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.

Baseline Characteristics of PATHWEIGH: A Stepped-Wedge Cluster Randomized Study for Weight Management in Primary Care.

PURPOSE: To describe the characteristics of patients and practice of clinicians during standard-of-care for weight management in a large, multiclinic health system before the implementation of PATHWEIGH, a pragmatic weight management intervention. METHODS: We analyzed baseline characteristics of patients, clinicians, and clinics during standard-of-care for weight management before the implementation of PATHWEIGH, which will be evaluated for effectiveness and implementation in primary care using an effectiveness-implementation hybrid type-1 cluster randomized stepped-wedge clinical trial design. A total of 57 primary care clinics were enrolled and randomized to 3 sequences. Patients included in the analysis met the eligibility requirements of age ≥18 years and body mass index (BMI) ≥25 kg/m2 and had a weight-prioritized visit (defined a priori) during the period March 17, 2020 to March 16, 2021. RESULTS: A total of 12% of patients aged ≥18 years and with a BMI ≥25 kg/m2 seen in the 57 practices during the baseline period (n = 20,383) had a weight-prioritized visit. The 3 randomization sequences of 20, 18, and 19 sites were similar, with an overall mean patient age of 52 (SD 16) years, 58% women, 76% non-Hispanic White patients, 64% with commercial insurance, and with a mean BMI of 37 (SD 7) kg/m2. Documented referral for anything weight related was low (<6%), and 334 prescriptions of an antiobesity drug were noted. CONCLUSIONS: Of patients aged ≥18 years and with a BMI ≥25 kg/m2 in a large health system, 12% had a weight-prioritized visit during the baseline period. Despite most patients being commercially insured, referral to any weight-related service or prescription of antiobesity drug was uncommon. These results fortify the rationale for trying to improve weight management in primary care.

Baseline Characteristics of PATHWEIGH: A Stepped-Wedge Cluster Randomized Study for Weight Management in Primary Care.

Context: Despite the fact that obesity is both treatable and preventable, treating the comorbidities, rather than obesity per se remains the mainstay of therapy. Objective: To evaluate the efficacy and implementation of a pragmatic approach to weight management in primary care that prioritizes treatment of weight rather than weight-related diseases (PATHWEIGH). Study Design and Analysis: PATHWEIGH is a hybrid type 1 cluster randomized stepped wedge clinical trial. Clinics were enrolled and randomized to three sequences using covariate constrained randomization. Descriptive statistics were used to summarize clinic and patient characteristics with t-tests, Wilcoxon rank sums or Fisher's exact tests used to compare groups. Setting: Fifty-seven primary care clinics in rural, suburban and urban Colorado in a single healthcare system were utilized. Population Studied: Patients age >18 years and body mass index (BMI) >25 kg/m2 who had a weight-prioritized visit (WPV) in the prior year were enrolled. A WPV was defined as a chief complaint or reason for visit that included "weight", ICD-10 codes for weight or use of an intake questionnaire for weight. Intervention: None. This abstract describes the baseline (pre-intervention) characteristics of the clinics and patients treated with standard-of-care (SOC) for weight management. Outcome Measures: Baseline characteristics of the clinics and patients undergoing a WPV from March 17, 2020 - March 16, 2021. Results: 20,410 patients met these eligibility requirements representing 12% of patients >18 years and body mass index (BMI) >25 kg/m2 seen at the clinic during this baseline period. The three randomization sequences of 20, 18, and 19 sites were similar with an overall median age of 53 years (IQR: 39-65), 58% women, 76% non-Hispanic whites, 64% commercial insurance, and median BMI of 36 kg/m2 (IQR: 32-41). No sequence differences were seen for vital signs, relevant laboratory values, or numbers of comorbidities or medications that cause weight loss or weight gain. Referral for anything weight-related was low (<6%) and only 334 prescriptions of an anti-obesity medication were noted. Conclusions: Of patients >18 years and body mass index (BMI) >25 kg/m2 seen in the 57 primary care clinics, 12% had a weight-prioritized visit during the baseline period. Despite most being commercially insured, referral to any weight-related service or prescription of anti-obesity medication was uncommon.

