Gestational Diabetes MellitusNCT05852054
Supporting Transitions to Primary Care Among Under-resourced, Postpartum Women (STEP-UP)
A study testing OB Provider Clinical Decision Support (CDS), Patient Education (OB Visit) and Text messaging in people with Gestational Diabetes Mellitus and Hypertension in Pregnancy, run by Northwestern University at 2 sites in United States.
Trial summary
STEP-UP will promote linkage to primary care and ongoing chronic disease evaluation for postpartum women with prior gestational diabetes mellitus (GDM) and/or hypertensive disorders of pregnancy (HDP). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gestational Diabetes Mellitus, Hypertension in Pregnancy, Dysglycemia
- What is being tested?
- OB Provider Clinical Decision Support (CDS), Patient Education (OB Visit) and Text messaging
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,306 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Nov 2023to 31 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Delivered during an accrual period,
- Had a chart diagnosis during their index pregnancy of GDM and/or HDP,
- Attended at least 1 prenatal care visit at a study site in the 6 months prior to delivery,
- Speak English or Spanish,
- Age 18 or older
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Cook County Health
Chicago, Illinois, 60612
AllianceChicago
Chicago, Illinois, 60654
About this study
Official title: Supporting Transitions to Primary Care Among Under-resourced, Postpartum Women: The STEP-UP Trial
STEP-UP will promote linkage to primary care and ongoing chronic disease evaluation for postpartum women with prior gestational diabetes mellitus (GDM) and/or hypertensive disorders of pregnancy (HDP).
Read the detailed description
STEP-UP will promote linkage to primary care and ongoing chronic disease evaluation for postpartum women with prior gestational diabetes mellitus (GDM) and/or hypertensive disorders of pregnancy (HDP) by promoting:
- counseling and referral to primary care, during OB visits, via electronic health record (EHR)-based clinical decision support (CDS)
- dysglycemia testing for women with prior GDM, prompted via CDS during both OB and primary care visits
- dissemination of understandable information on future risk and the need for ongoing evaluation generated automatically via the EHR and printed for patients with after-visit summaries (AVS)
- motivational messaging and reminders supporting transitions of care delivered directly to patients via short message service (SMS) text messages
- individualized outreach and support for those who need additional help arranging a primary care visit
We will utilize a stepped wedge design to achieve the study's specific aims, which are to:
Aim 1 Test the effectiveness of STEP-UP, compared with usual care, to improve patient: 1) knowledge of reproductive risks associated with T2DM and recommended self-care activities; 2) engage in self-care behaviors, including diet, physical activity, adherence to diabetes medications, and use of folic acid and most or moderately effective contraception, when indicated; and 3) clinical measures, including hemoglobin A1c, blood pressure, and LDL cholesterol.
Aim 2 Investigate the heterogeneity of STEP-UP intervention effects by patients' race, ethnicity, and language.
Aim 3 Assess the reach, adoption, implementation, maintenance and costs of STEP-UP components.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Patients will receive the usual standard of care |
| STEP-UP | Active comparator | STEP-UP will promote linkage to primary care and ongoing chronic disease evaluation for postpartum women with prior GDM and/or HDP Receives: Behavioral: OB Provider Clinical Decision Support (CDS); Behavioral: Patient Education (OB Visit); Behavioral: Text messaging; Behavioral: Patient Outreach; Behavioral: Primary Care Provider Clinical Decision Support (CDS); Behavioral: Patient Education (Primary Care Visit) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Secondary outcomes (3)
Completion of dysglycemia testing
Assess rates of testing for dysglycemia among eligible women who had a diagnosis of GDM in their index pregnancy. This binary outcome (yes/no) will be ascertained by the presence of a value from any dysglycemia test (e.g. A1c, fasting glucose, oral glucose tolerance test) at any time within the 6-month follow-up period. The testing rate across STEP-UP vs. UC will be calculated by dividing this numerator by the denominator of all eligible patients with GDM in their index pregnancy.
Measured: 6 months
Orders for dysglycemia testing
Assess whether eligible patients have an order for any dysglycemia test (e.g. A1c, fasting glucose, oral glucose tolerance test) at any time during the 6-month follow-up period. This dichotomous outcome largely assesses the effectiveness of the provider-facing STEP-UP components. The investigator ascertain orders in this same way across STEP-UP and UC conditions. As an exploratory outcome, the investigator will examine the proportion of total tests ordered through the CDS versus the routine lab order entry mechanism. The investigator will also examine the association of orders with patient characteristics (e.g. age, BMI, race, ethnicity, language) and provider characteristics available in the EHR (i.e. physician vs. advanced practice provider, patient panel size).
