Introduction

Vaccination in pregnancy (VIP) keeps parents and babies safer by preventing infection-related morbidity and mortality [-].Despite these benefits, vaccine uptake in pregnancy remains low in Canada and globally, particularly after the COVID-19 pandemic, which exacerbated vaccine hesitancy and mistrust in health care systems [,].

Even though there is extensive data on barriers to VIP [-] and VIP decision-making [,], there is limited literature regarding interventions that apply evidence-based strategies to address these barriers.A recent systematic review and meta-analysis of VIP interventions for influenza, pertussis, tetanus, and COVID-19 was carried out, including 36 randomized and nonrandomized quasi-experimental studies in 15 high- and low-middle-income countries []. The study found very limited evidence on the effect of existing interventions to improve VIP uptake []. However, 2 systematic reviews looking at the effectiveness of interventions to improve influenza VIP uptake in high-income countries [,], 1 focusing on the effect of digital interventions [], suggested that educational interventions for pregnant individuals, like pamphlets, websites, and brief one-to-one education, can be effective. Digital interventions can be more effective than nondigital or no intervention at all,and digital interventions should include videos,social media,and e-books,rather than text messages []. These reviews highlighted the lack of high-quality studies and the high heterogeneity of existing ones, underscoring the need for further research and better intervention design.

A VIP intervention that has demonstrated positive outcomes is the Sharing Knowledge About Immunization (SKAI), an Australian intervention developed prior to the COVID-19 pandemic by patients and experts to provide credible, evidence-based vaccine details using a presumptive vaccine dialog approach [-]. A SKAI evaluation study described an increase in self-reported pregnancy and childhood vaccination uptake [-], leading to its use in primary care clinics nationally in Australia, with Commonwealth government support. SKAI was developed for the Australian context, and further investigation was needed to identify if this intervention could be adopted as is in Canada. Therefore, we undertook a program of research to understand if the SKAI was appropriate for the Canadian setting and met the needs of Canadian health care providers (HCPs) and patients.

We used the Double Diamond process model [] and the associated framework for innovation design principles [] to guide our research program activities. The Double Diamond encompasses four phases: (1) Discover, which refers to problem understanding; (2) Define, which is about summarizing and making sense of the Discover findings toward developing solutions; (3) Develop, which refers to co-designing solutions through iterative co-design cycles; and (4) Deliver, which refers to refining solutions, validation, and usability testing. This paper reports on the last 2 phases, Develop and Deliver; however, we provide a summary () highlighting the findings from multiple studies and activities from the Discover and Define phases [-].

our findings from previous phases indicated that a new intervention tailored specifically for the Canadian context was required, instead of adopting SKAI, for the following reasons: (1) a mismatch between the needs of Canadian patients and HCPs and the components of SKAI, as documented by our behavioral sciences-informed inquiry [,,]; (2) the need for a communication approach that would balance the advantages of both a presumptive communication (as seen in SKAI, where the provider presumes the patient will accept vaccination and provides a leading statement []) and participatory communication approaches (ie, where the provider explores the patient’s intentions and supports them in making an informed decision, in the tradition of shared decision-making and motivational interviewing []); (3) the need for better digital interventions to improve VIP uptake []; and (4) the need to include content pertaining to new vaccines that were not available when SKAI was originally developed (eg, COVID-19 and respiratory syncytial virus).

In the following text, we report on the co-design (Develop phase) and testing (Deliver phase) of a new multicomponent intervention, Vaccines in Pregnancy Canada (VIP Canada), aimed at supporting and improving informed vaccine decision-making and co

Adapting a Digital Health Intervention for the Canadian Context: A Mixed-Methods Approach to Develop and Deliver a Perinatal Mental Health Program

Abstract

Background: Perinatal mental health disorders are prevalent and often undertreated. The Supporting Knowledge Submission in Individuals (SKAI) program is a digital health intervention designed to improve perinatal mental health care. This paper details the methods used to adapt SKAI for the Canadian context, focusing on the Develop and Delivery phases of our research.

