EHR Embedded Comparative Effectiveness Studies--WWC

NCT04514679 | Completed Results

• 1 other identifier: D19107a
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (2)

• Compliance Rate

  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

  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 Outcomes (1)

• Change in Body Mass Index (BMI) at 30 Days

  30 days since baseline

Study Arms (2)

Dietician / Health Coach

ACTIVE COMPARATOR

Patients having obesity treatment would first see a dietician, and then see a health coach.

Behavioral: Dietician / Health Coach

Health Coach / Dietician

ACTIVE COMPARATOR

Patients having obesity treatment would first see a health coach, and then see a dietician.

Behavioral: Health Coach / Dietician

Interventions

Dietician / Health Coach BEHAVIORAL

The order of visit for the two types of providers is first Dietician then Health Coach.

Dietician / Health Coach

Health Coach / Dietician BEHAVIORAL

The order of visit for the two types of providers is first Health Coach then Dietician.

Health Coach / Dietician

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• Trustees of Dartmouth College: collaborator
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

Dartmouth-Hitchcock

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Nutritionists

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health Personnel; Health Care Facilities Workforce and Services

Limitations and Caveats

This study is part of a project that evaluates the utility of methods to use randomized methods for evaluating comparative effectiveness questions using the electronic health record of a health system. The primary focus is on the feasibility of the method, including the patient participation and compliance rates for an intervention in an obesity clinic involving timing of visits to a health coach and a dietician. The results regarding the efficacy of the intervention are secondary outcomes.

Results Point of Contact

• Title: Tor D. Tosteson, ScD
• Organization: Dartmouth Geisel School of Medicine

tor.d.tosteson@dartmouth.edu

603 646-5274

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 10, 2020
• First Posted: August 17, 2020
• Study Start: October 23, 2020
• Primary Completion: September 27, 2021
• Study Completion: September 27, 2021
• Last Updated: June 12, 2025
• Results First Posted: June 12, 2025

Record last verified: 2025-05

Locations

US (1)