Promoting Preconception Care and Diabetes Self-Management Among Reproductive-Aged Women With Diabetes (PREPARED)

Northwestern University

Status: Enrolling

Conditions: Electronic Health Record; Primary Health Care; Diabetes Mellitus, Type 2; Reproductive Behavior

Treatments: Behavioral: Text Messaging; Behavioral: Medication Reconciliation (MedRec) Tool; Behavioral: Provider Alert and Decision Support; Behavioral: PREPSheet

Study type: Interventional

Funder types: Other

Identifiers

NCT04976881

STU00214604

Details and patient eligibility

About

This study is being done to investigate strategies that may improve patient's knowledge of type 2 diabetes during reproductive age and improve knowledge and engagement in self-care activities.

Full description

Our Promoting REproductive Planning, And REadiness in Diabetes (PREPARED) strategy will utilize health information and consumer technologies to 'hardwire' preconception care and promote diabetes self-management among reproductive-aged, adult women with T2DM in primary care. Specifically, PREPARED will leverage electronic health record (EHR) technology at clinic visits to: [1] promote medication reconciliation and safety, [2] prompt patient-provider preconception counseling and reproductive planning, and [3] deliver low literacy print tools to reinforce counseling and promote goal-setting for diabetes self-care activities. Post-visit, a widely-available text messaging platforms will be used to: [4] encourage healthy lifestyle behaviors through goal-setting and daily reminders. Our randomized trial will assess the effectiveness and fidelity of a technology-based strategy to promote preconception care and diabetes self-management among women with type 2 diabetes in primary care.

Aim 1: Test the effectiveness of PREPARED, compared to usual care, to improve patient: a) knowledge of reproductive risks associated with T2DM and recommended self-care activities b) engagement in self-care behaviors, including: i) diet, ii) physical activity, iii) adherence to diabetes medications; and use of iv) folic acid, and v) most or moderately effective contraception, when indicated; and c) clinical measures, including hemoglobin A1c, blood pressure, and LDL cholesterol.

Aim 2: Assess whether PREPARED reduces disparities in the above outcomes versus usual care.

Aim 3: Evaluate the fidelity of PREPARED to prompt medication reconciliation and preconception counseling, and to deliver patient education and post-visit support of diabetes self-care behaviors.

Enrollment: 840 estimated patients

Sex: Female

Ages: 18 to 44 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• female
• age 18-44
• English or Spanish-speaking
• have a chart diagnosis of type 2 diabetes
• not currently pregnant
• not infecund, sterilized, or in a monogamous relationship with a sterilized partner
• have a private cell phone with text messaging capability.

Exclusion criteria

• severe, uncorrectable vision, hearing, or cognitive impairments that would preclude study consent or participation

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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840 participants in 2 patient groups

Usual Care

No Intervention group

Description:

Usual care includes: 1) no specific materials to promote medication reconciliation, reproductive planning, or patient education on diabetes self-management within the context of preconception care, 2) variable physician preconception counseling without any EHR notifications or counseling support; and 3) no specific patient support or prompts to promote healthy behaviors post-visits.

PREPARED Strategy

Active Comparator group

Description:

Our PREPARED strategy will utilize health information and consumer technologies to 'hardwire' preconception care and promote diabetes self-management among reproductive-aged, adult women with T2DM in primary care. PREPARED will leverage electronic health record technology at clinic visits to: \[1\] promote medication reconciliation and safety, \[2\] prompt provider preconception counseling, and \[3\] deliver low literacy print tools to reinforce counseling and promote diabetes self-care. Post-visit, text messaging will be used to: \[4\] encourage healthy lifestyle behaviors.

Treatment:

Behavioral: PREPSheet

Behavioral: Provider Alert and Decision Support

Behavioral: Medication Reconciliation (MedRec) Tool

Behavioral: Text Messaging