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

NCT ID: NCT01174706

Last Updated: 2018-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 3940 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2011-12-31

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.

Conditions

Patient Compliance; Medication Adherence; Medication Non-Adherence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Information prescriptions

Intervention Type: BEHAVIORAL

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.

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.

Group Type: EXPERIMENTAL

Information prescriptions

Intervention Type: BEHAVIORAL

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.

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.

Group Type: EXPERIMENTAL

Information prescriptions

Intervention Type: BEHAVIORAL

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.

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

Group Type: EXPERIMENTAL

Information prescriptions

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

-

Exclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Library of Medicine (NLM)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Melissa L McCarthy, ScD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor

Nancy Roderer, MLS

Role: PRINCIPAL_INVESTIGATOR

Professor and Director of the Welch Medical Library

Locations

Johns Hopkins Hospital

Baltimore, Maryland, United States

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, United States

Howard County General Hospital

Columbia, Maryland, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 23561463 (View on PubMed)

Other Identifiers

1RC1LM010424-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NA_00038209

Identifier Type: -

Identifier Source: org_study_id