Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Individuals with prediabetes are at increased risk for developing diabetes. Higher hemoglobin A1c's (6.1-6.4%) are associated with a high risk of developing diabetes. It is known that programs such weight management classes and one-on-one counseling with registered dieticians can lead to weight loss and decrease the risk of diabetes. However, engagement of Kaiser Permanente Colorado members in these activities is low. The purpose of this study is to determine which of three outreach methods is most effective in increasing engagement in these activities.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care | No Intervention | Usual care | |
| Electronic health record "gaps" | Active Comparator | Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient |
|
| Bulk outreach | Active Comparator | Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient; in addition a bulk letter or email will be sent |
|
| Personalized outreach | Active Comparator | Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient; in addition a bulk letter or email will be sent and patients will receive a personalized call by a registered dietitian |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EHR gaps | Other | Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient |
|
| Measure | Description | Time Frame |
|---|---|---|
| Enrollment in Diabetes Prevention or Weight Management Class (Online) | Percent of individuals who have enrolled in online diabetes prevention or weight management classes (online) over a 4.5 month period | 4.5 months (6/26/2017-11/10/2017) |
| Measure | Description | Time Frame |
|---|---|---|
| Enrollment in Diabetes Prevention or Weight Management Class (in Person) | Percent of individuals who have enrolled in diabetes prevention or weight management class (in person) over a 4.5 month follow-up period | 4.5 months (6/26/2017-11/10/2017) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
- Pregnancy
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Emily Schroeder, MD, PhD | Kaiser Permanente | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente Coloado | Denver | Colorado | 80014 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | Usual care |
| FG001 | Electronic Health Record "Gaps" | Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient EHR gaps: Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient |
| FG002 | Bulk Outreach | Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient; in addition a bulk letter or email will be sent EHR gaps: Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient Bulk outreach: A bulk letter or email will be sent |
| FG003 | Personalized Outreach | Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient; in addition a bulk letter or email will be sent and patients will receive a personalized call by a registered dietitian EHR gaps: Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient Bulk outreach: A bulk letter or email will be sent Dietician call: Patients will receive a personalized call by a registered dietitian |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care | Usual care |
| BG001 | Electronic Health Record "Gaps" | Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient EHR gaps: Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient |
| 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 | Enrollment in Diabetes Prevention or Weight Management Class (Online) | Percent of individuals who have enrolled in online diabetes prevention or weight management classes (online) over a 4.5 month period | Entire population was analyzed | Posted | Count of Participants | Participants | 4.5 months (6/26/2017-11/10/2017) |
|
4.5 months (6/26/2017-11/10/2017)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care | Usual care | 2 |
Not provided
Not provided
We were unable to analyze the change in BMI and change in A1c due to the low number of individuals who enrolled in diabetes prevention classes
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Emily Schroeder | Kaiser Permanente Colorado | 303-636-2478 | emily.b.schroeder@kp.org |
Not provided
| 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 | Jun 6, 2019 | Aug 6, 2019 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Individuals with a body mass index between 25 and 30 are randomized 1:1 to the Usual Care or EHR Gap arms. Individuals with a body mass index >=30 are randomized to all 4 arms, with n=1000 for the Personalized Outreach arm and 1:1:1 for the other three arms.
Not provided
Not provided
Not provided
Not provided
| Bulk outreach | Other | A bulk letter or email will be sent |
|
| Dietician call | Other | Patients will receive a personalized call by a registered dietitian |
|
| BG002 | Bulk Outreach | Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient; in addition a bulk letter or email will be sent EHR gaps: Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient Bulk outreach: A bulk letter or email will be sent |
| BG003 | Personalized Outreach | Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient; in addition a bulk letter or email will be sent and patients will receive a personalized call by a registered dietitian EHR gaps: Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient Bulk outreach: A bulk letter or email will be sent Dietician call: Patients will receive a personalized call by a registered dietitian |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | 17 participants had missing data on gender | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| A1c | Mean | Standard Deviation | % |
|
| OG002 | Bulk Outreach | Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient; in addition a bulk letter or email will be sent EHR gaps: Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient Bulk outreach: A bulk letter or email will be sent |
| OG003 | Personalized Outreach | Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient; in addition a bulk letter or email will be sent and patients will receive a personalized call by a registered dietitian EHR gaps: Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient Bulk outreach: A bulk letter or email will be sent Dietician call: Patients will receive a personalized call by a registered dietitian |
|
|
|
| Secondary | Enrollment in Diabetes Prevention or Weight Management Class (in Person) | Percent of individuals who have enrolled in diabetes prevention or weight management class (in person) over a 4.5 month follow-up period | Posted | Count of Participants | Participants | 4.5 months (6/26/2017-11/10/2017) |
|
|
|
|
| 1,863 |
| 0 |
| 1,863 |
| 0 |
| 1,863 |
| EG001 | Electronic Health Record "Gaps" | Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient EHR gaps: Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient | 2 | 1,863 | 0 | 1,863 | 0 | 1,863 |
| EG002 | Bulk Outreach | Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient; in addition a bulk letter or email will be sent EHR gaps: Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient Bulk outreach: A bulk letter or email will be sent | 3 | 1,862 | 0 | 1,862 | 0 | 1,862 |
| EG003 | Personalized Outreach | Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient; in addition a bulk letter or email will be sent and patients will receive a personalized call by a registered dietitian EHR gaps: Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient Bulk outreach: A bulk letter or email will be sent Dietician call: Patients will receive a personalized call by a registered dietitian | 1 | 1,000 | 0 | 1,000 | 0 | 1,000 |
Not provided
Not provided
| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Male |
|