Evaluating the Implementation of the Connect for Health Pediatric Weight Management Program.

Importance: Adoption of primary care interventions to reduce childhood obesity is limited. Progress in reducing obesity prevalence and eliminating disparities can be achieved by implementing effective childhood obesity management interventions in primary care settings. Objective: To examine the extent to which implementation strategies supported the uptake of research evidence and implementation of the Connect for Health pediatric weight management program. Design, Setting, and Participants: This quality improvement study took place at 3 geographically and demographically diverse health care organizations with substantially high numbers of children living in low-income communities in Denver, Colorado; Boston, Massachusetts; and Greenville, South Carolina, from November 2019 to April 2022. Participants included pediatric primary care clinicians and staff and families with children aged 2 to 12 years with a body mass index (BMI) in the 85th percentile or higher. Exposures: Pediatric weight management program with clinician-facing tools (ie, clinical decision support tools) and family-facing tools (ie, educational handouts, text messaging program, community resource guide) along with implementation strategies (ie, training and feedback, technical assistance, virtual learning community, aligning with hospital performance metrics) to support the uptake. Main Outcomes and Measures: Primary outcomes were constructs from the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) Framework examined through parent, clinician, and leadership surveys and electronic health record data to understand the number of children screened and identified, use of the clinical decision support tools, program acceptability, fidelity to the intervention and implementation strategies, and program sustainability. Results: The program screened and identified 18 333 children across 3 organizations (Denver Health, 8480 children [46.3%]; mean [SD] age, 7.97 [3.31] years; 3863 [45.5%] female; Massachusetts General Hospital (MGH), 6190 children [33.8%]; mean [SD] age, 7.49 [3.19] years; 2920 [47.2%] female; Prisma Health, 3663 children [20.0%]; mean [SD] age, 7.33 [3.15] years; 1692 [46.2%] female) as having an elevated BMI. The actionable flagging system was used for 8718 children (48%). The reach was equitable, with 7843 children (92.4%) from Denver Health, 4071 children (65.8%) from MGH, and 1720 children (47%) from Prisma Health being from racially and ethnically minoritized groups. The sites had high fidelity to the program and 6 implementation strategies, with 4 strategies (67%) used consistently at Denver Health, 6 (100%) at MGH, and 5 (83%) at Prisma Health. A high program acceptability was found across the 3 health care organizations; for example, the mean (SD) Acceptability of Intervention Measure score was 3.72 (0.84) at Denver Health, 3.82 (0.86) at MGH, and 4.28 (0.68) at Prisma Health. The implementation strategies were associated with 7091 (39%) uses of the clinical decision support tool. The mean (SD) program sustainability scores were 4.46 (1.61) at Denver Health, 5.63 (1.28) at MGH, and 5.54 (0.92) at Prisma Health. Conclusions and Relevance: These findings suggest that by understanding what strategies enable the adoption of scalable and implementation-ready programs by other health care organizations, it is feasible to improve the screening, identification, and management of children with overweight or obesity and mitigate existing disparities.

Adapting Connect for Health pediatric weight management program for telehealth in response to the COVID-19 pandemic.

BACKGROUND: To address the evolving needs and context changes due to the COVID-19 pandemic, we adapted Connect for Health, an evidence-based, primary care, pediatric weight management intervention. The objective of this study is to describe the planned adaptation process to ensure continued and equitable program uptake during the pandemic. METHODS: Guided by adaptation frameworks, we identified the core functions and forms of Connect for Health and then adapted the intervention in response to a changing healthcare context. We engaged stakeholders and surveyed parents of children with a BMI ≥ 85th percentile and pediatric clinicians and examined their experiences using telehealth for pediatric weight management and needs and preferences. Using multivariable logistic regression, we examined the preferences of parents with limited English proficiency regarding key aspects of pediatric weight management. RESULTS: We surveyed 200 parents and 43% had a primary language of Spanish. Parents wanted care to be a combination of in-person and virtual visits (80%). We found that parents with limited English proficiency had a higher odds ratio of affirming in-person visits are better than virtual visits for ensuring their child's health concern can be taken care of (OR: 2.91; 95% CI: 1.36, 6.21), feeling comfortable when discussing personal information (OR: 3.91; 95% CI: 1.82, 8.43), talking about healthy behaviors and setting goals (OR: 3.09; 95% CI: 1.39, 6.90), and talking about mental health and overall well-being (OR: 4.02; 95% CI: 1.83, 8.87) than parents without limited English proficiency. We surveyed 75 clinicians and 60% felt telehealth was a useful tool to provide care for pediatric weight management. Clinicians felt virtual visits did not pose barriers to all aspects of care. Informed by the surveys and stakeholder input, we made clinician- and family-level adaptations while retaining the program's function. CONCLUSIONS: By engaging stakeholders and adapting the program for telehealth, we optimized the reach and fit of Connect for Health to ensure its continued uptake. We have provided a real-world example of how clinical innovations can evolve and how to systematically plan adaptations in response to changing healthcare contexts. TRIAL REGISTRATION: Clinicaltrials.gov (NCT04042493), Registered on August 2, 2019.

