairs), and two tail effect size (0.5), alpha (0.05), and power (0.8). In addition, a dropout rate of 20% that is the maximum expected dropout rate for clinical trials (Cramer et al., 2016) was added. The rationale for counting sample size by separating nursing staff and other health professions was that nursing staff comprised the largest workforce segment in the healthcare service. Moreover, nursing staff were among the key professionals who performed various critical services for women from pregnancy to postpartum under the continuous interprofessional collaboration services. A sample size of 40 each for (a) nursing staff, and (b) other health professionals was also adopted, based on Lancaster et al. (2004), as a reasonable number of participants through which to assess feasibility.
Semi-structured interview [QUAL]The sample size of the semi-structured interview was estimated to be approximately 20 participants. To ensure representation, the minimum number was set at two or more for each of the following professions: obstetricians, endocrinologists, nutritionists, nurses, and midwives. We determined a sample size of 20 was adequate to reach data saturation based on a similar study (N = 17) (Warner et al., 2018), which used the Consolidated Framework for Implementation Research (CFIR) (Damschroder et al., 2009) to conduct a framework analysis. Further, this sample size was consistent with the results of a systematic review of appropriate sample sizes in qualitative studies (N = 9-17) (Hennink & Kaiser, 2022). All interviews were conducted by the author (MM), who was trained in, and had experience of, conducting semi-structured interviews for qualitative studies. Data were collected from December 2020 to September 2021.
The Integrated GDM Clinical Care PathwayWe used a 4-step process to create an integrated GDM clinical care pathway: (1) developed the pathway based on the Japanese GDM guidelines (Japan Society of Obstetrics and Gynecology & Japan Association of Obstetricians and Gynecologists, 2020) and international guidelines for management and support of GDM (Zhang et al., 2019; Mensah et al., 2019); (2) included the actual status of current hospital support; (3) established face validity by interviews with eight women with GDM, and (4) modified the pathway based on interviews with health professionals involved in GDM support (N=11: 2 obstetricians, 1 endocrinologist, 1 pediatrician, 1 dietitian, 1 nurse, 5 midwives). See supplemental file 1 for the integrated GDM clinical care pathway.
Data collection Study procedureThe integrated GDM clinical care pathway was presented to participants via an e-learning format, which was developed by the authors (MM and SH) to explain the content and implementation features of the clinical care pathway. After participants learned about the clinical care pathway, their qualitative and quantitative data were collected and analyzed separately and independently. The convergent design requires that the two methods be equally weighed and conducted within the same timeframe. Therefore, the results were integrated and interpreted together (Creswell & Plano Clark, 2017). Figure 1 is a procedural diagram of this study.
Survey participants provided the following information: occupation, number of years of professional experience, number of years working with women with GDM, frequency of involvement with women with GDM, regional location of the participant’s hospital, and interprofessional collaboration strategy for GDM management.
(2). Implementation intentionImplementation requires behavioral changes and intentions to make such changes are critical determinants for implementation (Moullin et al., 2018). Therefore, we developed a 4-item scale based on the Moullin et al. (2018). Measure of Innovation-Specific Implementation Intentions (MISII). The MISII originally consisted of three items, representing three factors (Plans, Desire and Scope). However, because this study focused on implementation at an organizational level, rather than an individual level, the following four items were used: I plan to talk to my colleague or manager about the clinical care pathway with my clients; Using the clinical care pathway is a high priority for me; Using the clinical care pathway is a high priority for my hospital; I will suggest using all aspects of the clinical care pathway with my clients. Participants rated their responses on a 5-point Likert scale (0 = not at all to 4 = to a very great extent), with higher scores indicating a stronger intention to implement.
(3). Perceptions of Acceptability, Appropriateness and FeasibilityFor perceptions of acceptability, appropriateness, and feasibility, we used Weiner et al. (2017)’s three scales for implementation outcome on the basis of their robustness and reliability: Acceptability of Measurement (AIM); Intervention Appropriateness Measurement (IAM) and Feasibility of Intervention Measurement (FIM). Each scale consists of four items measured on a 5-point ordinal scale (1 = completely disagree and 5 = completely agree). Higher scores indicate better outcomes.
