Dataset Information

'Reducing Delays In Vaccination' (REDIVAC) trial: a protocol for a randomised controlled trial of a web-based, individually tailored, educational intervention to improve timeliness of infant vaccination.

ABSTRACT: 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.

SUBMITTER: Dempsey AF

PROVIDER: S-EPMC6538084 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature

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'Reducing Delays In Vaccination' (REDIVAC) trial: a protocol for a randomised controlled trial of a web-based, individually tailored, educational intervention to improve timeliness of infant vaccination.

Dempsey Amanda F AF Wagner Nicole N Narwaney Komal K Pyrzanowski Jennifer J Kwan Bethany M BM Kraus Courtney C Gleason Kathy K Resnicow Ken K Sevick Carter C Cataldi Jessica J Brewer Sarah E SE Glanz Jason M JM

BMJ open 20190522 5

<h4>Introduction</h4>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.<h4>Methods and analysis</h4>This man ...[more]

PMID: 31122997

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Project description:BACKGROUND:In the Netherlands, human papillomavirus (HPV) vaccination uptake remains low. To improve informed decision making (IDM) and HPV vaccination acceptability, we systematically developed an interactive, web-based tailored intervention to which mothers of Dutch girls were invited to participate. OBJECTIVE:The aim of this study was to provide insight into the intervention's working mechanisms by evaluating (1) program use, (2) program acceptability, and (3) the relationship of program use with program acceptability and intervention effects (ie, dose-response relationship). METHODS:Only mothers from the intervention arm of a randomized controlled trial that assessed the effectiveness of the web-based, tailored intervention were included in this study. They were invited to visit the website of the web-based intervention between baseline (January 2015, just before access to the intervention) and follow up (March 2015, prior to the first HPV vaccination). Indicators for program use were time of website use (ie, duration of intervention exposure) and completeness (ie, proportion of all available web pages visited). HPV vaccination uptake registered by Praeventis was used as the primary outcome. Secondary outcomes were IDM, decisional conflict, and social-psychological determinants of HPV vaccination uptake. RESULTS:Among the 3995 invited mothers, 2509 (62.80%) logged on to the website, 2239 of whom (89.24%) visited at least one page of the intervention components. On average, mothers spent 21.39 minutes (SD 12.41) on the website and completed 50.04% (SD 26.18%) of the website components. Participants rated the website 7.64 (SD 1.39) on a 10-point scale. Program acceptability was significantly associated with completeness (?=4.36, P<.001), but not with time of website use (?=-.07, P=.77). Intention-to-treat analysis (N=3995) showed a significant positive effect of completeness on all outcome measures (all P<.003; Bonferroni-corrected ?=.05/15 factors), including on HPV vaccination uptake. Time of website use had a significant positive effect on all outcomes (all P<.003), except for uptake (P=.20), risk perception when not vaccinated (P=.14), subjective norms (P=.03), and habit (P=.01). CONCLUSIONS:Program use and acceptability of the intervention were adequate. Completeness was positively associated with acceptability. Furthermore, positive effects (ie, dose-response effects) were found for completeness and time of website use on the mothers' IDM, decisional conflict, and almost all of the social-psychological determinants of HPV vaccination acceptability. In addition, the extent to which mothers completed the intervention had a positive impact on their daughters' vaccination uptake. This indicates that the web-based, tailored intervention fits well with the mothers' needs, and that completeness of use is essential for improving HPV vaccination uptake, acceptability, and IDM. Program use should therefore be promoted. TRIAL REGISTRATION:Netherlands Trial Register NTR4795; https://www.trialregister.nl/trial/4795.

