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

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ClinicalTrials.gov Identifier: NCT04520009
Recruitment Status : Completed
First Posted : August 20, 2020
Last Update Posted : November 16, 2021
Sponsor:
Collaborators:
Trustees of Dartmouth College
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Tor D. Tosteson, Dartmouth-Hitchcock Medical Center

Study Description
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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.

Condition or disease Intervention/treatment
Degenerative Spondylolisthesis Behavioral: Activity Restriction Behavioral: Activity as Tolerated

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 Design
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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Randomize Everyone: Creating Valid Instrumental Variables for Learning Health Care Systems
Actual Study Start Date : August 3, 2020
Actual Primary Completion Date : October 31, 2021
Actual Study Completion Date : October 31, 2021
Groups and Cohorts
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Group/Cohort Intervention/treatment
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).
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


Outcome Measures
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Primary Outcome Measures :
  1. Factors for patient participation in EHR imbedded study [ Time Frame: Baseline ]
    Patient Survey

  2. Receipt of treatment [ Time Frame: 6 months post-enrollment ]
    Patient Survey

  3. Satisfaction with Treatment [ Time Frame: 6 months post-enrollment ]
    Patient Survey


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients eligible for discectomy
Criteria

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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04520009


Locations
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United States, New Hampshire
Dartmouth-HItchcock
Lebanon, New Hampshire, United States, 03756
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Trustees of Dartmouth College
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Tor Tosteson Dartmouth
More Information
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Responsible Party: Tor D. Tosteson, Professor, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT04520009    
Other Study ID Numbers: SFD20160
First Posted: August 20, 2020    Key Record Dates
Last Update Posted: November 16, 2021
Last Verified: November 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spondylolisthesis
Spondylolysis
Spondylosis
 Spinal Diseases
Bone Diseases
Musculoskeletal Diseases