Costs to Implement a Pediatric Weight Management Program Across 3 Distinct Contexts.

BACKGROUND: The Connect for Health program is an evidence-based program that aligns with national recommendations for pediatric weight management and includes clinical decision support, educational handouts, and community resources. As implementation costs are a major driver of program adoption and maintenance decisions, we assessed the costs to implement the Connect for Health program across 3 health systems that primarily serve low-income communities with a high prevalence of childhood obesity. METHODS: We used time-driven activity-based costing methods. Each health system (site) developed a process map and a detailed report of all implementation actions taken, aligned with major implementation requirements (eg, electronic health record integration) or strategies (eg, providing clinician training). For each action, sites identified the personnel involved and estimated the time they spent, allowing us to estimate the total costs of implementation and breakdown costs by major implementation activities. RESULTS: Process maps indicated that the program integrated easily into well-child visits. Overall implementation costs ranged from $77,103 (Prisma Health) to $84,954 (Denver Health) to $142,721 (Massachusetts General Hospital). Across implementation activities, setting up the technological aspects of the program was a major driver of costs. Other cost drivers included training, engaging stakeholders, and audit and feedback activities, though there was variability across systems based on organizational context and implementation choices. CONCLUSIONS: Our work highlights the major cost drivers of implementing the Connect for Health program. Accounting for context-specific considerations when assessing the costs of implementation is crucial, especially to facilitate accurate projections of implementation costs in future settings.

Direct Oral Anticoagulants vs Low-Molecular-Weight Heparin and Recurrent VTE in Patients With Cancer: A Randomized Clinical Trial.

Importance: In patients with cancer who have venous thromboembolism (VTE) events, long-term anticoagulation with low-molecular-weight heparin (LMWH) is recommended to prevent recurrent VTE. The effectiveness of a direct oral anticoagulant (DOAC) compared with LMWH for preventing recurrent VTE in patients with cancer is uncertain. Objective: To evaluate DOACs, compared with LMWH, for preventing recurrent VTE and for rates of bleeding in patients with cancer following an initial VTE event. Design, Setting, and Participants: Unblinded, comparative effectiveness, noninferiority randomized clinical trial conducted at 67 oncology practices in the US that enrolled 671 patients with cancer (any invasive solid tumor, lymphoma, multiple myeloma, or chronic lymphocytic leukemia) who had a new clinical or radiological diagnosis of VTE. Enrollment occurred from December 2016 to April 2020. Final follow-up was in November 2020. Intervention: Participants were randomized in a 1:1 ratio to either a DOAC (n = 335) or LMWH (n = 336) and were followed up for 6 months or until death. Physicians and patients selected any DOAC or any LMWH (or fondaparinux) and physicians selected drug doses. Main Outcomes and Measures: The primary outcome was the recurrent VTE rate at 6 months. Noninferiority of anticoagulation with a DOAC vs LMWH was defined by the upper limit of the 1-sided 95% CI for the difference of a DOAC relative to LMWH of less than 3% in the randomized cohort that received at least 1 dose of assigned treatment. The 6 prespecified secondary outcomes included major bleeding, which was assessed using a 2.5% noninferiority margin. Results: Between December 2016 and April 2020, 671 participants were randomized and 638 (95%) completed the trial (median age, 64 years; 353 women [55%]). Among those randomized to a DOAC, 330 received at least 1 dose. Among those randomized to LMWH, 308 received at least 1 dose. Rates of recurrent VTE were 6.1% in the DOAC group and 8.8% in the LMWH group (difference, -2.7%; 1-sided 95% CI, -100% to 0.7%) consistent with the prespecified noninferiority criterion. Of 6 prespecified secondary outcomes, none were statistically significant. Major bleeding occurred in 5.2% of participants in the DOAC group and 5.6% in the LMWH group (difference, -0.4%; 1-sided 95% CI, -100% to 2.5%) and did not meet the noninferiority criterion. Severe adverse events occurred in 33.8% of participants in the DOAC group and 35.1% in the LMWH group. The most common serious adverse events were anemia and death. Conclusions and Relevance: Among adults with cancer and VTE, DOACs were noninferior to LMWH for preventing recurrent VTE over 6-month follow-up. These findings support use of a DOAC to prevent recurrent VTE in patients with cancer. Trial Registration: ClinicalTrials.gov Identifier: NCT02744092.

Stakeholder engagement in developing a father-inclusive early life obesity prevention intervention: First Heroes.

