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

NCT04976881 | Recruiting DMC

• 1 other identifier: STU00214604
• Study Type: interventional
• Target: 840
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Average difference in HbA1c values between Intervention and Control Patients

  We will abstract HbA1c values from performance sites EHRs to investigate effects of PREPARED.

  6 months

• Knowledge of reproductive risks

  We will use a questionnaire, developed by our team and the scientific literature, to evaluate patient knowledge of reproductive risks and recommended health behaviors for women with type 2 diabetes. It includes items assessing knowledge of pregnancy planning, reproductive risks, and desired diabetes self-care behaviors. Correctly answered questions will be summed and a total knowledge score will be generated. Higher scores indicate greater knowledge.

  1 month

Secondary Outcomes (5)

• Average difference in blood pressure values between Intervention and Control Patients

  6 months

• Average difference in cholesterol values between Intervention and Control Patients

  6 months

• Engagement in diabetes self-care activities

  at 1 month and 3 months

• Contraceptive use

  at 1 month and 3 months

• Folic acid use

  at 1 month and 3 months

Study Arms (2)

Usual Care

NO INTERVENTION

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

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.

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

Interventions

Medication Reconciliation (MedRec) Tool BEHAVIORAL

Patients will receive a print MedRec tool, generated via the EHR, which includes a list of medications prescribed according to the patient record. Patients are asked to review this list, to add/remove drugs to reflect actual use, to note how they are taking each medication, and to describe any concerns.

PREPARED Strategy

Provider Alert and Decision Support BEHAVIORAL

During the clinic visit, an automated, EHR alert will notify the provider that the patient is a woman of reproductive age with T2DM and should receive counseling on the importance of glycemic control, the use of contraception until glycemic control is achieved, and the benefits of folic acid.

PREPARED Strategy

PREPSheet BEHAVIORAL

When patients leave an encounter, they will receive a patient-friendly educational material (a.k.a. the PREPSheet) that reviews potential risks of pregnancy in the context of T2DM and highlights the importance of: 1) achieving glycemic control through diabetes self-care, 2) using effective contraception until glycemic control is achieved and pregnancy is desired, 3) discussing medication use with a provider if planning or becoming pregnant, and 4) taking folic acid daily to reduce increased risk of neural tube defects.

PREPARED Strategy

Text Messaging BEHAVIORAL

Within \~5 days of their index clinic visit, intervention patients will begin to receive daily, unidirectional text messages to reinforce diabetes self-care behaviors.

PREPARED Strategy

Eligibility Criteria

• Age: 18 Years - 44 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Northwestern University: lead
• Northwestern Memorial Hospital: collaborator
• AllianceChicago: collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

Related Publications (1)

• Bailey SC, Pack AP, Wismer G, Calderon N, Velazquez E, Batio S, Ekong A, Eggleston A, Wallia A, Wolf MS, Schauer JM, Tenfelde S, Liebovitz DM, Grobman WA. Promoting REproductive Planning And REadiness in Diabetes (PREPARED) Study protocol: a clinic-randomised controlled trial testing a technology-based strategy to promote preconception care for women with type 2 diabetes. BMJ Open. 2023 Nov 8;13(11):e078282. doi: 10.1136/bmjopen-2023-078282.

  PMID: 37940161 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Reproductive Behavior

Interventions

Medication Reconciliation; Equipment and Supplies

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Medication Errors; Drug Therapy; Therapeutics; Medical Errors; Health Services; Health Care Facilities Workforce and Services; Medication Systems; Organization and Administration; Health Services Administration; Patient Care Management

Study Officials

• Stacy Bailey, PhD MPH

  Northwestern University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stacy Bailey, PhD MPH

CONTACT

312-503-5595; stacy-bailey@northwestern.edu

Guisselle Wismer, MPH

CONTACT

312-503-3272; guisselle.wismer@northwestern.edu

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: Associate Professor

Study Record Dates

• First Submitted: July 15, 2021
• First Posted: July 26, 2021
• Study Start: May 6, 2022
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data and other documents will be made available upon reasonable request to the PI 24 months after study termination

Locations

US (1)