EHR Embedded Comparative Effectiveness Studies--CPS

Disk Herniated Lumbar Clinical Trial

— EHR-CPS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04520009
• Other study ID #: SFD20160
• Status: Completed
• Phase: N/A
• Start date: October 23, 2020
• Est. completion date: October 27, 2021

Study information

• Verified date: July 2023
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: October 27, 2021
• Est. primary completion date: August 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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).

Related Conditions & MeSH terms

• Disk Herniated Lumbar

Intervention

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).
• Activity as Tolerated
Instructions advising activity as tolerated and return to work based on patient discretion

Locations

Country	Name	City	State
United States	Dartmouth-HItchcock	Lebanon	New Hampshire

Sponsors (3)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	Patient-Centered Outcomes Research Institute, Trustees of Dartmouth College

Country where clinical trial is conducted

United States, 

Outcome

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