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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus Type II; Diabetes Mellitus Type I
• Intervention / Treatment: Other: EHR Based Strategy to promote Safe and Appropriate Drug Use

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 Type: Interventional
• Enrollment (Actual): 541
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
    • Chicago, Illinois, United States, 60654
      • University of Illinois at Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Arm; 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.	Other: EHR Based Strategy to promote Safe and Appropriate Drug Use; The printed tools presented in the intervention include: Medication Review: a consolidated list of the medications a patient is currently taking.; Medication Sheet: a medication information sheet, including simplified prescription instructions, for each medication that a patient is newly prescribed.; Medication List: a table that lists all medications taken by the patient and provides an orientation on how to best organize and simplify their medication regimen
No Intervention: Standard Care Arm; The control group will receive regular standard care at the Clinic. They will not receive any print tools.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication adherence	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.	One month after patients receive intervention materials

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical outcomes-systolic blood pressure, HbA1, and LDL cholesterol.	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.	Baseline interview and after 6 months

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: University of Illinois at Chicago
• Investigators: Principal Investigator: Bruce Lambert, PhD, Northwestern University

Publications and helpful links

General Publications

• Przytula K, Bailey SC, Galanter WL, Lambert BL, Shrestha N, Dickens C, Falck S, Wolf MS. A primary care, electronic health record-based strategy to promote safe drug use: study protocol for a randomized controlled trial. Trials. 2015 Jan 27;16:17. doi: 10.1186/s13063-014-0524-x.

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: August 3, 2012
• First Submitted That Met QC Criteria: August 16, 2012
• First Posted (Estimate): August 21, 2012

Study Record Updates

• Last Update Posted (Estimate): September 22, 2016
• Last Update Submitted That Met QC Criteria: September 20, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Diabetes
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 1U19HS021093-01 (U.S. AHRQ Grant/Contract)