NCT01174706

Brief Summary

The main objectives of this research are:

  1. 1.To identify factors that influence medication adherence rates in Emergency Department (ED) patients.
  2. 2.To measure the effects of alternative information prescriptions on medication adherence rates of ED patients.
  3. 3.To measure the effects of alternative information prescriptions (IRxs) on health and service utilization.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,940

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2010

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 4, 2010

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

August 21, 2018

Status Verified

August 1, 2018

Enrollment Period

10 months

First QC Date

August 3, 2010

Last Update Submit

August 18, 2018

Conditions

Keywords

infectionsfluabdominal painchest paincoldfeverdifferent acute care conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Filling of prescription medicine

    within one week of index ED visit

Study Arms (4)

Usual care arm

EXPERIMENTAL

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

Information prescription

EXPERIMENTAL

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

Informationist

EXPERIMENTAL

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

practical assistance

EXPERIMENTAL

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

Interventions

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 prescriptionInformationistUsual care armpractical assistance

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Johns Hopkins Hospital

Baltimore, Maryland, 21201, United States

Location

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

Howard County General Hospital

Columbia, Maryland, 21044, United States

Location

Related 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 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.

MeSH Terms

Conditions

Patient ComplianceMedication AdherenceInfectionsInfluenza, HumanAbdominal PainChest PainCommon ColdFever

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorRespiratory Tract InfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, DigestivePicornaviridae InfectionsBody Temperature Changes

Study Officials

  • Melissa L McCarthy, ScD

    Associate Professor

    PRINCIPAL INVESTIGATOR
  • Nancy Roderer, MLS

    Professor and Director of the Welch Medical Library

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2010

First Posted

August 4, 2010

Study Start

November 1, 2010

Primary Completion

September 1, 2011

Study Completion

December 1, 2011

Last Updated

August 21, 2018

Record last verified: 2018-08

Locations