Implementation strategies preferred by primary care clinicians to facilitate cancer prevention and control activities.

Key clinical and community members need to be involved in the identification of feasible and impactful implementation strategies for translation of evidence-based interventions into practice. While a wide range of implementation strategies has been developed, there is little research on their applicability for cancer prevention and control (CPC) efforts in primary care. We conducted a survey of primary care physicians to identify implementation strategies they perceive as most feasible and impactful. The survey included both primary prevention behavior change counseling and cancer screening issues. Analyses contrasted ratings of feasibility and impact of nine implementation strategies, and among clinicians in different settings with a focus on comparisons between clinicians in rural vs. non-rural settings. We recruited a convenience sample of 326 respondents from a wide range of practice types from four practice-based research networks in 49 states and including 177 clinicians in rural settings. Ratings of impact were somewhat higher than those for feasibility. Few of the nine implementation strategies were high on both impact and feasibility. Only 'adapting to my practice' was rated higher than a 4 ("moderate") on both impact and feasibility. There were relatively few differences between rural and non-rural clinicians or associated with other clinician or setting characteristics. There is considerable variability in perceived impact and feasibility of implementation strategies for CPC activities among family medicine clinicians. It is important to assess both feasibility and impact of implementation strategies as well as their generalizability across settings. Our results suggest that optimal strategies to implement evidence-based CPC activities will likely need to be adapted for primary care settings. Future research is needed to replicate these findings and identify practical, implementation partner informed implementation strategies.

Continuous Glucose Monitoring in Primary Care: Understanding and Supporting Clinicians' Use to Enhance Diabetes Care.

PURPOSE: Diabetes affects approximately 34 million Americans and many do not achieve glycemic targets. Continuous glucose monitoring (CGM) is associated with improved health outcomes for patients with diabetes. Most adults with diabetes receive care for their diabetes in primary care practices, where uptake of CGM is unclear. METHODS: We used a cross-sectional web-based survey to assess CGM prescribing behaviors and resource needs among primary care clinicians across the United States. We used descriptive statistics and multivariable regression to identify characteristics associated with prescribing behaviors, openness to prescribing CGM, and to understand resources needed to support use of CGM in primary care. RESULTS: Clinicians located more than 40 miles from the nearest endocrinologist's office were more likely to have prescribed CGM and reported greater likelihood to prescribe CGM in the future than those located within 10 miles of an endocrinologist. Clinicians who served more Medicare patients reported favorable attitudes toward future prescribing and higher confidence using CGM to manage diabetes than clinicians with lower Medicare patient volume. The most-needed resources to support CGM use in primary care were consultation on insurance issues and CGM training. CONCLUSIONS: Primary care clinicians are interested in using CGM for patients with diabetes, but many lack the resources to implement use of this diabetes technology. Use of CGM can be supported with education in the form of workshops and consultation on insurance issues targeted toward residents, recent graduates, and practices without a nearby endocrinologist. Continued expansion of Medicare and Medicaid coverage for CGM can also support CGM use in primary care.

Relationship of primary care clinician characteristics with continuous glucose monitoring use and confidence.

