Comparative Effectiveness of Patient-Driven versus Standardized Diabetes Shared Medical Appointments: A Pragmatic Cluster Randomized Trial.

BACKGROUND: Diabetes self-management education and support can be effectively and efficiently delivered in primary care in the form of shared medical appointments (SMAs). Comparative effectiveness of SMA delivery features such as topic choice, multi-disciplinary care teams, and peer mentor involvement is not known. OBJECTIVE: To compare effects of standardized and patient-driven models of diabetes SMAs on patient-level diabetes outcomes. DESIGN: Pragmatic cluster randomized trial. PARTICIPANTS: A total of 1060 adults with type 2 diabetes in 22 primary care practices. INTERVENTIONS: Practice personnel delivered the 6-session Targeted Training in Illness Management (TTIM) curriculum using either standardized (set content delivered by a health educator) or patient-driven SMAs (patient-selected topic order delivered by health educators, behavioral health providers [BHPs], and peer mentors). MAIN MEASURES: Outcomes included self-reported diabetes distress and diabetes self-care behaviors from baseline and follow-up surveys (assessed at 1st and final SMA session), and HbA1c, BMI, and blood pressure from electronic health records. Analyses used descriptive statistics, linear regression, and linear mixed models. KEY RESULTS: Both standardized and patient-driven SMAs effectively improved diabetes distress, self-care behaviors, BMI (- 0.29 on average), and HbA1c (- 0.45% (mmol/mol) on average, 8.3 to 7.8%). Controlling for covariates, there was a small, significant effect of condition on overall diabetes distress in favor of standardized SMAs (F(1,841) = 4.3, p = .04), attributable to significant effects of condition on emotion and regimen distress subscales. There was a small, significant effect of condition on diastolic blood pressure in favor of standardized SMAs (F(1,5199) = 4.50, p = .03). There were no other differences between conditions. CONCLUSIONS: Both SMA models using the TTIM curriculum yielded significant improvement in diabetes distress, self-care, and HbA1c. Patient-driven diabetes SMAs involving BHPs and peer mentors and topic selection did not lead to better clinical or patient-reported outcomes than standardized diabetes SMAs facilitated by a health educator following a set topic order. NIH TRIAL REGISTRY NUMBER: NCT03590041.

A Multi-Method Study of Patient Reach and Attendance in a Pragmatic Trial of Diabetes Shared Medical Appointments.

Shared medical appointments (SMAs) are an evidence-based approach to diabetes care in primary care settings, yet practices can struggle to ensure participation, especially among racial and ethnic minority and low-income patients. We conducted a multimethod evaluation of reach and attendance in the Invested in Diabetes study of the comparative effectiveness of two SMA delivery models (standardized and patient-driven) in two practice settings (federally qualified health centers [FQHCs] and clinics serving more commercially insured patients). Through this study, 22 practices reached 6.2% of patients with diabetes through SMAs over 3 years, with good attendance for both practice types and both SMA delivery models. FQHCs were especially successful at enrolling underserved populations and improved attendance with virtual SMAs.

Patient perspectives on diabetes shared medical appointments before, during, and after the COVID-19 pandemic.