(4). Perceived BarriersWe also developed a 19-item questionnaire, listing potential barriers to implementing clinical care pathways, based on the results of existing literature (Evans-Lacko et al., 2010; Jabbour et al., 2018) and the four domains of the CFIR framework (inner setting, outer setting, intervention, and individuals involved) (Damschroder et al., 2009). Participants’ responses were rated on a 5-point Likert scale (1=completely disagree and 5= completely agree). The higher the score the greater the barrier.
Semi-structured interview [QUAL]We conducted in-depth interviews using an interview guide, developed in accordance with the procedure proposed by Kallio et al. (2016). The interviews sought information regarding the following: (a) intentions toward the implementation of the integrated GDM clinical care pathway and the rationale; (b) the acceptability, appropriateness, and feasibility of adopting the pathway, and the rationale, and (c) the perceived barriers to the introduction of the integrated GDM clinical care pathway and the rationale.
Data Analyses Online survey [QUAN]Descriptive statistics (frequency, percentage, mean, median, SD, and range) for all variables were calculated using SPSS Statistics ver. 28. Cronbach’s alpha was used to assess the internal consistency of each scale.
Semi-structured interview [QUAL]We prepared a verbatim transcript from the IC recorded interview data and proceeded with content analysis (Erlingsson & Brysiewicz, 2017) for the following: acceptability, appropriateness, feasibility, and intention. To identify barriers, we used framework analysis (Ritchie & Spencer, 1994) based on the CFIR (Damschroder et al., 2009). The two authors (MM and SH) conducted the data analysis to ensure rigor; when disagreement arose, it was resolved through discussion with the third author (SP). NVivo software ver.12 was used throughout the data analysis.
Integration processHaving separately analyzed the quantitative and qualitative data, we used a joint display analysis to achieve a comprehensive prospective integration of the data. Joint display is an approach of integrating quantitative and qualitative results, which involves extracting overall conclusions, explanations, or understanding, termed meta-inferences (Creswell & Plano Clark, 2017; Tashakkori et al., 2020). Joint display analysis is further defined as “the process of discovering linkages between the qualitative and quantitative constructs, organizing and recognizing the findings into a matrix or figure to optimize the presentation as a finalized joint display” (Fetters, 2020, p. 194). Given the complexity of mixed method studies, using joint displays is highly recommended (Fetters & Tajima, 2022).
For this study, joint display analysis was accomplished via the strategy of comparing the results of the two data sets (Fetters, 2020), and examining the relationships, agreements, and disagreements between them. In addition, we used qualitative data to support and interpret the characteristics of the quantitative data. Regarding the analysis of Perceived Barriers, pillar integration (Johnson et al., 2019) using the CFIR framework (Damschroder et al., 2009) was also applied to integrate data as a joint display building technique.
A total of 77 health professionals participated in the online survey: (nursing staff [n = 40]; other health professionals [n = 37]); 19 participated in the semi-structured interviews.
Table 1 Participant Characteristics (N=77; Nursing Staff - n=40; other Health Professionals - n=37)
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The characteristics of the participants of the online survey are shown in Table 1. The vast majority of nursing participants were midwives (n=33; 82.5%). The mean number of years in nursing/midwifery was 11.8 (SD 9.14), and the mean number of working years for women with GDM was 7.93 years (SD 6.16). The majority in the other health professionals’ group, were nutritionists (n=16, 43.2%), followed by endocrinologists (n=10, 27.0%), The mean number of years in each professional was 14.59 (SD 8.54), and the mean number of working years for women with GDM was 9.35 years (SD 6.75). Participants worked at hospitals across Japan, although most participants were from Kanto region (including Tokyo) (nursing staff =40.0%; other health professionals =78.4%).