Context: Continuous glucose monitoring (CGM) provides clearer readings of blood glucose levels than traditional finger-stick glucose tests and is associated with improved diabetes outcomes such as reduced HbA1c. CGM can inform insulin dosing and diet decisions, and alert patients to hypoglycemia. A lack of endocrinologists in the majority of U.S. counties, particularly rural areas, and long wait times in many endocrinologists' offices create disparities in CGM access for patients with diabetes. Expanding use of CGM in primary care can improve care and patient diabetes outcomes. Objective: Understand primary care clinicians' experience with CGM to determine feasibility and resources needed to prescribe CGM. Study Design: Quantitative phase of explanatory sequential mixed methods study using cross-sectional online survey. Setting: Primary care. Population studied: Primary care physicians and advanced practice providers across the U.S. Outcome Measures: Past CGM prescribing behaviors, future likelihood to prescribe, resources needed to prescribe. Results: 632 respondents. Role: 72% attending physicians. Organization: Federally Qualified Health-Center (or similar) (27%), hospital-owned (27%), private practice (22%). Half (47%) had seen patients with CGM but never prescribed; two-fifths (39%) had prescribed CGM. Three-fifths (62%) moderately or very likely to prescribe CGM in the future. Likelihood to have prescribed CGM: Post-training physicians more likely than residents (OR=0.303, CI=.160-.575) or PA/NPs (OR=0.356, CI=.165-.766), part-time practice less likely than full-time (OR=0.546, CI=.305-.978), <75% time delivering primary care less likely than 75%+ (OR=0.595, CI=.371-.955), and location greater than 40 miles from an endocrinologist more likely than endocrinologist within 10 miles (OR=1.941, CI=1.17-3.21). Likelihood to prescribe with access to various resources greatest for consultation on insurance issues (72% moderately/very likely) and CGM education/training (72% moderately/very likely). Conclusions: Primary care clinicians have interest in prescribing CGM for patients with diabetes. Clinician type, percentage of time spent practicing, portion of time delivering primary care, and distance from endocrinologist are related to likelihood to prescribe CGM. Previous experience prescribing CGM may improve confidence and likelihood of future prescribing. Consultation, education and training on CGM for primary care clinicians may increase access to CGM.

Considerations Before Selecting a Stepped-Wedge Cluster Randomized Trial Design for a Practice Improvement Study.

PURPOSE: Despite the growing popularity of stepped-wedge cluster randomized trials (SW-CRTs) for practice-based research, the design's advantages and challenges are not well documented. The objective of this study was to identify the advantages and challenges of the SW-CRT design for large-scale intervention implementations in primary care settings. METHODS: The EvidenceNOW: Advancing Heart Health initiative, funded by the Agency for Healthcare Research and Quality, included a large collection of SW-CRTs. We conducted qualitative interviews with 17 key informants from EvidenceNOW grantees to identify the advantages and challenges of using SW-CRT design. RESULTS: All interviewees reported that SW-CRT can be an effective study design for large-scale intervention implementations. Advantages included (1) incentivized recruitment, (2) staggered resource allocation, and (3) statistical power. Challenges included (1) time-sensitive recruitment, (2) retention, (3) randomization requirements and practice preferences, (4) achieving treatment schedule fidelity, (5) intensive data collection, (6) the Hawthorne effect, and (7) temporal trends. CONCLUSIONS: The challenges experienced by EvidenceNOW grantees suggest that certain favorable real-world conditions constitute a context that increases the odds of a successful SW-CRT. An existing infrastructure can support the recruitment of many practices. Strong retention plans are needed to continue to engage sites waiting to start the intervention. Finally, study outcomes should be ones already captured in routine practice; otherwise, funders and investigators should assess the feasibility and cost of data collection.VISUAL ABSTRACT.

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 .

Personal and area exposure assessment at a stainless steel fabrication facility: an evaluation of inhalable, time-resolved PM10, and bioavailable airborne metals.

This study describes a comprehensive exposure assessment in a stainless steel welding facility, measuring personal inhalable PM and metals, time-resolved PM10 area metals, and the bioavailable fraction of area inhalable metals. Eighteen participants wore personal inhalable samplers for two, nonconsecutive shifts. Area inhalable samplers and a time-resolved PM10 X-ray fluorescence spectrometer were used in different work areas each sampling day. Inhalable and bioavailable metals were analyzed using inductively coupled plasma mass spectrometry (ICP-MS). Median exposures to chromium, nickel, and manganese across all measured shifts were 66 (range: 13-300) µg/m3, 29 (5.7-132) µg/m3, and 22 (1.5-119) µg/m3, respectively. Most exposure variation was seen between workers ( 0.79

Effect of State Immunization Information System Based Reminder/Recall for Influenza Vaccinations: A Randomized Trial of Autodialer, Text, and Mailed Messages.