Context: Shared Medical Appointments for diabetes (SMAs) are an evidence-based strategy improve health outcomes. However, which elements of SMAs are important remain unknown. Invested in Diabetes studied two implementation approaches (standardized [STD] vs. patient-driven [PTD]), using a curriculum focused on mental health and skill building in addition to diabetes self-management. Objective: To understand patient experiences and preferences, including care team and peer mentor involvement, and how teaching style affected satisfaction. Those completing SMAs after the COVID pandemic began discussed their experience with virtual SMAs. Study Design: Semi-structured interviews, conducted between 2019-21. Setting: 21 primary care practices in Colorado and Kansas. Population: Patients with type 2 diabetes who attended SMAs at participating sites. Outcome Measures: Transcripts were analyzed using qualitative thematic analysis (data triangulation and a constant comparative technique). Results: Forty-one patients from 14 participating clinics agreed to participate (25 STD, 16 PTD). All patients completed their 6-class cohort. Both newly diagnosed patients and those living with diabetes for longer found classes useful. Patients generally enjoyed the content, with nutrition favored most. Opinion on mental health topics and skill building varied, but overall deemed valuable. The social aspect of SMAs was seen as the biggest benefit. However, the peer mentor role (PTD only) was not always appreciated. Patient topic order selection and behavioral health as part of the care team (PTD only) were viewed as helpful but not necessary, though guest lecturers were supported by all. Facilitators were mostly seen as supportive and their teaching style agreeable, which contributed considerably to positive experiences. Those who did virtual SMAs had mostly positive views. The format allowed continuation of care that may have been halted due to the pandemic, let people with busy schedules to participate, and in some instances made sharing easier to do. Some would still have preferred an in-person class. Conclusions: Patients found SMAs beneficial, favoring classic diabetes self-management topics over mental health and skill building. The peer mentor role was not always well received, likely due to variations in the peer mentor. Teaching style was very important to satisfaction, and all patients wanted guest speakers with varied expertise. A virtual format was acceptable. .

Protocol refinement for a diabetes pragmatic trial using the PRECIS-2 framework.

BACKGROUND: This report describes how we refined a protocol for a pragmatic comparative effectiveness study of two models of an evidence-based diabetes shared medical appointment intervention and used the PRECIS-2 rating system to evaluate these adaptations. METHODS: We report primary data collected between June and August 2019, and protocol refinements completed between 2018 and 2020. Twenty-two members of the study team collaborated in protocol refinement and completed the PRECIS-2 ratings of study pragmatism. We discuss study design refinements made to achieve the desired level of pragmatism vs. experimental control for each of the nine PRECIS-2 dimensions. Study team members received training on PRECIS-2 scoring and were asked to rate the study protocol on the nine PRECIS-2 dimensions. Ratings were compared using descriptive statistics. RESULTS: In general, the PRECIS-2 ratings revealed high levels of pragmatism, but somewhat less pragmatic ratings on the categories of Delivery and Organization (costs and resources). This variation was purposeful, and we provide the rationale for and steps taken to obtain the targeted level of pragmatism on each PRECIS-2 dimension, as well as detail design changes made to a) make the design more pragmatic and b) address COVID-19 issues. There was general agreement among team members and across different types of stakeholders on PRECIS-2 ratings. CONCLUSIONS: We discuss lessons learned from use of PRECIS-2 and experiences in refining the study to be maximally pragmatic on some dimensions and less so on other dimensions. This paper expands on prior research by describing actions to achieve higher levels of pragmatism and revise our protocol fit to the changed context. We make recommendations for future use of PRECIS-2 to help address changing context and other strategies for the planning of and transparent reporting on pragmatic research and comparative effectiveness research. TRIAL REGISTRATION: Clinicaltrials.gov Registration ID: NCT03590041 .

Delivering diabetes shared medical appointments in primary care: early and mid-program adaptations and implications for successful implementation.

BACKGROUND: Self-management is essential for good outcomes in type 2 diabetes and patients often benefit from self-management education. Shared medical appointments (SMAs) can increase self-efficacy for self management but are difficult for some primary care practices to implement. Understanding how practices adapt processes and delivery of SMAs for patients with type 2 diabetes may provide helpful strategies for other practices interested in implementing SMAs. METHODS: The Invested in Diabetes study was a pragmatic cluster-randomized, comparative effectiveness trial designed to compare two different models of diabetes SMAs delivered in primary care. We used a multi-method approach guided by the FRAME to assess practices' experience with implementation, including any planned and unplanned adaptations. Data sources included interviews, practice observations and field notes from practice facilitator check-ins. RESULTS: Several findings were identified from the data: 1) Modifications and adaptations are common in implementation of SMAs, 2) while most adaptations were fidelity-consistent supporting the core components of the intervention conditions as designed, some were not, 3) Adaptations were perceived to be necessary to help SMAs meet patient and practice needs and overcome implementation challenges, and 4) Content changes in the sessions were often planned and enacted to better address the contextual circumstances such as patient needs and culture. DISCUSSION: Implementing SMAs in primary care can be challenging and adaptations of both implementation processes and content and delivery of SMAS for patients with type 2 diabetes were common in the Invested in Diabetes study. Recognizing the need for adaptations based on practice context prior to implementation may help improve fit and success with SMAs, but care needs to be given to ensure that adaptations do not weaken the impact of the intervention. Practices may be able to assess what might need to adapted for them to be successful prior to implementation but likely will continue to adapt after implementation. CONCLUSION: Adaptations were common in the Invested in Diabetes study. Practices may benefit from understanding common challenges in implementing SMAs and adapting processes and delivery based on their own context. TRIAL REGISTRATION: This trial is registered on clinicaltrials.gov under Trial number NCT03590041, posted 18/07/2018.

