EHR Embedded Comparative Effectiveness Studies--CPS

NCT ID: NCT04520009

Last Updated: 2024-03-01

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-23

Study Completion Date

2021-10-27

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Disk Herniated Lumbar

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Activity Restriction

Discharge orders for activity restriction

Group Type ACTIVE_COMPARATOR

Activity Restriction

Intervention Type 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

Discharge orders written for activity as tolerated

Group Type ACTIVE_COMPARATOR

Activity as Tolerated

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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).

Intervention Type BEHAVIORAL

Activity as Tolerated

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Trustees of Dartmouth College

OTHER

Sponsor Role collaborator

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role collaborator

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Tor D. Tosteson

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Tor Tosteson, ScD

Role: PRINCIPAL_INVESTIGATOR

Dartmouth

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Dartmouth-HItchcock

Lebanon, New Hampshire, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SFD20160

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Putting CDSMP to Work
NCT02409056 COMPLETED NA
Clinical Trial Preference Study
NCT06735469 COMPLETED