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

May 1, 2022 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-WWC will be held in the Weight and Wellness Clinics at Dartmouth-Hitchcock Medical Center. This study consists of randomizing enrollees to either the dietitian/health coach appointment sequence or the health coach/dietitian appointment sequence.

Study Type

Observational

Enrollment (Actual)

60

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

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients in the Weight & Wellness Clinic who are eligible for either Healthy Living Program or Obesity Medicine Program

Description

Inclusion Criteria: Adults (>18) able to consent, with sufficient fluency in English; Able to be appropriately treated with either the Healthy Lifestyles Program or Obesity Medicine Program as determined by a WWC provider -

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy Lifestyles Program
Usual care in the Healthy Lifestyles Program.
Behavioral: Healthy Lifestyles Program
Regular group visits with a health coach in addition to routine dietician and clinician visits, reviewing successes and challenges from the previous session as well as data collected through self-monitoring
Obesity Medicine Program
Usual care in the Obesity Medicine program.
Behavioral: Obesity Medicine Program
A tailored approach to obesity care for patients including individual dietician and health coach visits as appropriate.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Factors for patient participation in EHR imbedded study
Time Frame: Baseline
Patient Survey
Baseline
Receipt of treatment
Time Frame: 6 months post-enrollment
Patient Survey
6 months post-enrollment
Satisfaction with Treatment
Time Frame: 6 months post-enrollment
Patient Survey
6 months post-enrollment

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

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 20, 2020

Primary Completion (Actual)

January 21, 2021

Study Completion (Actual)

January 21, 2021

Study Registration Dates

First Submitted

January 10, 2020

First Submitted That Met QC Criteria

August 12, 2020

First Posted (Actual)

August 17, 2020

Study Record Updates

Last Update Posted (Actual)

May 3, 2022

Last Update Submitted That Met QC Criteria

May 1, 2022

Last Verified

July 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • D19107a

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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