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

NCT01669473 | Completed DMC

• 1 other identifier: 1U19HS021093-01
• Study Type: interventional
• Target: 541
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetes Mellitus Type I; Diabetes Mellitus Type II

Keywords

Diabetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Clinical outcomes-systolic blood pressure, HbA1, and LDL cholesterol.

  Baseline interview and after 6 months

Study Arms (2)

Intervention Arm

EXPERIMENTAL

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

Standard Care Arm

NO INTERVENTION

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

Interventions

EHR Based Strategy to promote Safe and Appropriate Drug Use OTHER

The printed tools presented in the intervention include: 1. Medication Review: a consolidated list of the medications a patient is currently taking. 2. Medication Sheet: a medication information sheet, including simplified prescription instructions, for each medication that a patient is newly prescribed. 3. 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

Intervention Arm

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Northwestern University: lead
• University of Illinois at Chicago: collaborator

Study Sites (2)

Northwestern University

Chicago, Illinois, 60611, United States

Location

University of Illinois at Chicago

Chicago, Illinois, 60654, United States

Location

Related Publications (1)

• 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.

  PMID: 25622970 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Bruce Lambert, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Center for Communication and Health

Study Record Dates

• First Submitted: August 3, 2012
• First Posted: August 21, 2012
• Study Start: June 1, 2013
• Primary Completion: August 1, 2016
• Study Completion: September 1, 2016
• Last Updated: September 22, 2016

Record last verified: 2016-09

Locations

US (2)