Semi-structured interview [QUAL]The characteristics of the participants from the semi-structured interviews are shown in Table 2. Participants were 19 professionals (4 nurses, 3 midwives, 8 physicians, 3 nutritionists and 1 pharmacist). The median number of years in each professional was 18 years (range 7-37), and the median number of working years with women having GDM was 10 years (range 2-30).
Table 2 Participant Characteristics from Interviews (N=19)
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The joint display is shown in Figure 2. Italics have been used for extracting themes and raw data from the interviews, as well as for references to the specific wording used in the online survey.
Most, but not all participants, had positive intentions to implement the integrated GDM clinical care pathway: 95.0% of nurses and midwives, and 89.2% of other health professionals. However, a minority of participants responded negatively. When asked if the introduction of the pathway was a priority for them personally, 22.5% of nursing staff and 24.3% of other health professionals answered, ‘not at all’. Asked whether implementation was a priority for their hospital, 17.5 % of nursing staff and 16.2 % of other health professionals also answered, ‘not at all’. A comparison of the results of the nursing staff and other health professionals shows relatively similar trends. However, responding to ‘planning to talk to my colleagues and manager about introducing the clinical care pathway with my clients’, 37.5% of the nursing staff answered, ‘to a great extent’ or ‘to a very great extent’, which was much higher than that of the other health professional group (8.1%). Cronbach’s alpha for the modified MISII was 0.86 for the nursing staff group and 0.84 for the health professional group in this study.
Semi-structured interview [QUAL]The results of the semi-structured interviews surfaced the underlying reasons of participants’ intentions. Both nursing staff and other health professionals expressed positive opinions. By adopting the clinical care pathway, they felt able to improve multidisciplinary cooperation and continuous support until the postpartum, keep patients motivated, and introduce the pathway relatively smoothly due to adequate acceptance of other pathways by staff. Regarding the perception that the clinical care pathway would improve multidisciplinary cooperation, one midwife also expressed midwife ‘O’s opinion that:
Midwives need to guide patients while navigating the varied ways of working of doctors, nutritionists, and other health professionals. But it is sometimes difficult to understand the role of each professional and what kind of guidance they are giving, and different doctors have different policies. So, it is very helpful to have a common clinical path like this. （Midwife O）
However, negative opinions were also heard from participants from both nursing staff and other health professionals with the following reasons:
In addition, the following opinion was heard from a nutritionist in the ‘other health professional’ group: Not in a position to propose or decide on the introduction of the clinical care pathway.
Meta-inference: online survey and semi-structured interviewMost participants expressed positive intentions to introduce the integrated GDM clinical care pathway. In particular, nursing staff tended to have more positive responses than the other health professionals due to the interdisciplinary nature of their roles. However, implementing the clinical care pathway was not considered a high priority for the majority of participants, with a higher percentage responding ‘Not at all’ in relation to both themselves and their hospitals. This is consistent with the results of the interview data.
Perceptions of Acceptability, Appropriateness, and FeasibilityThe joint display is shown in Figure 3. Italics have been used for extracting themes and raw data from the interviews, as well as for references to the specific wording used in the online survey.
For acceptability (AIM), the mean scores from both nursing staff and other health professionals were slightly lower than 4.0=agree (nursing staff: mean 3.73, SD 0.55; other health professionals: mean 3.70, SD 0.41). For appropriateness (IAM), the scores for both nursing staff and other health professionals ranged from neither agree or disagree to agree (nursing staff: mean 3.55, SD 0.53; other health professionals: mean 3.47, SD 0.53). For feasibility (FIM), both nursing staff and other health professionals answered slightly higher than neither agree or disagree (nursing staff: mean 3.35, SD 0.54; other health professionals: mean 3.31, SD 0.59). For this study, the Cronbach’s alpha used for each scale (acceptability, appropriateness and feasibility) was: nursing staff = 0.79, 0.82, and 0.82 respectively; Cronbach’s alpha for each scale for other health professionals was: = 0.74, 0.89, and 0.87 respectively.
Semi-structured interview [QUAL]The following opinions were heard from nursing staff and other health professionals for each item. There were no discernable differences among different professionals.
AcceptabilityPositive opinions were based upon the:
It is important to note that some hospitals had their own protocol for GDM treatment and support, but the treatment methods and support were not in written form. Therefore, some participants commented that the clinical care pathway would make it concrete and thus easier for multiple professions to collaborate. Negative opinions were only heard regarding the feasibility of introducing the clinical care pathway. Acceptability was seen as dependent on the feasibility of implementation.
AppropriatenessThe positive perceptions were as follows:
Participants from hospitals that had already developed protocols and care sheets for GDM management, but not clinical care pathways, stated that clinical pathways are more appropriate because they can be revised based upon the evidence.
Conversely, negative opinions regarding the appropriateness of the clinical care pathway included: the necessity of improvements to the content of the clinical care pathway and goal setting; for example, participants thought the clinical care pathway needed simplifying because of the complexity and demanding nature of the content, which made it difficult for less experienced staff to implement. Additionally, the roles of non-nursing professionals were unclear, and the level of patient goals was inappropriate in some areas.
FeasibilityPositive opinions about feasibility were heard from participants employed in hospitals that already had a multidisciplinary team and were using protocols for the treatment and support of GDM. They felt that the clinical care pathway would be relatively easy to incorporate into the existing system in their hospitals. In contrast, many participants in hospitals that did not currently have a multidisciplinary team identified the difficulty of holding conferences as a factor that would reduce feasibility even though the pathway was seen as acceptable. Moreover, participants identified various difficulties that reduced perceived feasibility (these difficulties are detailed in the Perceived Barriers section below).
Meta-inference: online survey and semi-structured interviewThe integrated GDM clinical care pathway was perceived as a relatively acceptable way to improve current GDM support. Appropriateness and feasibility were perceived less positively, in that order. Perceptions of feasibility were found to be neutral due to various difficulties.
Perceived BarriersThe joint display (Figure 4) presents the 19 potential barriers comprising the online survey and categorized into the CFIR framework (Damschroder et al., 2009): outer setting of the hospital, inner setting of the hospital, characteristics of individuals, and characteristics of implementation of the GDM clinical care pathway. In addition, the potential barriers with which more than 30 % of participants completely agreed or agreed are described with bar graphs and the others described in grey squares (see Figure 4). Interview data were analyzed using framework analysis and categorized by four themes of the CFIR framework (Damschroder et al., 2009) and 13 categories. The four themes were the same as the online survey and no other themes were extracted. Italics have been used for extracted themes and raw data from the interviews, as well as for references to the specific wording used in the online survey.
Online survey [QUAN]For some potential barriers, there were obvious differences between the nursing staff and other health professionals. For nursing staff, the following three barriers were identified as the main barriers, with more than 50% of nursing staff agreeing or completely agreeing:
Conversely, there were no other barriers where 50.0% or more of the other health professionals agreed or completely agreed.
