Clinical trial NCT01669473: A Primary Care, EHR- Based Strategy to Promote Safe and Appropriate Drug Use
Official title: A Primary Care, EHR- Based Strategy to Promote Safe and Appropriate Drug Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus Type I
Diabetes Mellitus Type II
Keywords: Diabetes
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: University of Illinois at Chicago
First posted: 2012-08-21
Enrollment: 541
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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;

Primary outcomes:
measure: Medication adherence
timeFrame: One month after patients receive intervention materials
Secondary outcomes:
measure: Clinical outcomes-systolic blood pressure, HbA1, and LDL cholesterol.
timeFrame: Baseline interview and after 6 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
Study officials:
affiliation: Northwestern University
name: Bruce Lambert, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.