EHR Embedded Comparative Effectiveness Studies--CPS

NCT04520009 | Completed Results

• 1 other identifier: SFD20160
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Disk Herniated Lumbar

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Activity Restriction

ACTIVE COMPARATOR

Discharge orders for activity restriction

Behavioral: Activity Restriction

Activity As Tolerated

ACTIVE COMPARATOR

Discharge orders written for activity as tolerated

Behavioral: Activity as Tolerated

Interventions

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 Restriction

Activity as Tolerated BEHAVIORAL

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

Activity As Tolerated

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• Trustees of Dartmouth College: collaborator
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

Dartmouth-HItchcock

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Limitations and Caveats

Primary limitations of the trial include limited enrollment compared to the original goal of 60 randomized patients due in part to the limitations in elective surgery during the Covid-19 pandemic. By design, the study is pragmatic, and primarily intended to evaluated methodologies for embedding randomization in the electronic record system of a regional health care center.

Results Point of Contact

• Title: Tor D. Tosteson, ScD
• Organization: Dartmouth Geisel School of Medicine

tor.d.tosteson@dartmouth.edu

603 646-5724

Study Officials

• Tor Tosteson, ScD

  Dartmouth

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 10, 2020
• First Posted: August 20, 2020
• Study Start: October 23, 2020
• Primary Completion: August 7, 2021
• Study Completion: October 27, 2021
• Last Updated: March 1, 2024
• Results First Posted: March 1, 2024

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)