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| Name | Class |
|---|---|
| Trustees of Dartmouth College | OTHER |
| Patient-Centered Outcomes Research Institute | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dietician / Health Coach | Active Comparator | Patients having obesity treatment would first see a dietician, and then see a health coach. |
|
| Health Coach / Dietician | Active Comparator | Patients having obesity treatment would first see a health coach, and then see a dietician. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietician / Health Coach | Behavioral | The order of visit for the two types of providers is first Dietician then Health Coach. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Mass Index (BMI) at 30 Days | 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 |
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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)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth-Hitchcock | Lebanon | New Hampshire | 03756 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dietician / Health Coach | Patients having obesity treatment would first see a dietician, and then see a health coach. Dietician / Health Coach: The order of visit for the two types of providers is first Dietician then Health Coach. |
| FG001 | Health Coach / Dietician | Patients having obesity treatment would first see a health coach, and then see a dietician. Health Coach / Dietician: The order of visit for the two types of providers is first Health Coach then Dietician. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Age was unavailable due to missing data in the patient record.
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| ID | Title | Description |
|---|---|---|
| BG000 | Dietician / Health Coach | Patients having obesity treatment would first see a dietician, and then see a health coach. Dietician / Health Coach: The order of visit for the two types of providers is first Dietician then Health Coach. |
| BG001 | Health Coach / Dietician |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Compliance Rate | Percentage of those in each arm who complete the two visits in the correct order assigned. | Those who had health record data, which eliminated 3 patients. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline through approximately 2 months |
|
6 months post randomization
Adverse events were assessed by the participating clinic as part of routine clinical practice.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dietician / Health Coach | Patients having obesity treatment would first see a dietician, and then see a health coach. Dietician / Health Coach: The order of visit for the two types of providers is first Dietician then Health Coach. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tor D. Tosteson, ScD | Dartmouth Geisel School of Medicine | 603 646-5274 | tor.d.tosteson@dartmouth.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 5, 2021 | Jun 20, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D064686 | Nutritionists |
| ID | Term |
|---|---|
| D006282 | Health Personnel |
| D005159 | Health Care Facilities Workforce and Services |
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| Health Coach / Dietician | Behavioral | The order of visit for the two types of providers is first Health Coach then Dietician. |
|
Patients having obesity treatment would first see a health coach, and then see a dietician. Health Coach / Dietician: The order of visit for the two types of providers is first Health Coach then Dietician. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
|
| Primary | Percentage of Eligible Patients Participating | Percentage of those identified as being eligible who were enrolled in the study. | All patients who were identified as being eligible. | Posted | Number | 95% Confidence Interval | percentage of eligible patients | One day, during the recruitment period of October 23, 2020 to February 3, 2021. |
|
|
|
| Secondary | Change in Body Mass Index (BMI) at 30 Days | 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. | Those who had health record data, which eliminated 3 patients. | Posted | Mean | Standard Error | kg/m^2 | 30 days since baseline |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Health Coach / Dietician | Patients having obesity treatment would first see a health coach, and then see a dietician. Health Coach / Dietician: The order of visit for the two types of providers is first Health Coach then Dietician. | 0 | 30 | 0 | 30 | 0 | 30 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |