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

NCT ID: NCT01577602

Last Updated: 2013-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 424 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2012-05-31

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.

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.

Conditions

Medication Reconciliation Between Patients' Self Report and Electronic Medical Record List

Study Design

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

Study Groups

Standard practice

Group Type: NO_INTERVENTION

No interventions assigned to this group

Printed list intervention

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

Group Type: EXPERIMENTAL

Printed medication list

Intervention Type: OTHER

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

Open ended question intervention

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

Group Type: EXPERIMENTAL

Open ended question

Intervention Type: OTHER

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

Combined intervention

Group Type: EXPERIMENTAL

Combined intervention

Intervention Type: OTHER

Combines the printed medication list with the open ended question

Interventions

Printed medication list

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

Intervention Type: OTHER

Open ended question

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

Intervention Type: OTHER

Combined intervention

Combines the printed medication list with the open ended question

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

John Hickner

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John Hickner, MD, MSc

Role: STUDY_DIRECTOR

The Cleveland Clinic

Locations

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

11-667

Identifier Type: -

Identifier Source: org_study_id