The Psychosocial Needs of Patients Participating in Diabetes Shared Medical Appointments.

BACKGROUND: Patient reported outcomes (PROs) for diabetes are self-reported and often give insight into outcomes important to people with diabetes. Federally Qualified Health Centers (FQHCs) see patients who may have higher levels of diabetes distress and lower levels of self-care behaviors. METHODS: The Invested in Diabetes study is a comparative effectiveness trial of diabetes Shared Medical Appointments (SMAs) in FQHCs and non-FQHC settings. PROs measure outcomes including validated measures on diabetes distress. SETTING AND PARTICIPANTS: 616 people from 22 practices completed PROs prior to SMAs. At FQHCs, participants were younger (average 57.7 years vs 66.9 years, p < 0.0001), more likely to be female (36.8% vs 46.1%, p = 0.02), and fewer spoke English (72.7% vs 99.6%, p < 0.0001). RESULTS: At FQHCs, diabetes distress was higher (2.1 vs 1.8, P = .02), more people were current smokers (14.3% vs 4.7%, P = .0002), on insulin (48.9% vs 22.3%, P < .0001) and reported food insecurity (52.7% vs 26.2%, P < .0001). After controlling for sociodemographic factors, these differences were nonsignificant. CONCLUSIONS: Higher numbers of patients at FQHCs report diabetes distress and food insecurity compared with patients in non-FQHC settings, indicating that patient social circumstances need to be considered as part of program implementation.

Methods for capturing and analyzing adaptations: implications for implementation research.

BACKGROUND: Interventions are often adapted; some adaptations may provoke more favorable outcomes, whereas some may not. A better understanding of the adaptations and their intended goals may elucidate which adaptations produce better outcomes. Improved methods are needed to better capture and characterize the impact of intervention adaptations. METHODS: We used multiple data collection and analytic methods to characterize adaptations made by practices participating in a hybrid effectiveness-implementation study of a complex, multicomponent diabetes intervention. Data collection methods to identify adaptations included interviews, observations, and facilitator sessions resulting in transcripts, templated notes, and field notes. Adaptations gleaned from these sources were reduced and combined; then, their components were cataloged according to the framework for reporting adaptations and modifications to evidence-based interventions (FRAME). Analytic methods to characterize adaptations included a co-occurrence table, statistically based k-means clustering, and a taxonomic analysis. RESULTS: We found that (1) different data collection methods elicited more overall adaptations, (2) multiple data collection methods provided understanding of the components of and reasons for adaptation, and (3) analytic methods revealed ways that adaptation components cluster together in unique patterns producing adaptation "types." These types may be useful for understanding how the "who, what, how, and why" of adaptations may fit together and for analyzing with outcome data to determine if the adaptations produce more favorable outcomes rather than by adaptation components individually. CONCLUSION: Adaptations were prevalent and discoverable through different methods. Enhancing methods to describe adaptations may better illuminate what works in providing improved intervention fit within context. TRIAL REGISTRATION: This trial is registered on clinicaltrials.gov under Trial number NCT03590041 , posted July 18, 2018.

A validated modification of the vaccine hesitancy scale for childhood, influenza and HPV vaccines.

