Standard Medication Reconciliation Protocol in the Primary Care Office-based Setting

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
John Hickner, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01577602
First received: April 12, 2012
Last updated: March 13, 2013
Last verified: March 2013
  Purpose

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.

Condition Intervention
Medication Reconciliation Between Patients' Self Report and Electronic Medical Record List
Other: Printed medication list
Other: Open ended question
Other: Combined intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
Official Title: Standard Medication Reconciliation Protocol in the Primary Care Office-based Setting: A Focused Investigation of Two Interventions

Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • Assessment of EMR medication lists and patient report agreement [ Time Frame: Within one week of enrolled patient's visit ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Assessment of number of medication list discrepancies [ Time Frame: Within one week of patients' visit ] [ Designated as safety issue: Yes ]
    Data will be collected in same manner as primary outcome. The secondary outcome focuses on the actual number of discrepancies and what may have caused the discrepancy.


Enrollment: 424
Study Start Date: October 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Standard practice
Experimental: Printed list intervention
Providing patients a list of their current medications before they see medical assistant and begin their visit.
Other: Printed medication list
Provide a list of patient's current medication list as noted in the EMR
Experimental: Open ended question intervention
Medical assistants begin the medication review with a scripted, open ended question (i.e., "tell me about your medications")
Other: Open ended question
medical assistants begin medication reconciliation with a scripted open ended question.
Experimental: Combined intervention Other: Combined intervention
Combines the printed medication list with the open ended question

Detailed Description:

This is a randomized clinical trial of the implementation and initial effectiveness of two interventions for improving medication reconciliation in primary care offices. The interventions we will test are 1) patients reviewing a printed paper copy of their EMR medication list just prior to seeing the physician and 2) medical assistants beginning the interview with an open-ended question. We will test the following two hypotheses:

  1. Providing patients a paper copy of their EMR medication list upon check-in, to review for accuracy prior to their office visit, will improve the agreement between the EMR medication list and patient report during a phone interview within one week of the office visit.
  2. The medical assistant practice of routinely using an open-ended question to introduce the medication review will improve the agreement between the EMR medication list and patient report during a phone interview within one week of the office visit.

The main outcome measure for this study is full agreement of prescription medications between the medication list in the electronic medical record at the conclusion of patient's office visit and the list generated by pharmacists during a phone interview performed within a week of the office visit.

The study will take place at 2-4 Cleveland Clinic Health Centers in primary care offices. A sample size of 400 patients will be enrolled: 20 pairs of physicians and medical assistants will be invited to volunteer for the study, and 20 patients per MD/MA pair will be recruited. Medical assistants will be trained in using scripted open-ended questions to begin reviewing medications with patients. The study coordinator will implement the printed list intervention by providing a paper list to patients.

Consenting patients will be randomized to one of four groups (A-D):

A: NO patient review of printed medication list & NO open-ended question B: Patient review of printed medication list ONLY C: Open-ended question ONLY D: BOTH patient review of printed medication list & open-ended question

To document the medications that patients report taking, a pharmacist will conduct a detailed phone interview with the patient and/or caretaker within a week of the office visit using a prepared script. The pharmacist will note any discrepancies between the EMR and the patient's/caretaker'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.

Our goal is to statistically test whether the proportion of medication lists in agreement with patient report differs in the intervention group compared to the non-intervention group. First, an unadjusted analysis utilizing a difference of proportions test and linear contrasts as described in the above planned comparisons. Then, a multivariable mixed model will be used to determine the significance of the intervention with adjustment.

If the interventions are successful, they will be incorporated into a standard medication reconciliation protocol for Cleveland Clinic primary care office practice. If highly successful, this protocol could serve as a new standard for medication reconciliation in outpatient primary care practice in the United States.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01577602

Locations
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Study Director: John Hickner, MD, MSc The Cleveland Clinic
  More Information

No publications provided

Responsible Party: John Hickner, Professor, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01577602     History of Changes
Other Study ID Numbers: 11-667
Study First Received: April 12, 2012
Last Updated: March 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:
Medication reconciliation
Self report
Electronic medical record medication list

ClinicalTrials.gov processed this record on April 17, 2014