A Novel Decision Aid Improves Quality of Reproductive Decision-Making and Pregnancy Knowledge for Women with Inflammatory Bowel Disease

Inflammatory bowel disease (IBD), including ulcerative colitis (UC) and Crohn’s disease (CD), commonly affects reproductive-aged women. Women with IBD experience more “voluntary childlessness,” at rates of 18% in CD and 14% in UC, compared to 6.2% in the general population [1]. This may be due to misconceptions surrounding IBD therapies in pregnancy [2‐4]. Despite robust safety evidence for many IBD medications in pregnancy [5‐7], this knowledge remains deficient for many patients and generalist clinicians[8‐10]. Only half of surveyed Canadian physicians felt comfortable managing pregnant patients with IBD, which may explain the wide variability in physician practice for this population [9]. Only a third of reproductive-aged women with IBD had discussed family planning with their general practitioner [11]. These knowledge gaps should be addressed, as inappropriate medication cessation during conception is not uncommon [8] and increases risk of disease relapse. Active disease in the antenatal period is associated with low birth weight, premature birth, pregnancy loss, and infant infection [7, 12‐14].

As therapeutic complexity increases, patients desire more education on the intersection of IBD and pregnancy[15]. Women with IBD who receive specialized preconception (PC), intrapartum, and post-partum counseling experience enhanced IBD-related pregnancy knowledge and fewer disease flares, thereby translating into improved maternal and fetal outcomes[16, 17]; however, few patients have access to specialized clinics. Websites and information sheets may enhance IBD-specific reproductive knowledge [15, 18], but patients should also be equipped with tools to improve their quality of decision making. The tenets of high-quality patient decision making include (1) recognizing a decision must be made, (2) feeling informed about options and outcomes, (3) being clear about values and preferences, (4) having facilitated discussion of goals with healthcare providers, and (5) being involved in decisions[19]. Decision aids (DAs) present evidence in patient-centric formats and prepare patients for shared decision making (SDM) with their healthcare providers. They are designed to improve knowledge as well as the decision-making process [19]. Women with IBD have voiced a desire for a DA for pregnancy [20].

In order to address this unmet need, we developed the interactive, web-based Pregnancy in IBD Decision Aid (PIDA) following International Patient Decision Aids Standards (IPDAS) [21, 22] with an international steering committee comprised of patient representatives and experts from IBD, general gastroenterology, obstetrics, obstetric medicine, pediatric gastroenterology, perinatal pharmacoepidemiology, SDM, and knowledge translation. Patient and clinician focus groups, a systematic review of the pregnancy-IBD literature, and in-depth iterative reviews of content topics were performed to guide PIDA development. PIDA offers personalized decision support for fertility, pregnancy, and post-partum concerns; it is thus relevant for all reproductive stages. PIDA focuses on two key decisions: (1) possibility and timing of conception for PC patients and (2) medication management in pregnancy for pregnant patients. These decisions are consistent with patient priorities reported in the literature [23].

This study conducted pilot testing of PIDA to assess its impact on the quality of reproductive decision-making and IBD-related pregnancy knowledge among PC and pregnant women with IBD. In addition, we determined PIDA’s acceptability among patients and clinicians.

The quality of decision making in PC and pregnant patients with IBD significantly improved after reviewing our novel decision aid, PIDA. High-quality decision making involves minimal decisional conflict, high perceived self-efficacy in the process, and consideration of one’s values. After using PIDA, decisional conflict, measured by the DCS, decreased significantly from 38.95 to 26.77 for PC patients (large effect size) and from 23.30 to 18.99 for pregnant patients (medium effect size). DCS scores below 25 are associated with implementing decisions; scores above 37.5 are associated with decision delay or feeling unsure about implementation [24]. Improvement in decisional conflict was more comprehensive in the PC group, as indicated by a significant decrease in all five subscores for PC patients compared to two subscores for pregnant patients. Notably, decisional conflict is an independent predictor of propensity to ascribe fault to physicians; in an Australian study, for every unit increase in DCS, patients were 19% more likely to blame their physicians for poor outcomes related to prostate cancer screening decisions [33].

Further, patients developed enhanced self-efficacy and a stronger belief in their ability to make effective pregnancy decisions after using PIDA. The DSES revealed a significant, medium effect size in PC patient, and a small-to-medium but non-significant effect size in pregnant patients. The smaller DSES improvement in pregnant women is plausibly because they had already made several reproductive decisions.

Improving quality of decision making through tools such as PIDA is essential for values-concordant care [34]. Patients value being involved in treatment decisions, and are disappointed by the lack of opportunities to do so [35]. A review of 134 observational studies found that patients without opportunities to participate in health discussions were more likely to be misdiagnosed and undergo potentially harmful, values-discordant treatments [36]. Lower patient participation is also tied to treatment non-adherence, which may worsen disease activity [37, 38]. Strategies that facilitate SDM, including DAs, offer patients ownership over disease control and may improve outcomes and reduce healthcare expenditure. For example, self-driven management of stable UC was not only preferred by patients, but also accelerated treatment provision and reduced medical visits without increasing morbidity [39]. A systematic review of 115 trials of DAs demonstrated that they increase knowledge and the likelihood that therapies align with patient values [40]. In a feasibility study of a DA for UC, patients reported that the DA enhanced their understanding of UC therapy and improved their ability to participate in SDM effectively and confidently [41]. Further, patients in our study found PIDA helped them identify their values.

