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

NCT03200535 | Completed Results

• 1 other identifier: CO-17-2437
• Study Type: interventional
• Target: 6,588
• Locations: 1 country
• Sites: 1

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.

Conditions

PreDiabetes; Obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Enrollment in Diabetes Prevention or Weight Management Class (in Person)

  4.5 months (6/26/2017-11/10/2017)

Study Arms (4)

Usual care

NO INTERVENTION

Usual care

Electronic health record "gaps"

ACTIVE COMPARATOR

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

Other: EHR gaps

Bulk outreach

ACTIVE COMPARATOR

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

Personalized outreach

ACTIVE COMPARATOR

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

Interventions

EHR gaps OTHER

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

Bulk outreach; Electronic health record "gaps"; Personalized outreach

Bulk outreach OTHER

A bulk letter or email will be sent

Bulk outreach; Personalized outreach

Dietician call OTHER

Patients will receive a personalized call by a registered dietitian

Personalized outreach

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Kaiser Permanente Member
• Age 18-75
• Prediabetes
• BMI \>= 25
• A1c 6.1-6.4%
• No dietitian visit within the past 3 years

You may not qualify if:

• \- Pregnancy

Sponsors & Collaborators

• Kaiser Permanente: lead

Study Sites (1)

Kaiser Permanente Coloado

Denver, Colorado, 80014, United States

Location

MeSH Terms

Conditions

Prediabetic State; Obesity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

We were unable to analyze the change in BMI and change in A1c due to the low number of individuals who enrolled in diabetes prevention classes

Results Point of Contact

• Title: Dr. Emily Schroeder
• Organization: Kaiser Permanente Colorado

emily.b.schroeder@kp.org

303-636-2478

Study Officials

• Emily Schroeder, MD, PhD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Model Details: 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.

Study Record Dates

• First Submitted: June 23, 2017
• First Posted: June 27, 2017
• Study Start: June 26, 2017
• Primary Completion: November 10, 2017
• Study Completion: November 10, 2017
• Last Updated: December 13, 2019
• Results First Posted: December 13, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)