Measured: 6 months
Dysglycemia and hypertension cases detected
Assess the rate of dysglycemia and hypertension cases detected among eligible patients. Rate of detection for dysglycemia will be determined by the proportion of eligible patients with a prior diagnosis of GDM (i.e. denominator) who have a test value indicating dysglycemia according to ADA guidelines during follow-up (i.e. numerator). The rate of dysglycemia cases detected will be compared between STEP-UP and UC conditions. The investigator will run similar analyses for hypertension, using 2017 American College of Cardiology/American Heart Association criteria (hypertension: systolic blood pressure (SBP) greater than or equal to 130 mmHg or diastolic blood pressure (DBP)greater than or equal to 80 mmHg; stage 2 hypertension defined as SBP greater than or equal to 140 mmHg or DBP greater than or equal to 90 mmHg).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study start1 Nov 2023
- Primary completion31 Jan 2026
- 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.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a stepped wedge, pragmatic design. Study sites deliver usual care until they are randomized to provide the STEP-UP intervention.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,306 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- AllianceChicago, Cook County Health, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Stacy C Bailey, Northwestern University
- Investigators
- Stacy Bailey, PhD MPH, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05852054
- Sponsor's protocol ID
- STU00217979
- Other IDs
- R01HL168832
- Status last verified
- Sep 2026
- First submitted
- 1 May 2023
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supporting Transitions to Primary Care Among Under-resourced, Postpartum Women: The STEP-UP Trial
- ClinicalTrials.gov ID
- NCT05852054
- Acronym / sponsor ID
- STU00217979
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,306 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- AllianceChicago, Cook County Health, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 10 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
STEP-UP will promote linkage to primary care and ongoing chronic disease evaluation for postpartum women with prior gestational diabetes mellitus (GDM) and/or hypertensive disorders of pregnancy (HDP).
Detailed description
STEP-UP will promote linkage to primary care and ongoing chronic disease evaluation for postpartum women with prior gestational diabetes mellitus (GDM) and/or hypertensive disorders of pregnancy (HDP) by promoting:
- counseling and referral to primary care, during OB visits, via electronic health record (EHR)-based clinical decision support (CDS)
- dysglycemia testing for women with prior GDM, prompted via CDS during both OB and primary care visits
- dissemination of understandable information on future risk and the need for ongoing evaluation generated automatically via the EHR and printed for patients with after-visit summaries (AVS)
- motivational messaging and reminders supporting transitions of care delivered directly to patients via short message service (SMS) text messages
- individualized outreach and support for those who need additional help arranging a primary care visit
We will utilize a stepped wedge design to achieve the study's specific aims, which are to:
Aim 1 Test the effectiveness of STEP-UP, compared with usual care, to improve patient: 1) knowledge of reproductive risks associated with T2DM and recommended self-care activities; 2) engage in self-care behaviors, including diet, physical activity, adherence to diabetes medications, and use of folic acid and most or moderately effective contraception, when indicated; and 3) clinical measures, including hemoglobin A1c, blood pressure, and LDL cholesterol.
Aim 2 Investigate the heterogeneity of STEP-UP intervention effects by patients' race, ethnicity, and language.
Aim 3 Assess the reach, adoption, implementation, maintenance and costs of STEP-UP components.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a stepped wedge, pragmatic design. Study sites deliver usual care until they are randomized to provide the STEP-UP intervention.
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Patients will receive the usual standard of care |
| STEP-UP | Active comparator | Behavioral: OB Provider Clinical Decision Support (CDS), Behavioral: Patient Education (OB Visit), Behavioral: Text messaging, Behavioral: Patient Outreach, Behavioral: Primary Care Provider Clinical Decision Support (CDS), Behavioral: Patient Education (Primary Care Visit)STEP-UP will promote linkage to primary care and ongoing chronic disease evaluation for postpartum women with prior GDM and/or HDP |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Delivered during an accrual period,
- Had a chart diagnosis during their index pregnancy of GDM and/or HDP,
- Attended at least 1 prenatal care visit at a study site in the 6 months prior to delivery,
- Speak English or Spanish,
- Age 18 or older
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OB Provider Clinical Decision Support (CDS)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. | Behavioural | STEP-UP |
| Patient Education (OB Visit)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. | Behavioural | STEP-UP |
| Text messagingAt 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. | Behavioural | STEP-UP |
| Patient OutreachPatients 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. | Behavioural | STEP-UP |
| Primary Care Provider Clinical Decision Support (CDS)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. | Behavioural | STEP-UP |
| Patient Education (Primary Care Visit)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. | Behavioural | STEP-UP |
Primary outcome
Primary care visit (PCV) completion
Time frame: 6 months
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.
3 secondary outcomes
Completion of dysglycemia testing
Time frame: 6 months
Orders for dysglycemia testing
Time frame: 6 months
Dysglycemia and hypertension cases detected
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stacy Bailey, PhD MPH principal investigator
Northwestern University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OB Provider Clinical Decision Support (CDS), Patient Education (OB Visit) and Text messaging in people with Gestational Diabetes Mellitus and Hypertension in Pregnancy, run by Northwestern University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary care visit (PCV) completion (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.