Diabetes Self-Management Education for Reproductive-Aged Women With Type 2 Diabetes

(PREPARED Trial)

Overseen By Guisselle Wismer, MPH

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Severe vision, hearing, cognitive impairments

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

840 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find better ways to help women with type 2 diabetes manage their condition during their reproductive years. It will test a strategy using digital tools, such as electronic health records and text messaging (also known as SMS or Mobile Health Messaging), to support diabetes care and healthy lifestyle habits. Participants will either receive this new approach or continue with usual care, which excludes these specific tools. Women with type 2 diabetes who can become pregnant may be a good fit, especially if they have access to a cell phone with text messaging. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance diabetes management for women in their reproductive years.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these strategies are safe for improving diabetes self-management in reproductive-aged women?

Research shows that the treatments in this study are generally safe and well-tolerated. The Medication Reconciliation Tool prevents medication mistakes by tracking all the medicines a patient takes. Studies indicate this tool can reduce the risk of negative medication reactions.

The Provider Alert and Decision Support system uses electronic health records to offer doctors helpful reminders and advice. This system aims to improve patient care, especially in diabetes management, without causing harm.

Text messaging is another part of the treatment plan. Research shows that supportive text messages can help people manage their diabetes better. These messages can improve blood sugar control and encourage adherence to the treatment plan.

Specific safety data for the PREPSheet is unavailable, but the overall strategy aims to support diabetes self-management and appears safe based on the supportive nature of its components. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PREPARED Strategy because it integrates modern health information technology to enhance diabetes self-management for reproductive-aged women with Type 2 Diabetes. Unlike traditional care, which often lacks structured support for medication reconciliation and preconception counseling, this approach uses electronic health records to automate these processes and ensure consistent patient education. Additionally, it extends support beyond clinic visits by employing text messaging to reinforce healthy lifestyle habits, making it a comprehensive and continuous care model. This innovative use of technology could lead to more effective diabetes management and improved health outcomes for these women.

What evidence suggests that this trial's treatments could be effective for diabetes self-management in reproductive-aged women with type 2 diabetes?

Research shows that the PREPARED strategy, a treatment arm in this trial, includes tools such as the Medication Reconciliation Tool, Provider Alert and Decision Support, and Text Messaging, which may assist women with type 2 diabetes. Studies have found that a medication reconciliation tool can enhance medication adherence and lead to better health outcomes. Clinical decision support systems significantly improve blood sugar control and other health measures in diabetes management. Additionally, text messaging effectively helps people improve blood sugar levels by promoting self-care and healthy lifestyle choices. Together, these tools aim to help women manage their diabetes more effectively and engage in self-care activities. ^{6 7 8 9 10}

Who Is on the Research Team?

Stacy Bailey, PhD MPH

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

This trial is for women aged 18-44 with type 2 diabetes who are not currently pregnant, can get pregnant, and aren't in a relationship with someone unable to have children. They must speak English or Spanish, be able to consent, and have a private cell phone that can send texts.

Inclusion Criteria

Not currently pregnant

Have a private cell phone with text messaging capability

I am female.

Exclusion Criteria

Severe, uncorrectable vision, hearing, or cognitive impairments that would preclude study consent or participation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in the PREPARED strategy, which includes medication reconciliation, preconception counseling, and diabetes self-care promotion using EHR technology and text messaging

6 months

Regular clinic visits with EHR prompts and post-visit text messaging

Follow-up

Participants are monitored for changes in knowledge of reproductive risks, engagement in self-care behaviors, and clinical measures such as HbA1c, blood pressure, and cholesterol

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Medication Reconciliation (MedRec) Tool
• PREPSheet
• Provider Alert and Decision Support
• Text Messaging

Trial Overview

The study tests if certain tools like provider alerts, decision support systems, medication reconciliation tools (MedRec), PREPSheets for planning pregnancy care, and text messaging improve knowledge and self-care in reproductive-aged women with type 2 diabetes.

How Is the Trial Designed?

Group I: PREPARED Strategy Active Control 4 Interventions

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.

Group II: Usual Care Active Control 1 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.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Northwestern Memorial Hospital

Collaborator

Trials

42

Recruited

15,800+

AllianceChicago

Collaborator

Trials

8

Recruited

18,700+

Published Research Related to This Trial

The integration of the MedsCheck program into the Complex Care Clinic workflow was successful, with 39% of eligible patients receiving a best possible medication history (BPMH) from their community pharmacy, which helps reduce medication discrepancies.

Medical residents experienced an average time savings of 7.9 minutes per appointment when using the MedsCheck program, indicating improved efficiency in managing patient medication histories.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MedIntegrate: Incorporating provincially funded community pharmacist services into an ambulatory internal medicine clinic to enhance medication reconciliation. Tomas, M., Crown, N., Borschel, D., et al.[2022]

In a four-month study involving 42 patients, the patient app for medication reconciliation was found to be acceptable to 69% of users, indicating a positive reception and high perceived usefulness.

