Background:Asthma is a prevalent chronic pediatric condition associated with significant health disparities. The Better Asthma Control for Kids (BACK) program aims to reduce asthma disparities and improve asthma control for children in high-need schools in four regions of Colorado. Methods:We conducted in-depth, semi-structured interviews (Dec 2023-June 2024) with key roles involved in BACK including school nurses, asthma navigators, and caregivers of participating students with asthma. Interviews and rapid qualitative analysis were informed by the Practical Robust, Implementation, and Sustainability Model (PRISM). We gathered perspectives, feedback, and recommendations about BACK to inform adaptation of the intervention and implementation strategy packages. Results:Participants (n = 39) included 6 asthma navigators, 17 school nurses, and 16 caregivers. Four overarching themes emerged: 1) perceived benefits of the BACK program, 2) challenges with school nurse engagement, communication, and perceptions of BACK, 3) difficulty with identification, documentation, and enrollment of students with asthma at the beginning of the school year, and 4) mismatches in program scope and alignment with school and family contexts. Conclusion:Identifying key challenges and participant recommendations supported the research team's "adapt and tailor to context" strategy in annual rapid evaluation and planning cycles. Obtaining feedback from program adopters, implementers, and recipients led to complementary recommendations to improve program delivery and user experiences. This approach may be transferable to other implementation-effectiveness trials, particularly those in schools or with other natural pauses that facilitate annual iterations in program delivery. Trial registration:Clinicaltrials.gov identifier NCT06003569, registered on August 22, 2023, https://clinicaltrials.gov/study/NCT06003569.

Incorporating people who use substances into a community-engaged research process can support the implementation and evaluation of evidence-based harm reduction programs. Attending to their voice ensures those who need these programs will use them. Yet, ongoing co-learning with people who use substances, often the ideal for community engaged research, poses a challenge for recruitment, ongoing participation, and obtaining diverse perspectives. We need novel strategies to support flexibility among populations experiencing legal and social instability so that community engaged work includes more diverse perspectives. In this paper, we describe a novel community engagement approach called Effective Adaptable and Sustainable in Your Community: Operationalizing Program Sustainability (EASY OPS). EASY OPS uses iterative engagement with people with lived/living substance use experience to design and implement harm reduction vending machine and kiosk programs, aiming to increase program use in those who would benefit most. The EASY OPS approach addresses two key challenges to access and use of evidence-based harm reduction programs in underrepresented populations: (1) the need for attention to elements of the environment, and (2) ways to navigate challenges to ongoing research collaboration with community members experiencing substance use disorders. EASY OPS uses walking interviews with participants to identify environmental factors contributing to perceived use of services. Iterative engagement with community members–through interviews, surveys, and focus groups–was conducted to inform program development from the community’s perspective as feasibility challenges emerged. This paper describes the novel EASY OPS strategy that facilitates iterative community engagement for harm reduction research and program development to better tailor implementation to the needs of diverse populations with lived/living experience. The potential impact is to reduce disparities by enhancing representative reach and access to substance use service and harm reduction programs.

Meaningful community engagement is an essential component of impactful public health and implementation research. Multiple community engagement methods have been defined, including co-creation. Co-creation involves an iterative process that advances from identifying opportunities for value creation and solutions, to defining partner priorities, to evaluating co-created outcomes. This study reports our methods to co-create culturally and linguistically meaningful mHealth messages to promote preventive healthcare engagement for Arabic, Spanish, and Vietnamese – speaking communities. This multi-method study is part of a larger program of research, “Working towards Empowered community-driven Approaches to increase Vaccination and preventive care Engagement” (WEAVE), that aims to co-create and test a preventive healthcare program that includes mHealth and care coordination with medically underserved patients at multiple federally qualified health center (FQHC) locations near the US/Mexico border and surrounding region. A multi-level partner process was used to engage in co-creation across six partner groups (n = 27): (1) Community Advisory Boards (CAB), (2) Community Weavers (individuals with lived experience as members of an underserved community who act as cultural brokers between communities, public health systems, and researchers), (3) FQHC Care Coordinators, (4) FQHC Administrators, (5) a FQHC Clinical Expert, and (6) Research Experts in health communication, vaccine behavior research, and/or mHealth. Each of these partner groups was distinctly engaged through structured CAB meetings, weekly research and operations team meetings, topic-specific meetings, and e-review of content. The Research Engagement Survey Tool (REST) was used as a global assessment of partner engagement in the co-creation process. Results are organized by a co-creation framework anchored to identify, analyze, define, and design steps. Across four CAB meetings and engagement activities with the other co-creation partners, 262 mHealth messages (89 Arabic, 85 Spanish, 88 Vietnamese) were refined and approved. A message cadence and delivery mode were finalized. On the REST, the average ratings were over 4.50 (out of 5), indicating strong perceptions of engagement with the co-creation process and members. We successfully engaged six co-creation partner groups to develop and approve the content, cadence, and delivery mode of mHealth preventive care messages. These messages will be embedded in the multicomponent health program that will be tested in a randomized adaptive trial. NCT05841810, registration date: 03/28/2023.

