A Primary Care, EHR- Based Strategy to Promote Safe and Appropriate Drug Use

Not Applicable

Completed

• Conditions: Diabetes Mellitus Type I; Diabetes Mellitus Type II
• Interventions: Other: EHR Based Strategy to promote Safe and Appropriate Drug Use

• Registration Number: NCT01669473
• Lead Sponsor: Northwestern University

Brief Summary

This study seeks to evaluate a low-literacy strategy in a primary health care setting for promoting safe and effective prescription medication use among English and Spanish-speaking patients with diabetes.

The investigators hypothesize that in comparison with patients receiving standard care, the patients that received the Electronic Health Record (EHR) strategy will 1) demonstrate better understanding of how to safely dose out their medication regimen; 2) have fewer discrepancies in their medication lists; 3) take their medication regimen more efficiently; 4) have greater adherence to their medication regimen.

Detailed Description

The strategy takes advantage of health information technology to assist patients with Medication Therapy Management (MTM) tasks, intervening with a set of low-literacy MTM printed tools triggered by the Electronic Health Record (EHR) in a primary health care clinic. Patients at the University of Illinois at Chicago (UIC) Medicine Clinic who are randomized to the intervention arm will be given three printed tools, one when they check in to the clinic and the other two when they check out. The Electronic Health Record (EHR) triggers the printing of these tools, and the receptionist hands them to the patient. Patients receive either English or Spanish language materials depending on the preference determined in the screening process and stored in their EHR.

Specific Aims

1. Refine and Field Test an EHR strategy for generating and distributing low literacy prescription information for English and Spanish-speaking patients

2. Assess the process of the EHR intervention and its fidelity for providing prescription information for patients at the point of prescribing and dispensing medications.

3. Evaluate the effectiveness of the EHR strategy to improve medication understanding, reconciliation, regimen consolidation, and adherence compared to standard care.

In addition, we will be powered to also investigate our strategy's impact on intermediary clinical outcomes including systolic blood pressure, HbA1c, and LDL cholesterol.

Study Timeline

• Study First Submitted: 2012-08-03
• Study First Submitted QC: 2012-08-16
• Study First Posted: 2012-08-21
• Study Start: 2013-06
• Primary Completion: 2016-08
• Status Verified: 2016-09
• Study Completion: 2016-09
• Last Update Submitted: 2016-09-20
• Last Update Posted: 2016-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 541

Inclusion Criteria

• 18-years old or older;
• have a diagnosis of diabetes mellitus either by ICD-billing codes or indicative medications;
• are prescribed at least (3) chronic condition medications according to the EHR medication list;
• are English or Spanish-speaking;
• have no imminent intention to move or change clinics within the next year;
• score 4 or higher on the six-question screener based on the Mini-Mental Status Exam;
• are primarily responsible for administering their own medications;
• prescribed a new chronic condition medication (including refills, and change in titrations) during their clinic visit and day.

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Exclusion Criteria

• under age of 18 years-old;
• does not speak English or Spanish;
• dependent on assistance for medication administration;
• scored less than 4 on the six-question screener;
• not prescribed a new medication or changed medication at clinical appointment;

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Arm	EHR Based Strategy to promote Safe and Appropriate Drug Use	EHR Based Strategy to promote Safe and Appropriate Drug Use Patients randomized to the intervention arm will be given (3) print tools to assist in safe and appropriate medication use. These include a Medreview, Medsheet,and Medlist.

Primary Outcome Measures

Name	Time	Method
Medication adherence	One month after patients receive intervention materials	We will determine to what extent presenting low-literacy information about prescription medicines to patients with diabetes affects their adherence to a medication regimen compared to patients under standard care.; Adherence for each prescription medication will be measured through multiple methodologies.

Secondary Outcome Measures

Name	Time	Method
Clinical outcomes-systolic blood pressure, HbA1, and LDL cholesterol.	Baseline interview and after 6 months	We will investigate our strategy's impact on intermediary clinical outcomes including systolic blood pressure for patients with hypertension, HbA1 for patients with diabetes, and LDL cholesterol for patients with hyperlipidemia, through chart extraction at pre and post-intervention.

Trial Locations

Locations (2)

Northwestern University; 🇺🇸 Chicago, Illinois, United States

University of Illinois at Chicago; 🇺🇸 Chicago, Illinois, United States