Adapting adaptive design methods to accelerate adoption of a digital asthma management intervention.

Investigators conducting translational research in real-world settings may experience changes that create challenges to the successful completion of the trial as well as post-trial adoption and implementation. Adaptive designs support translational research by systematically adapting content and methods to meet the needs of target populations, settings and contexts. This manuscript describes an adaptive implementation research model that provides strategies for changing content, delivery processes, and research methods to correct course when anticipated and unanticipated circumstances occur during a pragmatic trial. The Breathewell Program included two large pragmatic trials of the effectiveness of a digital communication technology intervention to improve symptom management and medication adherence in asthma care. The first trial targeted parents of children with asthma; the second targeted adults with asthma. Adaptations were made iteratively to adjust to dynamic conditions within the healthcare setting, informed by prospectively collected stakeholder input, and were categorized retrospectively by the authors as proactive or reactive. Study outcomes demonstrated improved treatment adherence and clinical efficiency. Kaiser Permanente Colorado, the setting for both studies, adopted the speech recognition intervention into routine care, however, both interventions required numerous adaptations, including changes to target population, intervention content, and internal workflows. Proactive and reactive adaptations assured that both trials were successfully completed. Adaptive research designs will continue to provide an important pathway to move healthcare delivery research into practice while conducting ongoing effectiveness evaluation.

Health care research often moves slowly and consequently important results may take a long time to reach the patients they are intended to help. Implementation studies conducted in routine clinical practice are intended to accelerate the process of delivering new discoveries into settings where they can be more quickly put to use. However, conducting research in real-world settings can be challenging if changes occur in those settings during the course of the study. Therefore, an adaptive implementation approach that allows researchers to make changes during the course of a study can facilitate study completion and improve likelihood of intervention adoption into routine care. This report demonstrates the use of an adaptive implementation model in two large studies of asthma in children and adults. In both studies, communication technology including computerized phone calls, texts, and email helped improve treatment consistency and efficiency.

Can digital communication technology reduce health system personnel time? An evaluation of personnel requirements and costs in a randomized controlled trial.

Use of digital communication technologies (DCT) shows promise for enhancing outcomes and efficiencies in asthma care management. However, little is known about the impact of DCT interventions on healthcare personnel requirements and costs, thus making it difficult for providers and health systems to understand the value of these interventions. This study evaluated the differences in healthcare personnel requirements and costs between usual asthma care (UC) and a DCT intervention (Breathewell) aimed at maintaining guidelines-based asthma care while reducing health care staffing requirements. We used data from a pragmatic, randomized controlled trial conducted in a large integrated health system involving 14,978 patients diagnosed with asthma. To evaluate differences in staffing requirements and cost between Breathewell and UC needed to deliver guideline-based care we used electronic health record (EHR) events, provider time tracking surveys, and invoicing. Differences in cost were reported at the patient and health system level. The Breathewell intervention significantly reduced personnel requirements with a larger percentage of participants requiring no personnel time (45% vs. 5%, p < .001) and smaller percentage of participants requiring follow-up outreach (44% vs. 68%, p < .001). Extrapolated to the total health system, cost for the Breathewell intervention was $16,278 less than usual care. The intervention became cost savings at a sample size of at least 957 patients diagnosed with asthma. At the population level, using DCT to compliment current asthma care practice presents an opportunity to reduce healthcare personnel requirements while maintaining population-based asthma control measures.

Addressing personal parental values in decisions about childhood vaccination: Measure development.

OBJECTIVE: Evidence-based strategies to address vaccine hesitancy are lacking. Personal values are a measurable psychological construct that could be used to deliver personalized messages to influence vaccine hesitancy and behavior. Our objectives were to develop a valid, reliable self-report survey instrument to measure vaccine values based on the Schwartz theory of basic human values, and to test the hypothesis that vaccine values are distinct from vaccine attitudes and are related to vaccine hesitancy and behavior. METHODS: Parental Vaccine Values (PVV) scale items were generated using formative qualitative research and expert input, yielding 24 items for testing. 295 parents of children aged 14-30 months completed a self-report survey with measures of Schwartz's global values, the PVV, vaccine attitudes, and vaccine hesitancy. Factor analysis was used to determine vaccine values factor structure. Associations between vaccine values, vaccine attitudes, vaccine hesitancy, and vaccination behavior were assessed using linear and logistic regression models. Late vaccination was assessed from electronic medical records. RESULTS: A six-factor structure for vaccine values was determined with good fit (RMSEA = 0.07, Bentler's CFI = 0.91) with subscales for Conformity, Universalism, Tradition, Self-Direction, Security- Disease Prevention, and Security- Vaccine Risk. Vaccine values were moderately associated with Schwartz global values and vaccine attitudes, indicating discriminant validity from these constructs. Multivariable linear regression showed vaccine hesitancy was associated with vaccine values Conformity (partial R2 = 0.10) and Universalism (0.04) and vaccine attitudes Vaccine Safety (0.52) and Vaccine Benefit (0.16). Multivariable logistic regression showed that late vaccination was associated with vaccine value Self-direction (OR = 1.80, 95% CI: 1.26-2.65) and vaccine attitude of Vaccine Benefit (OR = 0.44, 95% CI: 0.32-0.60). CONCLUSIONS: The PVV scale had good psychometric properties and appears related to but distinct from Schwartz global values and vaccine attitudes. Vaccine values are associated with vaccine hesitancy and late vaccination and may be useful in tailoring future interventions.