Clinical decision support (CDS) tools are critical for improving care delivery and guideline adherence but are associated with clinician burnout when inadequately designed and implemented. User-centered design (UCD) and implementation science (IS) methods are evidence-based approaches to optimizing CDS tools, but are infrequently used in part due to limited guidance on how to apply them within resource-constrained health systems.This paper focuses on pragmatic application of an integrated UCD-IS approach, demonstrating how it can be adapted to meet operational constraints through two real-world case studies.We applied an integrated UCD-IS approach guided by the Practical Robust Implementation and Sustainability Model (PRISM) to two CDS projects within a large regional health system: (1) adapting a CDS for improving prescribing of goal-directed medical therapy in patients with heart failure during virtual visits, and (2) expanding a naloxone co-prescribing CDS across outpatient settings. Each project followed iterative phases-partner engagement, design, prototyping, deployment, and evaluation tailored to time and resource constraints of the health system. Methods used included interviews, focus groups, surveys, and usability testing.Multilevel partner engagement surfaced critical insights that informed design adaptations. The heart failure CDS was adapted using minimal changes while the naloxone CDS underwent more extensive design iterations. Both projects balanced rigor and pragmatism, enabling timely implementation and rigorous design evaluation while supporting feasibility and sustainability. Iterative evaluations of both CDS are ongoing and structured to inform real-time refinements that support patient, clinician, and system-level outcomes.This work provides practical guidance on applying an integrated UCD-IS approach to CDS design and evaluation in time and resource-constrained health system environments. By flexibly applying this integrated approach, health systems can better address multilevel partner needs, ensure contextual relevance, and support sustained adoption.

Introduction Public health efforts to reduce opioid overdose fatalities include educating people at risk and expanding access to naloxone, a medication that reverses opioid-induced respiratory depression. People receiving long-term opioid therapy (LTOT) are at increased risk for overdose, yet naloxone uptake in this population remains low. The objective of this study was to determine if a targeted, digital health intervention changed patient risk behaviour, increased naloxone uptake and increased knowledge about opioid overdose prevention and naloxone.Methods We conducted a pragmatic randomised clinical trial among patients prescribed LTOT in a healthcare delivery system in Colorado. Participants were randomly assigned to receive an animated overdose prevention and naloxone educational video (intervention arm) or usual care (control arm). The 6 min video was designed to educate patients about opioid overdose and naloxone, increase overdose risk perception and prompt them to purchase naloxone from the pharmacy. Over an 8-month follow-up, opioid risk behaviour was assessed with the Opioid-Related Behaviours in Treatment survey instrument, and overdose and naloxone knowledge was measured with the Prescription Opioid Overdose Knowledge Scale after viewing the video at baseline. Naloxone dispensations were evaluated using pharmacy data over a 12-month period. Data were analysed with generalised linear mixed effects and log-binomial regression models.Results There were 519 participants in the intervention arm and 485 participants in the usual care arm. Opioid risk behaviour did not differ between the study arms over time (study arm by time interaction p=0.93). There was no difference in naloxone uptake between the arms (risk ratio 1.13, 95% CI 0.77 to 1.66). Knowledge was significantly greater in the intervention arm compared with usual care (p<0.001).Conclusions A targeted, digital health intervention video effectively increased knowledge about opioid overdose and naloxone, without increasing opioid risk behaviour. Naloxone uptake did not differ between the intervention and usual care arms.Trial registration number NCT03337009.