Note: GDM = gestational diabetes mellitus
Four categories were extracted for this theme: Perceived difficulty of cooperation with the community; Lack of external policies and incentives; Social impact of COVID-19, and Does not fit patients’ characteristics. Regarding the first category, a participant stated:
Inner setting of the hospital“We don't have a lot of collaboration outside the hospital, so I'm wondering how much we can do since we don't have any experience.” (Pharmacist S)
Five categories were extracted for this theme: There are other issues to be prioritized over GDM; Does not fit the hospital’s size, role, or policies; Lack of team cohesion, and Lack of time and resources for providing GDM support. Regarding the first category, one participant stated:
Characteristics of individuals“I think everyone wants to do it, but I think it's going to be tough because a lot of things are getting overwhelming. [….] We're just now getting started with the mental health support that's being talked about the most.” （Obstetrician B）
There were two categories about individual characteristics: Lack of professional knowledge and skills about GDM and Lack of motivation of health professionals for GDM. Regarding the first category, participants pointed out the reasons behind this. For example, one participant stated:
“There is a lot of turnover of nurses and midwives in both the outpatient and inpatient wards, and it is difficult to establish staff knowledge of GDM support”. (Endocrinologist D)
Another participant stated:
Characteristics of implementation of the GDM clinical care pathway“Midwives are very knowledgeable about pregnancy and childbirth. However, they seem to have difficulty understanding the GDM treatment plan given by the doctor, such as blood sugar control. Conversely, nurses may know more about blood sugar control, but not a lot about pregnancy, so it can be difficult to provide enough support for women with GDM”.（Nurse I）
Three categories were extracted for this theme: Lack of evidence strength and content appropriateness; Lack of perception of relative advantage and Perceived complexity and difficulty of implementation of the GDM clinical care pathway. Regarding the third category, participants pointed out the difficulty in implementing a long-term clinical care pathway that spans outpatient and inpatient wards, and the difficulty in imagining the long-term follow-up after childbirth.
Meta-inference: online survey and semi-structured interviewComparing the potential barriers surveyed in the online survey with those identified in the interviews, the results were similar, and the only barrier, newly identified in the interviews, that did not appear in the online survey was the social impact of COVID-19. When integrating the results of the online survey, the main barriers to introducing the pathway were:
Overall, this study showed that most participants, in particular nursing staff, have positive intentions to introduce the integrated GDM clinical care pathway. Furthermore, the pathway was perceived as generally acceptable. However, appropriateness and feasibility of the pathway were perceived less positively in that order. In addition, various barriers were identified to the implementation of the pathway.
Perception of Acceptability, Appropriateness and Feasibility of Implementing the Integrated GDM Clinical Care PathwayThe percentages of participants already using clinical care pathways for GDM in this study were 35% for nursing staff and 27% for other professionals. Although this result was higher than the national average, 8.5% (Matsunaga et al., 2021a), it remains low. Nonetheless, the result of the online survey confirmed that the integrated GDM clinical care pathway was seen as generally acceptable. According to Proctor et al. (2011) acceptability is defined as ‘the perception among implementation stakeholders that a given treatment, service, practice, or innovation is agreeable, palatable, or satisfactory’(p67), and high acceptability is one of the important factors for successful implementation. Furthermore, they also state that for acceptability to be meaningful, staff opinions must be grounded in their understanding and actual experience of all aspects of the treatment or procedure, in other words the ‘real life’ application (Proctor et al., 2011). Therefore, the fact that the study identified, not only quantitative data on acceptability, but also in-depth reasons for acceptability through semi-structured interviews is meaningful for future implementation.
Although acceptability was quite positive, appropriateness and feasibility were perceived less positively. These results were less promising than results found in several other studies (Adrian et al., 2020; Swindle et al.,2021). Regarding appropriateness, the results of the interviews in this study revealed important areas for improvement. First, participants pointed out that the roles played by other health professionals were not clearly specified in the clinical care pathway. Several studies (Schrijvers et al., 2012; Mayer et al., 2018) emphasized the importance of clearly defining the roles and responsibilities of healthcare professionals in an integrated clinical care pathway to facilitate the effective implementation of interprofessional collaborative practice. However, existing studies conducted in Japan have revealed that ‘role uncertainty and inability to accomplish the role as a team member’ and ‘lack of mutual understanding of roles and cooperation among professions and departments’ are key challenges facing interprofessional collaboration regarding GDM in Japan (Matsunaga et al., 2021a). Therefore, to improve the appropriateness of the clinical care pathway, clearly defining the roles and tasks of the multiple professions in the clinical care pathway is essential.
Second, participants pointed out that the demanding nature of the content of the pathway made it challenging for less experienced staff to implement. In fact, one of the main barriers identified in this study to the implementation of the pathway was a lack of knowledge, skill, and self-confidence among nursing staff to implement it. For a new program to be evaluated as appropriate, it needs to be aligned not only with the mission of the health care setting but also the skills and roles of those who would be assigned to implement the program (Proctor et al., 2011). Regarding feasibility, perceptions were found to be neutral due to various difficulties, namely the barriers identified in this study. This will be discussed below.