Methods: We employed a participatory approach, actively involving patients and healthcare professionals (hcps) throughout the research process. Their ongoing involvement reflects our commitment to patient-oriented research principles and ensures our work is person-centered,inclusive,and responsive to real-world needs.

Participants: Patients and HCPs were recruited to participate in relevant activities within the develop and delivery phases. Patient participants met the following inclusion criteria: planning a pregnancy, currently pregnant, recently postpartum, or nursing; aged 18 years or older; and residing in Canada.Recruitment was primarily conducted through social media platforms, such as Facebook and Instagram. Perinatal HCPs were recruited through purposive snowball sampling across 6 Canadian provinces (Alberta, Ontario, New Brunswick, Manitoba, Quebec, and British Columbia) and included nurses, midwives, doulas, pharmacists, physicians, and a lactation consultant.

Develop Phase: Activities and Methods

Overview: The Develop phase focused on operationalizing, prototyping, and refining the intervention components we identified as priorities for the Canadian context during the Define phase, including a patient-facing website, a provider skills course, a pregnancy-specific communication approach, and a provider practice change plan. We conducted a structured review of the SKAI website, created new content, conducted focus groups and interviews with patients regarding parental communication preferences, and held 11 iterative co-design sessions with end users (4 with the Patient Council and patient partners and 7 with the multidisciplinary HCP Expert Panel). This work was iterative in nature.

SKAI Content Review and Creation of New Content: Study team members (MMS, MSS, and EC) developed a structured Microsoft Excel-based inventory of SKAI’s patient-facing website and accompanying resources for HCPs.The team reviewed the content page by page (website) and resource by resource to identify areas requiring adaptation for the Canadian context, including clinical information such as recommended vaccines, immunization schedules, and available products. Proposed adaptations were recorded in the inventory alongside the rationale for adaptation. We also identified topics where new content would need to be developed to meet the needs of Canadian HCPs and patients, like COVID-19 vaccinations, and later confirmed in co-design sessions with the HCP Expert Panel and Patient Council.Study team members (MMS and MSS) synthesized Canadian national guidelines and drafted new content that was reviewed by the study team’s clinical expert (EC) and HCP partners (nurses,midwives,and pharmacists) and continued to be reviewed and refined based on feedback from the Patient Council and HCP Expert Panel.

Co-Design Meetings With the HCP Expert Panel,Patient Council,and Patient Partners: We held a total of 11 co-design meetings (8 online and 3 in-person) to develop and refine the 4 components of the intervention. All co-design meetings were facilitated by study team members (MB, MCP, MSS, and MMS), including 2 patient partners (MB and MCP) trained in PaCER, using participatory tools, including commentary charts and virtual whiteboards. Online meetings were 60-90 minutes in length, conducted over Zoom (Zoom Communications, Inc), recorded with consent, transcribed, and supplemented with facilitator notes. In-person sessions were 90 minutes in length. One in-person session included unscripted interactions with patient partners that were filmed with consent and later included in the provider course’s online modules as exhibition videos.After each meeting, the core study team (EC, MB, MCP, MSS, and MMS) synthesized feedback, reached consensus on revisions, and refined prototypes accordingly. We used the Absorb Learning Management System (Absorb Software Inc) to house the providers’ course and Whimsical UX (Whimsical Inc) to build the initial website wireframe, as well as Squarespace (Squarespace, Inc) to develop the functional prototypes.

Focus Groups and Interviews on Parental communication Preferences: On the suggestion of our Patient Council and to support the advancement of the pregnancy-specific communication approach and the website’s name, tone, format, and presentation, we conducted several focus groups and interviews. These included 4 semistructured focus groups and 4 individual interviews with 14 participants identifying as currently pregnant,recently pregnant,or planning a pregnancy from diverse cultural backgrounds between June and July 2023. Details on participant characteristics, recruitment, methods, and data analysis are reported in Castre