Context School-based asthma programs (SBAPs) have improved health and educational disparities among youth with asthma. Design To support scaling out effective SBAPs, our school partners identified a need for online implementation guides that are “always available,” to meet the needs of school nurses’ demanding schedules. School nurses play a key role in the adoption and implementation of SBAPs, so it is important to ensure the implementation guide would be highly usable and acceptable to them. Objective Accordingly, our research team collaborated with human-centered design experts to identify the “user journeys” of school nurses and co-created our online implementation guide as a public-facing website with input from local and national school nurse partners. Main Results In this perspectives article, our school nurse implementation partners and human-centered design experts reflect on challenges overcome in this process of developing a tailored implementation guide to school nurses and offer lessons from the field to others seeking to co-create implementation guides with community partners.

Abstract Background Asthma is a leading cause of children’s hospitalizations, emergency department visits, and missed school days. Our school-based asthma intervention has reduced asthma exacerbations for children experiencing health disparities in the Denver Metropolitan Area, due partly to addressing care coordination for asthma and social determinants of health (SDOH), such as access to healthcare and medications. Limited dissemination of school-based asthma programs has occurred in other metropolitan and rural areas of Colorado. We formed and engaged community advisory boards in socioeconomically diverse regions of Colorado to develop two implementation strategy packages for delivering our school-based asthma intervention — now termed “Better Asthma Control for Kids (BACK)" — with tailoring to regional priorities, needs and resources. Methods In this proposed type 2 hybrid implementation-effectiveness trial, where the primary goal is equitable reach to families to reduce asthma disparities, we will compare two different packages of implementation strategies to deliver BACK across four Colorado regions. The two implementation packages to be compared are: 1) standard set of implementation strategies including Tailor and Adapt to context, Facilitation and Training termed, BACK-Standard (BACK-S); 2) BACK-S plus an enhanced implementation strategy, that incorporates network weaving with community partners and consumer engagement with school families, termed BACK-Enhanced (BACK-E). Our evaluation will be guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework, including its Pragmatic Robust Implementation Sustainability Model (PRISM) determinants of implementation outcomes. Our central hypothesis is that our BACK-E implementation strategy will have significantly greater reach to eligible children/families than BACK-S (primary outcome) and that both BACK-E and BACK-S groups will have significantly reduced asthma exacerbation rates (“attacks”) and improved asthma control as compared to usual care. Discussion We expect both the BACK-S and BACK-E strategy packages will accelerate dissemination of our BACK program across the state – the comparative impact of BACK-S vs. BACK-E on reach and other RE-AIM outcomes may inform strategy selection for scaling BACK and other effective school-based programs to address chronic illness disparities. Trial registration Clinicaltrials.gov identifier: NCT06003569, registered on August 22, 2023, https://classic.clinicaltrials.gov/ct2/show/NCT06003569.

Background: Take home naloxone (THN) programs have been shown to effectively reverse opioid overdose events with limited adverse events, yet often miss young adults who use opioids. To identify opportunities for naloxone expansion, we conducted interviews with young adults who had used opioids. We explored young adults' experience with current THN programs, and perspectives on ideal THN programs and emerging naloxone public health vending machine (PHVM) programs shown to increase access to sterile syringes in young adults. Methods: We interviewed 16 young adults receiving substance treatment services within an integrated safety net healthcare system. Participants were 18-30 years of age with a history of nonmedical prescription opioid use. Interviews obtained the patient perspective of current THN, ideal THN and PHVM programs. Interviews were transcribed and coded by team-based methods. Themes were developed using an inductive-deductive iterative approach and defined through consensus. Results: Treatment was often the first exposure to naloxone. Participants recommended easy to access programs for ideal naloxone distribution and had overall positive feedback on PHVMs. Three key themes were identified to improve naloxone uptake: knowledge, convenience, and privacy. Participants identified safety, lack of police presence, and low costs as important vending machine features. Conclusions: Our results identified implementation opportunities to increase naloxone uptake including convenient location and hours, privacy, and using trusted sources of information to improve program awareness. PHVMs present an opportunity to maximize these opportunities and increase access to naloxone in young adults.

