Trial Outcomes & Findings for Comparison of Outreach Methods to Encourage Enrollment in Diabetes Prevention and Weight Management Programs (NCT NCT03200535)
NCT ID: NCT03200535
Last Updated: 2019-12-13
Results Overview
Percent of individuals who have enrolled in online diabetes prevention or weight management classes (online) over a 4.5 month period
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
6588 participants
Primary outcome timeframe
4.5 months (6/26/2017-11/10/2017)
Results posted on
2019-12-13
Participant Flow
Participant milestones
| Measure |
Usual Care
Usual care
|
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
|
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
|
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
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
1863
|
1863
|
1862
|
1000
|
|
Overall Study
COMPLETED
|
1863
|
1863
|
1862
|
1000
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
17 participants had missing data on gender
Baseline characteristics by cohort
| Measure |
Usual Care
n=1863 Participants
Usual care
|
Electronic Health Record "Gaps"
n=1863 Participants
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
|
Bulk Outreach
n=1862 Participants
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
|
Personalized Outreach
n=1000 Participants
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
|
Total
n=6588 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
59.1 years
STANDARD_DEVIATION 10.9 • n=1863 Participants
|
58.2 years
STANDARD_DEVIATION 11.0 • n=1863 Participants
|
58.0 years
STANDARD_DEVIATION 11.1 • n=1862 Participants
|
58.3 years
STANDARD_DEVIATION 10.9 • n=1000 Participants
|
58.2 years
STANDARD_DEVIATION 11.0 • n=6588 Participants
|
|
Sex: Female, Male
Female
|
999 Participants
n=1857 Participants • 17 participants had missing data on gender
|
1023 Participants
n=1856 Participants • 17 participants had missing data on gender
|
990 Participants
n=1861 Participants • 17 participants had missing data on gender
|
544 Participants
n=997 Participants • 17 participants had missing data on gender
|
3556 Participants
n=6571 Participants • 17 participants had missing data on gender
|
|
Sex: Female, Male
Male
|
858 Participants
n=1857 Participants • 17 participants had missing data on gender
|
833 Participants
n=1856 Participants • 17 participants had missing data on gender
|
871 Participants
n=1861 Participants • 17 participants had missing data on gender
|
453 Participants
n=997 Participants • 17 participants had missing data on gender
|
3015 Participants
n=6571 Participants • 17 participants had missing data on gender
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
BMI
|
36.3 kg/m^2
STANDARD_DEVIATION 5.6 • n=1863 Participants
|
36.3 kg/m^2
STANDARD_DEVIATION 6.1 • n=1863 Participants
|
36.6 kg/m^2
STANDARD_DEVIATION 5.9 • n=1862 Participants
|
36.4 kg/m^2
STANDARD_DEVIATION 5.5 • n=1000 Participants
|
36.4 kg/m^2
STANDARD_DEVIATION 5.8 • n=6588 Participants
|
|
A1c
|
6.3 %
STANDARD_DEVIATION 0.18 • n=1863 Participants
|
6.3 %
STANDARD_DEVIATION 0.18 • n=1863 Participants
|
6.3 %
STANDARD_DEVIATION 0.18 • n=1862 Participants
|
6.3 %
STANDARD_DEVIATION 0.18 • n=1000 Participants
|
6.3 %
STANDARD_DEVIATION 0.17 • n=6588 Participants
|
PRIMARY outcome
Timeframe: 4.5 months (6/26/2017-11/10/2017)Population: Entire population was analyzed
Percent of individuals who have enrolled in online diabetes prevention or weight management classes (online) over a 4.5 month period
Outcome measures
| Measure |
Usual Care
n=1863 Participants
Usual care
|
Electronic Health Record "Gaps"
n=1863 Participants
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
|
Bulk Outreach
n=1862 Participants
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
|
Personalized Outreach
n=1000 Participants
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
|
|---|---|---|---|---|
|
Enrollment in Diabetes Prevention or Weight Management Class (Online)
|
7 Participants
|
12 Participants
|
39 Participants
|
59 Participants
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Usual Care
n=1863 Participants
Usual care
|
Electronic Health Record "Gaps"
n=1863 Participants
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
|
Bulk Outreach
n=1862 Participants
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
|
Personalized Outreach
n=1000 Participants
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
|
|---|---|---|---|---|
|
Enrollment in Diabetes Prevention or Weight Management Class (in Person)
|
15 Participants
|
14 Participants
|
24 Participants
|
25 Participants
|
Adverse Events
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Electronic Health Record "Gaps"
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Bulk Outreach
Serious events: 0 serious events
Other events: 0 other events
Deaths: 3 deaths
Personalized Outreach
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place