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

NCT ID: NCT03200535

Last Updated: 2019-12-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6588 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-26

Study Completion Date

2017-11-10

Brief Summary

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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.

Detailed Description

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Conditions

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PreDiabetes Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Usual care

Usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Electronic health record "gaps"

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

Group Type ACTIVE_COMPARATOR

EHR gaps

Intervention Type OTHER

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

Group Type ACTIVE_COMPARATOR

EHR gaps

Intervention Type OTHER

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

Bulk outreach

Intervention Type OTHER

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

Group Type ACTIVE_COMPARATOR

EHR gaps

Intervention Type OTHER

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

Bulk outreach

Intervention Type OTHER

A bulk letter or email will be sent

Dietician call

Intervention Type OTHER

Patients will receive a personalized call by a registered dietitian

Interventions

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EHR gaps

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

Intervention Type OTHER

Bulk outreach

A bulk letter or email will be sent

Intervention Type OTHER

Dietician call

Patients will receive a personalized call by a registered dietitian

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kaiser Permanente

OTHER

Sponsor Role lead

Responsible Party

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Emily Schroeder

Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Emily Schroeder, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente

Locations

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Kaiser Permanente Coloado

Denver, Colorado, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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CO-17-2437

Identifier Type: -

Identifier Source: org_study_id