Minimizing Harm From ADEs by Improving Nurse-Physician Communication (MED-COMM)

May 22, 2015 updated by: US Department of Veterans Affairs

The purpose of this research study is to examine the clinical processes of care involved with the sharing and communicating of medication management information in the inpatient setting between nurses, pharmacists and physicians. The study is unique in that few studies have examined communication content and processes in depth and in relation to specific clinical care. The study will be conducted in two phases. The first phase involves using three focus groups across three sites (a total of nine) each involving between 6-8 individuals to examine perceptions regarding role and procedures associated with medication management. The focus group discussions will be tape-recorded and analyzed using qualitative methods. The information gleaned will assist us in identifying patterns of problems in enhancing the sharing of information, to develop better measures for assessing communication as well as designing effective interventions to enhance communication.

In the second phase of the study, 400 2-4 hour time slots will be randomly selected over about a 5-week period for nursing staff and 500 events over a 6-week period for physicians to conduct ethnographic observations during which specific communication events will be recorded and coded. Every effort will be made to minimize interruptions during clinical care. This research has not been done in terms of medication management content in the inpatient setting (non-ICU).

Study Overview

Detailed Description

Background:

Medication management is a complex clinical task. It requires substantial collaboration and coordination between physicians, nurses and pharmacists. Addressing ineffective communication has been identified by the Institute of Medicine as a high priority. Ineffective communication regarding medication management coordination can result in increased medication errors, rates of adverse drug events (ADEs), delays in treating adverse drug events and less effective treatment. ADEs are frequent in hospitalized patients, ranging from less than 3% to over 32%. The purpose of this study was to evaluate communication patterns associated with medication management between providers, physicians and pharmacists in the inpatient setting.

Objectives:

Specific Aim 1. Assess clinicians' beliefs and concerns regarding the role of communication in preventing, detecting and managing ADEs in elderly inpatients (focus groups).

Specific Aim 2. Evaluate and characterize communication events between VA nurses, physicians and pharmacists in an inpatient medicine setting (ethnographic observation).

Methods:

Phase 1: Focus Groups Design: The design of this study was qualitative and used focus group methodology.

Settings: Three VA sites that differed in size, location and academic affiliation were selected.

Participants: Three focus groups were conducted at each site (one each of pharmacists, nurses and physicians). A total of 19 nurses, 16 pharmacists and 13 doctors participated.

Phase 2: Observation Design: The design of this study was quantitative and descriptive. Settings: Two inpatient units at the VA Salt Lake City Health Care System (medicine and telemetry).

Participants: Twelve residents were selected randomly from each of the 4 medical teams, 19 nurses were selected randomly from the two in-patient medicine wards, and 8 clinical pharmacists (the total number of clinical pharmacists available) agreed to participate.

Status:

All data have been collected and initial analyses has been completed.

Study Type

Observational

Enrollment (Actual)

39

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • San Francisco, California, United States, 94121
        • VA Medical Center, San Francisco
    • North Carolina
      • Asheville, North Carolina, United States, 28805
        • VA Medical Center, Asheville
    • Utah
      • Salt Lake City, Utah, United States, 84148
        • Salt Lake City

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

VA Physicians, Nurses, and Pharmacists had worked at least one year in the VA and were familiar with the VA's electronic health record, CPRS.

Description

Inclusion Criteria:

Providers who are working in the VA on the inpatient setting, including pharmacists, nurses, and physicians.

Exclusion Criteria:

Staff who have worked at the VA less than 1 year.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
VA Physicians
VA providers who had worked at least one year in the VA and were familiar with the VA's electronic health record, CPRS.
VA Nurses
VA nurses who had worked at least one year in the VA and were familiar with the VA's electronic health record, CPRS.
VA Pharmacists
VA pharmacists who had worked at least one year in the VA and were familiar with the VA's electronic health record, CPRS.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incident Rate for Communication Events
Time Frame: 6 months
Observation periods were approximately two-hours long. Some providers were observed more than once. The number of communication events were counted per each observation period.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Involvement in Conversation by Roles
Time Frame: 6 months
The number of communication events was recorded on electronic notepads during each observation period. The communication events recorded included: a) physicians to physicians, to nurses, to pharmacists, and to patients; b) nurses to nurses, to physicians, to pharmacists, and to patients; and c) pharmacists to pharmacists, to physicians, to nurses, and to patients. The percentage of each of these types of verbal communications was calculated from the total number of communication events.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Charlene R Weir, PhD RN, Salt Lake City

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

December 12, 2007

First Submitted That Met QC Criteria

December 14, 2007

First Posted (Estimate)

December 17, 2007

Study Record Updates

Last Update Posted (Estimate)

June 9, 2015

Last Update Submitted That Met QC Criteria

May 22, 2015

Last Verified

May 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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