NCT01577602

Brief Summary

The purpose of this study is to determine if two basic medical office visit interventions improve the agreement of medication lists between electronic medical record and patient self, home-based report. The interventions are:

  • giving patients a printed list of medications before the visit
  • asking the patients about their medications with a scripted, open ended question.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
424

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 12, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 16, 2012

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

March 14, 2013

Status Verified

March 1, 2013

Enrollment Period

7 months

First QC Date

April 12, 2012

Last Update Submit

March 13, 2013

Conditions

Keywords

Medication reconciliationSelf reportElectronic medical record medication list

Outcome Measures

Primary Outcomes (1)

  • Assessment of EMR medication lists and patient report agreement

    To document medications patients report taking, a pharmacist will conduct a detailed phone interview with the patient within a week of the office visit using a prepared script. The pharmacist will note any discrepancies between the EMR and the patient's self report. In order to be considered in full agreement, the medication list and patient report must agree on the five following elements: 1) name, 2) dose, 3) frequency, 4) route, and 5) PRN status.

    Within one week of enrolled patient's visit

Secondary Outcomes (1)

  • Assessment of number of medication list discrepancies

    Within one week of patients' visit

Study Arms (4)

Standard practice

NO INTERVENTION

Printed list intervention

EXPERIMENTAL

Providing patients a list of their current medications before they see medical assistant and begin their visit.

Other: Printed medication list

Open ended question intervention

EXPERIMENTAL

Medical assistants begin the medication review with a scripted, open ended question (i.e., "tell me about your medications")

Other: Open ended question

Combined intervention

EXPERIMENTAL
Other: Combined intervention

Interventions

Provide a list of patient's current medication list as noted in the EMR

Printed list intervention

medical assistants begin medication reconciliation with a scripted open ended question.

Open ended question intervention

Combines the printed medication list with the open ended question

Combined intervention

Eligibility Criteria

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

You may qualify if:

  • Over 18 years of age
  • English speaking
  • Current medication list has at least 2 medications listed

You may not qualify if:

  • less than 18 years of age
  • English is not primary language
  • Less than 2 medications on medication list
  • Enrollment only applies to one visit. Patients cannot be enrolled more than one time on the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Study Officials

  • John Hickner, MD, MSc

    The Cleveland Clinic

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 12, 2012

First Posted

April 16, 2012

Study Start

October 1, 2011

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

March 14, 2013

Record last verified: 2013-03

Locations