Results

Overview

We collaborated with our patient and HCP partners (n=43) and used data collected from research participants (n=42) for a total of 85 patients and providers to co-design and test the digital components of the VIP Canada intervention. All research patient participants (n=19) self-identified as women; 21% (n=4) were pregnant, and 74% (n=14) had recently given birth or were breastfeeding; 79% (n=15) were 28-37 years of age; 79% (n=15) reported living in urban areas; and self-reported ethnocultural backgrounds were 37% (n=7) Caucasian, 32% (n=6) South Asian, 16% (n=3) Latin American, and 16% (n=3) Indigenous, Filipino, or multiracial. All research HCP participants (n=23) self-identified as women; 48% (n=11) were family physicians, and 35% (n=8) were nurses or midwives; 87% (n=20) practiced in urban areas; and 70% (n=16) had been practicing for more than 10 years.

The intervention includes the following four interrelated components: (1) the DECIDE (Determine, Elicit, Consent, Interactive discussion, Deliver, and Empower) communication approach, (2) the VIP skills course for HCPs, (3) the practice change plan, and (4) the VIP Canada website. Together, the intervention components aim to guide patients and hcps toward meaningful behavior change.

(Figure 2. Vaccines in Pregnancy Canada (VIP Canada) intervention implementation.DECIDE: Determine, Elicit, Consent, Interactive discussion, Deliver, and empower; HCP: health care provider.)

Develop Phase: Results of Prototyping and Refining Intervention Components

Pregnancy-Specific Communication Approach (DECIDE)

DECIDE is a patient-centered, pregnancy-specific communication approach for HCPs to deliver a clear vaccine recommendation while respecting patient autonomy based on shared decision-making principles.We have previously reported on how we developed DECIDE. DECIDE combines a participatory communication style with a clear vaccine recommendation to meet patients’ desire for both autonomy and a clear recommendation in decision-making, as informed by parental communication preferences focus groups and interviews and co-design sessions with Patient council and HCP Expert Panel. DECIDE stands for “Determine” if your patient is aware and ready to discuss vaccination, “Elicit” your patient’s questions, “Consent” to share information and engage in a discussion about vaccination, “Interactive discussion” to address your patient’s specific questions, “Deliver” a vaccine recommendation that considers your patient’s perspectives, and “Empower” your patient to take next step toward an informed decision. the HCP Expert Panel confirmed that the final DECIDE approach was more realistic, relevant, and user-friendly than earlier communication approach prototypes that required providers to select either a participatory or

Vaccines in Pregnancy Canada (VIP Canada) Intervention: A Focus on Provider Skills and Behavior Change

The Vaccines in Pregnancy Canada (VIP canada) intervention aims to improve vaccination uptake during pregnancy by targeting healthcare providers. This is achieved through a multi-component approach centered around a structured communication technique – DECIDE – and a skills course designed to address provider-level barriers. Table 1 details the intervention components, associated behavior change techniques, and the barriers to VIP in Canada they address.

The DECIDE Communication Approach

At the core of VIP Canada is the DECIDE acronym, providing a clear, step-by-step guide for healthcare providers to effectively communicate the benefits of vaccination to pregnant patients. The acronym itself serves as an instruction on how to perform the desired behavior – initiating and maintaining a productive conversation about vaccination.

VIP Skills Course for Providers

The provider skills course is structured to enhance knowledge and confidence in recommending vaccines during pregnancy.

* Module 1: Why Vaccinate in Pregnancy? This module utilizes animations and suggested readings to reinforce the rationale behind VIP, aiming to address gaps in provider knowledge and influence beliefs about the consequences of both vaccination and non-vaccination. It also includes a call-to-action, encouraging providers to actively engage in VIP communication.

Provider Practice Change Plan & Consensus Session

To translate knowledge into action, the intervention incorporates a practice change plan. A key element is a consensus session where providers collaboratively develop a plan to integrate vaccine communication into their routine practice. This involves:

* Identifying who will initiate VIP conversations.
* Determining when and where these conversations will take place.
* Planning environmental modifications – ensuring necessary materials are readily available to support the plan.

This process leverages behavior change techniques such as goal setting (both behavioral and outcome-focused), action planning, and commitment. It directly addresses barriers related to environmental context, resources, social professional role, and intentions.

