EHR Embedded Comparative Effectiveness Studies--CPS (EHR-CPS)

July 31, 2023 updated by: Tor D. Tosteson, Dartmouth-Hitchcock Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hitchcock

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Study Population

Patients eligible for discectomy

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Activity Restriction
Discharge orders for activity restriction
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).
Active Comparator: Activity As Tolerated
Discharge orders written for activity as tolerated
Behavioral: Activity as Tolerated
Instructions advising activity as tolerated and return to work based on patient discretion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Upon completion of surgery approximately 24 days post-randomization
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.
1 day, during the recruitment period from October 23 2020 to August 7, 2021

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dartmouth-Hitchcock Medical Center

Collaborators

Patient-Centered Outcomes Research Institute
Trustees of Dartmouth College

Investigators

  • Principal Investigator: Tor Tosteson, ScD, Dartmouth

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 23, 2020

Primary Completion (Actual)

August 7, 2021

Study Completion (Actual)

October 27, 2021

Study Registration Dates

First Submitted

January 10, 2020

First Submitted That Met QC Criteria

August 17, 2020

First Posted (Actual)

August 20, 2020

Study Record Updates

Last Update Posted (Estimated)

March 1, 2024

Last Update Submitted That Met QC Criteria

July 31, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SFD20160

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plans at this time share IPD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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