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

Diabetes Mellitus Type II Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01669473
• Other study ID #: 1U19HS021093-01
• Status: Completed
• Phase: N/A
• First received: August 3, 2012
• Last updated: September 20, 2016
• Start date: June 2013
• Est. completion date: September 2016

Study information

• Verified date: September 2016
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 541
• Est. completion date: September 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type I
• Diabetes Mellitus Type II
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2

Intervention

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

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois
United States	University of Illinois at Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No