Use of digital communication technologies (DCT) shows promise for enhancing outcomes and efficiencies in asthma care management. However, little is known about the impact of DCT interventions on healthcare personnel requirements and costs, thus making it difficult for providers and health systems to understand the value of these interventions. This study evaluated the differences in healthcare personnel requirements and costs between usual asthma care (UC) and a DCT intervention (Breathewell) aimed at maintaining guidelines-based asthma care while reducing health care staffing requirements. We used data from a pragmatic, randomized controlled trial conducted in a large integrated health system involving 14,978 patients diagnosed with asthma. To evaluate differences in staffing requirements and cost between Breathewell and UC needed to deliver guideline-based care we used electronic health record (EHR) events, provider time tracking surveys, and invoicing. Differences in cost were reported at the patient and health system level. The Breathewell intervention significantly reduced personnel requirements with a larger percentage of participants requiring no personnel time (45% vs. 5%, p < .001) and smaller percentage of participants requiring follow-up outreach (44% vs. 68%, p < .001). Extrapolated to the total health system, cost for the Breathewell intervention was $16,278 less than usual care. The intervention became cost savings at a sample size of at least 957 patients diagnosed with asthma. At the population level, using DCT to compliment current asthma care practice presents an opportunity to reduce healthcare personnel requirements while maintaining population-based asthma control measures.

Background: As the rates of vaccination decline in children with logistical barriers to vaccination, new strategies to increase vaccination are needed. The goal of this study was to develop and evaluate the effectiveness of the Vaccines For Babies (VFB) intervention, an automated reminder system with online resources to address logistical barriers to vaccination in caregivers of children enrolled in an integrated healthcare system. Effectiveness was evaluated in a randomized controlled trial. Methods: Qualitative interviews were conducted with parents of children less than two years old to identify logistical barriers to vaccination that were used to develop the VFB intervention. VFB included automated reminders to schedule the 6-and 12-month vaccine visit linking caregivers to resources to address logistic barriers, sent to the preferred mode of outreach (text, email, and/or phone). Parents of children between 3 and 10 months of age with indicators of logistical barriers to vaccination were randomized to receive VFB or usual well child care (UC). The primary outcome was percentage of days undervaccinated at 2 years of life. A difference in differences analysis was conducted. Results: Qualitative interviews with 6 parents of children less than 2 years of age identified transportation, scheduling challenges, and knowledge of vaccine timing as logistical barriers to vaccination. We enrolled 250 participants in the trial, 45% were loss to follow-up. There were no significant differences in vaccination uptake between those enrolled in UC or the VFB intervention (0.51%, p = 0.86). In Medicaid enrolled participants, there was a modest decrease in percentage of days undervaccinated in the VFB intervention compared to UC (6.3%, p = 0.07). Conclusion: Automated Reminders and with links to heath system resources was not shown to increase infant vaccination uptake demonstrating additional resources are needed to address the needs of caregivers experiencing logistical barriers to vaccination. (c) 2021 Elsevier Ltd. All rights reserved.

A recent childhood vaccine promotion intervention trial showed no effects on vaccination outcomes relative to usual care. The purpose of this paper was to test assumptions and theory-based relationships underlying hypothesised mechanisms for two vaccine promotion educational websites (one tailored to parental values, beliefs, and intentions; one untailored) compared with usual care. This is a secondary analysis of a three-arm randomized controlled trial. Parental vaccine values, hesitancy, attitudes, and intention to vaccinate surveys were administered at baseline (≤2 months) and at 4-6 and 10-12 months of age. Vaccination was assessed using electronic health records. Analyses included random coefficient models and risk differences with exact confidence limits. Parental vaccine values were mostly stable over time. Vaccine attitudes were generally positive, with no differences among study arms. Both tailored and untailored website arms showed similar increases in intention to vaccinate more than usual care. Positive changes in intentions were associated with lower rates of late vaccination. Although attitudes and intentions predicted vaccination behavior and the intervention increased intention to vaccinate all on time, the web-based education and values-tailored messaging approaches were not effective at increasing vaccination rates. Intentions are necessary but insufficient targets for vaccine promotion interventions.

Background: Youth are vulnerable to opioid use initiation and its complications. With growing rates of opioid overdose, strategies to identify youth at risk of opioid use disorder (OUD) to efficiently focus prevention interventions are needed. This study developed and validated a prediction model of OUD in youth aged 14-18 years. Methods: The model was developed in a Colorado healthcare system (derivation site) using Cox proportional hazards regression analysis. Model predictors and outcomes were identified using electronic health record data. The model was externally validated in a separate Denver safety net health system (validation site). Youth were followed for up to 3.5 years. We evaluated internal and external validity using discrimination and calibration. Results: The derivation cohort included 76,603 youth, of whom 108 developed an OUD diagnosis. The model contained 3 predictors (smoking status, mental health diagnosis, and non-opioid substance use or disorder) and demonstrated good calibration (p = 0.90) and discrimination (bootstrap-corrected C-statistic = 0.76: 95 % CI = 0.70, 0.82). Sensitivity and specificity were 57 % and 84 % respectively with a positive predictive value (PPV) of 0.49 %. The validation cohort included 45,790 youth of whom, 74 developed an OUD diagnoses. The model demonstrated poorer calibration (p < 0.001) but good discrimination (C-statistic = 0.89; 95 % CI = 0.84, 0.95), sensitivity of 87.8 % specificity of 68.6 %, and PPV of 0.45 %. Conclusions: In two Colorado healthcare systems, the prediction model identified 57-88 % of subsequent OUD diagnoses in youth. However, PPV < 1% suggests universal prevention strategies for opioid use in youth may be the best health system approach.

CONTEXTRefill reminders can help patients improve adherence to inhaled corticosteroid (ICS) therapy. However, little is known about patient preferences for reminder type or whether patients who express a preference differ from patients who do not.OBJECTIVESTo describe patient preferences for ICS prescription refill reminder type and to compare baseline ICS therapy adherence, measured as proportion of days covered (PDC) 1 year before initiating preference-based reminders, between patients who did and did not express a preference.DESIGNThis substudy within a randomized multi-intervention study was conducted at Kaiser Permanente Colorado. Adults with asthma randomized to intervention were offered the opportunity to choose text, telephone, or email reminders. Patients who did and did not provide a preference were compared by baseline characteristics using log-binomial models.MAIN OUTCOME MEASURE(S)The primary outcomes were reminder preference and type.RESULTSA total of 1497 of 4545 patients (32.9%) expressed a preference; 789 (52.7%) chose text. The adjusted relative risk (aRR) of not providing a preference increased with decreasing PDC (PDC of 0.50 to < 0.80: aRR, 1.14; 95% confidence interval [CI], 1.04-1.25; PDC < 0.5: aRR, 1.76; 95% CI, 1.59-1.95) compared with patients with a PDC of 0.80 or greater.CONCLUSIONAmong patients who expressed a preference, text reminders were preferred. Patients who expressed a preference had higher baseline adherence. Further research is needed to determine whether expressing a preference for a refill reminder type is itself associated with adherence. Given that offering the opportunity to choose a reminder type only engaged a subset of patients, further work is needed to understand how best to leverage technology-enabled communication outreach to help patients optimize adherence.

BACKGROUND:Vaccine hesitancy among parents leads to childhood undervaccination and outbreaks of vaccine-preventable disease. As the reasons for vaccine hesitancy are diverse, there is often not enough time during regular clinical visits for medical providers to adequately address all the concerns that parents have. Providing individually tailored vaccine information via the internet before a clinical visit may be a good mechanism for effectively allaying parents' vaccination concerns while also being time efficient. Including tailoring based on values is a promising, but untested, approach to message creation.OBJECTIVE:This study aimed to describe the process by which we developed a Web-based intervention that is being used in an ongoing randomized controlled trial aimed at improving the timeliness of infant vaccination by reducing parental vaccine hesitancy.METHODS:Development of the intervention incorporated evidence-based health behavior theories. A series of interviews, surveys, and feedback sessions were used to iteratively develop the intervention in collaboration with vaccination experts and potential end users.RESULTS:In all, 41 specific content areas were identified to be included in the intervention. User feedback elucidated preferences for specific design elements to be incorporated throughout the website. The tile-based architecture chosen for the website was perceived as easy to use. Creating messages that were two-sided was generally preferred over other message formats. Quantitative surveys identified associations between specific vaccine values and vaccination beliefs, suggesting that values tailoring should vary, depending on the specific belief being endorsed.CONCLUSIONS:Using health behavior theories, qualitative and quantitative data, and significant expert and end user input, we created a novel, Web-based intervention to improve infant vaccination timeliness. The intervention is based on tailoring messages according to each individual's values and beliefs. This intervention is currently being tested in a controlled randomized clinical trial.

