Promoting Preconception Care and Diabetes Self-Management Among Reproductive-Aged Women With Diabetes
- Conditions
- Electronic Health RecordReproductive BehaviorPrimary Health CareDiabetes Mellitus, Type 2
- Interventions
- Behavioral: Medication Reconciliation (MedRec) ToolBehavioral: Provider Alert and Decision SupportBehavioral: PREPSheetBehavioral: Text Messaging
- Registration Number
- NCT04976881
- Lead Sponsor
- Northwestern University
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 840
- 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.
- severe, uncorrectable vision, hearing, or cognitive impairments that would preclude study consent or participation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PREPARED Strategy Provider Alert and Decision Support 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. PREPARED Strategy Text Messaging 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. PREPARED Strategy Medication Reconciliation (MedRec) Tool 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. PREPARED Strategy PREPSheet 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.
- Primary Outcome Measures
Name Time Method Average difference in HbA1c values between Intervention and Control Patients 6 months We will abstract HbA1c values from performance sites EHRs to investigate effects of PREPARED.
Knowledge of reproductive risks 1 month 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.
- Secondary Outcome Measures
Name Time Method Average difference in cholesterol values between Intervention and Control Patients 6 months We will abstract cholesterol values from performance sites EHRs to investigate effects of PREPARED.
Contraceptive use at 1 month and 3 months 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'
Average difference in blood pressure values between Intervention and Control Patients 6 months We will abstract blood pressure values (systolic and diastolic) from performance sites EHRs to investigate effects of PREPARED.
Engagement in diabetes self-care activities at 1 month and 3 months 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.
Folic acid use at 1 month and 3 months Patients are asked if they have taken folic acid supplements or a vitamin containing folic acid over the past month (yes/no).
Trial Locations
- Locations (1)
Northwestern University
🇺🇸Chicago, Illinois, United States