Abstract
The objective of the CONTINUE (conversations in routine OB care) pilot study was to gather preliminary data on the benefits of integrating a well-designed pregnancy support tool (“CONTINUE Tool”) in low-income prenatal care. A total of 184 tools were distributed by 21 OB providers during the study implementation period. Follow-up data were collected from 71 (38.5%) prenatal patients across three community-based midwestern OB clinics serving a diverse prenatal patient population. Early-gestation prenatal patients received the strategically designed CONTINUE Tool during routine prenatal care and later completed a semi-structured interview or electronic survey to report pre-determined individual benefit items experienced due to tool usage. Factor analysis used individual benefit items to identify factors representing common underlying benefits (“factor benefits”). Logistic regression analyses were performed to describe the relative odds of participants with low income (public insurance) experiencing individual and factor benefits of tool use compared to participants of higher income (private insurance). Chi square tests (or Fisher’s exact tests) were performed to generate P values reflecting statistically significant differences by income group. More low-income prenatal participants reported experiencing individual benefits as compared to higher-income participants. Among factor benefits, low-income participants were statistically more likely to report experiencing a time-related logistics benefit (OR = 4.00; 95% CI 1.02-15.73; P = .045). Low-income participants reported experiencing an overall logistics factor benefit (OR = 4.29; 95% CI 0.47-38.75), including a cost-related logistics benefit (OR = 3.08; CI 0.59-16.00), as well as an understanding benefit (OR = 1.90; 95% CI 0.72-5.04) and a self-efficacy benefit (OR = 1.30; 95% CI 0.44-3.87). While this study is limited by sample size due to being a pilot study, the findings suggest there may be tangible benefits to introducing the CONTINUE Tool among low-income prenatal patients. Given the staggering inequity in OB care and subsequent health outcomes, any preliminary findings on ways to help combat this are necessary and should lay the groundwork for subsequent randomized trials. Our preliminary findings show that supplementing routine OB care with the CONTINUE Tool can confer benefits to both providers and patients, but particularly for low-income prenatal patients who tend to have more structural barriers to adequate care in the first place.
Introduction
There is great need for alternative and/or supplemental approaches to mitigating barriers to routine prenatal care for low-income women. Research has demonstrated that low-income women are more likely to face a myriad of internal and external barriers to adequate prenatal care,1-5 including insufficient or no insurance,6,7 increased mental health issues, 8 perceptions of long wait times, 9 fear of procedures and examinations,2,10 and poorer treatment.11,12 Given that adequate prenatal care is considered essential for ensuring healthy pregnancy outcomes, it follows that critical maternal and infant health indicators are especially poor among low-income groups in the U.S.13-16
The use of support tools to supplement prenatal care has shown promising benefits. 17 A recent systematic review of tools developed to support prenatal women’s health-related decisions indicated that, relative to women who did not use a tool, women who used a tool reported higher knowledge scores,18-25 more awareness of care option risks and benefits,18-21,24,26 decreased decisional conflict, 17 safer lifestyle choices,27,28 closer health monitoring,29,30 increased specialist referrals, 31 more individualized prenatal care, 31 lower anxiety, 32 higher confidence, 32 and more care satisfaction. 33 These studies reveal the potential of a patient-centered prenatal support tool to promote communication, as prenatal patients who used the tool discussed their concerns with providers to a greater extent.24,29,31,34,35 Given poorer maternal and child outcomes among low-income groups,13-15 exploring benefits of a pregnancy support tool by income is critical. However, little research to date has demonstrated the effectiveness of a pregnancy support tool on prenatal care plan adherence, nor has the effect of pregnancy support tools on the interpersonal aspects of care (e.g., trust, partnership, understanding, communication) been demonstrated in lower-income prenatal patients. 17
The
CONTINUE Tool
The CONTINUE Tool was iteratively co-designed with low-income prenatal patients, physicians, and nurses in a prior study (COST) 36 and then integrated into routine care during a subsequent pilot study (CONTINUE), reflected in this manuscript, to determine feasibility and assess tool use-derived benefits (Figure 1). The CONTINUE Tool is a trifold, paper-based tool intended to be completed by providers to reflect a patient’s personalized prenatal care plan, as decided between the patient and provider at the onset of prenatal care (Figure 2). Further, the tangible tool was created to act as a shared informational tool to bridge and mediate communication surrounding the prenatal care plan between stakeholders with different knowledge levels and goals, like providers, clinic staff, and patients. Given recommended prenatal care plans are visit-intensive, the idea of the tool is that, by making explicit the care plan trajectory, prenatal patients would have time to identify needed resources and activate the supports they may need to actively participate in their care. Through semi-structured interviews conducted in the COST study, low-income patients, OB clinic staff, and providers identified 18 potential benefits they believed the CONTINUE Tool could offer prenatal patients. These 18 tool use-derived benefits were derived from the COST study and subsequently validated in CONTINUE study. The 18 individual benefits and the four factor benefits identified through a factor analysis are the focus of this paper. The cost-specific benefits 37 implementation of the study 38 and can be found in other publications.
CONTINUE study overview.
CONTINUE tool.
Methods
In this prospective observational pilot study, the CONTINUE Tool was integrated into three midwestern community-based OB clinics throughout Chicago, IL to determine feasibility of tool implementation and to measure the 18 potential tool use-derived benefits. The three involved clinics represented a diversity of patients and typical clinical practice structures. The three clinics were served by four different OB provider types (OB attendings, OB residents, Certified Nurse Midwives, and Nurses), each implementing the CONTINUE Tool as part of their routine OB care. Clinic 1 primarily serves prenatal patients who are privately insured, predominantly White, high and low risk, with four OB attendings on staff. Clinic 2 primarily serves prenatal patients who are publicly insured (insured by Medicaid, at or below 213% of the federal poverty line for a pregnant person), 39 predominantly Hispanic/Latino/Spanish, high and low risk with 12 OB residents on rotation and 3 nurse providers on staff. Clinic 3 primarily serves prenatal patients who are privately insured, predominantly White, low risk, with 2 certified Nurse-Midwives (“midwife”) providers on staff. The CONTINUE Tool was implemented between September 2020 and July 2021, with providers primarily distributing tools to prenatal patients early in their prenatal care (8-12 weeks of gestation). The CONTINUE Tool was available in English or Spanish, and version was chosen by the patient at the time of introduction by the provider. Study approval was granted by the health system’s institution review board (IRB #20-264E).
Participants
At the end of CONTINUE Tool implementation, prenatal patients who received the CONTINUE Tool were recruited to participate in either an in-person or virtual semi-structured interview or to remotely complete an electronic survey to provide feedback on their experiences with the CONTINUE Tool. Prenatal patient participants were at least 18 years old, at least 27 weeks pregnant, and had received the tool at least 8 weeks prior. Due to this study being an early implementation pilot, and given pandemic-related circumstances, participants self-selected their participation method, as interview (in-person or virtual) or electronic survey, as well as their preferred language (English or Spanish). Surveys were provided and interviews were conducted in the preferred language.
Demographic and Health-Related Items
Demographic variables were collected on all prenatal patients, including: Age (categorized) as 18-25, 26-35, or 36-45; Race as White, Black, Asian, AI/AN, or other; Race (binary) as White or Non-White; Ethnicity as Hispanic/Latino/Spanish or Non-Hispanic/Latino/Spanish; Insurance status as public or private; Language as English or Spanish (as self-selected by patient); Currently working as yes or no; and Current partner as yes or no. Pregnancy-specific variables were also collected, including: Provider type as midwife, nurse, OB resident, or OB attending; Parity as first or subsequent; Risk as high, low, or unknown (as self-reported by patient); and Clinic as 1, 2, or 3. It is important to note that insurance status is being used as a proxy for income in this study. Given research indicating low-income women are more likely to suffer due to burdensome care plans, this study aimed to highlight potential differences in benefits by income status; however, to mitigate potential feelings of being targeted based on perceived income level, patient income was not asked in data collection. Therefore, patients will be referred to by insurance status (public vs private) throughout this paper, with publicly insured patient participants representing low-income and privately insured patient participants representing higher income.
Tool-Use Benefit Items and Factors
Prenatal patient participants completed a 60-minute semi-structured interview or 20-minute electronic survey to capture patients’ self-report of whether they had experienced the 18 previously identified benefits of CONTINUE Tool use. 36 Interview participants reviewed the benefit items during a card sort activity, which each potential benefit on a unique card, and asked to sort the benefits into three categories: benefits experienced due to the CONTINUE Tool; benefits neither experienced nor not experienced (i.e. neutral); or benefits not experienced due to the CONTINUE Tool. Survey participants reviewed the benefit items in the electronic survey, with each potential benefit as a unique survey question, and asked to rate their experiences of the benefits similarly as interview participants (i.e., as experienced, neutral or not experienced benefits). Next, participant responses were collapsed into two categories—participants who self-reported experiencing all items comprising a factor were scored as having experienced that factor benefit (Yes) and participants who self-reported any of the individual benefits comprising a factor as neutral or not experienced were scored as having not experienced the factor benefit (No). Then, an exploratory factor analysis was performed to identify underlying factors structure of the 18 benefit items, as determined by interrelationships of the items (Figure 3). Participant responses on the collapsed ratings were used as observed data to determine factor benefits. Through the factor analysis, three factors—logistics (Factor 1), efficacy (Factor 2), and patient understanding (Factor 3)—and two logistics sub-factors—cost and time—were identified. Of the 18 benefit items, 8 loaded as logistics (with 4 each loading as cost-related and time-related); 5 loaded as efficacy; and 5 loaded as understanding. Specifically, the logistics factor benefit included cost-related factor benefit items of “make the financial tradeoffs needed to get through my pregnancy,” “navigate insurance more effectively,” “see the ‘Big Picture’ and link it to the family budget,” and “feel my financial situation was being considered” and time-related factor benefit items of “attending more appointments,” “managing other life responsibilities,” “showing up on time to appointments,” and “feeling their time related to prenatal care was respected.” Efficacy factor benefit items included feeling more in control of their pregnancy, feeling confident she was “doing things right,” increased trust in the care team, asking questions she wouldn’t have thought to ask and being a stronger partner in her care. Understanding factor benefit items included “understanding what was coming next in their pregnancy care,” “understanding how appointments differed,” “planning ahead and feeling less stressed,” “knowing how to plan for tests,” and “explaining their care plan to others (family, employers, other doctors).” The purpose of the factor analysis was to identify a smaller, more comprehensive set of “factor benefits” that were experienced by prenatal participants who received the tool. 40
Exploratory factor analysis final model path diagram.
Statistical Analyses
Analyses were performed using SAS version 9.4 (SAS Institute, Cary, NC, USA). Counts and percentages are used to describe (1) participants demographics and pregnancy-specific variable distributions overall and by insurance status in Table 1, (2) the proportion of participants who experienced individual benefits by insurance status in Table 2, and (3) the proportion of participants who experienced factor benefits by insurance status in Table 3. Logistic regression analyses were performed to generate odds ratios (OR) with corresponding 95% confidence intervals (CI) reflecting the relative odds of publicly insured (low-income) participants, as compared to privately insured (higher income) participants, experiencing an individual benefit and factor benefit in Tables 2 and 3, respectively. Due to small sample issues, P values were generated from Chi square tests, or Fisher’s Exact Tests for cell counts <5, to reflect statistically significant differences in demographic and pregnancy-specific variables by insurance status in Table 1 and statistically significant differences in experiencing individual and factor benefits by insurance status in Tables 2 and 3, respectively. Alpha of P < 0.05 was considered statistically significant for all analyses.
Demographics of Patient Sample, Overall (N = 71) and by Insurance Status.
