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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
840
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.
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.
Northwestern University
Chicago, Illinois, United States
RECRUITINGAverage difference in HbA1c values between Intervention and Control Patients
We will abstract HbA1c values from performance sites EHRs to investigate effects of PREPARED.
Time frame: 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.
Time frame: 1 month
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.
Time frame: 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.
Time frame: 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.
Time frame: 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'
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
Within \~5 days of their index clinic visit, intervention patients will begin to receive daily, unidirectional text messages to reinforce diabetes self-care behaviors.
Time frame: 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).
Time frame: at 1 month and 3 months