EHR Embedded Comparative Effectiveness Studies--WWC

Obesity Clinical Trial

— EHR-WWC  

Official title:

Randomize Everyone: Creating Valid Instrumental Variables for Learning Health Care Systems

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04514679
• Other study ID #: D19107a
• Status: Completed
• Start date: October 20, 2020
• Est. completion date: January 21, 2021

Study information

• Verified date: July 2021
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 21, 2021
• Est. primary completion date: January 21, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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)

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Related Conditions & MeSH terms

• Obesity

Intervention

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
A tailored approach to obesity care for patients including individual dietician and health coach visits as appropriate.

Locations

Country	Name	City	State
United States	Dartmouth-Hitchcock	Lebanon	New Hampshire

Sponsors (3)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	Patient-Centered Outcomes Research Institute, Trustees of Dartmouth College

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Factors for patient participation in EHR imbedded study	Patient Survey	Baseline
Primary	Receipt of treatment	Patient Survey	6 months post-enrollment
Primary	Satisfaction with Treatment	Patient Survey	6 months post-enrollment