VIP Canada Website Resources

The VIP Canada website provides ongoing support with resources like Frequently asked Questions (faqs), vaccine-specific information, and trimester-specific guidance, further reinforcing knowledge and addressing provider concerns.

^aBehavior change techniques are adapted from the Behavior Change technique taxonomy (BCTTv1).
^bBarriers to VIP are based on a scoping review of the literature and qualitative interviews with Canadian healthcare providers.
^cFAQ = Frequently Asked Questions.

Co-Developing and Evaluating “vaccines in Pregnancy Canada” (VIP Canada): A Patient-Centered approach

Development Phase: Patient Engagement and Website Creation

The development of “Vaccines in Pregnancy Canada” (VIP canada) was deeply rooted in patient engagement, ensuring the resulting resources were relevant, accessible, and trustworthy. This phase involved several key steps: (1) Initial Intervention & Refinement: We began with an intervention informed by the SKAI framework and meticulously refined it based on direct feedback from a Patient Council, translating insights into a visually engaging website.(2) Content Prioritization: Patients identified critical knowledge gaps surrounding vaccinations – both pre- and post-pregnancy – and the significant role of social support in vaccine decision-making. This led to dedicated website pages covering recommended vaccinations before pregnancy, postpartum, and during breastfeeding, alongside a “Support Person” page offering resources for partners, family, and friends. (3) Tone & Messaging: Patients emphasized the need for supportive, autonomy-respecting language that highlighted the protective benefits of vaccination for both the pregnant individual and their baby. This guidance shaped the website’s overall tone and inspired the co-created slogan, “Protection for you is protection for two.” (4) Diversity & Representation: Recognizing the importance of inclusivity, patients stressed the need for diverse representation in all website visuals. Consequently, generic stock photos were replaced with images showcasing a wider range of families, cultural backgrounds, gender identities, and body types. (5) Branding & Terminology: Participants favored the term “vaccines” over “immunizations” for broader accessibility, particularly for those with English as an additional language. They also responded positively to the acronym “VIP,” perceiving it as both memorable and empowering.This feedback ultimately led to the selection of “Vaccines in Pregnancy Canada” and “VIP canada” as the website’s official name and public identity.

Deliver Phase: Results of Functionality and Usability Testing

The VIP skills course, incorporating the DECIDE communication approach, underwent rigorous evaluation through: (1) functionality and usability testing of the four online course modules to assess technical performance and user experience, and (2) guided role-play sessions to test and refine the group practice component where healthcare professionals (HCPs) practice and receive peer feedback on their communication skills.

VIP Skills course Online Modules Functionality Results

Initial functionality testing was conducted by the study team (MB, MCP, and ZJ), members of the HCP Expert Panel (n=6), and additional provider partners (n=5). Revisions were made to audio clips and closed captioning, and instances of excessive clicking were reduced. Downloadable outlines and reference lists were added to each module, as testers found these resources valuable for navigating the course content.

VIP Skills Course Online Modules Usability Results

Usability testing of the online course modules involved 10 HCP research participants, representing diverse roles including nurses (n=4), midwives (n=2), a pharmacist (n=1), a doula/lactation consultant (n=1), a family physician specializing in low-risk obstetrics (n=1), and an adult learning specialist (n=1).All participants completed module-specific evaluations, and nine completed the overall course evaluation survey.

Overall course evaluation survey findings demonstrated high participant satisfaction with the course’s layout and navigability. All respondents (n=9, 100%) reported the course was either “easy” (n=3, 33%) or “very easy” (n=6, 67%) to navigate, with a mean rating of 4.67 (SD 0.50). Similarly, all participants rated the overall course layout positively as either “good” (n=1, 11%) or “excellent” (n=8, 89%), with a mean rating of 4.89 (SD 0.33).

course Evaluation Results: A Summary of Student Feedback

This report summarizes student feedback on a recent course, based on a survey utilizing both quantitative data (numerical ratings) and qualitative assessments. The data is presented across several key areas, including content quality, inclusivity, and course layout, with ratings provided on a scale of 1 to 5 (1=very poor, 2=poor, 3=neutral, 4=good, 5=excellent). Percentage breakdowns and standard deviations are included for each metric.