Background: RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) and CFIR (Consolidated Framework for Implementation Research) dissemination and implementation frameworks define theory-based domains associated with the adoption, implementation and maintenance of evidence-based interventions. Used together, the two frameworks identify metrics for evaluating implementation success, i.e., high reach and effectiveness resulting in sustained practice change (RE-AIM), and modifiable factors that explain and enhance implementation outcomes (CFIR). We applied both frameworks to study the implementation planning process for a technology-delivered asthma care intervention called Breathewell within an integrated care organization. The goal of the Breathewell intervention is to increase the efficiency of delivering resource-intensive asthma care services. Methods: We reviewed historical documents (i.e., meeting agendas; minutes) from 14 months of planning to evaluate alignment of implementation team priorities with RE-AIM domains. Key content was extracted and analyzed on topics, frequency and amount of discussion within each RE-AIM domain. Implementation team members were interviewed using questions adapted from the CFIR Interview Guide Tool to focus their reflection on the process and contextual factors considered during pre-implementation planning. Documents and transcripts were initially coded using RE-AIM domain definitions, and recoded using CFIR constructs, with intent to help explain how team decisions and actions can contribute to adoption, implementation and maintenance outcomes. Results: Qualitative analysis of team documents and interviews demonstrated strong alignment with the RE-AIM domains: Reach, Effectiveness, and Implementation; and with the CFIR constructs: formal inclusion of provider and staff stakeholders in implementation planning, compatibility of the intervention with workflows and systems, and alignment of the intervention with organizational culture. Focus on these factors likely contributed to RE-AIM outcomes of high implementation fidelity. However, team members expressed low confidence that Breathewell would be adopted and maintained post-trial. A potential explanation was weak alignment with several CFIR constructs, including tension for change, relative priority, and leadership engagement that contribute to organizational receptivity and motivation to sustain change. Conclusions: While RE-AIM provides a practical framework for planning and evaluating practice change interventions to assure their external validity, CFIR explains why implementation succeeded or failed, and when used proactively, identifies relevant modifiable factors that can promote or undermine adoption, implementation, and maintenance.

BACKGROUND Use of digital communication technology has shown potential to improve asthma adherence and outcomes. Few studies have looked at patient preference around mode of medication reminders used to improve and maintain asthma medication adherence. OBJECTIVE To determine if, in a population already receiving automated medication reminders, offering a choice for preferred mode of reminder (text, email, phone) would improve their adherence and asthma outcomes over a 1-year period. METHODS This was a pragmatic, randomized controlled trial conducted at Kaiser Permanente Colorado involving 7522 adult patients with persistent asthma. Study patients were randomized to receive usual care or their choice of medication reminder. Differences between the 2 groups in both medication adherence and asthma outcomes were then assessed over the following year. RESULTS Only 30% of those offered a choice of medication reminder modality responded by making a choice, with 52% preferring text messaging. There was less of a decrease in adherence rate over the 1-year period in those who made a choice regarding the mode of medication refill reminder. There was no difference in asthma outcomes between those who did make a choice compared with those who did not make a choice regarding the mode of medication refill reminder. CONCLUSION In a patient population already receiving medication reminders, offering a choice about what type of technology-enabled asthma medication reminder patients wanted did not improve outcomes but did enable a subgroup to better maintain their medication adherence.