Implementing Health Care Technology Research into Practice to Improve Adult Asthma Management.

BACKGROUND: Use of health technology has shown potential to improve asthma adherence and outcomes. Few studies have looked at the implementation of such research within larger asthma populations. OBJECTIVE: This report examines the process of translating results from a pragmatic trial using speech recognition (SR) in children with persistent asthma into the standard operating procedure within a large health maintenance organization. Medication adherence and outcomes in adults with asthma were examined. METHODS: The SR protocol was implemented for the total Kaiser Permanente Colorado (KPCO) patient population of 480,142, of whom 36,356 had asthma. Patients had persistent asthma, filled 1 or more inhaled corticosteroid prescriptions in the prior 6 months, and remained continuously enrolled with KPCO for 2 years. Documented exacerbations included the presence of a hospitalization, emergency department visit, or course of oral corticosteroid where asthma was the principal diagnosis. Adherence and exacerbation events were compared 1 year before and 1 year after intervention for 4,510 adults aged 19 to 64. RESULTS: Patient adherence demonstrated a small but significant improvement from 39.5% to 41.7% (P < .0001). Although not significant, data trends suggested greater improvement for patients with lower socioeconomic status. When an outlier month was removed from both the pre- and postintervention time periods, courses of oral corticosteroids decreased. Emergency department visits and hospitalizations were infrequent in both time periods and did not decrease over time. CONCLUSIONS: A low-cost SR intervention reminding patients to fill and take their daily controller asthma medication can improve treatment adherence and decrease the need for oral corticosteroids due to asthma exacerbations, but not decrease emergency department visits or hospitalizations.

Vaccine adverse events in a safety net healthcare system and a managed care organization.

BACKGROUND: The Institute of Medicine, in a 2013 report, recommended that the Vaccine Safety Datalink (VSD) expand collaborations to include more diversity in the study population. Kaiser Permanente Colorado (KPCO), an established VSD site, partnered with Denver Health (DH), an integrated safety net healthcare system, to demonstrate the feasibility of integrating DH data within the VSD. Prior to incorporating the data, we examined the identification of specific vaccine associated adverse events (VAEs) in these two distinct healthcare systems. METHODS: We conducted retrospective cohort analyses within KPCO and DH to compare select VAEs between the two populations. We examined the following associations between January 1, 2004 and December 31, 2013: Measles, Mumps, and Rubella (MMR) vaccine and febrile seizures in children 2years and younger, intussusception after rotavirus vaccine in infants 4-34weeks, syncope after adolescent vaccines (Tetanus, Diphtheria, acellular Pertussis; Meningococcal and Human Papillomavirus) in adolescents 13-17years and medically attended local reactions after pneumococcal polysaccharide (PPSV23) vaccine in adults 65years and older. Both sites used similar data procurement methods and chart review processes. RESULTS: For seizures after MMR vaccine (KPCO - 3.15vs. DH - 2.97/10,000 doses) and syncope after all adolescent vaccines (KPCO - 3.0vs. DH - 2.37/10,000 doses), the chart confirmed rates were comparable at the two sites. However, for medically attended local reactions after PPSV23, there were differences in chart confirmed rates between the sites (KPCO - 31.65vs. DH - 14.90/10,000 doses). For intussusception after rotavirus vaccine, the number of cases was too low to make a valid comparison (KPCO - 0vs. DH - 0.13/10,000 doses). CONCLUSION: We demonstrated that data on important targeted VAEs can be captured at DH and rates appear similar to those at KPCO. Work is ongoing on the optimal approach to assimilate DH data as a potential safety net healthcare system in the VSD.

Integration of data from a safety net health care system into the Vaccine Safety Datalink.