INTRODUCTION: Vaccine hesitancy contributes to outbreaks of preventable disease worldwide. The Vaccine Hesitancy Scale (VHS), developed by the international WHO SAGE Working Group, has been validated previously for measuring hesitancy towards childhood vaccines; some psychometric properties were suboptimal. METHODS: We collected data using large, nationally-representative samples of parents in the U.S. We adapted the VHS items, and additional hesitancy items, to assess hesitancy towards influenza and HPV vaccines in addition to routine childhood vaccines. We then used exploratory and confirmatory factor analysis to identify latent constructs and create modified scales for childhood (VHS-child), influenza (VHS-flu) and HPV (VHS-HPV) vaccines with improved psychometric properties. Finally, we compared hesitancy scores on the VHS-child, VHS-flu, and VHS-HPV, to self-reported receipt of each vaccine category, and compared subscale scores to assess whether drivers of hesitancy differed by vaccine category. RESULTS: 2052 parents of children <18 years old completed the VHS-child and VHS-flu while 2020 parents of adolescents completed the VHS-HPV. A two-factor structure of 'risks' and a 'lack of confidence' was found for each vaccine category. Slight modifications to the VHS improved psychometric properties. Hesitancy was strongly associated with vaccine receipt: e.g., 76% of parents not hesitant towards influenza vaccine had vaccinated their child the past season, versus 9% of hesitant parents (p < 0.0001). Subscale scores also differed significantly between vaccines: lack of confidence was greater towards influenza (Median (IQR): 2.0 (1.2, 3.3)) and HPV (2.0 (1.3, 3.0)) vaccines than childhood (1.2 (1.0, 1.8), p < 0.0001 for both) vaccines; perceived risks of HPV vaccines (2.7 (1.7, 3.7)) were greater than for childhood vaccines (2.0 (1.3, 3.0), p < 0.0001). CONCLUSIONS: Our modified VHS scales perform well psychometrically and allow for consistent measurement of the extent and reasons for hesitancy between vaccine categories. We suggest that future work use these scales to examine hesitancy towards other vaccines and to monitor hesitancy over time.

The potential for centralized reminder/recall to increase immunization rates: A national survey of immunization information systems (IIS) managers.

Little is known about Immunization Information System (IIS) attitudes and experiences using Centralized IIS-based Reminder/Recall (CI-R/R), an effective approach to increasing immunization rates. To describe among IIS managers as it relates to CI-R/R: 1) past experiences and future plans conducting it; 2) attitudes and barriers, 3) IIS capabilities and polices that influence, and 4) factors that differentiate IIS who have and have not conducted CI-R/R. Electronic Surveys were sent to all IIS managers in July 2018 using a member listserve. Fifty-seven of 62 IIS programs contacted (92%) responded. The majority (61%) had ever conducted CI-R/R; 34% reported they were "very likely" to conduct CI-R/R within 6 months. The majority (64%) were in favor of CI-R/R. Barriers included lack of staff (78%), competing demands (76%), and cost (63%). Thirty percent reported receiving a ≥75% of immunization data via real-time electronic interfaces (HL7). Overall, 49% and 24% of jurisdictions had mandatory immunization reporting from private and public health entities for childhood and adult immunizations, respectively. Differences between IIS that ever and never performed CI-R/R, respectively, included: mandatory reporting from private and public entities for children (65% v 27%, p = 0.006), having a legal mandate for CI-R/R (50% v 19%, p = 0.02), less likely to prefer practice-based R/R to CI-R/R (68% v. 91%, p = 0.04), and not reporting having too many competing demands (29% v 67%, p = 0.007). Most IIS have conducted CI-R/R and have positive attitudes towards it. Given it effectiveness and low cost, efforts to sustain it should be considered.

Centralized Reminder/Recall for Human Papillomavirus Vaccination: Findings From Two States-A Randomized Clinical Trial.

