The NIH Pragmatic Trials Collaboratory (https://rethinkingclinicaltrials.org/) supports the design and execution of pragmatic clinical trials and engages healthcare delivery systems in research partnerships. These projects help to establish best practices and provide proof of concept for innovative designs in pragmatic clinical research.
The Harvard Pilgrim Health Care Institute is part of the Collaboratory’s Coordinating Center. Harvard Pilgrim leads the development and maintenance of the Collaboratory’s Distributed Research Network, which provides a mechanism for investigators funded by NIH and other not-for-profit sponsors to conduct research in partnership with many of the nation’s largest health plans.
Our ongoing projects within the NIH Pragmatic Trials Collaboratory include:
Collaborative Care Coordination Program for Alzheimer’s Disease and Related Dementias (Co-CARE-AD)
Co-CARE-AD is a pragmatic randomized clinical trial to evaluate a collaborative care-coordination program embedded in a health plan for persons living with Alzheimer’s Disease and Related Dementias (ADRD) and their caregivers. Eligible community dwelling Medicare Advantage members living with ADRD along with their caregiver were randomized into intervention or usual care groups. The Dementia Care Consultation (DCC) program, delivered by a care consultant over a 6-month period, provided an in-depth, personalized service for individuals and families facing ADRD. The program consists of comprehensive needs assessments, creation and implementation of personalized care plans, monitoring and revising care plans, disease education and support coaching, referrals to community-based organizations for service and support, and access to assistance. Healthcare utilization outcomes of people with ADRD will be assessed over 6 and 12 months of follow-up.
Developing a Program to Educate and Sensitize Caregivers to Reduce the Inappropriate Prescription Burden in Elderly with Alzheimer's Disease Study (D-PRESCRIBE-AD)
The goal of the D-PRESCRIBE-AD study is to develop, implement, and evaluate the effect of a patient/caregiver-centered, multifaceted educational intervention on inappropriate prescribing (i.e. use of medications that may no longer be necessary or that may increase the risk of harm or indicate the need to carefully asses the risks of continued use vs the benefits) in patients with Alzheimer’s disease and Alzheimer’s disease-related dementias (AD/ADRD). Inappropriate prescribing can be thought of as a “morbidity multiplier,” increasing overall symptom burden, and adversely affecting health-related quality of life and function. Addressing this challenge requires an intervention in which patients, caregivers, providers, and health systems can play an active role.
Big data apprOaches fOr Safe Therapeutics in Healthy Pregnancies (BOOST-HP)
BOOST-HP evaluates numerous exposures and outcomes simultaneously to enhance risk-benefit information on medications used by pregnant patients. Building on prior work in data-mining in FDA’s Sentinel System and CDC’s Vaccine Safety Datalink, and conduct of formal causal inference studies to evaluate prenatal medication safety, BOOST-HP will implement a three-stage novel reverse translational framework to accelerate evidence generation: (1) Data-mining (“scans”) to identify new exposure-outcome associations; (2) expert triage of statistical signals from data-mining to assess plausibility of pharmacologic pathways; and (3) formal evaluation of two of the signals considered to have the greatest clinical and public health importance. Pilot work has demonstrated the effectiveness of applying statistical scanning methods to large, well curated datasets, uncovering drug safety concerns. To accomplish goals, BOOST-HP will use extensive infrastructure developed for drug evaluations in pregnancy, including billing records from the NIH Collaboratory’s Distributed Research Network and the national Transformed Medicaid Statistical Information System (T-MSIS), representing a broad cross-section of privately and publicly insured pregnant patients and their offspring.
ACHIEVE (A Cluster-randomized trial to improve use of High IntEnsity statins for Vascular protection)
This prospective cluster randomized open label embedded pragmatic trial will test the effectiveness of a multifaceted intervention. Clinicians will be randomized with their cohort of eligible patients, and the outcomes, improvement of prescription and adherence to moderate/high intensity statins will be assessed in the individual patients. This will leverage the National Committee for Quality Assurance’s (NCQA) HEDIS quality improvement program measures to assess the impact of a provider- and patient-directed intervention to increase the prescription of appropriate statin therapy among those with atherosclerotic cardiovascular disease (ASCVD) who are not already on moderate/high intensity statins. The intervention will be further customized for race-specific factors for the Black population, as Black Americans are up to one-third less likely to be treated with statins than White patients. Interventions will be delivered in partnership with national health plans, enabling identification of eligible providers and a providing a platform for dissemination to their patients if the intervention is successful. Additionally, full partnership with the NCQA provides the prospect of leveraging the nation’s most extensive health plan-focused quality improvement program to facilitate dissemination by incorporating the intervention into their efforts to increase compliance with the HEDIS metric system. Thus, the intervention will capitalize on aligned interests among patients, providers, health systems, and payers.
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Jutkowitz E, Bynum JPW, Mitchell SL, et al. Diagnosed prevalence of Alzheimer’s disease and related dementias in Medicare Advantage plans. Alzheimers Dement (Amst). 2020;12(1). doi:10.1002/dad2.12048
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Marsolo KA, Brown JS, Hernandez AF, et al. Considerations for using distributed research networks to conduct aspects of randomized trials. Contemporary Clinical Trials Communications. 2020;17:100515. doi:10.1016/j.conctc.2019.100515
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