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Not recruiting

Preconception Care

Sponsor:

Northwestern University

Code:

NCT04976881

Conditions

Diabetes Mellitus, Type 2

Electronic Health Record

Primary Health Care

Reproductive Behavior

Eligibility Criteria

Sex: Female

Age: 18 - 44

Healthy Volunteers: Not accepted

Interventions

Medication Reconciliation (MedRec) Tool

Provider Alert and Decision Support

PREPSheet

Text Messaging

Study Details

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

Study ID

NCT04976881

Start date

May 6, 2022

Status verified date

Jul, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 44

Healthy Volunteers: Not accepted

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 Design

Enrollment

840 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

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.

Interventions

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.

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.

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.

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.

Primary outcome measure

  • Average difference in HbA1c values between Intervention and Control Patients [ Time Frame: 6 months ]
  • Knowledge of reproductive risks [ Time Frame: 1 month ]

Central Contacts and Locations

More Information

Sponsor

Northwestern University

Last update posted

Jul 9, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-25. This information was provided to ClinicalTrials.gov by Northwestern University on 2026-07-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.