PURPOSE: Centralized reminder/recall (C-R/R) using Immunization Information Systems has been effective in increasing childhood immunization rates. Previously, C-R/R using autodialer for human papillomavirus (HPV) vaccine did not raise rates. We assessed C-R/R for HPV vaccine using other modalities and focused on younger adolescents. METHODS: We conducted a three-arm pragmatic RCT in randomly sampled primary care practices in Colorado (n = 88) and New York (n = 136), proportionate to where adolescents received care. We randomized, within practices, adolescents aged 11-14 years who had not completed the HPV vaccination series to receive C-R/R using different modalities (Colorado: autodialer, mail, or control; New York: autodialer, text, or control). Up to two reminders were sent in intervention arms for each dose needed between 2/2017 and 12/2018. RESULTS: In Colorado, no significant differences were found for series initiation (31.3% control, 31.1% autodial, 31.8% mail), with slight improvement for series completion in the autodialer arm (29.7% control, 31.1% autodialer, p = .04) but not the mail arm (30.9%, p = .06). No significant differences were found in New York for series initiation (24.1% for all arms) or completion (17.1% control, 16.9% autodial, 17.9% text). Adjusted analyses showed higher completion rates for the autodialer arm in Colorado but not for other arms. In Colorado, C-R/R reduced time to series completion by around 2 months. Cost per adolescent was $1.81 for mail; under $.40 for all other modalities. CONCLUSIONS: C-R/R has less benefit for raising HPV vaccination rates than other studies have noted for childhood immunizations, although it may quicken series completion at little cost.

Prevalence and characteristics of HPV vaccine hesitancy among parents of adolescents across the US.

BACKGROUND: While many clinicians encounter parents or adolescents who refuse HPV vaccine, little is known about the prevalence of hesitancy for HPV vaccine nationally or its association with vaccination. METHODS: In April 2019, we surveyed families with adolescents 11-17 years using a national online panel (Knowledge Panel®) as the sampling frame. We assessed the prevalence of HPV vaccine hesitancy with the validated 9-item Vaccine Hesitancy Scale (VHS). We used multivariate analyses to assess demographic factors associated with HPV vaccine hesitancy. We also assessed practical barriers to receipt of HPV vaccine and the relationship between barriers and hesitancy. Finally, we evaluated the association between both HPV vaccine hesitancy and practical barriers on HPV vaccine receipt or refusal. RESULTS: 2,177 parents out of 4,185 sampled (52%) completed the survey, 2,020 qualified (lived with adolescent). Using a VHS cut-off score > 3 out of 5 points, 23% of US parents were hesitant about HPV vaccine. Hesitancy was lower among those with Hispanic ethnicity. At least one out of five parents disagreed that the HPV vaccine is beneficial for their adolescent, that the vaccine is effective, protects against HPV-related cancers, or that they followed their adolescent's health-care provider's recommendation about the vaccine. Many were concerned about vaccine side effects and the novelty of the vaccine. Adolescents living with vaccine-hesitant parents were less than one-third as likely to have received the vaccine (RR = 0.29, 95% CI 0.24, 0.35) or completed the vaccine series (RR = 0.29, 95% CI 0.23, 0.36), and were 6-fold more likely to have refused the vaccine because of parental vaccine-related concerns (RR = 6.09, 95% CI = 5.26, 7.04). Most practical barriers were independently associated with vaccine receipt but not with vaccine refusal. CONCLUSIONS: HPV vaccine hesitancy is common nationally and strongly related to both under-vaccination and vaccine refusal.

Correction to: The Invested in Diabetes Study Protocol: a cluster randomized pragmatic trial comparing standardized and patient-driven diabetes shared medical appointments.

After publication of our article [1] the authors have notified us that the title for Figure 1 was incorrectly captioned.

The Invested in Diabetes Study Protocol: a cluster randomized pragmatic trial comparing standardized and patient-driven diabetes shared medical appointments.

