ABSTRACT
Objectives: There is a dearth of data regarding the design and implementation of pragmatic clinical trials (PCTs) in the field of child and adolescent psychiatry and a need to educate child and adolescent psychiatrists about PCTs. We exemplify the differences, advantages, and challenges in designing and conducting a randomized, large pragmatic trial in child and adolescent psychiatry, including the adjustments needed due to the pandemic. Method(s): Metformin for overweight and OBese chILdren with bIpolar spectrum disorders Treated with second-generation antipsYchotics (MOBILITY) is a Patient-Centered Outcomes Research Institute (PCORI)-funded, large PCT that compares the effectiveness of metformin (MET) and a simple healthy lifestyle intervention (LIFE) vs LIFE alone that focuses on patient-centered outcomes in real-world community mental health settings in the Greater Cincinnati and New York regions. Enrolled patients are 8 to 19 years old, diagnosed with bipolar spectrum disorders, overweight, or obese, and treated with second-generation antipsychotics. Each participant undergoes 2 years of follow-up assessments, with the primary outcome timepoint being at 6 months. MOBILITY seeks to inform decisions made by clinicians and patients about MET and LIFE in the overall randomized groups and relevant subgroups. During the COVID-19 pandemic, PCORI supported a COVID enhancement supplement to MOBILITY (MOBILITY-TEACH), focusing on the effects of the pandemic on the MOBILITY cohort. Result(s): Since study inception in September 2015, there were 1624 subjects across approximately 50 sites who have been enrolled and 1555 who have been randomized. Analyzable 6-month data are available in 1139 patients, and 2-year data are available in 665 patients. Details about the design, implementation, and adaptation of the trial conduct before and during the pandemic, use of remote recruitment and assessment, and effects on recruitment and retention will be presented. Conclusion(s): Current best evidence from traditional explanatory trials is often not perceived by decision makers as relevant to clinical practice. PCTs have the advantage of broad inclusion and minimal exclusion criteria, enhancing external validity. MOBILITY highlights how conducting a multisite, patient-centered pragmatic trial is different from an explanatory trial and what adaptations are needed during a pandemic. TREAT, APS, OBE Copyright © 2022
ABSTRACT
Objectives: The objective of this presentation is to examine how visit completion rates were affected by the transformation of a large community-based pragmatic clinical trial (entitled Metformin for overweight and OBese chILdren with bIpolar spectrum disorders Treated with second-generation antipsYchotics [MOBILITY]) to remote follow-up visits with the use of telepsychiatry and virtual research methodology in light of a pandemic. Methods: MOBILITY is a Patient-Centered Outcome Research Institute (PCORI)-funded, large, randomized pragmatic clinical trial designed to examine the effectiveness of metformin and healthy lifestyle instruction vs healthy lifestyle instruction alone on BMI and other metabolic and clinically useful parameters. We examined visit completion rates of patients due for a study visit on April 1, 2020 performed in the remote care visit window (April 1, 2020 to May 31, 2020) by visit type (month 6, month 24, other visit) and institution type (community vs academic) to in-person visits from the coinciding preceding enrollment period (April 1, 2019 to May 31, 2019). Results: Of the total 603 patients in-window on April 1, 2020 for a visit, 180 patients (29.9%) had an in-window remote visit. Of the total 620 patients in-window on April 1, 2019 for a visit, 159 patients (25.6%) had an in-window in-person visit. There were no significant time x type interaction effects for visit type (p = 0.37) or institution type (p = 0.26). However, there were significant main effects for visit type and institution type, with higher month-24 in-window visits for remote visits vs in-person visits (2020 = 14.9% vs 2019 = 9.4%;p < 0.01) and higher overall visits in academic vs nonacademic centers (2020 = 34.4% vs 2019 = 27.7%). Conclusions: Overall visit completion rates comparing the pre-COVID-19 enrollment period in 2019 to the same period in 2020 did not show significant changes in visit completion rates. Despite the shift to remote visits, visit completion rates for this large, pragmatic study that are linked to clinical care visits did not suffer. However, month-24 visit completion rates were significantly improved. Academic institutions were able to hold or improve visit completion rates more effectively than community-based ones. Making virtual visits available in clinical effectiveness research may be beneficial by decreasing patient and caregiver burden, improving data quality, and reducing cost, although this may be more easily accomplished in academic centers. R, BRD, TVM