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

Standard Medication Reconciliation Protocol in the Primary Care Office-based Setting: A Focused Investigation of Two Interventions

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01577602
Enrollment
424
Registered
2012-04-16
Start date
2011-10-31
Completion date
2012-05-31
Last updated
2013-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Medication reconciliation, Self report, Electronic medical record medication list

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.

Interventions

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

OTHEROpen ended question

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

Combines the printed medication list with the open ended question

Sponsors

The Cleveland Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Assessment of EMR medication lists and patient report agreementWithin one week of enrolled patient's visitTo 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

MeasureTime frameDescription
Assessment of number of medication list discrepanciesWithin one week of patients' visitData 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026