BACKGROUND: Shared medical appointments (SMAs) have been shown to be an efficient and effective strategy for providing diabetes self-management education and self-management support. SMA features vary and it is not known which features are most effective for different patients and practice settings. The Invested in Diabetes study tests the comparative effectiveness of SMAs with and without multidisciplinary care teams and patient topic choice for improving patient-centered and clinical outcomes related to diabetes. METHODS: This study compares the effectiveness of two SMA approaches using the Targeted Training for Illness Management (TTIM) curriculum. Standardized SMAs are led by a health educator with a set order of TTIM topics. Patient-driven SMAs are delivered collaboratively by a multidisciplinary care team (health educator, medical provider, behavioral health provider, and a peer mentor); patients select the order and emphasis on TTIM topics. Invested in Diabetes is a cluster randomized pragmatic trial involving approximately 1440 adult patients with type 2 diabetes. Twenty primary care practices will be randomly assigned to either standardized or patient-driven SMAs. A mixed-methods evaluation will include quantitative (practice- and patient-level data) and qualitative (practice and patient interviews, observation) components. The primary patient-centered outcome is diabetes distress. Secondary outcomes include autonomy support, self-management behaviors, clinical outcomes, patient reach, and practice-level value and sustainability. DISCUSSION: Practice and patient stakeholder input guided protocol development for this pragmatic trial comparing SMA approaches. Implementation strategies from the enhanced Replicating Effective Programs framework will help ensure practices maintain fidelity to intervention protocols while tailoring workflows to their settings. Invested in Diabetes will contribute to the literature on chronic illness management and implementation science using the RE-AIM model. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03590041. Registered on 5 July 2018.

Centralized Reminder/Recall to Increase Influenza Vaccination Rates: A Two-State Pragmatic Randomized Trial.

OBJECTIVE: Centralized reminder/recall (C-R/R) by health departments using immunization information systems is more effective and cost effective than practice-based approaches for increasing childhood vaccines but has not been studied for influenza vaccination. We assessed effectiveness and cost of C-R/R for increasing childhood influenza vaccination compared with usual care. METHODS: Within Colorado (CO) and New York (NY), random samples of primary care practices (pediatric, family medicine, and health center) were selected proportionate to where children are served-65 practices (N = 54,353 children) in CO; 101 practices (N = 65,777) in NY. We conducted 4-arm RCTs per state (1, 2, or 3 autodial reminders vs usual care), with randomization at the patient level within practices from 10/2016 to 1/2017. RESULTS: In CO, the maximum absolute difference in receipt of ≥1 influenza vaccine was 1.7% between the 2 R/R group and control (adjusted risk ratio [ARR] of 1.06 [1.01, 1.10]); other R/R arms did not differ significantly. In NY, ARRs for the study arms versus control varied from 1.05 (1.01, 1.10) for 3 R/R to 1.06 (1.01, 1.11) for 1-2 R/R groups and maximum absolute increase in vaccination was 0.6%. In time-to-event analyses, study arm was a significant predictor of vaccination in CO (P = .001) but not in NY. Costs/child randomized to one message were $.17 in CO and $.23 in NY. CONCLUSIONS: C-R/R for influenza vaccine using autodial had low-level effects on increasing influenza rates in 2 states. Given the feasibility and low cost of C-R/R in previous trials, its utility for influenza should be re-examined using different modalities.

Effect of State Immunization Information System Centralized Reminder and Recall on HPV Vaccination Rates.

BACKGROUND: Although autodialer centralized reminder and recall (C-R/R) from state immunization information systems (IISs) has been shown to raise childhood vaccination rates, its impact on human papillomavirus (HPV) vaccination rates is unclear. METHODS: In a 4-arm pragmatic randomized controlled trial across 2 states, we randomly selected practices representative of the specialty (pediatrics, family medicine, and health center) where children received care. Within each practice, patients 11 to 17.9 years old who had not completed their HPV vaccine series (NY: N = 30 616 in 123 practices; CO: N = 31 502 in 80 practices) were randomly assigned to receive 0, 1, 2, or 3 IIS C-R/R autodialer messages per vaccine dose. We assessed HPV vaccine receipt via the IIS, calculated intervention costs, and compared HPV vaccine series initiation and completion rates across study arms. RESULTS: In New York, HPV vaccine initiation rates ranged from 37.0% to 37.4%, and completion rates were between 29.1% and 30.1%, with no significant differences across study arms. In Colorado, HPV vaccine initiation rates ranged from 31.2% to 33.5% and were slightly higher for 1 reminder compared with none, but vaccine completion rates, ranging from 27.0% to 27.8%, were similar. On adjusted analyses in Colorado, vaccine initiation rates were slightly higher for 1 and 3 C-R/R messages (adjusted risk ratios 1.07 and 1.04, respectively); completion rates were slightly higher for 1 and 3 C-R/R messages (adjusted risk ratios 1.02 and 1.03, respectively). CONCLUSIONS: IIS-based C-R/R for HPV vaccination did not improve HPV vaccination rates in New York and increased vaccination rates slightly in Colorado.

