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

22 de maio de 2015 atualizado por: 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).

Visão geral do estudo

Descrição detalhada

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 de estudo

Observacional

Inscrição (Real)

39

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 75 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra Não Probabilística

População do estudo

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.

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Incident Rate for Communication Events
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Overall Involvement in Conversation by Roles
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Investigador principal: Charlene R Weir, PhD RN, Salt Lake City

Publicações e links úteis

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Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de janeiro de 2008

Conclusão Primária (Real)

1 de setembro de 2009

Conclusão do estudo (Real)

1 de setembro de 2009

Datas de inscrição no estudo

Enviado pela primeira vez

12 de dezembro de 2007

Enviado pela primeira vez que atendeu aos critérios de CQ

14 de dezembro de 2007

Primeira postagem (Estimativa)

17 de dezembro de 2007

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

9 de junho de 2015

Última atualização enviada que atendeu aos critérios de controle de qualidade

22 de maio de 2015

Última verificação

1 de maio de 2015

Mais Informações

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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