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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; PreDiabetes
• Intervention / Treatment: Other: EHR gaps; Other: Bulk outreach; Other: Dietician call

• Study Type: Interventional
• Enrollment (Actual): 6588
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80014
      • Kaiser Permanente Coloado

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual care
Active Comparator: Electronic health record "gaps"; 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
Active Comparator: 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	Other: EHR gaps; Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient; Other: Bulk outreach; A bulk letter or email will be sent
Active Comparator: 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	Other: EHR gaps; Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient; Other: Bulk outreach; A bulk letter or email will be sent; Other: Dietician call; Patients will receive a personalized call by a registered dietitian

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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)

Collaborators and Investigators

• Sponsor: Kaiser Permanente
• Investigators: Principal Investigator: Emily Schroeder, MD, PhD, Kaiser Permanente

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2017
• Primary Completion (Actual): November 10, 2017
• Study Completion (Actual): November 10, 2017

Study Registration Dates

• First Submitted: June 23, 2017
• First Submitted That Met QC Criteria: June 23, 2017
• First Posted (Actual): June 27, 2017

Study Record Updates

• Last Update Posted (Actual): December 13, 2019
• Last Update Submitted That Met QC Criteria: November 21, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Prediabetic State
• Other Study ID Numbers: CO-17-2437

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No