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OpenTrials
Completed

NCT Number: NCT04520009

EHR Embedded Comparative Effectiveness Studies--CPS

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.

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Key information

Conditions

Disk Herniated Lumbar

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dartmouth-HItchcock

Lebanon, New Hampshire, 03756, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Activity Restriction

Behavioral

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

Behavioral

Instructions advising activity as tolerated and return to work based on patient discretion

Primary outcomes

  1. Compliance Rate With Assigned Treatment

    Time frame: Upon completion of surgery approximately 24 days post-randomization

    Compliance with assigned treatment as measured by presence of appropriate surgical discharge instructions.

  2. Percentage Eligible Patients Participating in Study

    Time frame: 1 day, during the recruitment period from October 23 2020 to August 7, 2021

    Percentage of those identified as being eligible who were enrolled.

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Collaborators

  • Patient-Centered Outcomes Research Institute
  • Trustees of Dartmouth College

Registry information

Official study title

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

Acronym: EHR-CPS

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 20, 2020
Registry last updated
Mar 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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