A Primary Care, EHR- Based Strategy to Promote Safe and Appropriate Drug Use
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|ClinicalTrials.gov Identifier: NCT01669473|
Recruitment Status : Completed
First Posted : August 21, 2012
Last Update Posted : September 22, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus Type I Diabetes Mellitus Type II||Other: EHR Based Strategy to promote Safe and Appropriate Drug Use||Not Applicable|
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.
- Refine and Field Test an EHR strategy for generating and distributing low literacy prescription information for English and Spanish-speaking patients
- Assess the process of the EHR intervention and its fidelity for providing prescription information for patients at the point of prescribing and dispensing medications.
- 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 (Clinical Trial)|
|Actual Enrollment :||541 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||A Primary Care, EHR- Based Strategy to Promote Safe and Appropriate Drug Use|
|Study Start Date :||June 2013|
|Actual Primary Completion Date :||August 2016|
|Actual Study Completion Date :||September 2016|
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:
No Intervention: Standard Care Arm
The control group will receive regular standard care at the Clinic. They will not receive any print tools.
- Medication adherence [ Time Frame: One month after patients receive intervention materials ]
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.
- Clinical outcomes-systolic blood pressure, HbA1, and LDL cholesterol. [ Time Frame: Baseline interview and after 6 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01669473
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|University of Illinois at Chicago|
|Chicago, Illinois, United States, 60654|
|Principal Investigator:||Bruce Lambert, PhD||Northwestern University|