NCT04520009

EHR Embedded Comparative Effectiveness Studies--CPS

Randomize Everyone: Creating Valid Instrumental Variables for Learning Health Care Systems

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Dartmouth-Hitchcock Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Randomize Everyone is a research project to develop new informatics systems and statistical methods for supporting randomization processes in EHR systems to do comparative effectiveness research. Two demonstration projects are being conducted in the Dartmouth Hitchcock Medical Center, designed to evaluate different weight loss interventions and common practices in the treatment of chronic low back pain.

Detailed description

EHR Embedded Comparative Effectiveness Studies-CPS will be held in the Center for Pain and Spine at Dartmouth-Hitchcock Medical Center. This study consists of randomizing enrollees to either activity restriction or no activity restriction following lumbar discectomy.

Conditions

• Disk Herniated Lumbar

Interventions

Type	Name	Description
BEHAVIORAL	Activity Restriction	Standard post-operative activity instructions (i.e., no bending, twisting, or lifting more than 10 lbs for 4 weeks, no return to work until cleared to do so).
BEHAVIORAL	Activity as Tolerated	Instructions advising activity as tolerated and return to work based on patient discretion

Timeline

• Start date: 2020-10-23
• Primary completion: 2021-08-07
• Completion: 2021-10-27
• First posted: 2020-08-20
• Last updated: 2024-03-01
• Results posted: 2024-03-01

Locations

1 site across 1 country: United States