BACKGROUND: In 2013 the Institute of Medicine suggested that the Vaccine Safety DataLink (VSD) should broaden its population by including data of more patients from low income and racially and ethnically diverse backgrounds. In response, Kaiser Permanente Colorado (KPCO) partnered with Denver Health (DH), an integrated safety net health care system, to explore the integration of DH data. METHODS: We compared three different methods (reference date of September 1, 2013): "Empanelment" (any patient who has had a primary care visit in the past 18months), "Proxy-enrollment" (two health care visits in 3years separated by 90days), and "Enrollment" in a managed care plan. For each of these methods, we compared cohort size, vaccination rates, socio-demographic characteristics, and health care utilization. RESULTS: The empaneled population at DH provided the best comparison to KPCO. DH's empaneled population was 111,330 (57,173 adults; 54,157 children), while KPCO had 436,290 empaneled patients (336,462 adults; 99,828 children). Vaccination rates in both health care systems for empaneled patients were comparable. Two year-old up-to-date coverage rates were 83.2% (KPCO) and 86.9% (DH); rates for adolescent Tdap and MCV4 were 85.5% (KPCO) and 90.6% (DH). There were significant differences in the two populations in age, gender, race, preferred language, and % Federal Poverty Level (FPL) (DH 70.7%<100% FPL; KPCO 17.4%), as well as in healthcare utilization - for example pediatric emergency department utilization was twice as high at DH. CONCLUSIONS: Using a cohort of "empaneled" patients, it is possible to integrate data from a safety net health care system that does not have a uniform managed care population into the VSD, and to compare vaccination rates, socio-demographic characteristics, and health care utilization across the two systems. The KPCO-DH collaboration may serve as a model for incorporating data from a safety net healthcare system into the VSD.

Effectiveness and cost of influenza vaccine reminders for adults with asthma or chronic obstructive pulmonary disease.

OBJECTIVES: To assess the effectiveness and cost of interactive voice response (IVR) reminders for influenza vaccination compared with postcards, among adults with asthma or chronic obstructive pulmonary disease (COPD). STUDY DESIGN: Pragmatic, 3-arm, randomized control trial. METHODS: The trial was conducted in an integrated healthcare organization during 2012 and 2013, using an existing IVR system. All adults aged 19 through 64 years with asthma or COPD (n = 12,285) were randomized to receive 1 of the following vaccination reminders: 1) postcard reminder only, 2) IVR reminder only, or 3) postcard plus IVR reminder. The primary outcome was influenza vaccination by October 31, 2012; the secondary outcomes were influenza vaccination by December 31, 2012, and by March 31, 2013. RESULTS: For subjects receiving an IVR call, 57% received a message on their answering machine; 27% answered the call; and 16% were not reached. Influenza vaccination rates were 29.5%, 31.1%, and 30.6% in the postcard-only, IVR-only, and postcard-plus-IVR study arms, respectively. After controlling for relevant covariates, IVR reminders were not significantly more or less effective than postcard reminders. Program costs were $0.78, $1.23, and $1.93 per subject for postcard-only, IVR-only, and postcard-plus-IVR reminders, respectively. Extrapolating costs to the entire population at the study site that typically receives influenza vaccination reminders (approximately 100,000 individuals), reminder costs would have been $0.55, $0.05, and $0.60 per subject for postcard-only, IVR-only, and postcard-plus-IVR reminders, respectively. CONCLUSIONS: IVR reminders are not more effective at promoting influenza vaccination than postcard reminders, but IVR reminders may be less expensive for large patient populations.

Assessment of morbidity over time in predicting health outcomes.

BACKGROUND: Administratively derived morbidity measures are often used in observational studies as predictors of outcomes. These typically reflect a limited time period before an index event; some outcomes may be affected by rate of morbidity change over longer preindex periods. OBJECTIVES: The aim of the study was to develop statistical models representing the trajectory of individual morbidity over time and to evaluate the performance of trajectory versus other summary morbidity measures in predicting a range of health outcomes. METHODS: From a retrospective cohort study of integrated health system members aged 65 years or older with 3 or more common chronic medical conditions, we used available diagnoses for up to 10 years to examine associations between variations of the Charlson Comorbidity Index (CCI, Quan adaptation) and health outcomes. A linear mixed effects model was used to estimate the trajectory of individual CCI over time; estimated parameters describing individual trajectories were used as predictors for health outcomes. Other variations of CCI were: a "snapshot" measure, a cumulative measure, and actual baseline and rate of change. Models were developed in an initial cohort for whom we had survey data, and verified in a larger cohort. RESULTS: Among 961 surveyed members and 13,163 members of a secondary cohort, cumulative and snapshot measures provided best fit and predictive ability for utilization outcomes. Incorporating trajectory resulted in a slightly better model for self-reported health status. CONCLUSIONS: Modeling longitudinal morbidity trajectories did not add substantially to the association between morbidity and utilization or mortality. Standard snapshot morbidity measures likely sufficiently capture multimorbidity in assessing these outcomes.