Supporting and sustaining centralized reminder/recall for immunizations: Qualitative insights from stakeholders.

Centralized reminder/recall (C-R/R) is an evidence-based strategy for increasing vaccination rates that uses a population-level database such as a state immunization information system (IIS) to send notifications across large geographic areas. IISs are usually based in state public health departments, which could initiate C-R/R. While C-R/R is a promising strategy, the factors influencing its initiation and sustainment are not clear. Utilizing qualitative content analysis methodology and interviews with key stakeholders involved in or knowledgeable about C-R/R, we examined the characteristics of these initiatives and factors influencing their success. We identified and spoke with managers and senior leaders across IISs, health plans, health systems, pharmaceutical companies, and advocacy organizations and focused especially on C-R/R activities within IISs. Several considerations were determined important to C-R/R success: decision-making, stakeholder buy-in, partnerships, funding, data and technology, evaluation, and message content. Salient barriers were costs and lack of funding, poor contact data quality (i.e. telephone number, home address), and messaging that is either overly broad or too specific. Pertinent facilitators of C-R/R included notifying health providers in advance of an initiative, conducting a rigorous post-reminder/recall evaluation, and engaging a range of partners. Partnerships were important to stakeholders for multiple reasons including technical assistance, resource sharing, and sharing of best practices. Overall, our results illustrate the many opportunities to advance C-R/R through further collaboration within and across public health departments and potentially via public-private partnerships.

Randomized controlled trial of centralized vaccine reminder/recall to improve adult vaccination rates in an accountable care organization setting.

Our objectives were to assess 1) effectiveness of using Colorado's Immunization Information System (CIIS) to send out vaccine reminder/recalls (R/Rs) centrally vs. usual care for adult vaccine delivery within an accountable care organization (ACO) and 2) practice staff's perception of centralized R/R. From 9/2016 to 4/2017, we conducted a randomized controlled trial among adults enrolled in a Medicaid ACO at six healthcare entities. Adults were divided into two strata: 15,153 age 19-64 and 616 age 65+. Adults age 19-64 who needed influenza and/or Tdap vaccine, and adults age 65+ who needed influenza, and/or Tdap, and/or a pneumococcal vaccine were randomized to receive up to 3 R/Rs by autodialed telephone and mail or usual care. Documentation of receipt of any needed vaccines in CIIS within six months was the primary outcome. We assessed intervention effectiveness using mixed effect logistic regression. Thirteen semi-structured exit interviews were conducted with staff from each healthcare entity. The intervention was not associated with the primary outcome for the age 19-64 population [OR 1.06 (95% CI 0.98-1.15)] or age 65+ population [(OR 0.96 (0.69-1.32)]. Practice staff perceived the intervention to be beneficial and not burdensome. Perceived barriers included lack of availability of appointments and adults receiving only influenza vaccine when other vaccines were needed. In conclusion, centralized R/R was not effective at improving adult vaccination rates in a Medicaid ACO. Future studies should consider better harmonizing vaccine centralized R/Rs with vaccine delivery efforts within the practice setting. Clinical Trials Registration Number: NCT02133391.

Potential Strategies to Achieve Universal Influenza Vaccination for Children: Provider Attitudes in Two States.

