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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00574990
Other study ID # NRI 05-275
Secondary ID
Status Completed
Phase N/A
First received December 12, 2007
Last updated May 22, 2015
Start date January 2008
Est. completion date September 2009

Study information

Verified date May 2015
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 39
Est. completion date September 2009
Est. primary completion date September 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 75 Years
Eligibility 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 Design

Time Perspective: Prospective


Locations

Country Name City State
United States VA Medical Center, Asheville Asheville North Carolina
United States Salt Lake City Salt Lake City Utah
United States VA Medical Center, San Francisco San Francisco California

Sponsors (1)

Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (2)

Flaherty JH, Shay K, Weir C, Kamholz B, Boockvar KS, Shaughnessy M, Shapiro R, Gordon S, Stein J, Rudolph JL; VA Delirium Working Group. The development of a mental status vital sign for use across the spectrum of care. J Am Med Dir Assoc. 2009 Jul;10(6): — View Citation

Vogelsmeier A, Pepper GA, Oderda L, Weir C. Medication reconciliation: A qualitative analysis of clinicians' perceptions. Res Social Adm Pharm. 2013 Jul-Aug;9(4):419-30. doi: 10.1016/j.sapharm.2012.08.002. Epub 2012 Oct 23. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Incident Rate for Communication Events 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 No
Secondary Overall Involvement in Conversation by Roles 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 No
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