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

May 27, 2025 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

Interventional

Enrollment (Actual)

60

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

Yes

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; Initial RD and HC visits are part of routine care as recommended by the provider; willing to be randomized

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: Dietician / Health Coach
Patients having obesity treatment would first see a dietician, and then see a health coach.
Behavioral: Dietician / Health Coach
The order of visit for the two types of providers is first Dietician then Health Coach.
Active Comparator: Health Coach / Dietician
Patients having obesity treatment would first see a health coach, and then see a dietician.
Behavioral: Health Coach / Dietician
The order of visit for the two types of providers is first Health Coach then Dietician.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compliance Rate
Time Frame: Baseline through approximately 2 months
Percentage of those in each arm who complete the two visits in the correct order assigned.
Baseline through approximately 2 months
Percentage of Eligible Patients Participating
Time Frame: One day, during the recruitment period of October 23, 2020 to February 3, 2021.
Percentage of those identified as being eligible who were enrolled in the study.
One day, during the recruitment period of October 23, 2020 to February 3, 2021.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Body Mass Index (BMI) at 30 Days
Time Frame: 30 days since baseline
Linear trends (or "slopes") for per 30 days are calculated in each group. The slopes were calculated from repeated BMI measurements in each treatment group, and expressed in terms of the change in BMI predicted at 30 days post randomization.
30 days since baseline

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 23, 2020

Primary Completion (Actual)

September 27, 2021

Study Completion (Actual)

September 27, 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)

June 12, 2025

Last Update Submitted That Met QC Criteria

May 27, 2025

Last Verified

May 1, 2025

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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