Supporting Transitions to Primary Care Among Under-resourced, Postpartum Women (STEP-UP)

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 years and older
• Women only
• No healthy volunteers
• Adult, Older adult

Trial locations and contacts

2 sites in 1 country.

About this study

Official title: Supporting Transitions to Primary Care Among Under-resourced, Postpartum Women: The STEP-UP Trial

Conditions

Gestational Diabetes Mellitus, Hypertension in Pregnancy, Dysglycemia

Being tested

OB Provider Clinical Decision Support (CDS), Patient Education (OB Visit), Text messaging, Patient Outreach, Primary Care Provider Clinical Decision Support (CDS)

Medical subject headings

Diabetes, Gestational, Hypertension, Pregnancy-Induced

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• OB Provider Clinical Decision Support (CDS)Behavioural

  When an eligible patients' chart is opened by a provider, the provider will be alerted to counsel patients about future risk for T2D and hypertension and the need to establish a primary care medical home. The alert will include a 'referral' to primary care and a brief guide with 'key points for counseling'. For patients with prior GDM, this will also include an option to order guideline-recommended oral glucose tolerance test (OGTT) with a single click.

• Patient Education (OB Visit)Behavioural

  A 1-page document will be printed or delivered electronically for eligible patients after every postpartum OB visit during the STEP-UP condition. The document will encourage patients to know the risk and will describe the importance of routine primary care and chronic disease evaluation and management. It will also provide tips for lowering risk through lifestyle changes. Patient materials will be delivered in English or Spanish based on the structured EHR variable for preferred language.

• Text messagingBehavioural

  At 3 months postpartum, all eligible patients who have not scheduled a primary care visit will receive a motivational text to prompt scheduling; a second text will be sent for those who still have not made an appointment. Among those who schedule a visit, a reminder text will be sent before the visit. Texts will be in English or Spanish based on patients' preferred language field in the EHR and written at a <5th grade reading level.

• Patient OutreachBehavioural

  Patients who have not scheduled a primary care visit by 4 months postpartum will receive outreach from a trained coordinator who will assist with scheduling and help patients troubleshoot common barriers, such as concerns about transportation or cost.

• Primary Care Provider Clinical Decision Support (CDS)Behavioural

  The CDS will notify the provider that the patient had a recent high-risk pregnancy and signal the need to counsel the individual about their future risk for T2D and/or hypertension and the need for ongoing care. A brief guide with 'key points for counseling' described in plain language will be provided. For patients with prior GDM, the CDS will also include an easy to access 'smartset' to order appropriate testing (A1c, FG, or OGTT) based on time since delivery and provider discussions with the patient.

• Patient Education (Primary Care Visit)Behavioural

  A 1-page material will again be automatically printed or delivered electronically for eligible patients after their first primary care visit; it will replicate content from prior material provided after the OB visit.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Primary care visit (PCV) completion

   Assess completion of a primary care visit (yes/no) within 6 months of delivery. Using procedures from a pilot study, the investigator will consider an encounter a PCV if it occurred by 6 months after the delivery date; had an assigned provider type of "nurse practitioner," "physician," "internal medicine," "family medicine," and/or "physician assistant;" and did not have an assigned provider type of "OB/GYN" and/or "certified nurse midwife." The PCV rate across STEP-UP vs. UC will be calculated by dividing eligible patients with greater than or equal to 1 PCV (numerator) by the denominator of all eligible patients.

   Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted10 May 2023
2. Study start1 Nov 2023
3. Primary completion31 Jan 2026
4. Study completion31 Jan 2026

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Gestational Diabetes MellitusStudies of the same condition, open and under way.
• More trials run by Northwestern UniversityThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.