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

(PREPARED Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Stacy Bailey, PhD MPH

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Northwestern University

Disqualifiers: Severe vision, hearing, cognitive impairments

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests the PREPARED strategy, which uses technology to help reproductive-aged women with type 2 diabetes manage their health and plan for pregnancy. It aims to improve their knowledge and engagement in self-care activities by using electronic records, printed materials, and text messages.

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 data supports the effectiveness of the treatment Medication Reconciliation (MedRec) Tool for Diabetes Self-Management Education for Reproductive-Aged Women With Type 2 Diabetes?

Research shows that electronic medication reconciliation (MedRec) tools can help reduce medication discrepancies, which improves patient safety. This suggests that using MedRec tools in diabetes management could help ensure patients are taking the correct medications, potentially improving their overall health outcomes. ^{1 2 3 4 5}

Is the Medication Reconciliation (MedRec) process safe for humans?

The Medication Reconciliation (MedRec) process is generally considered safe and is used to reduce medication errors and improve patient safety by ensuring accurate medication information is communicated across healthcare settings. ^{1 2 3 5 6}

How does the treatment for diabetes self-management education differ from other treatments for type 2 diabetes?

The treatment focuses on diabetes self-management education specifically for reproductive-aged women with type 2 diabetes, which is unique as it targets a specific demographic and emphasizes education to empower patients in managing their condition effectively. ^{1 2 3 4 7}

Research Team

Stacy Bailey, PhD MPH

Principal Investigator

Northwestern University

Eligibility Criteria

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

I speak English or Spanish.

Not currently pregnant

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

Trial Timeline

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

Treatment Details

Interventions

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

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.

Participant Groups

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+

Dr. Jeffrey Sherman

Northwestern University

Chief Medical Officer

MD from Northwestern University

Dr. Alicia Löffler

Northwestern University

Chief Executive Officer since 2010

PhD from the University of Massachusetts at Amherst, post-doctoral training at Caltech

Northwestern Memorial Hospital

Collaborator

Trials

42

Recruited

15,800+

AllianceChicago

Collaborator

Trials

8

Recruited

18,700+

Findings from Research

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Electronic tools to support medication reconciliation: a systematic review. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Unintended medication discrepancies and associated factors upon patient admission to the internal medicine wards: identified through medication reconciliation. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Implementation of medication reconciliation in outpatient cancer care. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Electronic medication reconciliation in hospitals: a systematic review and meta-analysis. [2022]

5. England pubmed.ncbi.nlm.nih.gov

A web application to involve patients in the medication reconciliation process: a user-centered usability and usefulness study. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

MedIntegrate: Incorporating provincially funded community pharmacist services into an ambulatory internal medicine clinic to enhance medication reconciliation. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

A review of medication reconciliation issues and experiences with clinical staff and information systems. [2022]