Diabetes Mellitus, Type 2PREPAREDNCT04976881
Promoting Preconception Care and Diabetes Self-Management Among Reproductive-Aged Women With Diabetes
A study testing Medication Reconciliation (MedRec) Tool, Provider Alert and Decision Support and PREPSheet in people with Diabetes Mellitus, Type 2 and Electronic Health Record, run by Northwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- Diabetes Mellitus, Type 2, Electronic Health Record, Primary Health Care
- What is being tested?
- Medication Reconciliation (MedRec) Tool, Provider Alert and Decision Support and PREPSheet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 840 participants
- Where
- 1 siteUnited States
- Study dates
- 6 May 2022to 9 Apr 2027
- Phase
- Interventional
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 to 44 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- severe, uncorrectable vision, hearing, or cognitive impairments that would preclude study consent or participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2, Electronic Health Record, Primary Health Care, Reproductive Behavior
- Being tested
- Medication Reconciliation (MedRec) Tool, Provider Alert and Decision Support, PREPSheet, Text Messaging
- Medical subject headings
- Diabetes Mellitus, Type 2, Reproductive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medication Reconciliation (MedRec) ToolBehavioural
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 SupportBehavioural
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.
PREPSheetBehavioural
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 MessagingBehavioural
Within ~5 days of their index clinic visit, intervention patients will begin to receive daily, unidirectional text messages to reinforce diabetes self-care behaviors.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | 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. |
| PREPARED Strategy | Active comparator | 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. Receives: Behavioral: Medication Reconciliation (MedRec) Tool; Behavioral: Provider Alert and Decision Support; Behavioral: PREPSheet; Behavioral: Text Messaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average difference in HbA1c values between Intervention and Control Patients
We will abstract HbA1c values from performance sites EHRs to investigate effects of PREPARED.
Measured: 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.
Measured: 1 month
Secondary outcomes (5)
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.
Measured: 6 months
Average difference in cholesterol values between Intervention and Control Patients
We will abstract cholesterol values from performance sites EHRs to investigate effects of PREPARED.
Measured: 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.
Measured: at 1 month and 3 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'
Measured: 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).
Measured: at 1 month and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2021
- Study start6 May 2022
- Primary completion9 Apr 2027 (estimated)
- Study completion9 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 840 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Northwestern Memorial Hospital, AllianceChicago
- 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
- NCT04976881
- Sponsor's protocol ID
- STU00214604
- Acronym
- PREPARED
- Status last verified
- Sep 2026
- First submitted
- 15 Jul 2021
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be made available upon reasonable request to the study principal investigator.
Publications
Bailey SC, Pack AP, Wismer G, Calderon N, Velazquez E, Batio S, Ekong A, Eggleston A, Wallia A, Wolf MS, Schauer JM, Tenfelde S, Liebovitz DM, Grobman WA. Promoting REproductive Planning And REadiness in Diabetes (PREPARED) Study protocol: a clinic-randomised controlled trial testing a technology-based strategy to promote preconception care for women with type 2 diabetes. BMJ Open. 2023 Nov 8;13(11):e078282. doi: 10.1136/bmjopen-2023-078282.
PubMed 37940161