Generated from Chi square tests or ^Fisher’s Exact Test if cell counts <5.
Statistically significant at P < .05.
Variable level removed for P-value calculation.
Individual Benefits of the CONTINUE Tool Experienced by Insurance Status, Within Factors, and Sub-Factors.
Generated from Chi square tests or ^Fisher’s Exact Test if cell counts <5.
Statistically significant at P < .05.
These items made up a pre-defined cost measure, explored further elsewhere. 41
Factor Benefits of the CONTINUE Tool Experienced by Insurance Status.
Generated from Chi square tests or ^Fisher’s Exact Test if cell counts <5.
Statistically significant at P < .05.
Results
Among the 184 prenatal patients who were given the CONTINUE Tool, 71 (38.50%) participated in the study. Thirty-seven (52.11%) completed the interview and 34 (47.89%) completed the survey. Overall, the sample was primarily prenatal women who were English-speaking (95.77%), White (71.43%), Hispanic/Latino/Spanish (56.34%), age 26-35 (57.75%), and currently working (66.67%). Regarding participants’ pregnancies, most were experiencing a low-risk pregnancy (54.93%) and a subsequent pregnancy (56.34%), received care at Clinic 2, and received the tool by an OB resident provider (32.39%).
Table 1 displays differences by insurance status, revealing that, relative to those with private insurance, participants with public insurance had significantly greater odds of being ages 18-25 (P = .006) and Hispanic/Latino/Spanish (P = .001), having received care at Clinic 2 (P < .001), having received the tool from a nurse provider (P < .001), and not currently working (P = .001).
Table 2 displays the individual benefit items that comprise each factor benefit and describes differences in experiences of individual benefits reported by patient participants. Participants with public insurance were more likely to experience every individual benefit item compared to those with private insurance. The following items were statistically significantly more likely to be experienced by those with public insurance compared to those with private insurance: show up on time (OR 6.90, CI 1.80-26.49; P = .003), make the financial tradeoffs needed to get through my pregnancy (OR 5.50, CI 1.12-27.03; P = .031), navigate insurance more effectively (OR 4.49, CI 1.15-17.55; P = .025), see the “Big Picture” and link it to the family budget (OR 4.25, CI 1.36-13.33; P = .010), and feel my time was being respected (OR 3.38, CI 1.27-9.01; P = .014).
Table 3 displays factor benefits experienced due to the use of the CONTINUE Tool by insurance status. Participants with public insurance had 1.30-4.29 times greater odds of experiencing factor benefits, as compared to those with private insurance. Of statistical significance, relative to those with private insurance, participants with public insurance had 4.00 (CI 1.02-15.73) times greater odds of experiencing the time-related logistics sub-factor benefit due to use of the CONTINUE Tool (P = .045). Of clinical but not statistical significance, despite not being statistically significant, relative to participants with private insurance, participants with public insurance had 1.30 (CI 0.44-3.87) times greater odds of experiencing an efficacy benefit, 1.90 (CI 0.72-5.04) times greater odds of experiencing an understanding benefit, 4.29 (CI 0.47-38.75) times greater odds of experiencing an overall logistics benefit, with 3.08 (CI 0.59-16.00) times greater odds of experiencing the cost-related logistics sub-factor benefit.
Discussion
The CONTINUE pilot study highlights differences in tool-use benefits by income (as defined by insurance status), with low-income prenatal participants reporting experiencing all pre-determined potential benefits to a greater extent, some significant, from use of the CONTINUE Tool relative to higher-income prenatal participants. It should be noted that, in our study, prenatal participants with public insurance were more likely to be younger, Hispanic/Latino/Spanish, not currently working, and being served in a clinic dominated by nurses and OB residents as providers. This is important to consider, given the unique set of challenges faced when navigating a burdensome care plan, but particularly among more vulnerable groups, with limited avenues for support, who experience compounded barriers to adequate care.1,8,41 Therefore, it is possible that benefits observed in this study were the result of low-income women needing more support throughout their pregnancies, and subsequently utilizing an opportunity for that support. Or, low-income participants may have simply capitalized more on a tangible mechanism for additional support, as provided by the CONTINUE Tool.
