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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01174706
Other study ID # NA_00038209
Secondary ID 1RC1LM010424-01
Status Completed
Phase N/A
First received
Last updated
Start date November 2010
Est. completion date December 2011

Study information

Verified date August 2018
Source Johns Hopkins University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The main objectives of this research are:

1. To identify factors that influence medication adherence rates in Emergency Department (ED) patients.

2. To measure the effects of alternative information prescriptions on medication adherence rates of ED patients.

3. To measure the effects of alternative information prescriptions (IRxs) on health and service utilization.


Description:

People who are prescribed self-administered medications frequently take less than half the doses. Poor adherence to medication regimens is associated with worsening of disease, death and increased health care costs in the United States. The few studies conducted in the emergency department (ED) setting suggest that between 7 to 45 percent of patients do not fill their prescription; one study conducted in Canada reported that 45% of ED patients did not follow their prescribed regimen. One strategy that may improve medication adherence among ED patients is a better information exchange between the patient, provider and the health care system. This study will use a randomized controlled trial to test the effect that two alternative ways of delivering information prescriptions (IRxs) have on medication adherence and treatment outcomes of ED patients.

ED patients treated and released with a prescribed medication(s) from three hospitals serving different patient populations in the Baltimore metropolitan area over a 9 month period will be included in the study. Research assistants will consent eligible patients, interview them prior to ED discharge and randomize subjects to one of four study groups: (1) usual care (medication prescription and instructions provided at discharge); (2) practical assistance which consists of giving information to help subject obtain medicine (i.e. programs that offer drugs more cheaply, pharmacy hours of operation, etc)(3) an IRx that includes a MedlinePlus referral plus written information from MedlinePlus customized to the subject's health problem and prescribed medication; or (4) an IRx that consists of practical assistance and MedlinePlus referral plus customized written information from MedlinePlus plus access to information services provided by a medical librarian, herein referred to as a clinical informationist or informationist. Subjects will be contacted by telephone one week post ED visit and queried about medication use and patient outcomes (self-reported health, satisfaction with ED visit, and ED revisits or hospitalizations) and use of Internet to access health information. Medication instructions and ED discharge diagnosis data will be extracted from subjects' electronic medical record and use of informationist services documented. Medication adherence rates and patient outcomes will be compared among study groups. Self-reported use of MedlinePlus will also be compared to electronic data for all subjects. Self-reported medication and ED revisits/hospitalizations will be compared to pharmacy claims and utilization data for subjects covered by Medicaid.


Recruitment information / eligibility

Status Completed
Enrollment 3940
Est. completion date December 2011
Est. primary completion date September 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: The study population will consist of adult patients who present to one of these three EDs during a 6 - 9 month period and are discharged with a medication regimen, either a prescription or over the counter (OTC) medication.

Exclusion Criteria: Patients will be excluded for the following reasons: (1) less than 18 years of age at time of ED visit; (2) non English or non Spanish speaking; (3) unable to understand consent or complete the baseline interview for cognitive, psychiatric or substance abuse reasons.

Study Design


Intervention

Behavioral:
Information prescriptions
One arm will receive usual care at discharge. The other three arms will receive practical assistance and/or an information prescription which will consist of written information from Medline Plus and access to a clinical informationist if subject has additional information needs.

Locations

Country Name City State
United States Johns Hopkins Bayview Medical Center Baltimore Maryland
United States Johns Hopkins Hospital Baltimore Maryland
United States Howard County General Hospital Columbia Maryland

Sponsors (2)

Lead Sponsor Collaborator
Johns Hopkins University National Library of Medicine (NLM)

Country where clinical trial is conducted

United States, 

References & Publications (1)

McCarthy ML, Ding R, Roderer NK, Steinwachs DM, Ortmann MJ, Pham JC, Bessman ES, Kelen GD, Atha W, Retezar R, Bessman SC, Zeger SL. Does providing prescription information or services improve medication adherence among patients discharged from the emergen — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Medication adherence Self-reported medication adherence.For subjects discharged with a prescription medication or an over the counter (OTC) medication with a specified dosage and frequency, medication adherence will be measured by the number of doses taken divided by the number of doses specified. one week after index ED visit
Secondary Filling of prescription medicine This outcome will measure whether a patient filled the medication he was prescribed at ED discharge . within one week of index ED visit
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