NCT00574990

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2008

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2007

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 17, 2007

Completed
15 days until next milestone

Study Start

First participant enrolled

January 1, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
5.8 years until next milestone

Results Posted

Study results publicly available

June 9, 2015

Completed
Last Updated

June 9, 2015

Status Verified

May 1, 2015

Enrollment Period

1.7 years

First QC Date

December 12, 2007

Results QC Date

October 1, 2014

Last Update Submit

May 22, 2015

Conditions

Keywords

Interdisciplinary CommunicationSafety ManagementManagement, Medication TherapyCooperative BehaviorDrug Therapy ManagementPhysician Nurse RelationshipsSide EffectsHospital Information SystemsDocumentationQuality Assurance, Health Care

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Overall Involvement in Conversation by Roles

    6 months

Study Arms (3)

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.

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

VA Medical Center, San Francisco

San Francisco, California, 94121, United States

Location

VA Medical Center, Asheville

Asheville, North Carolina, 28805, United States

Location

Salt Lake City

Salt Lake City, Utah, 84148, United States

Location

Related 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):379-80. doi: 10.1016/j.jamda.2009.04.001. No abstract available.

  • 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.

MeSH Terms

Conditions

Cooperative Behavior

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Results Point of Contact

Title
Dr. Charlene Weir
Organization
Salt Lake City VA HSRD IDEAS 2.0 Center of Innovation

Study Officials

  • Charlene R Weir, PhD RN

    Salt Lake City

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2007

First Posted

December 17, 2007

Study Start

January 1, 2008

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

June 9, 2015

Results First Posted

June 9, 2015

Record last verified: 2015-05

Locations