Obesity, PreDiabetes
Conditions
Brief summary
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.
Interventions
OTHEREHR gaps
Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient
OTHERBulk outreach
A bulk letter or email will be sent
OTHERDietician call
Patients will receive a personalized call by a registered dietitian
Sponsors
Kaiser Permanente
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Kaiser Permanente Member * Age 18-75 * Prediabetes * BMI \>= 25 * A1c 6.1-6.4% * No dietitian visit within the past 3 years
Exclusion criteria
\- Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Enrollment in Diabetes Prevention or Weight Management Class (Online) | 4.5 months (6/26/2017-11/10/2017) | Percent of individuals who have enrolled in online diabetes prevention or weight management classes (online) over a 4.5 month period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Enrollment in Diabetes Prevention or Weight Management Class (in Person) | 4.5 months (6/26/2017-11/10/2017) | Percent of individuals who have enrolled in diabetes prevention or weight management class (in person) over a 4.5 month follow-up period |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Usual Care Usual care | 1,863 |
| 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 | 1,863 |
| 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 | 1,862 |
| 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 | 1,000 |
| Total | 6,588 |
Baseline characteristics
| Characteristic | Total | Personalized Outreach | Bulk Outreach | Electronic Health Record Gaps | Usual Care |
|---|---|---|---|---|---|
| A1c | 6.3 % STANDARD_DEVIATION 0.17 | 6.3 % STANDARD_DEVIATION 0.18 | 6.3 % STANDARD_DEVIATION 0.18 | 6.3 % STANDARD_DEVIATION 0.18 | 6.3 % STANDARD_DEVIATION 0.18 |
| Age, Continuous | 58.2 years STANDARD_DEVIATION 11 | 58.3 years STANDARD_DEVIATION 10.9 | 58.0 years STANDARD_DEVIATION 11.1 | 58.2 years STANDARD_DEVIATION 11 | 59.1 years STANDARD_DEVIATION 10.9 |
| BMI | 36.4 kg/m^2 STANDARD_DEVIATION 5.8 | 36.4 kg/m^2 STANDARD_DEVIATION 5.5 | 36.6 kg/m^2 STANDARD_DEVIATION 5.9 | 36.3 kg/m^2 STANDARD_DEVIATION 6.1 | 36.3 kg/m^2 STANDARD_DEVIATION 5.6 |
| Race and Ethnicity Not Collected | 0 Participants | — | — | — | — |
| Sex: Female, Male Female | 3556 Participants | 544 Participants | 990 Participants | 1023 Participants | 999 Participants |
| Sex: Female, Male Male | 3015 Participants | 453 Participants | 871 Participants | 833 Participants | 858 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 2 / 1,863 | 2 / 1,863 | 3 / 1,862 | 1 / 1,000 |
| other Total, other adverse events | 0 / 1,863 | 0 / 1,863 | 0 / 1,862 | 0 / 1,000 |
| serious Total, serious adverse events | 0 / 1,863 | 0 / 1,863 | 0 / 1,862 | 0 / 1,000 |
Outcome results
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
Time frame: 4.5 months (6/26/2017-11/10/2017)
Population: Entire population was analyzed
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Enrollment in Diabetes Prevention or Weight Management Class (Online) | 7 Participants |
| Electronic Health Record Gaps | Enrollment in Diabetes Prevention or Weight Management Class (Online) | 12 Participants |
| Bulk Outreach | Enrollment in Diabetes Prevention or Weight Management Class (Online) | 39 Participants |
| Personalized Outreach | Enrollment in Diabetes Prevention or Weight Management Class (Online) | 59 Participants |
p-value: <0.001Chi-squared
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
Time frame: 4.5 months (6/26/2017-11/10/2017)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Enrollment in Diabetes Prevention or Weight Management Class (in Person) | 15 Participants |
| Electronic Health Record Gaps | Enrollment in Diabetes Prevention or Weight Management Class (in Person) | 14 Participants |
| Bulk Outreach | Enrollment in Diabetes Prevention or Weight Management Class (in Person) | 24 Participants |
| Personalized Outreach | Enrollment in Diabetes Prevention or Weight Management Class (in Person) | 25 Participants |
p-value: <0.001Chi-squared