OBJECTIVE: To evaluate the effect of different modalities of centralized reminder/recall (autodialer, text, mailed reminders) on increasing childhood influenza vaccination. STUDY DESIGN: Two simultaneous randomized clinical trials conducted from October 2017 to April 1, 2018, in New York State and Colorado. There were 61 931 children in New York (136 practices) and 23 845 children in Colorado (42 practices) who were randomized to different centralized reminder/recall modalities-4 arms in New York (autodialer, text, mailed, and no reminder control) and 3 arms in Colorado (autodialer, mailed, and no reminder control). The message content was similar across modalities. Up to 3 reminders were sent for intervention arms. The main outcome measure was receipt of ≥1 influenza vaccine. RESULTS: In New York, compared with the control arm (26.6%), postintervention influenza vaccination rates in the autodialer arm (28.0%) were 1.4 percentage points higher (adjusted risk ratio, 1.06; 95% CI, 1.02-1.10), but the rates for text (27.6%) and mail (26.8%) arms were not different from controls. In Colorado, compared with the control arm (29.9%), postintervention influenza vaccination rates for the autodialer (32.9%) and mail (31.5%) arms were 3.0 percentage points (adjusted risk ratio, 1.08; 95% CI, 1.03-1.12) and 1.6 percentage points (adjusted risk ratio, 1.06; 95% CI, 1.02-1.10) higher, respectively. Compared with the control arm, the incremental cost per additional vaccine delivered was $20 (New York) and $16 (Colorado) for autodialer messages. CONCLUSIONS: Centralized reminder/recall for childhood influenza vaccine was most effective via autodialer, less effective via mail, and not effective via text messages. The impact of each modality was modest. Compared with no reminders, the incremental cost per additional vaccine delivered was also modest for autodialer messages. TRIAL REGISTRATION: ClinicalTrials.gov: NCT03294473 and NCT03246100.

Exemplary Practices in Cardiovascular Care: Results on Clinical Quality Measures from the EvidenceNOW Southwest Cooperative.

BACKGROUND: Identifying characteristics of primary care practices that perform well on cardiovascular clinical quality measures (CQMs) may point to important practice improvement strategies. OBJECTIVE: To identify practice characteristics associated with high performance on four cardiovascular disease CQMs. DESIGN: Longitudinal cohort study among 211 primary care practices in Colorado and New Mexico. Quarterly CQM reports were obtained from 178 (84.4%) practices. There was 100% response rate for baseline practice characteristics and implementation tracking surveys. Follow-up implementation tracking surveys were completed for 80.6% of practices. PARTICIPANTS: Adult patients, staff, and clinicians in family medicine, general internal medicine, and mixed-specialty practices. INTERVENTION: Practices received 9 months of practice facilitation and health information technology support, plus biannual collaborative learning sessions. MAIN MEASURES: This study identified practice characteristics associated with overall highest performance using area under the curve (AUC) analysis on aspirin therapy, blood pressure management, and smoking cessation CQMs. RESULTS: Among 178 practices, 39 were exemplars. Exemplars were more likely to be a Federally Qualified Health Center (69.2% vs 35.3%, p = 0.0006), have an underserved designation (69.2% vs 45.3%, p = 0.0083), and have higher percentage of patients with Medicaid (p < 0.0001). Exemplars reported greater use of cardiovascular disease registries (61.5% vs 29.5%,), standing orders (38.5 vs 22.3%) or electronic health record prompts (84.6% vs 49.6%) (all p < 0.05), were more likely to have medical home recognition (74.4% vs 43.2%, p = 0.0006), and reported greater implementation of building blocks of high-performing primary care: regular quality improvement team meetings (3.0 vs 2.2), patient experience survey (3.1 vs 2.2), and resources for patients to manage their health (3.0 vs 2.3). High improvers (n = 45) showed greater improvement implementing team-based care (32.8 vs 11.7, p = 0.0004) and population management (37.4 vs 20.5, p = 0.0057). CONCLUSIONS: Multiple strategies-registries, prompts and protocols, patient self-management support, and patient-team partnership activities-were associated with delivering high-quality cardiovascular care over time, measured by CQMs. TRIAL REGISTRATION: ClinicalTrials.gov registration: NCT02515578.

Self-management support for chronic disease in primary care: frequency of patient self-management problems and patient reported priorities, and alignment with ultimate behavior goal selection.

BACKGROUND: To enable delivery of high quality patient-centered care, as well as to allow primary care health systems to allocate appropriate resources that align with patients' identified self-management problems (SM-Problems) and priorities (SM-Priorities), a practical, systematic method for assessing self-management needs and priorities is needed. In the current report, we present patient reported data generated from Connection to Health (CTH), to identify the frequency of patients' reported SM-Problems and SM-Priorities; and examine the degree of alignment between patient SM-Priorities and the ultimate Patient-Healthcare team member selected Behavioral Goal. METHODS: CTH, an electronic self-management support system, was embedded into the flow of existing primary care visits in 25 primary care clinics and was used to assess patient-reported SM-Problems across 12 areas, patient identified SM-Priorities, and guide the selection of a Patient-Healthcare team member selected Behavioral Goal. SM-Problems included: BMI, diet (fruits and vegetables, salt, fat, sugar sweetened beverages), physical activity, missed medications, tobacco and alcohol use, health-related distress, general life stress, and depression symptoms. Descriptive analyses documented SM-Problems and SM-Priorities, and alignment between SM-Priorities and Goal Selection, followed by mixed models adjusting for clinic. RESULTS: 446 participants with ≥ one chronic diseases (mean age 55.4 ± 12.6; 58.5% female) participated. On average, participants reported experiencing challenges in 7 out of the 12 SM-Problems areas; with the most frequent problems including: BMI, aspects of diet, and physical activity. Patient SM-Priorities were variable across the self-management areas. Patient- Healthcare team member Goal selection aligned well with patient SM-Priorities when patients prioritized weight loss or physical activity, but not in other self-management areas. CONCLUSION: Participants reported experiencing multiple SM-Problems. While patients show great variability in their SM-Priorities, the resulting action plan goals that patients create with their healthcare team member show a lack of diversity, with a disproportionate focus on weight loss and physical activity with missed opportunities for using goal setting to create targeted patient-centered plans focused in other SM-Priority areas. Aggregated results can assist with the identification of high frequency patient SM-Problems and SM-Priority areas, and in turn inform resource allocation to meet patient needs. TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT01945918 .

Designing the relational team development intervention to improve management of mental health in primary care using iterative stakeholder engagement.

BACKGROUND: Team-based models of care are efficacious in improving outcomes for patients with mental and physical illnesses. However, primary care clinics have been slow to adopt these models. We used iterative stakeholder engagement to develop an intervention to improve the implementation of team-based care for this complex population. METHODS: We developed the initial framework for Relational Team Development (RELATED) from a qualitative study of Primary Care Providers' (PCPs') experiences treating mental illness and a literature review of practice facilitation and psychology clinical supervision. Subsequently, we surveyed 900 Colorado PCPs to identify factors associated with PCP self-efficacy in management of mental illness and team-based care. We then conducted two focus groups for feedback on RELATED. Lastly, we convened an expert panel to refine the intervention. RESULTS: We developed RELATED, a two-part intervention delivered by a practice facilitator with a background in clinical psychology. The facilitator observes PCPs during patient visits and provides individualized coaching. Next, the facilitator guides the primary care team through a practice change activity with a focus on relational team dynamics. CONCLUSION: The iterative development of RELATED using stakeholder engagement offers a model for the development of interventions tailored to the needs of these stakeholders. TRIAL REGISTRATION: Not applicable.

A Community Engagement Method to Design Patient Engagement Materials for Cardiovascular Health.