Content Quality & Coverage

Students generally rated the content quality positively. The statement “Content was accurate” received an average rating of 4.11 (SD 0.33), with 89% of respondents indicating a positive assessment (ratings of 4 or 5).Similarly, “Amount of information was adequate” scored 4.11 (SD 0.60), with 67% rating it as good or excellent.

Coverage of expected topics also received a favorable response, averaging 4.11 (SD 0.93), with 56% of students finding the coverage good and 33% excellent. Though, the perception of content depth was slightly lower, with an average rating of 4.11 (SD 1.27). While 56% found the content in-depth enough, a notable 22% rated it as poor or neutral.

Inclusivity

Inclusivity, encompassing both language and imagery, received consistently good ratings. Both “Language was inclusive” and “Images were inclusive” averaged 4.22 (SD 0.83), with 44% of students rating both aspects as excellent. This suggests a strong positive perception of the course’s commitment to inclusive practices.

Course Layout & readability

The overall course layout was highly rated, achieving an average of 4.89 (SD 0.33), with 89% of students providing a positive assessment. Readability of the text and content also scored well, averaging 4.67 (SD 0.50), with 67% of students rating it as good or excellent.

Further Analysis:

The standard deviations indicate relatively consistent responses across most categories, suggesting a general consensus among students. The slightly higher standard deviation for “Content was in-depth enough” suggests a wider range of opinions on this specific aspect, potentially warranting further investigation.

Website Usability testing Results: Positive Feedback with Content considerations

Website usability testing with 11 participants revealed overwhelmingly positive feedback regarding the site’s navigation, intuitiveness, and aesthetics. Participants consistently rated these aspects highly, with over 80% agreeing or strongly agreeing that the website was easy to navigate and pages loaded quickly. The mean scores for ease of navigation (4.82), intuitiveness (4.64), and page loading speed (4.80) all exceeded 4.6 on a 5-point Likert scale.Aesthetics also received strong positive ratings, with 73% finding the pages pleasing.

Notably, the “Vaccines by trimester” navigation feature was specifically praised for its utility in locating information relevant to individual pregnancy stages.

However, there was some disagreement regarding the amount of content presented on the website. While 46% of participants felt the amount of content was appropriate, a combined 36% either disagreed or were neutral, suggesting a potential need to explore choice content delivery methods, such as increased use of graphics.

Table 3. Website functionality testing ratings (n=11)

^aOne participant did not provide a rating for “Pages loaded quickly,” resulting in n=10 for that item; all other items had n=11.

Discussion

Principal Findings

VIP Canada is an evidence-based, multicomponent intervention designed to support vaccine communication and improve informed decision-making during pregnancy in Canada. VIP Canada was designed to drive behavior change by targeting the barriers to VIP communication and decision-making identified by Canadian patients and HCPs using fit-for-purpose,evidence-based behavior change strategies and practical tools. The final VIP Canada intervention consists of four interrelated components: (1) the DECIDE communication approach, (2) the VIP skills course for HCPs, (3) a practice change plan to support clinic-wide implementation, and (4) a public-facing VIP Canada website with evidence-based information, resources, and patient decision aids. VIP canada addresses 2 significant gaps in improving VIP acceptance through (1) a pregnancy-specific vaccine communication approach responsive to the postpandemic context and (2) advancing the digital health integration in patient-centered care by developing a skills-based course for HCPs within an LMS platform and a digital platform with videos,animations,and testimonials for patients,providing them with multiple ways to learn skills and access trusted information using evidence-based behavior change techniques,all in one intervention.

We report on the development of VIP Canada through rigorous co-design, grounded in a behavioral and implementation sciences-informed inquiry, and on the functionality and usability testing of its components before the launch of a feasibility study, which is now underway. usability testing results suggest that VIP Canada is a promising intervention that prioritizes skills development and addresses additional determinants of behavior change,such as implementation intentions and environmental modifications,beyond conventional information-focused websites and educational materials.

