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

Promoting Preconception Care and Diabetes Self-Management Among Reproductive-Aged Women With Diabetes: The PREPARED Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus, Type 2; Primary Health Care; Reproductive Behavior; Electronic Health Record
• Intervention / Treatment: Behavioral: Medication Reconciliation (MedRec) Tool; Behavioral: Provider Alert and Decision Support; Behavioral: PREPSheet; Behavioral: Text Messaging

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 840
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stacy Bailey, PhD MPH; Phone Number: 312-503-5595; Email: stacy-bailey@northwestern.edu
• Study Contact Backup: Name: Guisselle Wismer, MPH; Phone Number: 312-503-3272; Email: guisselle.wismer@northwestern.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Northwestern University
      • Contact: Guisselle Wismer, MPH; Phone Number: 312-503-3272; Email: guisselle.wismer@northwestern.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 44 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

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

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care; 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.
Active Comparator: PREPARED Strategy; 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; 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.; Behavioral: Provider Alert and Decision Support; 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.; Behavioral: PREPSheet; 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.; Behavioral: Text Messaging; Within ~5 days of their index clinic visit, intervention patients will begin to receive daily, unidirectional text messages to reinforce diabetes self-care behaviors.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average difference in cholesterol values between Intervention and Control Patients	We will abstract cholesterol values from performance sites EHRs to investigate effects of PREPARED.	6 months
Contraceptive use	we will use validated items to assess patient contraceptive use, which is categorized into use of a 'most or moderately effective' form of contraception or 'less effective/no contraception'	at 1 month and 3 months
Folic acid use	Patients are asked if they have taken folic acid supplements or a vitamin containing folic acid over the past month (yes/no).	at 1 month and 3 months
Average difference in blood pressure values between Intervention and Control Patients	We will abstract blood pressure values (systolic and diastolic) from performance sites EHRs to investigate effects of PREPARED.	6 months
Engagement in diabetes self-care activities	We will use the validated Summary of Diabetes Self Care Activities (SDSCA) measure. Scores range from 0 to 7 for each domain, with higher scores reflect greater engagement.	at 1 month and 3 months

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: Northwestern Memorial Hospital; AllianceChicago
• Investigators: Principal Investigator: Stacy Bailey, PhD MPH, Northwestern University

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2022
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: July 15, 2021
• First Submitted That Met QC Criteria: July 15, 2021
• First Posted (Actual): July 26, 2021

Study Record Updates

• Last Update Posted (Actual): September 8, 2023
• Last Update Submitted That Met QC Criteria: September 5, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: STU00214604

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data will be made available upon reasonable request to the study principal investigator.
• IPD Sharing Time Frame: Data and other documents will be made available upon reasonable request to the PI 24 months after study termination
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

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