PURPOSE: EvidenceNOW Southwest is a cluster-randomized trial evaluating the differential impact on cardiovascular disease (CVD) care of engaging patients and communities in practice transformation in addition to standard practice facilitation support. The trial included development of locally tailored CVD patient engagement materials through Boot Camp Translation (BCT), a community engagement process that occurred before practice recruitment but after cluster randomization. METHODS: We introduce a cluster randomization method performed before recruitment of small to medium-size primary care practices in Colorado and New Mexico, which allowed for balanced study arms while minimizing contamination. Engagement materials for the enhanced study arm were developed by means of BCT, which included community members, practice members, and public health professionals from (1) metropolitan Denver, (2) rural northeast Colorado, (3) Albuquerque, and (4) rural southeast New Mexico. Outcome measures were messages and materials from BCTs and population characteristics of study arms after using geographic-based covariate constrained randomization. RESULTS: The 4 BCTs' messages and materials developed by the BCT groups uniquely reflected each community and ranged from family or spiritual values to early prevention or adding relevance to CVD risk. The geographic-based covariate of a cluster randomization method constrained randomization-assigned regions to study arms, allowing BCTs to precede practice recruitment, reduce contamination, and balance populations. CONCLUSIONS: Cluster-randomized trials with community-based interventions present study design and implementation challenges. The BCTs elicited unique contextual messages and materials, suggesting that interventions designed to help primary care practices decrease CVD risk may not be one size fits all.

A protocol for a cluster randomized trial comparing strategies for translating self-management support into primary care practices.

BACKGROUND: Advanced primary care models emphasize patient-centered care, including self-management support (SMS), but the effective use of SMS for patients with type 2 diabetes (T2DM) remains a challenge. Interactive behavior-change technology (IBCT) can facilitate the adoption of SMS interventions. To meet the need for effective SMS intervention, we have developed Connection to Health (CTH), a comprehensive, evidence-based SMS program that enhances interactions between primary care clinicians and patients to resolve self-management problems and improve outcomes. Uptake and maintenance of programs such as CTH in primary care have been limited by the inability of practices to adapt and implement program components into their culture, patient flow, and work processes. Practice facilitation has been shown to be effective in helping practices make the changes required for optimal program implementation. The proposed research is designed to promote the translation of SMS into primary care practices for patients with T2DM by combining two promising lines of research, specifically, (a) testing the effectiveness of CTH in diverse primary-care practices, and (b) evaluating the impact of practice facilitation to enhance implementation of the intervention. METHODS: A three-arm, cluster-randomized trial will evaluate three discrete strategies for implementing SMS for patients with T2DM in diverse primary care practices. Practices will be randomly assigned to receive and implement the CTH program, the CTH program plus practice facilitation, or a SMS academic detailing educational intervention. Through this design, we will compare the effectiveness, adoption and implementation of these three SMS practice implementation strategies. Primary effectiveness outcomes including lab values and evidence of SMS will be abstracted from medical records covering baseline through 18 months post-baseline. Data from CTH assessments and action plans completed by patients enrolled in CTH will be used to evaluate practice implementation of CTH and the impact of CTH participation. Qualitative data including field notes from encounters with the practices and interviews of practice personnel will be analyzed to assess practice implementation of SMS. DISCUSSION: This study will provide important information on the implementation of SMS in primary care, the effectiveness of an IBCT tool such as CTH, and the use of practice facilitation to assist implementation. TRIAL REGISTRATION: Registered with ClinicalTrials.gov - ClinicalTrials.gov ID: NCT01945918 , date 08/27/2013. Modifications have been updated.

Effect of a multi-modal intervention on immunization rates in obstetrics and gynecology clinics.

