Addressing logistical barriers to childhood vaccination using an automated reminder system and online resource intervention: A randomized controlled trial.

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.

The Association between Opioid Discontinuation and Heroin Use: A Nested Case-Control Study.

BACKGROUND: Opioid prescribing guidelines recommend reducing or discontinuing opioids for chronic pain if harms of opioid treatment outweigh benefits. As opioid discontinuation becomes more prevalent, it is important to understand whether opioid discontinuation is associated with heroin use. In this study, we sought to assess the association between opioid discontinuation and heroin use documented in the medical record. METHODS: A matched nested case-control study was conducted in an integrated health plan and delivery system in Colorado. Patients receiving opioid therapy in the study period (January 2006-June 2018) were included. Opioid discontinuation was defined as ≥45 days with no opioids dispensed after initiating opioid therapy. The heroin use onset date represented the index date. Case patients were matched to up to 20 randomly selected patients without heroin use (control patients) by age, sex, calendar time, and time between initiating opioid therapy and the index date. Conditional logistic regression models estimated matched odds ratios (mOR) for the association between an opioid discontinuation prior to the index date and heroin use. RESULTS: Among 22,962 patients prescribed opioid therapy, 125 patients (0.54%) used heroin after initiating opioid therapy, of which 74 met criteria for inclusion in the analysis. The odds of opioid discontinuation were approximately two times higher in case patients (n = 74) than control patients (n = 1045; mOR = 2.19; 95% CI 1.27-3.78). CONCLUSIONS: Among patients prescribed chronic opioid therapy, the observed increased risk for heroin use associated with opioid discontinuation should be balanced with potential benefits.

Efficacy of a Web-Based Intervention to Increase Uptake of Maternal Vaccines: An RCT.

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. TRIAL REGISTRATION: This study is registered at www.clinicaltrials.gov NCT01873040.

Association Between Opioid Dose Variability and Opioid Overdose Among Adults Prescribed Long-term Opioid Therapy.

Importance: Attempts to discontinue opioid therapy to reduce the risk of overdose and adhere to prescribing guidelines may lead patients to be exposed to variability in opioid dosing. Such dose variability may increase the risk of opioid overdose even if therapy discontinuation is associated with a reduction in risk. Objective: To examine the association between opioid dose variability and opioid overdose. Design, Setting, and Participants: A nested case-control study was conducted in a large Colorado integrated health plan and delivery system from January 1, 2006, through June 30, 2018. Cohort members were individuals prescribed long-term opioid therapy. Exposures: Dose variability was defined as the SD of the milligrams of morphine equivalents across each patient's follow-up and categorized based on the quintile distribution of the SD in the cohort (0-5.3, 5.4-9.1, 9.2-14.6, 14.7-27.2, and >27.2 mg of morphine equivalents). Main Outcomes and Measures: Opioid overdose cases were identified using International Classification of Diseases, Ninth Revision and International Statistical Classification of Diseases and Related Health Problems, Tenth Revision codes. Each case patient with overdose was matched to up to 20 control patients using risk set sampling. Conditional logistic regression models were used to generate matched odds ratios and 95% CIs, adjusted for age, sex, race/ethnicity, drug or alcohol use disorder, tobacco use, benzodiazepine dispensings, medical comorbidities, mental health disorder, opioid dose, and opioid formulation. Results: In a cohort of 14 898 patients (mean [SD] age, 56.3 [16.0] years; 8988 [60.3%] female) prescribed long-term opioid therapy, 228 case patients with incident opioid overdose were matched to 3547 control patients. The mean (SD) duration of opioid therapy was 36.7 (33.7) months in case patients and 33.0 (30.9) months in control patients. High-dose variability (SD >27.2 mg of morphine equivalents) was associated with a significantly increased risk of overdose compared with low-dose variability (matched odds ratio, 3.32; 95% CI, 1.63-6.77) independent of opioid dose. Conclusions and Relevance: Variability in opioid dose may be a risk factor for opioid overdose, suggesting that practitioners should seek to minimize dose variability when managing long-term opioid therapy.

Addressing Parents' Vaccine Concerns: A Randomized Trial of a Social Media Intervention.

