EHR Embedded Comparative Effectiveness Studies--CPS

Not Applicable

Completed

• Conditions: Disk Herniated Lumbar
• Interventions: Behavioral: Activity Restriction; Behavioral: Activity as Tolerated

• Registration Number: NCT04520009
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

Brief 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.

Study Timeline

• Study First Submitted: 2020-01-10
• Study First Submitted QC: 2020-08-17
• Study First Posted: 2020-08-20
• Study Start: 2020-10-23
• Primary Completion: 2021-08-07
• Study Completion: 2021-10-27
• Results First Submitted: 2022-06-21
• Status Verified: 2023-07
• Results First Submitted QC: 2023-07-31
• Last Update Submitted: 2023-07-31
• Results First Posted: 2024-03-01
• Last Update Posted: 2024-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

• Adults (>18) able to consent
• Sufficient fluency in English
• Indications for discectomy
• Able to restrict activities or to resume activities as tolerated

Exclusion Criteria

• Pregnant women
• Prisoners
• Children (<18).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Activity Restriction	Activity Restriction	Discharge orders for activity restriction
Activity As Tolerated	Activity as Tolerated	Discharge orders written for activity as tolerated

Primary Outcome Measures

Name	Time	Method
Compliance Rate With Assigned Treatment	Upon completion of surgery approximately 24 days post-randomization	Compliance with assigned treatment as measured by presence of appropriate surgical discharge instructions.
Percentage Eligible Patients Participating in Study	1 day, during the recruitment period from October 23 2020 to August 7, 2021	Percentage of those identified as being eligible who were enrolled.

Trial Locations

Locations (1)

Dartmouth-HItchcock; 🇺🇸 Lebanon, New Hampshire, United States