Reproductive decision making is complex as women must consider maternal and neonatal aspects; as such, SDM is instrumental and many DAs exist [42]. Few cater to reproductive-aged women with chronic conditions: A pregnancy-related DA exists for rheumatoid arthritis [43], multiple sclerosis [44], epilepsy [28], depression [45], and breast cancer [46]; until now, no such DA had existed for IBD. Notably, these DAs focused on PC patients contemplating the motherhood decision: the choice to forego, start, or enlarge a family. In contrast, PIDA was designed to cover all reproductive stages: motherhood decisions with PC patients and intrapartum decisions with pregnant patients, while information pertaining to the post-partum stage has also been included.

Patients’ IBD-specific pregnancy knowledge improved after utilizing PIDA. CCPKnow scores increased with a large effect size and an improvement from an “adequate” to “good” level of knowledge for both PC and pregnant patients. Half of PC patients wanted children but were afraid to due to their IBD. After using PIDA, half of these patients no longer had major IBD-related pregnancy concerns. Knowledge deficits surrounding pregnancy and IBD are common [47] and associated with attitudes contrary to medical evidence [3] and ultimately contribute to the higher rates of childlessness observed in women with IBD [2]. For example, unfounded fertility concerns are common in nulliparous women with IBD and may link to childlessness [2, 47]; yet, they only seek fertility advice at the same rate as the general population [23, 48] and may not have these fears dispelled. Reassuringly, fertility counseling significantly increases consideration of pregnancy by patients with IBD [47]. Thus, patient education is invaluable in combating misinformation and improving reproductive knowledge [49‐51]. PIDA could reduce childlessness among women who would have otherwise avoided pregnancy due to unfounded fears about their IBD.

If PIDA could improve patient knowledge, it could impact medication adherence. Patients with limited knowledge may believe that IBD therapies broadly are teratogenic [3], which leads to inappropriate medication cessation [8] and higher potential for active disease—the greatest threat to pregnancy outcomes³⁴. In one study, half of patients who were pregnant or attempting to conceive had stopped IBD therapy, and half of these patients did so without medical advice [8]. A longitudinal study of 138 patients found that poor medication knowledge led to non-adherence, which led to increased IBD relapses [52]. Fortunately, safety data on IBD therapies in pregnancy are being translated into patient resources [53]. By delivering knowledge to patients in a personalized manner, PIDA may improve medication adherence and optimize disease activity, which may impact obstetric or fetal outcomes. Further studies are needed to evaluate these specific outcomes.

Regarding acceptability, patients deemed PIDA to be appropriate and highly useful, and would recommend it to others. Similarly, clinicians perceived PIDA to be acceptable and highly useful for themselves and patients. Clinician endorsement of DAs is necessary for their ongoing use; fortunately, several benefits exist for providers. In a Cochrane review, DAs enhanced the patient-clinician consultation in nine of ten studies with little to no impact on visit length [40] (it may be completed pre-visit [54]). DAs increase clinician satisfaction [55], as well as patient satisfaction [56] and trust in their physician[57]. Based on such literature, PIDA may strengthen patients’ therapeutic alliance with their physician.

In the future, we plan to further refine PIDA by adding keyword search functions and accessibility features such as audio, video, and expanded language availability. This study will inform the design of a randomized controlled trial, after which we hope to have a validated DA that can support reproductive decision making in IBD. We plan to promote the sustained use of PIDA through patient advocacy groups and integration into electronic medical records [58] and assess its impact on treatment adherence, disease activity, and pregnancy outcomes. We also envision PIDA as a DA prototype to be easily adjusted for use in other chronic conditions.

Our study has several limitations. Firstly, while our sample size was guided a priori by other pilot studies, the number of patients did limit our ability to capture a broader perspective and analyze subgroups. Further, inherent to our recruitment method is the risk of self-selection bias, as those enrolled may possess a particularly poor understanding of, or special interest in, pregnancy and IBD. PIDA’s readability is another area for improvement. In North America and Australia, it is recommended that patient education is written at a grade eight level [59]. PIDA surpassed this given the terminology associated with IBD therapy and reproduction; accordingly, PIDA is designed to be interpreted with clinician guidance for full comprehension and decision making. Nonetheless, PIDA would benefit from the above accessibility features for patients with lower literacy. Another weakness is our overrepresentation of highly educated women of high socioeconomic status. This stems from multiple reasons, including accessibility to tertiary care, health literacy, readability level, and technological resources or time to complete uncompensated surveys. Thus, it is unclear whether PIDA would generate a similarly favorable response in the general population. Reassuringly, DAs do improve outcomes for disadvantaged patients and may in fact benefit such groups more than those with higher socioeconomic status [60]. We hope PIDA will help bridge health inequities in patient education.

Overall, our pilot study has shown favorable and compelling results. PIDA is an accessible, individualized intervention that may be widely circulated and fulfills an unmet need in patient decisional support. It can empower women to build IBD- and pregnancy-related knowledge, gain self-efficacy, and make values-congruent, evidence-based decisions about their IBD in the context of family planning. There may be the potential for minimization of voluntary childlessness. While we cannot make firm conclusions about pregnancy-related outcomes, we believe that the insight and decisional support gained from PIDA has the potential to improve disease control and positively impact maternal and fetal outcomes. We look forward to validating PIDA for PC and pregnant patients in an upcoming multi-national randomized controlled trial.