Diabetes Mellitus, Type 2, Electronic Health Record, Primary Health Care, Reproductive Behavior
Conditions
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.
Interventions
BEHAVIORALMedication Reconciliation (MedRec) Tool
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.
BEHAVIORALProvider Alert and Decision Support
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.
BEHAVIORALPREPSheet
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.
BEHAVIORALText Messaging
Within \~5 days of their index clinic visit, intervention patients will begin to receive daily, unidirectional text messages to reinforce diabetes self-care behaviors.
Sponsors
Northwestern University
Northwestern Memorial Hospital
AllianceChicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 44 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* severe, uncorrectable vision, hearing, or cognitive impairments that would preclude study consent or participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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' |
| 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). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORStacy Bailey, PhD MPH
Northwestern University
Outcome results
None listed