search
Back to results

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

Primary Purpose

Gestational Diabetes Mellitus, Hypertension in Pregnancy, Dysglycemia

Status
Not yet recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
OB Provider Clinical Decision Support (CDS)
Patient Education (OB Visit)
Text messaging
Patient Outreach
Primary Care Provider Clinical Decision Support (CDS)
Patient Education (Primary Care Visit)
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Gestational Diabetes Mellitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: 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

Sites / Locations

  • Cook County Health
  • AllianceChicago

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Usual Care

STEP-UP

Arm Description

Patients will receive the usual standard of care

STEP-UP will promote linkage to primary care and ongoing chronic disease evaluation for postpartum women with prior GDM and/or HDP

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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).
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).

Full Information

First Posted
May 1, 2023
Last Updated
September 22, 2023
Sponsor
Northwestern University
Collaborators
AllianceChicago, Cook County Health
search

1. Study Identification

Unique Protocol Identification Number
NCT05852054
Brief Title
Supporting Transitions to Primary Care Among Under-resourced, Postpartum Women (STEP-UP)
Official Title
Supporting Transitions to Primary Care Among Under-resourced, Postpartum Women: The STEP-UP Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 15, 2023 (Anticipated)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
AllianceChicago, Cook County Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes Mellitus, Hypertension in Pregnancy, Dysglycemia

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
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
Outcomes Assessor
Allocation
Randomized
Enrollment
788 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Patients will receive the usual standard of care
Arm Title
STEP-UP
Arm Type
Active Comparator
Arm Description
STEP-UP will promote linkage to primary care and ongoing chronic disease evaluation for postpartum women with prior GDM and/or HDP
Intervention Type
Behavioral
Intervention Name(s)
OB Provider Clinical Decision Support (CDS)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Patient Education (OB Visit)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Text messaging
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Patient Outreach
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Primary Care Provider Clinical Decision Support (CDS)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Patient Education (Primary Care Visit)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Primary care visit (PCV) completion
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Completion of dysglycemia testing
Description
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.
Time Frame
6 months
Title
Orders for dysglycemia testing
Description
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).
Time Frame
6 months
Title
Dysglycemia and hypertension cases detected
Description
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).
Time Frame
6 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
All trial participants will be women with gestational diabetes and/or hypertensive disorders of pregnancy; they will be accrued into the study upon delivery.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stacy Bailey, PhD MPH
Phone
312-503-5595
Email
stacy-bailey@northwestern.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Guisselle Wismer, MPH
Phone
312-503-3272
Email
guisselle.wismer@northwestern.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stacy Bailey, PhD MPH
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cook County Health
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christina Urbina, MBA
Facility Name
AllianceChicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60654
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs