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Comparison of Outreach Methods to Encourage Enrollment in Diabetes Prevention and Weight Management Programs

Primary Purpose

PreDiabetes, Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EHR gaps
Bulk outreach
Dietician call
Sponsored by
Kaiser Permanente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for PreDiabetes

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kaiser Permanente Coloado

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Active Comparator

Active Comparator

Active Comparator

Arm Label

Usual care

Electronic health record "gaps"

Bulk outreach

Personalized outreach

Arm Description

Usual care

Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 23, 2017
Last Updated
November 21, 2019
Sponsor
Kaiser Permanente
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1. Study Identification

Unique Protocol Identification Number
NCT03200535
Brief Title
Comparison of Outreach Methods to Encourage Enrollment in Diabetes Prevention and Weight Management Programs
Official Title
Comparison of Outreach Methods to Encourage Enrollment in Diabetes Prevention and Weight Management Programs
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
June 26, 2017 (Actual)
Primary Completion Date
November 10, 2017 (Actual)
Study Completion Date
November 10, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kaiser Permanente

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PreDiabetes, Obesity

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6588 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Usual care
Arm Title
Electronic health record "gaps"
Arm Type
Active Comparator
Arm Description
Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient
Arm Title
Bulk outreach
Arm Type
Active Comparator
Arm Description
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
Arm Title
Personalized outreach
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
EHR gaps
Intervention Description
Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient
Intervention Type
Other
Intervention Name(s)
Bulk outreach
Intervention Description
A bulk letter or email will be sent
Intervention Type
Other
Intervention Name(s)
Dietician call
Intervention Description
Patients will receive a personalized call by a registered dietitian
Primary Outcome Measure Information:
Title
Enrollment in Diabetes Prevention or Weight Management Class (Online)
Description
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)
Secondary Outcome Measure Information:
Title
Enrollment in Diabetes Prevention or Weight Management Class (in Person)
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily Schroeder, MD, PhD
Organizational Affiliation
Kaiser Permanente
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaiser Permanente Coloado
City
Denver
State/Province
Colorado
ZIP/Postal Code
80014
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparison of Outreach Methods to Encourage Enrollment in Diabetes Prevention and Weight Management Programs

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