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

Northwestern University

Status: Completed

Conditions: Diabetes Mellitus Type II; Diabetes Mellitus Type I

Treatments: Other: EHR Based Strategy to promote Safe and Appropriate Drug Use

Study type: Interventional

Funder types: Other

Identifiers

NCT01669473

1U19HS021093-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 541 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

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;

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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541 participants in 2 patient groups

Intervention Arm

Experimental group

Description:

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.

Treatment:

Other: EHR Based Strategy to promote Safe and Appropriate Drug Use

Standard Care Arm

No Intervention group

Description:

The control group will receive regular standard care at the Clinic. They will not receive any print tools.