Clinical trial NCT01174706: Impact of Information Prescriptions on Medication Adherence in Emergency Department (ED) Patients
Official title: Impact of Information Prescriptions on Medication Adherence in ED Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient Compliance
Medication Adherence
Medication Non-Adherence
Keywords: infections
flu
abdominal pain
chest pain
cold
fever
different acute care conditions
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Library of Medicine (NLM)
First posted: 2010-08-04
Enrollment: 3940
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed 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.

Eligibility criteria: 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.

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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.

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Primary outcomes:
measure: Medication adherence
timeFrame: one week after index ED visit
Secondary outcomes:
measure: Filling of prescription medicine
timeFrame: within one week of index ED visit
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
city: Columbia
country: United States
facility: Howard County General Hospital
state: Maryland
Study officials:
affiliation: Associate Professor
name: Melissa L McCarthy, ScD
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor and Director of the Welch Medical Library
name: Nancy Roderer, MLS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 emergency department? A randomized controlled trial. Ann Emerg Med. 2013 Sep;62(3):212-23.e1. doi: 10.1016/j.annemergmed.2013.02.002. Epub 2013 Apr 3.