Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04514679
Recruitment Status : Recruiting
First Posted : August 17, 2020
Last Update Posted : July 9, 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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Obesity Behavioral: Healthy Lifestyles Program Behavioral: Obesity Medicine Program

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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated 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 : October 20, 2020
Estimated Primary Completion Date : October 1, 2021
Estimated Study Completion Date : October 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Healthy Living

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Criteria

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)

-

Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT04514679


Contacts
Layout table for location contacts
Contact: Tor D Tosteson, ScD 603-653-3677 tor.d.tosteson@dartmouth.edu
Contact: Lorettal Pearson, MA loretta.pearson@dartmouth.edu

Locations
Layout table for location information
United States, New Hampshire
Dartmouth-Hitchcock Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Tor D Tosteson, ScD       tor.tosteson@dartmouth.edu   
Contact: Loretta Pearson, MA       loretta.pearson@dartmouth.edu   
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Trustees of Dartmouth College
Patient-Centered Outcomes Research Institute
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Tor D. Tosteson, Professor, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT04514679    
Other Study ID Numbers: D19107a
First Posted: August 17, 2020    Key Record Dates
Last Update Posted: July 9, 2021
Last Verified: July 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No