Barriers to the Introduction of the Integrated GDM Clinical Care PathwayThree main barriers were identified in this study. First, difficulty of implementation of the long-term clinical care pathway into hospitals, and collaboration with local services and facilities was identified as a barrier. One of the key points of the integrated GDM clinical pathway is collaboration that is inclusive of other healthcare services and facilities in the community for GDM follow-ups. However, the current Japanese health system lacks a robust system of continuity of care from hospital to local healthcare facilities for GDM management (Matsunaga et al., 2021a). Therefore, the collaboration with local services and facilities was perceived as difficult.
Globally, there is no overall agreement on who should be responsible for regular follow-up visits after women with GDM are discharged from hospitals. For instance, in the United Kingdom, Denmark, and Australia, the local general practitioner (GP) is usually responsible. However, it is pointed out that this is a weak system in that attendance rates among women with a history of GDM remained low (McGovern et al., 2014; Damm et al., 2016; Laurie & McIntyre, 2020). Therefore, Damm et al. (2016), recommended placing continuous GDM follow-ups into an existing successful public health system. One example would be including continuous GDM follow-up for mothers bringing in their children for routine child examinations and vaccinations.
Currently, health checkups for the mother during health checkups for infants are not conducted in Japan. However, the trend in maternal-child health services in Japan is to provide seamless and comprehensive maternal and child health support from pregnancy to child-rearing (Morioka et al., 2022) including infant health checkups, which generally have a high participation based on vaccination completion rates (UNICEF, 2023). Therefore, it might be more effective in Japan to incorporate regular follow-ups for mothers with GDM into the maternal and child health services. Health checkups and health guidance for mothers with GDM and who have an increased risk of health problems such as gestational hypertension, should be provided as postconceptional care as part of comprehensive maternal and child health support.
Second, there is a barrier related to lack of time and resources as many issues need to be prioritized over the GDM clinical pathway. Participants in the interview of this study pointed out the difficulty in securing time to hold conferences for GDM, or that other issues took priority over GDM. The low priority of improving GDM support is also seen in the online survey regarding intention. Even though it is clear that many resources are required to provide adequate support, several studies point to resource shortages as barriers to enhancements within health services (Tabatabaee et al., 2016; Babaei & Taleghani, 2019). Likewise, this study identified lack of resources for the provision of GDM support as a barrier. However, clinical care pathways have been evidenced as a tool for efficient management in health care (Rotter et al., 2012). Therefore, it seems necessary to establish a support system for efficient GDM support due to the shortage of time and resources, and a long-term goal should be the introduction of clinical care pathways as an essential tool to achieve this, especially given recent data that suggests cost savings in the long term for providing GDM lifestyle interventions (Lloyd et al., 2023).
Third, according to the online survey, there is a huge barrier for nursing staff implementing the clinical care pathway related to their lack of knowledge, skill and confidence. Lack of knowledge and skills among nursing staff for GDM support was identified by the previous cross-sectional study in Japan (Matsunaga et al., 2021a) and the findings of this present study are consistent with those findings. Knowledge and skills are the first two fundamental domains of the Theoretical Domains Framework and must be understood and addressed when managing the behavioral changes inherent in the implementation of evidenced based findings (Atkins et al., 2017). Moreover, Lagarde et al. (2019) point out that if staff lack the clinical skills to deliver accurate diagnoses, neither money nor feedback would do anything to improve quality of care. In light of these factors, gaining sufficient knowledge and skills is essential to give nursing staff greater confidence in their ability to introduce and practice the integrated GDM clinical care pathway.