INTRODUCTION: Successful strategies are needed to address parental vaccine hesitancy, a significant public health issue. The study objective was to assess whether an Internet-based platform with vaccine information and interactive social media components improved parents' vaccine-related attitudes. STUDY DESIGN: A three-arm RCT. SETTING/PARTICIPANTS: The study was conducted in a large Colorado integrated healthcare organization. Parents were enrolled during September 2013 through October 2015 and followed through November 2016; data were analyzed in 2017. Parents, recruited during pregnancy, were given a survey about vaccine-related attitudes at enrollment (i.e., baseline) and when their child was aged 3-5 months and 12-15 months (Timepoints 1 and 2, respectively). Parental vaccine hesitancy was assessed at baseline. INTERVENTION: Study participants were randomized to the following: a study website with vaccine information and social media components (VSM arm); a website with vaccine information only (VI); or usual care. MAIN OUTCOME MEASURES: Change in parental vaccine attitudes over time by baseline degree of vaccine hesitancy. RESULTS: Among 1,093 study participants, 945 (86.5%) completed all three surveys. Comparing baseline with Timepoint 1 among vaccine-hesitant parents, the VSM and VI arms were associated with significant improvements in attitudes regarding vaccination benefits compared to usual care (VSM mean change 0.23 on a 5-point scale, 95% CI=0.05, 0.40, VI mean change 0.22, 95% CI=0.04, 0.40). Comparing baseline with Timepoint 2 among hesitant parents, the VSM and VI arms were also associated with significant reductions in parental concerns about vaccination risks compared to usual care (VSM mean change -0.37, 95% CI= -0.60, -0.14, VI mean change -0.31, 95% CI= -0.55, -0.07). Self-efficacy around vaccine decision making also improved among vaccine-hesitant parents. No intervention effect was observed among parents not vaccine-hesitant at baseline. CONCLUSIONS: Among vaccine-hesitant parents, an Internet-based intervention improved parents' attitudes about vaccines. TRIAL REGISTRATION: This study was registered at www.clinicaltrials.gov NCT01873040.

Prediction Model for Two-Year Risk of Opioid Overdose Among Patients Prescribed Chronic Opioid Therapy.

BACKGROUND: Naloxone is a life-saving opioid antagonist. Chronic pain guidelines recommend that physicians co-prescribe naloxone to patients at high risk for opioid overdose. However, clinical tools to efficiently identify patients who could benefit from naloxone are lacking. OBJECTIVE: To develop and validate an overdose predictive model which could be used in primary care settings to assess the need for naloxone. DESIGN: Retrospective cohort. SETTING: Derivation site was an integrated health system in Colorado; validation site was a safety-net health system in Colorado. PARTICIPANTS: We developed a predictive model in a cohort of 42,828 patients taking chronic opioid therapy and externally validated the model in 10,708 patients. MAIN MEASURES: Potential predictors and outcomes (nonfatal pharmaceutical and heroin overdoses) were extracted from electronic health records. Fatal overdose outcomes were identified from state vital records. To match the approximate shelf-life of naloxone, we used Cox proportional hazards regression to model the 2-year risk of overdose. Calibration and discrimination were assessed. KEY RESULTS: A five-variable predictive model showed good calibration and discrimination (bootstrap-corrected c-statistic = 0.73, 95% confidence interval [CI] 0.69-0.78) in the derivation site, with sensitivity of 66.1% and specificity of 66.6%. In the validation site, the model showed good discrimination (c-statistic = 0.75, 95% CI 0.70-0.80) and less than ideal calibration, with sensitivity and specificity of 82.2% and 49.5%, respectively. CONCLUSIONS: Among patients on chronic opioid therapy, the predictive model identified 66-82% of all subsequent opioid overdoses. This model is an efficient screening tool to identify patients who could benefit from naloxone to prevent overdose deaths. Population differences across the two sites limited calibration in the validation site.

Pharmacotherapy for incident attention-deficit/hyperactivity disorder: practice patterns and quality metrics.

INTRODUCTION: This study examines incident treatment patterns for attention-deficit/hyperactivity disorder (ADHD) in children seen in eight integrated healthcare delivery systems and identifies factors associated with adherence to Healthcare Effectiveness Data and Information Set (HEDIS) quality measures developed by the National Committee for Quality Assurance (NCQA). METHOD: A retrospective cohort analysis using electronic healthcare data from children aged 3 through 17 years with newly diagnosed ADHD between January 1, 2009 and December 31, 2010 was conducted. NCQA quality definitions for initiation and for continuation and maintenance (C&M) of ADHD medications were expanded to include preschoolers and adolescents. Poisson regression models with robust error variance were used to evaluate the association between NCQA HEDIS adherence measures, provider type, patient characteristics and care process measures. RESULTS: Of 6864 children aged 3-17 years old qualifying for incident treatment analyses, 5538 (80.7%) were started on ADHD medication within a year of diagnosis. Adherence to NCQA HEDIS measures was 49.8% for initiation and 45.8% for C&M, with adherence rates higher for mental health than non-mental health providers, school-aged children than adolescents, and for patients concurrently on other psychotropic medications than those who were not. Of those started on ADHD medication, 62.3% were not eligible for C&M analyses according to HEDIS guidelines, because they did not receive continuous (210 of 300 days) ADHD medication treatment, with adolescents less likely than school-aged children to persist with medications. CONCLUSION: Study limitations must be considered, including reliance on electronic medical record data, absence of patient race and sociodemographic data, and limited generalizability to other care contexts. Nevertheless, findings suggest novel strategies are needed to improve the quality of ADHD care processes for children of all ages, because even within integrated delivery systems less than half of children with ADHD received care consistent with NCQA HEDIS standards for initiation and C&M care. RESULTS suggest the need to refine quality measures by including follow-up care in those children not receiving or discontinuing medication treatment, a considerable quality concern not currently captured in NCQA HEDIS standards.