Existing interventions, such as the Brief Motivational Interviewing for Maternal Immunizations (MI4MI) and SKAI, have demonstrated promising approaches to addressing gaps in effective VIP communication.The MI4MI intervention aims to improve how providers talk with pregnant people about vaccines using a video and 2 interactive modules. MI4MI guides HCPs to begin with a vaccine recommendation and then use motivational interviewing techniques for patients who express hesitancy. Perinatal clinicians found MI4MI useful and relevant; however,its effectiveness in improving vaccine acceptance or uptake during pregnancy is not known. SKAI, as described in the introduction, reported an increase in self-reported VIP uptake from 43% to 81%.

VIP Canada: A Co-Designed Intervention for Vaccine Decision-Making During Pregnancy

Vaccine hesitancy during pregnancy presents a significant public health challenge. Effective communication and shared decision-making between healthcare providers (HCPs) and pregnant individuals are crucial for promoting informed choices. VIP Canada is a multicomponent intervention designed to address this complexity, developed through extensive collaboration with both HCPs and patients across Canada.

Understanding the Need for VIP Canada

Pregnant individuals often face unique challenges when making decisions about vaccination. These can include concerns about vaccine safety, misinformation, and a lack of clear, accessible information. Healthcare providers, in turn, may feel unprepared to address these concerns effectively, leading to missed opportunities for impactful conversations. VIP Canada aims to bridge this gap by providing practical tools and strategies for both parties.

Key Components of the VIP Canada Intervention

VIP Canada isn’t a single program, but rather a suite of resources built on behavioral and implementation science. The core components include:

• VIP Skills Course for Providers: This course equips HCPs with communication skills focused on respectful, patient-centered vaccine discussions. It emphasizes active listening, motivational interviewing, and addressing common vaccine concerns.
• Patient Decision Aids: These resources provide pregnant individuals and their families with clear, unbiased information about vaccine benefits and risks, helping them to understand their options and make informed decisions.
• Role-Play Scenarios: these interactive scenarios allow HCPs to practice their communication skills in a safe and supportive environment, preparing them for real-world conversations with patients.

Co-Design and Iterative Development

A defining feature of VIP Canada is its co-design process. The intervention wasn’t created *for* patients and providers, but *with* them. Throughout the development process, researchers actively engaged with diverse groups of HCPs and pregnant individuals to gather feedback, refine materials, and ensure relevance. This iterative approach helped to create an intervention that truly meets the needs of its intended users.

addressing Limitations and Future Directions

While VIP Canada shows promise, the researchers acknowledge several limitations:

• Digital Literacy & Access: The reliance on digital resources may exclude individuals with limited digital literacy or access to technology.
• Sampling Bias: The use of purposive snowball sampling could introduce bias,potentially overrepresenting HCPs with similar backgrounds.
• Cultural & Linguistic Adaptability: Current materials are primarily available in English and French, and may require tailoring for diverse cultural contexts, particularly for Indigenous communities or rural areas.

To address these limitations, the research team is actively working on:

Developing a digital repository of validated role-play scenarios adaptable to various clinical settings and cultural contexts.

expanding the availability of resources to include more languages.

exploring alternative delivery modes to ensure equitable access for all.

Conclusions

VIP Canada represents a significant step forward in addressing the complex issue of vaccine decision-making during pregnancy. By providing practical, tailored solutions for both HCPs and patients, and by prioritizing co-design and iterative development, VIP Canada offers a promising pathway to improved communication, increased vaccine confidence, and ultimately, better health outcomes for pregnant individuals and their babies.

Key Takeaways

• VIP Canada is a multicomponent intervention designed to improve vaccine communication during pregnancy.
• The intervention was co-designed with HCPs and patients, ensuring relevance and usability.
• Key components include a skills course for providers, patient decision aids, and role-play scenarios.
• Researchers are actively addressing limitations related to digital access, sampling bias, and cultural adaptability.