BACKGROUND: There is increasing attention on immunizations by obstetrician-gynecologists and a need to improve vaccination rates for all women. OBJECTIVE: To evaluate the effect of a multimodal intervention on rates of immunization with tetanus, diphtheria, and acellular pertussis (Tdap); human papillomavirus (HPV); and influenza in outpatient obstetrics and gynecology clinics. STUDY DESIGN: Immunization rates at 2 clinics were compared pre- and post-implementation of multiple interventions at a public integrated health-care system. Study interventions began on June 6, 2012 and concluded on May 31, 2014; the preimplementation time period used was June 6, 2010 to June 5, 2012. Interventions included stocking of immunizations in clinics, revision and expansion of standing orders, creation of a reminder/recall program, identification of an immunization champion to give direct provider feedback, expansion of a payment assistance program, and staff education. All women aged 15 and older who made a clinic visit during influenza season were included in the influenza cohort; women who delivered an infant during the study time period and had at least 1 prenatal visit within 9 months preceding delivery were included in the Tdap cohort; each clinic visit by a nonpregnant woman aged 15-26 years was assessed and included in the HPV analysis as an eligible visit if the patient was lacking any of the 3 HPV vaccines in the series. The primary outcome was receipt of influenza and Tdap vaccine per current American College of Obstetricians and Gynecologists guidelines and receipt of HPV vaccine during eligible visits. Influenza and Tdap were assessed with overall coverage rates at the institutional level, and HPV was assessed at the visit level by captured opportunities. All analyses included generalized estimating equations and the primary outcome was assessed with time as a covariate in all models. RESULTS: A total of 19,409 observations were included in the influenza cohort (10,231 pre- and 9178 post-intervention), 2741 in the Tdap cohort (1248 pre- and 1493 post-intervention), and 12,443 in the HPV cohort (7966 pre- and 4477 post-intervention). Our population was largely Hispanic, English-speaking, and publicly insured. The rate of influenza vaccination increased from 35.4% pre-intervention to 46.0% post-intervention (P < .001). The overall rate for Tdap vaccination increased from 87.6% pre-intervention to 94.5% post-intervention until the recommendation to vaccinate during each pregnancy was implemented (z = 4.58, P < .0001). The average Tdap up-to-date rate after that recommendation was 75.0% (z = -5.77, P < .0001). The overall rate of HPV vaccination with an eligible visit increased from 7.1% before to 23.7% after the intervention. CONCLUSION: Using evidence-based practices largely established in other settings, our intervention was associated with increased rates of influenza, Tdap, and HPV vaccination in outpatient underserved obstetrics and gynecology clinics. Integrating such evidence-based practices into routine obstetrics and gynecology care could positively impact preventive health for many women.

Practice context affects efforts to improve diabetes care for primary care patients: a pragmatic cluster randomized trial.

BACKGROUND: Efforts to improve primary care diabetes management have assessed strategies across heterogeneous groups of patients and practices. However, there is substantial variability in how well practices implement interventions and achieve desired outcomes. OBJECTIVE: To examine practice contextual features that moderate intervention effectiveness. DESIGN: Secondary analysis of data from a cluster randomized trial of three approaches for implementing the Chronic Care Model to improve diabetes care. PARTICIPANTS: Forty small to mid-sized primary care practices participated, with 522 clinician and staff member surveys. Outcomes were assessed for 822 established patients with a diagnosis of type 2 diabetes who had at least one visit to the practice in the 18 months following enrollment. MAIN MEASURES: The primary outcome was a composite measure of diabetes process of care, ascertained by chart audit, regarding nine quality measures from the American Diabetes Association Physician Recognition Program: HgA1c, foot exam, blood pressure, dilated eye exam, cholesterol, nephropathy screen, flu shot, nutrition counseling, and self-management support. Data from practices included structural and demographic characteristics and Practice Culture Assessment survey subscales (Change Culture, Work Culture, Chaos). KEY RESULTS: Across the three implementation approaches, demographic/structural characteristics (rural vs. urban + .70(p = .006), +2.44(p < .001), -.75(p = .004)); Medicaid: < 20 % vs. ≥ 20 % (-.20(p = .48), +.75 (p = .08), +.60(p = .02)); practice size: < 4 clinicians vs. ≥ 4 clinicians (+.56(p = .02), +1.96(p < .001), +.02(p = .91)); practice Change Culture (high vs. low: -.86(p = .048), +1.71(p = .005), +.34(p = .22)), Work Culture (high vs. low: -.67(p = .18), +2.41(p < .001), +.67(p = .005)) and variability in practice Change Culture (high vs. low: -.24(p = .006), -.20(p = .0771), -.44(p = .0019) and Work Culture (high vs. low: +.56(p = .3160), -1.0(p = .008), -.25 (p = .0216) were associated with trajectories of change in diabetes process of care, either directly or differentially by study arm. CONCLUSIONS: This study supports the need for broader use of methodological approaches to better examine contextual effects on implementation and effectiveness of quality improvement interventions in primary care settings.