OBJECTIVE: Childhood influenza vaccination rates remain suboptimal. Provider perceptions on strategies to achieve universal vaccination are needed. We assessed the perceptions and attitudes of primary care providers across 2 states regarding 2 strategies to potentially bolster rates: centralized reminder/recall (C-R/R), such as reminder/recall (R/R) notices from state immunization registries, and influenza vaccination by complementary community vaccinators (CCVs), such as retail pharmacies, schools, and health departments. METHODS: We sent a mailed survey to a representative sample of providers across Colorado and New York. Questions addressed R/R activities for influenza vaccine, preferences and attitudes about the health department sending C-R/R notices for influenza vaccine, and attitudes about CCVs. Bivariate analyses assessed provider perceptions and compared perceptions by state. RESULTS: The overall response rate was 56% (n = 590/1052). Twenty-two percent of providers in Colorado and 33% in New York performed practice-based R/R for all patients during the 2015-16 influenza season. Eighty-one percent of providers in both states preferred the health department or had no preference for who sent C-R/R notices for influenza vaccine to their patients; most preferred to include their practice names on C-R/R messages. Many providers in both Colorado (75%) and New York (46%, P < .001) agreed that their patients like the option of having CCVs where children can receive influenza vaccine. Some providers expressed concerns regarding potential loss of income and/or difficulty documenting receipt of influenza vaccine at CCVs. CONCLUSIONS: Most providers support C-R/R, and many support CCVs to increase influenza vaccination rates. Collaborations between traditional primary care providers and CCVs might boost coverage.

RCT of Centralized Vaccine Reminder/Recall for Adults.

INTRODUCTION: A proven, but underutilized, method to increase current low vaccination rates is reminder/recall. Centralized reminder/recall using an Immunization Information System reduces the burden of an individual practice conducting reminder/recall. The objectives were to assess the effectiveness of centralized vaccine reminder/recall on improving adult vaccination rates using Colorado's Immunization Information System. STUDY DESIGN: This study is a pragmatic RCT. SETTING/PARTICIPANTS: Denver Health patients were divided into three strata: 25,039 individuals aged 19-64 years without a high-risk condition for pneumococcal disease, 16,897 individuals aged 19-64 years with a high-risk condition, and 5,332 individuals aged ≥65 years. Data were collected from October 2015 to April 2016 and analyzed between September 2016 and June 2017. INTERVENTION: Adults aged 19-64 years without a high-risk condition who needed influenza or tetanus, diphtheria, acellular pertussis vaccine or both, and adults with a high-risk condition and adults aged ≥65 years who needed influenza, or tetanus, diphtheria, acellular pertussis, or pneumococcal vaccine, or all three vaccines were randomized to receive up to three reminder/recalls or usual care. MAIN OUTCOME MEASURES: Documentation of receipt of any needed vaccine in Immunization Information System ≤6 months after the reminder/recall was the primary outcome. A secondary outcome included implementation costs of the reminder/recall effort. A mixed effects model assessed the association between the intervention and receipt of any needed vaccine while controlling for gender, age, race, ethnicity, insurance type, and history of vaccine refusal. RESULTS: The intervention was associated with receipt of any needed vaccine in the adults aged ≥65 years population (AOR=1.15, 95% CI=1.02, 1.30), but not the other two populations. Influenza vaccine was the source of this difference, with 32.0% receiving a vaccine in intervention versus 28.6% in usual-care groups (p≤0.01). Start-up and implementation costs per person were $0.86. In the population aged ≥65 years, 29.4 patients would need to be contacted to gain one additional vaccination. CONCLUSIONS: Centralized reminder/recall was effective at increasing influenza vaccination rates in adults aged ≥65 years over a short time period, without burdening the practices, and at a reasonable cost. TRIAL REGISTRATION: This study is registered at www.clinicaltrials.gov NCT02133391.

Attitudes about adult vaccines and reminder/recall in a safety net population.

Little is known about adult patients' attitudes toward vaccination and preferences for reminder/recall. The objective of this study was to determine patient perspectives on adult vaccines generally; attitudes about Tdap, pneumococcal polysaccharide (PPSV-23), and seasonal influenza vaccines specifically; and preferences for adult reminder/recall delivery. Twelve focus groups were conducted with 68 patients in a safety net health system. The sample was stratified by preferred language (English or Spanish), age (18-64 or 65+), and health status (with or without chronic conditions). Participants expressed positive attitudes toward vaccines generally, but had little knowledge of specific vaccines other than influenza, about which they expressed concerns. Although none reported previous experience receiving reminder/recall notices for adult vaccines, all were in favor of receiving them. These results suggest potential patient interest in greater adoption of evidence-based methods to improve immunization rates, and highlight the need for improved communication between providers and patients about adult vaccines.