- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00574990
Minimizing Harm From ADEs by Improving Nurse-Physician Communication (MED-COMM)
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).
Panoramica dello studio
Stato
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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California
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San Francisco, California, Stati Uniti, 94121
- VA Medical Center, San Francisco
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North Carolina
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Asheville, North Carolina, Stati Uniti, 28805
- VA Medical Center, Asheville
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Utah
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Salt Lake City, Utah, Stati Uniti, 84148
- Salt Lake City
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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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.
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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.
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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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Incident Rate for Communication Events
Lasso di tempo: 6 months
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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.
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6 months
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Overall Involvement in Conversation by Roles
Lasso di tempo: 6 months
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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.
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6 months
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Collaboratori e investigatori
Investigatori
- Investigatore principale: Charlene R Weir, PhD RN, Salt Lake City
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- NRI 05-275
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .