Web-Based Tailored Messaging to Increase Vaccination: A Randomized Clinical Trial.
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ABSTRACT: 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.
SUBMITTER: Glanz JM
PROVIDER: S-EPMC7605085 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Human papillomavirus (HPV) causes a number of cancers that disproportionally affect Latinos yet there is a paucity of research on interventions to increase HPV vaccination among this population. We sought to evaluate the efficacy of a web-based, individually customizable intervention, called CHICOs (Combatting HPV Infection and Cancers, tailored intervention) for its impact on HPV vaccine utilization. We conducted a three-armed, randomized, controlled trial in the waiting rooms of five family medicine practices from June 2014-February 2016 where CHICOS was compared to an iPad-based version of the Vaccine Information Sheet from the Centers for Disease Control and Prevention (untailored intervention), and usual care. Pair-wise comparisons between study arms of 6 different measures of HPV vaccine uptake were assessed, with analyses stratified by adolescents versus young adults. Of the 1,294 participants enrolled in the study, 1,013 individuals could be assessed for vaccination. Across study arms, 265 adolescents, but only 18 young adults, received an HPV vaccine dose during the study period. In both intention-to-treat and per-protocol analyses there were essentially no differences between the CHICOS and untailored arms in any vaccination measure, or between the untailored or CHICOS arms and usual care. Our study suggests that a tailored educational intervention may not be effective for increasing HPV vaccine uptake among Latino adolescents or young adults. However, the higher than expected baseline levels of positive vaccination attitudes of study participants could have diminished the statistical power of the study. Trial Registration Number: ClinicalTrials.gov (NCT02145156).
| S-EPMC6746523 | biostudies-literature
Project description:ImportanceMore than 30% of pregnant people have at least 1 chronic medical condition, and nearly 20% develop gestational diabetes or pregnancy-related hypertension, increasing the risk of future chronic disease. While these individuals are often monitored closely during pregnancy, they face major barriers when transitioning to primary care following delivery, due in part to a lack of health care support for this transition.ObjectiveTo evaluate the impact of an intervention designed to improve postpartum primary care engagement by reducing patient administrative burden and information gaps.Design, setting, and participantsAn individual-level randomized clinical trial was conducted from November 3, 2022, to October 11, 2023, at 1 hospital-based and 5 community-based outpatient obstetric clinics affiliated with a large academic medical center. Participants included English- and Spanish-speaking pregnant or recently postpartum adults with obesity, anxiety, depression, diabetes, chronic hypertension, gestational diabetes, or pregnancy-related hypertension and a primary care practitioner (PCP) listed in their electronic health record.InterventionA behavioral economics-informed intervention bundle, including default scheduling of postpartum PCP appointments and tailored messages.Main outcome and measuresCompletion of a PCP visit for routine or chronic condition care within 4 months of delivery was the primary outcome, ascertained directly by reviewing the patient's electronic health record approximately 5 months after their estimated due date. Intention-to-treat analysis was conducted.ResultsA total of 360 patients were randomized (control, 176; intervention, 184). Individuals had a mean (SD) age of 34.1 (4.9) years and median gestational age of 36.3 (IQR, 34.0-38.6) weeks at enrollment. The distribution of self-reported race and ethnicity was 6.8% Asian, 7.4% Black, 68.6% White, and 15.0% multiple races or other. Most participants (75.4%) had anxiety or depression, 16.1% had a chronic or pregnancy-related hypertensive disorder, 19.5% had preexisting or gestational diabetes, and 40.8% had a prepregnancy body mass index of 30 or greater. Medicaid was the primary payer for 21.2% of patients. Primary care practitioner visit completion within 4 months occurred in 22.0% (95% CI, 6.4%-28.8%) of individuals in the control group and 40.0% (95% CI, 33.1%-47.4%) in the intervention group. In regression models accounting for randomization strata, the intervention increased PCP visit completion by 18.7 percentage points (95% CI, 9.1-28.2 percentage points). Intervention participants also had fewer postpartum readmissions (1.7% vs 5.8%) and increased receipt of the following services by a PCP: blood pressure screening (42.8% vs 28.3%), weight assessment (42.8% vs 27.7%), and depression screening (32.8% vs 16.8%).Conclusions and relevanceThe findings of this randomized clinical trial suggest that the current lack of support for postpartum transitions to primary care is a missed opportunity to improve recently pregnant individual's short- and long-term health. Reducing patient administrative burdens may represent relatively low-resource, high-impact approaches to improving postpartum health and well-being.Trial registrationClinicalTrials.gov Identifier: NCT05543265.
| S-EPMC11252898 | biostudies-literature
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.
