Pragmatic adaptation of implementation research measures for a novel context and multiple professional roles: a factor analysis study.

BACKGROUND: Although some advances have been made in recent years, the lack of measures remains a major challenge in the field of implementation research. This results in frequent adaptation of implementation measures for different contexts-including different types of respondents or professional roles-than those for which they were originally developed and validated. The psychometric properties of these adapted measures are often not rigorously evaluated or reported. In this study, we examined the internal consistency, factor structure, and structural invariance of four well-validated measures of inner setting factors across four groups of respondents. The items in these measures were adapted as part of an evaluation of a large-scale organizational change in a rehabilitation hospital, which involved transitioning to a new building and a new model of patient care, facilitated by a significant redesign of patient care and research spaces. METHODS: Items were tailored for the context and perspective of different respondent groups and shortened for pragmatism. Confirmatory factor analysis was then used to test study hypotheses related to fit, internal consistency, and invariance across groups. RESULTS: The survey was administered to approximately 1208 employees; 785 responded (65% response rate) across the roles of clinician, researcher, leader, support staff, or dual clinician and researcher. For each of the four scales, confirmatory factor analysis demonstrated adequate fit that largely replicated the original measure. However, a few items loaded poorly and were removed from the final models. Internal consistencies of the final scales were acceptable. For scales that were administered to multiple professional roles, factor structures were not statistically different across groups, indicating structural invariance. CONCLUSIONS: The four inner setting measures were robust for use in this new context and across the multiple stakeholder groups surveyed. Shortening these measures did not significantly impair their measurement properties; however, as this study was cross sectional, future studies are required to evaluate the predictive validity and test-retest reliability of these measures. The successful use of adapted measures across contexts, across and between respondent groups, and with fewer items is encouraging, given the current emphasis on designing pragmatic implementation measures.

An individually tailored family-centered intervention for pediatric obesity in primary care: study protocol of a randomized type II hybrid effectiveness-implementation trial (Raising Healthy Children study).

BACKGROUND: Pediatric obesity is a multi-faceted public health concern that can lead to cardiovascular diseases, cancers, and early mortality. Small changes in diet, physical activity, or BMI can significantly reduce the possibility of developing cardiometabolic risk factors. Family-based behavioral interventions are an underutilized, evidence-based approach that have been found to significantly prevent excess weight gain and obesity in children and adolescents. Poor program availability, low participation rates, and non-adherence are noted barriers to positive outcomes. Effective interventions for pediatric obesity in primary care are hampered by low family functioning, motivation, and adherence to recommendations. METHODS: This (type II) hybrid effectiveness-implementation randomized trial tests the Family Check-Up 4 Health (FCU4Health) program, which was designed to target health behavior change in children by improving family management practices and parenting skills, with the goal of preventing obesity and excess weight gain. The FCU4Health is assessment driven to tailor services and increase parent motivation. A sample of 350 families with children aged 6 to 12 years who are identified as overweight or obese (BMI ≥ 85th percentile for age and gender) will be enrolled at three primary care clinics [two Federally Qualified Healthcare Centers (FQHCs) and a children's hospital]. All clinics serve predominantly Medicaid patients and a large ethnic minority population, including Latinos, African Americans, and American Indians who face disparities in obesity, cardiometabolic risk, and access to care. The FCU4Health will be coordinated with usual care, using two different delivery strategies: an embedded approach for the two FQHCs and a referral model for the hospital-based clinic. To assess program effectiveness (BMI, body composition, child health behaviors, parenting, and utilization of support services) and implementation outcomes (such outcomes as acceptability, adoption, feasibility, appropriateness, fidelity, and cost), we use a multi-method and multi-informant assessment strategy including electronic health record data, behavioral observation, questionnaires, interviews, and cost capture methods. DISCUSSION: This study has the potential to prevent excess weight gain, obesity, and health disparities in children by establishing the effectiveness of the FCU4Health and collecting information critical for healthcare decision makers to support sustainable implementation of family-based programs in primary care. TRIAL REGISTRATION: NCT03013309 ClinicalTrials.gov.