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| Tracking Information | |||||
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| First Received Date ICMJE | December 12, 2007 | ||||
| Last Updated Date | October 2, 2009 | ||||
| Start Date ICMJE | January 2008 | ||||
| Primary Completion Date | September 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Qualitative information [ Time Frame: 6 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00574990 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Minimizing Harm From ADEs by Improving Nurse-Physician Communication | ||||
| Official Title ICMJE | Minimizing Harm From ADEs by Improving Nurse-Physician Communication | ||||
| 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 7-10 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-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. Information gleaned in this phase will help us measure the types of communication patterns, content and characteristics. This research has not been done in terms of medication management content in the inpatient setting (non-ICU). |
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| Detailed Description | Background: The purpose of this study is to explore the role that inter-provider communication plays in the management of medications in the inpatient setting. Tasks associated with medication management include prevention of error, monitoring of therapeutic response, early detection of adverse drug events (ADE) and appropriate response once they have occurred. At all steps in the process, harm can be significantly mitigated by effective communication between provider roles. Communication in this study refers specifically to the sharing of medical management information. We propose to do a series of three interconnected studies to triangulate on how, when, and what information content regarding medication management is shared in an acute care hospital setting. Objectives: 1.1 Specific Aim 1. Assess clinicians' beliefs and concerns regarding the role of communication in preventing, detecting and managing ADEs in elderly inpatients. 1.2 Specific Aim 2. Evaluate communication events among nurses, physicians and pharmacists in an inpatient medicine setting. (ethnographic observation) Characterize communication events for timing, source, recipient, channel and content. Assess the incidence rate of communication events among nurses, pharmacists and physicians, for both topics in general and related to medication management. Identify and categorize prevalent communication goals of nurses, pharmacists, and physicians. Identify and categorize role expectancies associated with communication events. Assess perceived communication satisfaction at the event level. Identify existing barriers and facilitators to effective communication. Methods: In the first study, we will conduct a series of focus groups to examine providers' beliefs and perceptions regarding barriers to and issues surrounding communication of this kind of information. The second study will use ethnographic techniques to directly observe patterns and forms of communication. Status: We are preparing to begin the observational stage of the study. |
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| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Other, Prospective | ||||
| Condition ICMJE |
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| Intervention ICMJE | |||||
| Study Arms / Comparison Groups | providers, nurses and pharmacists | ||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 50 | ||||
| Completion Date | September 2009 | ||||
| Primary Completion Date | September 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | 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. |
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| Gender | Both | ||||
| Ages | 18 Years to 75 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00574990 | ||||
| Responsible Party | Weir, Charlene - Principal Investigator, Department of Veterans Affairs | ||||
| Study ID Numbers ICMJE | NRI 05-275 | ||||
| Study Sponsor ICMJE | Department of Veterans Affairs | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Department of Veterans Affairs | ||||
| Verification Date | October 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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