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Table 1 NIH Collaboratory Demonstration Projects

From: Pragmatic clinical trials embedded in healthcare systems: generalizable lessons from the NIH Collaboratory

Study name Project goal Population Randomization
Pain Program for Active Coping and Training (PPACT; NCT02113592) Help patients adopt self-management skills for chronic pain, limit use of opioid medications, and identify factors amenable to treatment in the primary care setting [2] Patients with chronic pain on long-term opioid therapy (~1000+ patients) in three staff model health plans Cluster randomization by primary care provider
Strategies and Opportunities to Stop Colorectal Cancer in Priority Populations (STOP CRC; NCT01742065) Improve the rates of colorectal-cancer screening by mailing fecal immunochemical testing tests to patients at Federally Qualified Health Centers Individuals eligible for screening per the US Preventive Task Force guidelines (~35,000 patients) in 26 Federally Qualified Health Center clinics Cluster randomization by Federally Qualified Health Center clinic
Suicide Prevention Outreach Trial (SPOT; NCT02326883) Compare outcomes in patients who receive care-management or online skills training for suicide prevention versus usual care in three healthcare systems Individuals at elevated risk for suicide on a depressions scale (~19,500 patients) in three large healthcare systems Individual randomization
Time to Reduce Mortality in End-Stage Renal Disease (TiME; NCT02019225) Determine whether increasing the durations of hemodialysis sessions reduces mortality and hospitalization rates for patients receiving maintenance hemodialysis care Adults who have initiated treatment with maintenance hemodialysis within the past 120 days (~6800 patients) in 266 dialysis facilities operated by two dialysis provider organizations Cluster randomization by dialysis facility
Lumbar Image Reporting with Epidemiology (LIRE; NCT02015455) Determine if inserting epidemiological benchmarks (essentially representing the normal range) into lumbar spine imaging reports reduces subsequent spine-related tests and treatments 100 clinics
(~230,000 patients) in four health systems
Cluster randomization by clinic. Stepped-wedge one-way crossover design
Active Bathing to Eliminate Infection (ABATE; NCT02063867) Determine if using antiseptic bathing for all patients plus nasal ointments for patients harboring methicillin-resistant Staphylococcus aureus (MRSA) reduces multidrug-resistant organisms and bloodstream infections Patients in adult medical, surgical, oncology, and step-down units. (~600,000 patients) in 53 hospitals Cluster randomization by hospital
Blood Pressure Medication Timing Study (BPMedTime) To compare adverse cardiovascular events in patients who are instructed to take their currently prescribed once-daily antihypertensive medications at bedtime compared with patients who continue to take their once-daily antihypertensive medications in the morning or afternoon Initial plan was to test this question in 1000 patients, but to have enough power, it was determined that 5000 patients were needed This trial was not transitioned to the implementation phase
Pragmatic Trial of Video Education in Nursing Homes (PROVEN; NCT02612688) Determine if showing advance care planning videos in nursing homes affects the rates of hospitalization among frail, demented residents 2 nursing home health systems (360 nursing homes) serving long-stay (>12 months) patients with advanced comorbid conditions (~15,000 patients) Cluster randomization by nursing home
Improving Chronic Disease management with Pieces (ICD-Pieces; NCT02587936) Improve care for patients with chronic kidney disease, diabetes, and hypertension by using a novel technology platform (Pieces) that uses the electronic health record to identify patients and by assigning practice facilitators within primary care practices or community medical homes Patients with multiple co-morbid conditions (chronic kidney disease, diabetes, and hypertension; ~11,000) in 124 primary care practices in four healthcare systems Stratified cluster randomization of clinical practices within health systems
Trauma Survivors Outcomes and Support (TSOS; NCT01625416) Coordinate care and improve outcomes for trauma survivors with post-traumatic stress disorder(PTSD) and comorbidity Expect 40 patients at each center (~960 patients) in 24 US trauma centers Cluster randomization by trauma center. Stepped-wedge one-way crossover design
  1. This table is based on a table previously published by the Collaboratory in a white paper titled Lessons Learned from the NIH Health Care Systems Research Collaboratory Demonstration Projects and is used with permission [41].