Further Implications for Practice and ResearchFirstly, in order for the further development of the integrated GDM clinical care pathway in practice, the contents of the pathway need to be modified, implemented and evaluated in a sample of hospitals and local facilities. In particular, a strategy for establishing collaboration between and among hospitals and the community needs to be developed and evaluated. Drawing upon the study conducted by Yuliyanti et al. (2020), action research using the Delphi method, involving all key health professionals associated with GDM support, might be a better methodology for further development of the clinical care pathway.
In addition, Noto et al. (2016) found that a manual for clinical guidelines that outlined specific actions improved clinical practice. In the field of GDM management, the Japanese Society of Diabetes and Pregnancy has issued a clinical manual for GDM (Japanese Society of Diabetes and Pregnancy, 2022). However, this manual does not include interprofessional collaboration between and among hospitals and the community. Therefore, the creation of a manual addressing these points would allow for more effective implementation of the integrated GDM clinical care pathway. Furthermore, this pathway and manual need to be the result of a broad nationwide consensus to facilitate further dissemination.
Secondly, in order to strengthen the knowledge, skills, and confidence among nursing staff for the introduction of an integrated GDM clinical care pathway, further training programs targeting nursing staff need to be developed. Nurses and midwives are key professionals who are indispensable for GDM support (Mensah et al., 2019). In this study, it was not possible to clarify what specific knowledge and skills nurses and midwives felt were lacking in providing GDM support. Therefore, it is necessary to assess the difficulties they face in this area through further studies and tailor training programs accordingly.
Contribution to mixed methods researchIn the health care setting, research to verify the effectiveness of new interventions for problem solving is essential. Furthermore, pilot feasibility studies are indispensable to intervention development, adaptation, and testing. In terms of methodology, Aschbrenner et al. (2022) stated that mixed methods can maximize insights gained in pilot feasibility studies. This study has successfully proved that mixed methods, in particular a convergent mixed methods design, indeed contribute to gaining a more comprehensive understanding and evaluate the feasibility of the intervention, in this case the integrated GDM clinical care pathway. That we were able to demonstrate the effectiveness of a mixed methods study as a research tool to assess feasibility, strengthens the contribution of mixed methods in future feasibility health science research.
Limitations of the studyWhile the mixed-methods design provided a more in-depth understanding of the feasibility issues of the clinical care pathway, there were some limitations in the quantitative methods approach. The sample of nursing staff and other health professionals who agreed to participate in this study might have had some pre-existing awareness of and interest in issues associated with GDM. This may have affected the study results. We used an original survey (Barriers) and modified the intention to implement scale. Additional psychometric development may be warranted. Program implementation is always influenced by cultural practices such as how consensus is derived. Each country should consider taking advantage of its own cultural strengths and mitigating its weaknesses.
The results of the study showed the intention to implementing the integrated GDM clinical care pathway was generally well. However, some modifications to the content of the pathway are needed. In addition, the following potential barriers must be addressed to implement the pathway: a) difficulty of implementation of the long-term clinical care pathway into hospitals, and collaboration with local services and facilities; b) lack of time and resources as many other issues take priority over GDM, and c) insufficient knowledge, skill, and self-confidence among nursing staff to implement the GDM clinical care pathway.
We thank all the participants of this study. We also thank Dr. Erika Ota, Dr. Hiromi Oku at St Luke’s International University, and Dr. Mikio Momoeda at Aiiku Hospital for their guidance and advice for this study.
The Ethics Review Board of St. Luke’s International University (Research number: 20-A074) approved this study.
MM designed and coordinated this study, carried out the analysis and interpretation of the data, and drafted and revised the manuscript. SH contributed to the supervision of the whole process of this study, including analysis of the data, interpretation of the study findings, as well as critically reviewing the manuscript. SP contributed to the analysis and interpretation of the data, provided advice for writing the manuscript, and critically reviewed the manuscript. All authors read and approved the final manuscript.
The authors declare that they have no competing interests.
This study was supported by the Grants-in-Aid of the Yamaji Fumiko Nursing Research Fund and funded by the Japan Academy of Midwifery. The authors are solely responsible for the content of this article, and it does not represent the official views of the funding bodies.
