An interventional study of EHR gaps and Bulk outreach in PreDiabetes and Obesity, sponsored by Kaiser Permanente. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-12-13.
Sponsored by Kaiser Permanente · Not applicable, Interventional, and Health services research
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.
999 studies on the registry are indexed under Prediabetic State; 238 are open to participants now.
This study's enrollment of 6,588 is above the median of 65 across 844 interventional studies indexed under Prediabetic State.
Browse Prediabetic State studies →Kaiser Permanente is the lead sponsor of 385 studies on the registry; 41 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 3 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Usual care
Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient
Other: EHR gaps
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
Other: EHR gaps · Other: 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 and patients will receive a personalized call by a registered dietitian
Other: EHR gaps · Other: Bulk outreach · Other: Dietician call
Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient
A bulk letter or email will be sent
Patients will receive a personalized call by a registered dietitian
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
Time frame: 4.5 months (6/26/2017-11/10/2017)
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
Time frame: 4.5 months (6/26/2017-11/10/2017)
| Milestone | Usual Care | Electronic Health Record "Gaps" | Bulk Outreach | Personalized Outreach |
|---|---|---|---|---|
| Started | 1863 | 1863 | 1862 | 1000 |
| Completed | 1863 | 1863 | 1862 | 1000 |
| Not completed | 0 | 0 | 0 | 0 |
Percent of individuals who have enrolled in online diabetes prevention or weight management classes (online) over a 4.5 month period
| Participants | Usual Care | Electronic Health Record "Gaps" | Bulk Outreach | Personalized Outreach |
|---|---|---|---|---|
| Enrollment in Diabetes Prevention or Weight Management Class (Online) | 7 | 12 | 39 | 59 |
Percent of individuals who have enrolled in diabetes prevention or weight management class (in person) over a 4.5 month follow-up period
| Participants | Usual Care | Electronic Health Record "Gaps" | Bulk Outreach | Personalized Outreach |
|---|---|---|---|---|
| Enrollment in Diabetes Prevention or Weight Management Class (in Person) | 15 | 14 | 24 | 25 |
Collected over 4.5 months (6/26/2017-11/10/2017). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Usual Care | 2/1,863 (0.1%) | 0/1,863 (0%) | 0/1,863 (0%) |
| Electronic Health Record "Gaps" | 2/1,863 (0.1%) | 0/1,863 (0%) | 0/1,863 (0%) |
| Bulk Outreach | 3/1,862 (0.2%) | 0/1,862 (0%) | 0/1,862 (0%) |
| Personalized Outreach | 1/1,000 (0.1%) | 0/1,000 (0%) | 0/1,000 (0%) |
| Age, Continuous(years) | Usual Care | Electronic Health Record "Gaps" | Bulk Outreach | Personalized Outreach | Total |
|---|---|---|---|---|---|
| Mean | 59.1 ± 10.9 | 58.2 ± 11.0 | 58.0 ± 11.1 | 58.3 ± 10.9 | 58.2 ± 11.0 |
| Sex: Female, Male(Participants) | Usual Care | Electronic Health Record "Gaps" | Bulk Outreach | Personalized Outreach | Total |
|---|---|---|---|---|---|
| Female | 999 | 1023 | 990 | 544 | 3556 |
| Male | 858 | 833 | 871 | 453 | 3015 |
| Race and Ethnicity Not Collected(Participants) | Usual Care | Electronic Health Record "Gaps" | Bulk Outreach | Personalized Outreach | Total |
|---|---|---|---|---|---|
| Count of participants | — | — | — | — | 0 |
| BMI(kg/m^2) | Usual Care | Electronic Health Record "Gaps" | Bulk Outreach | Personalized Outreach | Total |
|---|---|---|---|---|---|
| Mean | 36.3 ± 5.6 | 36.3 ± 6.1 | 36.6 ± 5.9 | 36.4 ± 5.5 | 36.4 ± 5.8 |
| A1c(%) | Usual Care | Electronic Health Record "Gaps" | Bulk Outreach | Personalized Outreach | Total |
|---|---|---|---|---|---|
| Mean | 6.3 ± 0.18 | 6.3 ± 0.18 | 6.3 ± 0.18 | 6.3 ± 0.18 | 6.3 ± 0.17 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
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