| S-EPMC7395256 | biostudies-literature
Project description:BackgroundClinical trials are a critical source of evidence for oncology care, yet very few patients participate. Among healthcare providers, nurses spend the most time with cancer patients and are the most highly trusted professionals. We developed and evaluated an educational program for oncology nurses targeting knowledge, attitudes, self-efficacy and perceived norms to facilitate discussion about clinical trials and support patient decision making.MethodsA nationwide sample of oncology nurses were randomly assigned to receive general clinical trials education delivered as text (attention control) vs. tailored video vignettes (intervention) in a web-based continuing education program. Participants completed a baseline assessment and follow up assessments immediately after the educational program and three months later. The primary outcome was intention to discuss clinical trials with patients. Secondary outcomes were knowledge and attitudes about clinical trials, self-efficacy, and perceived norms.Results1393 nurses enrolled and completed the educational program and post-intervention assessment (720 control, 673 video). Both text education and tailored video education increased intention to discuss clinical trials with patients, with a greater effect in the video group (p < .0001). Likewise, knowledge, attitudes, perceived behavioral control, and perceived norms were all improved with education in both groups, and the magnitude of benefit was greater (p < .001) for the video group in all outcomes except knowledge.ConclusionA one-time online educational program for oncology nurses improves knowledge, attitudes, self-efficacy and intention to engage patients in discussions about clinical trials. A tailored video format was associated with a greater effect than standard text only material.
| S-EPMC8209078 | biostudies-literature
Project description:BackgroundLatino men in the United States report low physical activity (PA) levels and related health conditions (eg, diabetes and obesity). Engaging in regular PA can reduce the risk of chronic diseases and yield many health benefits; however, there is a paucity of interventions developed exclusively for Latino men.ObjectiveTo address the need for culturally relevant PA interventions, this study aims to develop and evaluate Hombres Saludables, a 6-month theory-based, tailored web- and text message-based PA intervention in Spanish for Latino men. This protocol paper describes the study design, intervention, and evaluation methods for Hombres Saludables.MethodsLatino men aged 18-65 years were randomized to either the individually tailored PA internet intervention arm or the nutrition and wellness internet control arm. The PA intervention included 2 check-in phone calls; automated SMS text messages; a pedometer; a 6-month gym membership; access to a private Facebook group; and an interactive website with PA tracking, goal setting, and individually tailored PA content. The primary outcomes were feasibility, acceptability, and efficacy (minutes per week of total moderate-to-vigorous PA assessed via the ActiGraph GT3X+ accelerometer worn at the waist and 7-day physical activity recall at baseline and 6 months). Secondary outcomes examined potential moderators (eg, demographics, acculturation, and environmental variables) and mediators (eg, self-efficacy and cognitive and behavioral processes of change) of treatment effects at 6 months post randomization.ResultsThis study was funded in September 2016. Initial institutional review board approval was received in February 2017, and focus groups and intervention development were conducted from April 2017 to January 2018. Recruitment for the clinical trial was carried out from February 2018 to July 2019. Baseline data collection was carried out from February 2018 to October 2019, with a total of 43 participants randomized. Follow-up data were collected through April 2020. Data cleaning and analysis are ongoing.ConclusionsWe developed and tested protocols for a highly accessible, culturally and linguistically relevant, theory-driven PA intervention for Latino men. Hombres Saludables used an innovative, interactive, web- and text message-based intervention for improving PA among Latino men, an underserved population at risk of low PA and related chronic disease. If the intervention demonstrates feasibility, acceptability, and preliminary efficacy, we will refine and evaluate it in a larger randomized control trial.Trial registrationClinicaltrials.gov: NCT03196570; https://clinicaltrials.gov/ct2/show/NCT03196570.International registered report identifier (irrid)DERR1-10.2196/23690.
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Project description:The primary care visit represents an important venue for intervening with a large population of smokers. However, physician adherence to the Smoking Cessation Clinical Guideline (5As) remains low. We evaluated the effectiveness of a computer-tailored intervention designed to increase smoking cessation counseling by primary care physicians.Physicians and their patients were randomized to either intervention or control conditions. In addition to brief smoking cessation training, intervention physicians and patients received a one-page report that characterized the patients' smoking habit and history and offered tailored recommendations. Physician performance of the 5As was assessed via patient exit interviews. Quit rates and smoking behaviors were assessed 6 months postintervention via patient phone interviews. Intervention effects were tested in a sample of 70 physicians and 518 of their patients. Results were analyzed via generalized and mixed linear modeling controlling for clustering.Intervention physicians exceeded controls on "Assess" (OR 5.06; 95% CI 3.22, 7.95), "Advise" (OR 2.79; 95% CI 1.70, 4.59), "Assist-set goals" (OR 4.31; 95% CI 2.59, 7.16), "Assist-provide written materials" (OR 5.14; 95% CI 2.60, 10.14), "Assist-provide referral" (OR 6.48; 95% CI 3.11, 13.49), "Assist-discuss medication" (OR 4.72;95% CI 2.90, 7.68), and "Arrange" (OR 8.14; 95% CI 3.98, 16.68), all p values being < 0.0001. Intervention patients were 1.77 (CI 0.94, 3.34,p = 0.078) times more likely than controls to be abstinent (12 versus 8%), a difference that approached, but did not reach statistical significance, and surpassed controls on number of days quit (18.4 versus 12.2, p < .05) but not on number of quit attempts.The use of a brief computer-tailored report improved physicians' implementation of the 5As and had a modest effect on patients' smoking behaviors 6 months postintervention.