A randomized, home-based, childhood obesity intervention delivered by patient navigators.

BACKGROUND: Although Colorado is perceived as a healthy state, in 2010, 14.1 % of children aged 2-5 were overweight and 9.1 % were obese. Despite the high prevalence of obesity in this population, evidence to support particular strategies to treat obese preschoolers is lacking. The efficacy of home-based, childhood obesity interventions to reduce a child's body mass index is inconclusive. However, this model uniquely provides an opportunity to observe and intervene with the home food and activity environment and engage the entire family in promoting changes that fit each family's unique dynamics. METHODS/DESIGN: Eligible participants are children aged 2-5 years who attended a well-child care visit at a Denver Health Community Health Service clinic within 12 months prior to recruitment and on that visit had a body mass index (BMI) >85th percentile-for-age. Participants are randomly recruited at study inception and allocated to the intervention in one of five defined 6-month stepped wedge engagements; the delayed intervention groups serves as control groups until the start of the intervention. The program is delivered by a patient navigator at the family' home and consists of a 16-session curriculum focused on 1) parenting styles, 2) nutrition, and 3) physical activity. At each visit, a portion of curriculum is delivered to guide parents and children in selecting one goal for behavior change in each of three work areas to work on during the following week. The primary study outcome measure is change in BMI z-score from baseline to post-intervention period. DISCUSSION: This childhood obesity study, innovative for its home-based intervention venue, provides rich data characterizing barriers and facilitators to healthy behavior change within the home. The study population is innovative as it is focused on preschool-aged, Latino children from low-income families; this population has not typically been targeted in obesity management assessments. The home-based intervention is linked to clinical care through update letters and assessment of the program's impact to the child's medical providers. Informing primary care providers about a child's accomplishments and challenges, allows the clinician to support the health weight effort when seeing families during subsequent clinical visits. TRIAL REGISTRATION: ClinicalTrials.gov NCT02024360 Registered December 21, 2013.

Effectiveness of primary care-public health collaborations in the delivery of influenza vaccine: a cluster-randomized pragmatic trial.

OBJECTIVE: To assess effectiveness and feasibility of public-private collaboration in delivering influenza immunization to children. METHODS: Four pediatric and four family medicine (FM) practices in Colorado with a common public health department (PHD) were randomized at the beginning of baseline year (10/2009) to Intervention (joint community clinics and PHD nurses aiding in delivery at practices); or control involving usual care without PHD. Generalized estimating equations compared changes in rates over baseline between intervention and control practices at end of 2nd intervention year (Y2=5/2011). Barriers to collaboration were examined using qualitative methods. RESULTS: Overall, rates increased from baseline to Y2 by 9.2% in intervention and 3.2% in control (p<.0001), with significant increases in both pediatric and FM practices. The largest increases were seen among school-aged and adolescent children (p<.0001 for both), with differences for 6-month-old to 5-year-old children and for children with high-risk conditions not reaching significance. Barriers to collaboration included uncertainty regarding the delivery of vaccine supplies, concerns about using up all purchased vaccine by practices, and concerns about documentation of vaccination if collaboration occurred. CONCLUSIONS: In spite of barriers, public-private collaboration resulted in significantly higher influenza immunization rates, particularly for older, healthy children who visit providers less frequently.