BACKGROUND: Although paternal involvement in the perinatal period is associated with benefits for maternal-child health and reduced obesity risk, fathers are seldom included in perinatal or obesity prevention efforts. Engaging community leaders and fathers as stakeholders in intervention development is a critical step in designing a father-inclusive intervention that is efficacious and responsive to their needs. METHODS: We conducted a structured engagement study, including community stakeholder engagement and qualitative interviews with new fathers, to inform the development of a prospective randomized controlled trial that includes mothers and fathers as equal partners in infant obesity prevention. We interpreted stakeholder feedback through the Consolidated Framework for Implementation Research (CFIR) framework. RESULTS: Between September 2019 and April 2020, we held a Community Engagement meeting, formed a Community Advisory Board, and conducted 16 qualitative interviews with new fathers. Stakeholder engagement revealed insights across CFIR domains including intervention characteristics (relative advantage, complexity, design quality & packaging), outer setting factors (cosmopolitanism and culture), individual characteristics (including self-efficacy, state of change, identification with the organization) and process (engagement and adaptation). Stakeholders discussed the diverse challenges and rewards of fatherhood, as well as the intrinsic paternal motivation to be a loving, supportive father and partner. Both community leaders and fathers emphasized the importance of tailoring program delivery and content to meet specific parental needs, including a focus on the social-emotional needs of new parents. CONCLUSIONS: A structured process of multidimensional stakeholder engagement was successful in improving the design of a father-inclusive perinatal obesity prevention interventions. Father engagement was instrumental in both reinforcing community ties and increasing our understanding of fathers' needs, resulting in improvements to program values, delivery strategies, personnel, and content. This study provides a practical approach for investigators looking to involve key stakeholders in the pre-implementation phase of intervention development. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04477577 . Registered 20 July 2020.

Implementation of the Connect for Health pediatric weight management program: study protocol and baseline characteristics.

We are implementing Connect for Health, a primary care-based intervention to improve family-centered outcomes for children, ages 2-12 years, in organizations that care for low-income children. We will use the 'Reach-Effectiveness-Adoption-Implementation-Maintenance' framework to guide our mixed-methods evaluation to examine the effectiveness of stakeholder-informed strategies in supporting program adoption and child outcomes. We also describe characteristics of children, ages 2-12 years with a BMI ≥85th percentile and obesity-related care practices. During the period prior to implementation, 26,161 children with a BMI ≥85th percentile were seen for a primary care visit and a majority lacked recommended diagnosis codes, referrals and laboratory evaluations. The findings suggest the need to augment current approaches to increase uptake of proven-effective weight management programs. Clinical trial registration number: NCT04042493 (Clinicaltrials.gov), Registered on 2 August 2019; https://clinicaltrials.gov/ct2/show/NCT04042493.

Engaging fathers in the first 1000 days to improve perinatal outcomes and prevent obesity: Rationale and design of the First Heroes randomized trial.

BACKGROUND: Early pregnancy through the first year of life represents an important period for family health promotion and obesity prevention. Overall, preventive interventions in pregnancy and infancy have insufficiently engaged fathers. We describe the rationale and design of First Heroes, an intervention to improve perinatal and obesity-related outcomes among mother-father-infant triads beginning in pregnancy. METHODS/DESIGN: First Heroes is a hybrid type 1 effectiveness-implementation randomized trial of mother-father-infant triads recruited in the second trimester of pregnancy from a large Obstetric practice in eastern Massachusetts and continuing through 12 months of infant age. Triads are randomized to the intervention arm or to an enhanced safety education control group. Triads randomized to the intervention arm receive three virtual visits with a health educator, in the 3rd trimester of pregnancy, at 3-4 weeks, and 3-4 months postpartum, and receive continuous multimedia education through text messaging, print material, and videos. The educational curriculum addresses parent health behaviors, family relationships, social determinants of health, and infant feeding, sleep, and development. The primary outcome is prevalence of rapid infant weight gain from birth to 6 months of age. Secondary outcomes include parent anthropometrics, parent obesogenic behaviors, family functioning, and infant behaviors. DISCUSSION: First Heroes will evaluate the extent to which intentional mother-father dyad engagement, coaching on adoption of early life health behaviors, and addressing social determinants of health, influence obesogenic behaviors and outcomes in the first year of life. Findings from this work will inform future obesity prevention efforts, especially those focused on whole family inclusion.

Narrowing the policy gap: lessons from years 2 and 3 of the British Columbia influenza prevention policy.

Influenza can be potentially fatal to vulnerable populations, particularly those in the hospital. Canada's National Advisory Committee on Immunization recommends that health-care workers (HCW) be immunized against influenza partly to avoid infecting high-risk populations. However, influenza immunization rates among HCW remain suboptimal. In 2012, health authorities across British Columbia (B.C.) implemented a province-wide influenza prevention policy requiring HCW to either be immunized or wear a mask when in patient-care areas during the influenza season. This paper describes the second of two studies focused on what was learned from years 2 and 3 of the policy. A case study approach was used to examine this policy implementation event. Qualitative data were collected through key documents and key informant interviews with members of leadership teams responsible for policy implementation. Framework analysis and Prior's approach were used to analyze data from interviews and documents, respectively. Policy implementation varied by geographic region and gaps persist in immunization tracking and discipline for noncompliance. Debate regarding the scientific evidence used to support the policy fuels resistance from particular groups. Despite these challenges, findings suggest that the policy has been habituated, largely due to consistent policy objectives. This study emphasizes the importance of ongoing inter-professional and cross-sectoral program evaluation. While adherence may be routine for many, implementation processes must continue to respond to contextual issues to narrow the gap in policy implementation and to continue to engage stakeholders to ensure compliance.