Table 1 NIH Collaboratory Demonstration Projects

2012

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

2014

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