Standard Medication Reconciliation Protocol in the Primary Care Office-based Setting
1 other identifier
interventional
424
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2011
Shorter than P25 for not_applicable
1 active site
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
CompletedFirst Submitted
Initial submission to the registry
April 12, 2012
CompletedFirst Posted
Study publicly available on registry
April 16, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedMarch 14, 2013
March 1, 2013
7 months
April 12, 2012
March 13, 2013
Conditions
Keywords
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 INTERVENTIONPrinted list intervention
EXPERIMENTALProviding patients a list of their current medications before they see medical assistant and begin their visit.
Open ended question intervention
EXPERIMENTALMedical assistants begin the medication review with a scripted, open ended question (i.e., "tell me about your medications")
Combined intervention
EXPERIMENTALInterventions
Provide a list of patient's current medication list as noted in the EMR
medical assistants begin medication reconciliation with a scripted open ended question.
Combines the printed medication list with the open ended question
Eligibility Criteria
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
Study Officials
- STUDY DIRECTOR
John Hickner, MD, MSc
The Cleveland Clinic
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