The app generated a complete medication list for only 25% of patients, with a notable 21.7% of medications showing discrepancies, highlighting the need for further improvements to enhance its effectiveness in ensuring accurate medication records.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A web application to involve patients in the medication reconciliation process: a user-centered usability and usefulness study. Marien, S., Legrand, D., Ramdoyal, R., et al.[2020]

A systematic review identified 11 electronic tools designed to support medication reconciliation (MedRec), highlighting their development primarily in North America and their reliance on electronic data from multiple sources.

Successful implementation of these tools requires careful attention to their design and the context in which they are used, with future research needed to assess their impact on healthcare quality and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic tools to support medication reconciliation: a systematic review. Marien, S., Krug, B., Spinewine, A.[2020]

In a study of 635 adult patients admitted to internal medicine wards, 39.1% experienced at least one unintended medication discrepancy (UMD), with the most common issues being medication omissions (41.75%) and incorrect dosages (21.9%).

Factors such as older age (≥65 years), polypharmacy, and low to medium medication adherence were significantly associated with UMDs, highlighting the importance of pharmacists-led medication reconciliation to enhance patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unintended medication discrepancies and associated factors upon patient admission to the internal medicine wards: identified through medication reconciliation. Moges, TA., Akalu, TY., Sema, FD.[2022]

A study involving interviews with 21 cancer centers in Canada revealed that while 81% had a process for collecting a Best Possible Medication History (BPMH), only 4.7% of patients received a full medication reconciliation (MedRec), indicating significant gaps in practice.

Despite achieving a BPMH for 26.6% of eligible patients, barriers such as resource limitations and lack of integrated medical records hindered the effectiveness of medication reconciliation efforts in outpatient cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of medication reconciliation in outpatient cancer care. Powis, M., Dara, C., Macedo, A., et al.[2023]

The use of electronic medication reconciliation (eMedRec) tools significantly reduced the number of medications with unintended discrepancies, indicating improved medication safety in hospital settings, based on a meta-analysis of 13 studies involving various trial designs.

Despite the reduction in medication discrepancies, the tools showed no significant impact on the number of patients experiencing these discrepancies, and issues with usability and user satisfaction were noted, suggesting that further evaluation of these tools is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic medication reconciliation in hospitals: a systematic review and meta-analysis. Wang, H., Meng, L., Song, J., et al.[2022]

Medication reconciliation is essential for reducing medical errors and injuries by creating and comparing accurate medication lists from various patient information sources, but its implementation faces challenges across different healthcare institutions.

Key issues include the need for a standardized system for drug identification, stakeholder engagement, and integration with electronic health records, which are crucial for effective and universal adoption of medication reconciliation practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of medication reconciliation issues and experiences with clinical staff and information systems. Porcelli, PJ., Waitman, LR., Brown, SH.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5028848/

Effects of a Patient-Provider, Collaborative, Medication ...

This EMR-enabled Medtable strategy was evaluated to determine its impact on medication use and health outcomes among patients with type II diabetes mellitus.

2.

mdpi.com

mdpi.com/2227-9032/13/7/778

Implementation and User Satisfaction Analysis of an ...

This study describes the implementation of an electronic medication reconciliation tool, ConciliaMed, in a multidisciplinary medication reconciliation programme ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04976881

Promoting Preconception Care and Diabetes Self- ...

Our PREPARED strategy will utilize health information and consumer technologies to 'hardwire' preconception care and promote diabetes self-management among ...

4.

diabetesjournals.org

diabetesjournals.org/clinical/article/38/4/382/35399/Design-and-Implementation-of-an-Electronic-Tool-to

Design and Implementation of an Electronic Tool to Measure ...

This series is intended to highlight best practices and strategies from programs and clinics that have successfully improved the quality of care ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10632823/

Promoting REproductive Planning And REadiness in Diabetes ...

A clinic-randomised controlled trial testing a technology-based strategy to promote preconception care for women with type 2 diabetes.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11988579/

Implementation and User Satisfaction Analysis of an ...

This study describes the implementation of an electronic medication reconciliation tool, ConciliaMed, in a multidisciplinary medication ...

7.

psnet.ahrq.gov

psnet.ahrq.gov/web-mm/challenges-diabetes-management-and-medication-reconciliation

Challenges of Diabetes Management and Medication ...

Medication reconciliation is especially important for vulnerable patient populations who are often on multiple or high-risk medications, such as patients with ...

8.

implementationsciencecomms.biomedcentral.com

implementationsciencecomms.biomedcentral.com/articles/10.1186/s43058-021-00162-5

Implementation strategies in the context of medication ...

Medication reconciliation (MedRec) is an important patient safety initiative that aims to prevent patient harm from medication errors.

9.

ashp.org

ashp.org/-/media/assets/pharmacy-practice/resource-centers/quality-improvement/learn-about-quality-improvement-match.pdf

MATCH Toolkit for Medication Reconciliation

While many health care providers already have medication reconciliation processes in place, this toolkit will facilitate a review and improvement of current ...

10.

diabetesjournals.org

diabetesjournals.org/care/article/41/8/1639/36364/Ambulatory-Medication-Reconciliation-and-Frequency

Ambulatory Medication Reconciliation and Frequency of ...

Medication reconciliation is an important patient safety measure. It can reduce medication discrepancies, potential adverse drug events, and ...