BACKGROUND: To increase vaccine acceptance, we created a Web-based the “Vaccines and Your Baby” intervention (VAYB) that provided new parents with vaccine information messages tailored to vaccine beliefs and values. We evaluated the effectiveness of the VAYB by comparing timely uptake of infant vaccines to an untailored version of the intervention (UT) or usual care intervention (UC) only. METHODS: Between April 2016 and June 2019, we conducted a randomized clinical trial. Pregnant women and new parents were randomly assigned to the VAYB, UT, or UC arms. In the VAYB and UT arms, participants were exposed to interventions at 4 time points from pregnancy until their child was 15 months of age. The primary outcome was up-to-date status for recommended vaccines from birth to 200 days of age. A modified intent-to-treat analysis was conducted. Data were analyzed with logistic regression to generate odds ratios (ORs) and 95% confidence intervals (CIs). RESULTS: We enrolled 824 participants (276 VAYB, 274 UT, 274 UC), 143 (17.4%) of whom were lost to follow-up. The up-to-date rates in the VAYB, UT, and UC arms were 91.44%, 92.86%, and 92.31%, respectively. Infants in the VAYB arm were not more likely to be up to date than infants in the UC arm (OR = 0.89; 95% CI, 0.45–1.76) or in the UT arm (OR = 0.82; 95% CI, 0.42–1.63). The odds of being up to date did not differ between UT and UC arms (OR = 1.08; 95% CI, 0.54–2.18). CONCLUSIONS: Delivering Web-based vaccine messages tailored to parents’ vaccine attitudes and values did not positively impact the timely uptake of infant vaccines.

Introduction Increasing numbers of children are failing to receive many recommended vaccines, which has led to significant outbreaks of vaccine-preventable diseases in the USA and worldwide. A major driver of undervaccination is parental vaccine hesitance. Prior research demonstrates that mothers are the primary decision maker for infant vaccination, and that their vaccination attitudes form primarily during pregnancy and early in their infant’s life. Methods and analysis This manuscript describes the protocol for an ongoing three-armed randomised controlled trial done at Kaiser Permanente Colorado (KPCO). The trial aims to test the efficacy of provided tailored, individualised information via the Internet to pregnant and new mothers versus untailored information versus usual care on the timeliness of infant vaccination. The primary outcome to be assessed is vaccination status, which is a dichotomous outcome (up to date vs not) assessed at age 200 days, reflecting the time when infants should have completed the first set of vaccine provided (at age 2, 4 and 6 months). Infants with one or more age-appropriate recommended vaccines at least 30 days delayed are categorised as not up to date whereas all other infants are considered up to date. Secondary outcomes include vaccination status at age 489 days, reflecting receipt of recommended vaccines at age 12–15 months, as well as vaccination attitudes, hesitancy and intention. Vaccination data will be derived from the electronic medical record and the state immunisation registry. Other secondary outcomes will be assessed by online surveys. Ethics and dissemination The study activities were approved by the Institutional Review Boards of the University of Colorado, KPCO and the University of Michigan. Results will be disseminated through peer-reviewed manuscripts and conference presentations. Trial registration number NCT02665013 ; Pre-results.

Introduction: Tetanus, diphtheria, and acellular pertussis (Tdap) and influenza vaccines are recommended for pregnant women in each pregnancy, yet uptake is suboptimal. This study tested the efficacy of an online vaccine resource in increasing uptake of Tdap and influenza vaccines among pregnant women. Study design: RCT. Setting/participants: This study was conducted among women in the third trimester of pregnancy in an integrated healthcare system in Colorado in September 2013-July 2016, with data analysis in 2017-2018. Intervention: Women were randomly assigned to 1 of 3 arms: website with vaccine information and interactive social media components, website with vaccine information only, or usual care. Participants in the website with vaccine information and interactive social media components and website with vaccine information only arms had access to the same base vaccine content. The website with vaccine information and interactive social media components also included a blog, discussion forum, and "Ask a Question" portal. Main outcome measures: Tdap and influenza vaccination. These outcomes were analyzed separately. Results: For influenza (n=289), women in both the website with vaccine information and interactive social media components (OR=2.19, 95% CI=1.06, 4.53) and website with vaccine information only (OR=2.20, 95% CI=1.03, 4.69) arms had higher vaccine uptake than the usual care arm. The proportions of women receiving the influenza vaccine were 57%, 55%, and 36% in the website with vaccine information and interactive social media components, website with vaccine information only, and usual care arms, respectively. For Tdap (n=173), there were no significant differences in vaccine uptake between study arms. The proportions of women receiving Tdap were 71%, 69%, and 68% in the website with vaccine information and interactive social media components, website with vaccine information only, and usual care arms, respectively. Conclusions: Web-based vaccination information sent to pregnant women can positively influence maternal influenza vaccine uptake. Because of potential scalability, the impact of robust vaccination information websites should be studied in other settings. (C) 2019 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.