Project description:Many pregnant women and parents have concerns about vaccines. This analysis examined the impact of MomsTalkShots, an individually tailored educational application, on vaccine attitudes of pregnant women and mothers. MomsTalkShots was the patient-level component of a multi-level intervention to improve maternal and infant vaccine uptake that also included provider- and practice-level interventions. The impact of these interventions was studied using a two-by-two factorial design, randomizing at both the patient- and the practice-level. Study staff recruited pregnant women from a diverse set of prenatal care practices in Colorado and Georgia between June 2017 and July 2018. All participants (n = 2087) received a baseline survey of maternal and infant vaccine intentions and attitudes, and two follow-up surveys at least 1 month and 1 year after their infant's birth, respectively. Half of participants (n = 1041) were randomly assigned to receive educational videos through MomsTalkShots, algorithmically tailored to their vaccine intentions, attitudes, and demographics. Since the practice/provider intervention did not appear impactful, this analysis focused on MomsTalkShots regardless of the practice/provider intervention. By 1 month post-birth, MomsTalkShots increased perceived risk of maternal influenza disease (61% among MomsTalkShots recipients vs 55% among controls; Odds Ratio: 1.61, 95% Confidence Interval: 1.23-2.09), confidence in influenza vaccine efficacy (73% vs 63%; OR: 1.97, 95%CI: 1.47-2.65), and perceived vaccine knowledge (55% vs 48%; OR: 1.39, 95%CI: 1.13-1.72). Among those intending not to vaccinate at baseline, MomsTalkShots increased perceived risk of maternal influenza disease (38% vs 32%; OR: 2.07, 95%CI: 1.15-3.71) and confidence in influenza vaccine efficacy (44% vs 28%; OR: 2.62, 95%CI: 1.46-4.69). By 1 year post-birth, MomsTalkShots increased perceived vaccine knowledge (62% vs 50%; OR: 1.74, 95%CI: 1.36-2.24) and trust in vaccine information from obstetricians and pediatricians (64% vs 55%; OR: 1.53, 95%CI: 1.17-2.00). Among those uncertain about vaccinating at baseline, MomsTalkShots increased perceived vaccine knowledge (47% vs 12%; OR: 6.89, 95%CI: 1.52-31.25) and reduced infant vaccine safety concerns (71% vs 91%; OR: 0.24, 95%CI: 0.06-0.98). MomsTalkShots improved pregnant women's and mothers' knowledge and perceptions of maternal and infant vaccines and the diseases they prevent, and offers a scalable tool to address vaccine hesitancy. Registered at Clinicaltrials.gov on 13/09/2016 (registration number: NCT02898688).

Project description:BackgroundWeb-based computer-tailored interventions for multiple health behaviors can improve the strength of behavior habits in people who want to reduce their cardiovascular risk. Nonetheless, few randomized controlled trials have tested this assumption to date.ObjectiveThe study aim was to test an 8-week Web-based computer-tailored intervention designed to improve habit strength for physical activity and fruit and vegetable consumption among people who want to reduce their cardiovascular risk. In a randomized controlled design, self-reported changes in perceived habit strength, self-efficacy, and planning across different domains of physical activity as well as fruit and vegetable consumption were evaluated.MethodsThis study was a randomized controlled trial involving an intervention group (n=403) and a waiting control group (n=387). Web-based data collection was performed in Germany and the Netherlands during 2013-2015. The intervention content was based on the Health Action Process Approach and involved personalized feedback on lifestyle behaviors, which indicated whether participants complied with behavioral guidelines for physical activity and fruit and vegetable consumption. There were three Web-based assessments: baseline (T0, N=790), a posttest 8 weeks after the baseline (T1, n=206), and a follow-up 3 months after the baseline (T2, n=121). Data analysis was conducted by analyzing variances and structural equation analysis.ResultsSignificant group by time interactions revealed superior treatment effects for the intervention group, with substantially higher increases in self-reported habit strength for physical activity (F1,199=7.71, P=.006, Cohen's d=0.37) and fruit and vegetable consumption (F1,199=7.71, P=.006, Cohen's d=0.30) at posttest T1 for the intervention group. Mediation analyses yielded behavior-specific sequential mediator effects for T1 planning and T1 self-efficacy between the intervention and habit strength at follow-up T2 (fruit and vegetable consumption: beta=0.12, 95% CI 0.09-0.16, P<.001; physical activity: beta=0.04, 95% CI 0.02-0.06, P<.001).ConclusionsOur findings indicate the general effectiveness and practicality of Web-based computer-tailored interventions in terms of increasing self-reported habit strength for physical activity and fruit and vegetable consumption. Self-efficacy and planning may play major roles in the mechanisms that facilitate the habit strength of these behaviors; therefore, they should be actively promoted in Web-based interventions. Although the results need to take into account the high dropout rates and medium effect sizes, a large number of people were reached and changes in habit strength were achieved after 3 months.Trial registrationClinicaltrials.gov NCT01909349; https://clinicaltrials.gov/ct2/show/NCT01909349 (Archived by WebCite at http://www.webcitation.org/6g5F0qoft) and Nederlands Trial Register NTR3706 http://www.trialregister.nl/ trialreg/admin/rctview.asp?TC=3706 (Archived by WebCite at http://www.webcitation.org/6g5F5HMLX).

Dataset Information

'Reducing Delays In Vaccination' (REDIVAC) trial: a protocol for a randomised controlled trial of a web-based, individually tailored, educational intervention to improve timeliness of infant vaccination.

Publications

'Reducing Delays In Vaccination' (REDIVAC) trial: a protocol for a randomised controlled trial of a web-based, individually tailored, educational intervention to improve timeliness of infant vaccination.

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