In terms of benefit items, five of 18 emerged as statistically significant, all of which loaded as items reflecting a logistic factor benefit. Three individual items—“make the financial tradeoffs needed to get through my pregnancy,” “navigate insurance more effectively,” “see the ‘Big Picture’ and link it to the family budget”—were cost-related factor benefit items that participants reported experiencing due to the use of the tool. The cost benefits of the CONTINUE Tool are explored more in depth in a separate paper. 37 Also, two items—“show up on time” and “feel my time was being respected”—were time-related factor benefit items that participants reported experiencing due to use of the tool. Low-income participants reported these benefits significantly more than higher-income participants, reflecting the tool’s potential to bridge the gap in disparity in clinic processes affecting time, as provider type (and related clinic processes) were different by income. Further, it is likely that differences in these two items drove the identified difference in the time-related logistic benefit by income.
Most notably, the time-related logistics benefit emerged as statistically significant in terms of differences by income. Relative to higher-income participants, low-income participants were four times more likely to report experiencing the time-related factor benefit due to the use of the CONTINUE Tool. These benefits together reflect the CONTINUE Tool’s effectiveness as a mutual consideration asset, allowing prenatal patients to take agency over some aspects of their care, which in turn benefits the provider. These findings also reiterate the CONTINUE Tool’s usefulness as a practical tool to help manage time-specific logistics to attend needed medical appointments and to balance other calendar responsibilities and time obligations. This finding suggests the CONTINUE Tool could have further implications for prenatal care, including improved treatment adherence.
Beyond statistical significance, the clinical significance of additional benefits is worth mentioning. In particular, the factor benefit of understanding was experienced most often across all participants due to use of the tool, with 19/40 (47.50%) of low-income participants and 10/31 (32.36%) of higher income participants reporting experiencing this benefit. Efficacy was also experienced often across both income groups, with 11/40 (27.50%) of low-income participants and 7/31 (22.58%) of higher income participants reporting this benefit. The fact that these factor benefits were reported as experienced often by both groups may speak to the fact that understanding and efficacy are lacking as components of prenatal care and that there is opportunity for an additional mechanism, like the CONTINUE Tool, to fill this need.
Another manuscript documenting different benefits of the CONTINUE study concluded that, relative to low-income prenatal patients, higher income prenatal patients more often used the CONTINUE Tool to facilitate cost-of-care conversations with their clinical teams, partners, HR, and insurance companies and were more likely to welcome a pregnancy support tool in their care. 37 The CONTINUE study demonstrates that introducing a pregnancy support tool, like the CONTINUE Tool, in routine care can benefit all prenatal patients, albeit in different ways, but especially low-income patients who may need extra support given the documented barriers they more often experience.1-12 Although preliminary, the findings of the CONTINUE pilot may be used to justify an experimental trial as a next step, to determine the effectiveness of a well-designed support tool in routine OB care.
Limitations
Implementation of this study occurred throughout the COVID-19 pandemic, resulting in multiple challenges to introducing the tool into standard clinical workflow during such an unstable time. This impacted our ability to recruit and interview prenatal patients, as we were restricted from being physically present in certain clinics. Feedback was collected from a small sample of prenatal patients overall and about 38% of those who received the CONTINUE Tool. Further, to accommodate comfort and availability, participants were able to self-select their participation method—in person or virtual interview or remote survey. Had we been able to utilize clinic space or be in person under safer circumstances, perhaps our study would have enrolled more individuals and produced more robust results. Finally, the CONTINUE Tool was not tested to evaluate associations between tool utilization and medical or clinical maternal or infant outcomes.
Footnotes
Declaration of Conflicting Interests
The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding
The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This study was funded by the Robert Wood Johnson Foundation (Grant #77290).
