Impact of Information Prescriptions on Medication Adherence in Emergency Department (ED) Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Johns Hopkins University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01174706
First received: August 3, 2010
Last updated: June 24, 2011
Last verified: June 2011
  Purpose

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.

Condition Intervention
Patient Compliance
Medication Adherence
Medication Non-Adherence
Behavioral: Information prescriptions

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Health Services Research
Official Title: Impact of Information Prescriptions on Medication Adherence in ED Patients

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Medication adherence [ Time Frame: one week after index ED visit ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Filling of prescription medicine [ Time Frame: within one week of index ED visit ] [ Designated as safety issue: No ]
    This outcome will measure whether a patient filled the medication he was prescribed at ED discharge .


Estimated Enrollment: 3800
Study Start Date: November 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Usual care arm
Patients randomized to this group will receive usual care. Usual care at the three study sites varies but will be defined as whatever information is usually given to patients regarding the prescription medication or over the counter medicine they were prescribed at emergency department discharge.
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.
Experimental: Information prescription
Patients randomized to this arm will receive written information from Medline Plus regarding the prescription or over the counter medicine they have been prescribed at ED discharge plus information on their health condition.
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.
Experimental: Informationist
Patients in this arm will receive the same information as patients in group 2 but will also be given contact information for a clinical informationist if they have further questions about their prescription medicine or over the counter medicine prescribed at ED discharge.
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.
Experimental: practical assistance
Subjects will be offered practical assistance with obtaining prescription such as location of most convenient pharmacy and hours of operation, programs that offer drugs more cheaply, fax prescription from ED to pharmacy
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

-

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.

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01174706

Contacts
Contact: Melissa L McCarthy, ScD 410-735-6421 mmccarth@jhmi.edu
Contact: Nancy Roderer, MLS 410- 502-7092 nrodere1@jhmi.edu

Locations
United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21201
Contact: Melissa L McCarthy, ScD    410-735-6421    mmccarth@jhmi.edu   
Contact: Julius C Pham, MD, PhD    410-735-6427    jpham3@jhmi.edu   
Principal Investigator: Julius C Pham, MD, PhD         
Johns Hopkins Bayview Medical Center Recruiting
Baltimore, Maryland, United States, 21224
Contact: Melissa L McCarthy, ScD    410-735-6421    mmccarth@jhmi.edu   
Contact: Rodica Retezar, MD, MPH    410-550-0497    rretezar@gmail.com   
Principal Investigator: Rodica Retezar, MD         
Howard County General Hospital Completed
Columbia, Maryland, United States, 21044
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Melissa L McCarthy, ScD Associate Professor
Principal Investigator: Nancy Roderer, MLS Professor and Director of the Welch Medical Library
  More Information

Additional Information:
No publications provided

Responsible Party: Melissa McCarthy, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01174706     History of Changes
Other Study ID Numbers: RC1LM010424-01
Study First Received: August 3, 2010
Last Updated: June 24, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
infections
flu
abdominal pain
chest pain
cold
fever
different acute care conditions

ClinicalTrials.gov processed this record on July 26, 2014