| S-EPMC1829425 | biostudies-other
Project description:ImportanceCOVID-19 vaccine uptake among urban populations remains low.ObjectiveTo evaluate whether text messaging with outbound or inbound scheduling and behaviorally informed content might increase COVID-19 vaccine uptake.Design, setting, and participantsThis randomized clinical trial with a factorial design was conducted from April 29 to July 6, 2021, in an urban academic health system. The trial comprised 16 045 patients at least 18 years of age in Philadelphia, Pennsylvania, with at least 1 primary care visit in the past 5 years, or a future scheduled primary care visit within the next 3 months, who were unresponsive to prior outreach. The study was prespecified in the trial protocol, and data were obtained from the intent-to-treat population.InterventionsEligible patients were randomly assigned in a 1:20:20 ratio to (1) outbound telephone call only by call center, (2) text message and outbound telephone call by call center to those who respond, or (3) text message, with patients instructed to make an inbound telephone call to a hotline. Patients in groups 2 and 3 were concurrently randomly assigned in a 1:1:1:1 ratio to receive different content: standard messaging, clinician endorsement (eg, "Dr. XXX recommends"), scarcity ("limited supply available"), or endowment framing ("We have reserved a COVID-19 vaccine appointment for you").Main outcomes and measuresThe primary outcome was the proportion of patients who completed the first dose of the COVID-19 vaccine within 1 month, according to the electronic health record. Secondary outcomes were the completion of the first dose within 2 months and completion of the vaccination series within 2 months of initial outreach. Additional outcomes included the percentage of patients with invalid cell phone numbers (wrong number or nontextable), no response to text messaging, the percentage of patients scheduled for the vaccine, text message responses, and the number of telephone calls made by the access center. Analysis was on an intention-to-treat basis.ResultsAmong the 16 045 patients included, the mean (SD) age was 36.9 (11.1) years; 9418 (58.7%) were women; 12 869 (80.2%) had commercial insurance, and 2283 (14.2%) were insured by Medicaid; 8345 (52.0%) were White, 4706 (29.3%) were Black, and 967 (6.0%) were Hispanic or Latino. At 1 month, 14 of 390 patients (3.6% [95% CI, 1.7%-5.4%]) in the outbound telephone call-only group completed 1 vaccine dose, as did 243 of 7890 patients (3.1% [95% CI, 2.7%-3.5%]) in the text plus outbound call group (absolute difference, -0.5% [95% CI, -2.4% to 1.4%]; P = .57) and 253 of 7765 patients (3.3% [95% CI, 2.9%-3.7%]) in the text plus inbound call group (absolute difference, -0.3% [95% CI, -2.2% to 1.6%]; P = .72). Among the 15 655 patients receiving text messaging, 118 of 3889 patients (3.0% [95% CI, 2.5%-3.6%]) in the standard messaging group completed 1 vaccine dose, as did 135 of 3920 patients (3.4% [95% CI, 2.9%-4.0%]) in the clinician endorsement group (absolute difference, 0.4% [95% CI, -0.4% to 1.2%]; P = .31), 100 of 3911 patients (2.6% [95% CI, 2.1%-3.1%]) in the scarcity group (absolute difference, -0.5% [95% CI, -1.2% to 0.3%]; P = .20), and 143 of 3935 patients (3.6% [95% CI, 3.0%-4.2%]) in the endowment group (absolute difference, 0.6% [95% CI, -0.2% to 1.4%]; P = .14).Conclusions and relevanceThere was no detectable increase in vaccination uptake among patients receiving text messaging compared with telephone calls only or behaviorally informed message content.Trial registrationClinicalTrials.gov Identifier: NCT04834726.
| S-EPMC9194662 | biostudies-literature
Project description:Screening for colorectal cancer is cost-effective, but many U.S. women are nonadherent, and the cost-effectiveness of web-based tailored screening interventions is unknown. A randomized controlled trial, COBRA (Increasing Colorectal and Breast Cancer Screening), was the source of information for the economic evaluation. COBRA compared screening among a Usual Care group to: (i) tailored Phone Counseling intervention; (ii) tailored Web intervention; and (iii) tailored Web + Phone intervention groups. A sample of 1,196 women aged 50 to 75 who were nonadherent to colorectal cancer screening were recruited from Indiana primary care clinics during 2013 to 2015. Screening status was obtained through medical records at recruitment with verbal confirmation at consent, and at 6-month follow-up via medical record audit and participant self-report. A "best sample" analysis and microcosting from the patient and provider perspectives were applied to estimate the costs and effects of the interventions. Statistical uncertainty was analyzed with nonparametric bootstrapping and net benefit regression analysis. The per participant cost of implementing the Phone Counseling, Web-based, and Web + Phone Counseling interventions was $277, $314, and $336, respectively. The incremental cost per person screened for the Phone Counseling compared with no intervention was $995, while the additional cost of Web and the Web + Phone compared with Phone Counseling did not yield additonal persons screened. Tailored Phone Counseling significantly increased colorectal cancer screening rates compared with Usual Care. Tailored Web interventions did not improve the screening rate compared with the lower cost Phone Counseling intervention.
| S-EPMC8802485 | biostudies-literature
Project description:BackgroundIn 2010, the human papillomavirus (HPV) vaccination was introduced in the Dutch National Immunization Program for 12-year-old girls, aiming to reduce the incidence of cervical cancer in women. HPV vaccination uptake turned out to be lower than expected: 61% versus 70%, respectively. Mothers were shown to play the most important role in the immunization decision about this vaccination. They had also expressed their need for interactive personal information about the HPV vaccination over and above the existing universal general information. To improve the effectiveness of the existing education about the HPV vaccination, we systematically developed a Web-based tailored intervention with virtual assistants providing mothers of girls to be invited with tailored feedback on their decision making about the HPV vaccination.ObjectiveThe aim of this study was to evaluate the effectiveness of the Web-based tailored intervention for promoting HPV vaccination acceptance by means of a randomized controlled trial (RCT).MethodsMothers were recruited via the Dutch vaccination register (Praeventis) (n=36,000) and three Web-based panels (n=2483). Those who gave informed consent (N=8062) were randomly assigned to the control (n=4067) or intervention condition (n=3995). HPV vaccination uptake, as registered by Praeventis once the HPV vaccination round was completed, was used as the primary outcome. Secondary outcomes were differential scores across conditions between baseline (before the provided access to the new tailored intervention) and follow-up (just before the first vaccination) regarding the mothers' degree of informed decision making (IDM), decisional conflict, and critical determinants of HPV vaccination uptake among which are intention, attitude, risk perception, and outcome beliefs.ResultsIntention-to-treat analysis (N=8062) showed a significant positive effect of the intervention on IDM, decisional conflict, and nearly all determinants of HPV vaccination uptake (P<.001). No effect was found on uptake (P=.60). This may be attributed to the overall high uptake rates in both conditions. Mothers evaluated the intervention as highly positive, including the website as well as the virtual assistants that were used to deliver the tailored feedback.ConclusionsThis computer-tailored intervention has the potential to improve HPV vaccination acceptability and IDM and to decrease decisional conflict among mothers of invited girls. Implications for future research are discussed.Trial registrationTrialregister.nl NTR4935; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4935 (Archived by WebCite at http://www.webcitation.org/6srT7l9EM).
| S-EPMC5607435 | biostudies-literature
Project description:Interventions to address vaccine hesitancy and increase vaccine acceptance are needed. This study sought to determine if a Web-based, social media intervention increases early childhood immunization. A 3-arm, randomized controlled trial was conducted in Colorado from September 2013 to July 2016. Participants were pregnant women, randomly assigned (3:2:1) to a Web site with vaccine information and interactive social media components (VSM), a Web site with vaccine information (VI), or usual care (UC). Vaccination was assessed in infants of participants from birth to age 200 days. The primary outcome was days undervaccinated, measured as a continuous and dichotomous variable. Infants of 888 participants were managed for 200 days. By using a nonparametric rank-based analysis, mean ranks for days undervaccinated were significantly lower in the VSM arm versus UC (P = .02) but not statistically different between the VI and UC (P = .08) or between VSM and VI arms (P = .63). The proportions of infants up-to-date at age 200 days were 92.5, 91.3, and 86.6 in the VSM, VI, and UC arms, respectively. Infants in the VSM arm were more likely to be up-to-date than infants in the UC arm (odds ratio [OR] = 1.92; 95% confidence interval [CI], 1.07-3.47). Up-to-date status was not statistically different between VI and UC arms (OR = 1.62; 95% CI, 0.87-3.00) or between the VSM and VI arms (OR = 1.19, 95% CI, 0.70-2.03). Providing Web-based vaccine information with social media applications during pregnancy can positively influence parental vaccine behaviors.
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