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Expanding the Role of Pharmacists in Treating Persons With Cardiovascular or Lung Diseases (IowaCOC)

18 de agosto de 2014 atualizado por: University of Iowa

Enhanced Continuity of Pharmacy Care for Cardiovascular or Pulmonary Diseases

This study will test whether enhanced continuity of pharmacy care that includes increased communication between inpatient and outpatient settings will improve the appropriateness of medication therapy and reduce the number of serious adverse drug events, hospitalizations and unscheduled office visits in vulnerable patients with cardiovascular disease, pulmonary disease or diabetes.

Visão geral do estudo

Descrição detalhada

Drugs used to treat cardiovascular and lung diseases are the most frequent cause of hospitalizations and emergency department visits related to inadequate therapy or ADEs. ADEs occur in 25% of patients who are able to walk and may cause up to 17% of hospital admissions among the elderly. A lack of communication and coordination between the hospital setting and the patient's own community setting, upon patient discharge, may contribute to the high number of ADEs. By expanding the role of pharmacists and encouraging communication between hospitals and pharmacists, the number of ADEs may be reduced. There have been a few small studies that have examined the way patient information is transferred between hospital and community pharmacists, but these studies did not involve the patients' primary care physicians nor did they fully evaluate the effect of communication between hospital and community pharmacists. The purpose of this study is to evaluate the effectiveness of providing a pharmacist case manager to hospitalized patients with cardiovascular or lung disease at reducing the number of ADEs, re-hospitalizations, and unscheduled medical visits.

This study will enroll individuals with certain conditions or diseases who are admitted to the hospital. Participants will be randomly assigned to either a control group, a minimal treatment group, or an enhanced treatment group. Participants in the minimal and enhanced treatment groups will meet with a pharmacist case manager while in the hospital to conduct a medication history review. The case manager will also meet with participants at the time of hospital discharge and provide them with a discharge summary and educational materials. Additionally, for participants in the enhanced treatment group, the case manager will do the following: transfer the discharge summary data to the participant's community physician and pharmacist; call the participant 3 to 5 days following discharge from the hospital and as needed thereafter to resolve medication problems; and communicate with and make recommendations to the participant's community physician and pharmacist. All participants will meet with a study research nurse immediately after study entry to complete questionnaires. Study nurses will also call all participants 30 and 90 days following hospital discharge to collect adverse event information. Surveys will be completed by each participant's pharmacist and primary care physician 90 days following the participant's discharge from the hospital.

Tipo de estudo

Intervencional

Inscrição (Real)

954

Estágio

  • Fase 3

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

    • Iowa
      • Iowa City, Iowa, Estados Unidos, 52242
        • The University of Iowa

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 e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Speaks either English or Spanish
  • Willing to obtain all long-term prescriptions from one community pharmacy during the 90-day study period
  • Diagnosed with at least one of the following conditions: high blood pressure, hyperlipidemia, heart failure, coronary artery disease, heart attack, stroke, transient ischemic attack, asthma, chronic obstructive pulmonary disease (COPD), diabetes, or receiving oral anticoagulation therapy
  • Admitted to the general medicine, family medicine, cardiology, or orthopedics services hospital department

Exclusion Criteria:

  • Does not have a working telephone
  • Has a hearing impairment that does not allow the use of a telephone
  • Enrolled in Iowa Care (i.e., individual has no community physician or community pharmacist following hospital discharge)
  • Life expectancy estimated at less than 6 months at the time of study entry
  • Dementia or cognitive impairment
  • Severe psychiatric or psychosocial factors, including substance abuse, that may impair the desire or ability to complete all aspects of the study
  • Admission to the psychiatric, surgery, or hematology/oncology services hospital department

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

  • Finalidade Principal: Prevenção
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: Minimal intervention
Minimal intervention group patients will be seen by a clinical pharmacist in the hospital but will not receive followup after hospital discharge.
Minimal intervention patients will be seen by a clinical pharmacist during the hospitalization period to improve continuity of pharmacy care following hospital discharge.
Experimental: Enhanced intervention
Enhanced intervention patients will receive care from a clinical pharmacist during hospitalization and followup by phone after hospitalization.
Enhanced intervention patients will be visited in the hospital and will also be called by the clinical pharmacist following discharge to follow-up on any problems that might have developed after discharge.
Sem intervenção: Control
Control arm patients will not be seen by the clinical pharmacist.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Prazo
ADEs
Prazo: Measured 30 and 90 days after hospital discharge
Measured 30 and 90 days after hospital discharge
Medication appropriateness
Prazo: Measured 30 and 90 days after hospital discharge by the Hanlon et al. Medication Appropriateness Index
Measured 30 and 90 days after hospital discharge by the Hanlon et al. Medication Appropriateness Index
Complications related to medications, including the number of hospital readmissions, unscheduled visits to emergency departments or urgent care facilities, and physician visits related to a medication problem or ADE
Prazo: Measured 30 and 90 days after hospital discharge
Measured 30 and 90 days after hospital discharge
Cost-effectiveness of the minimal or enhanced treatment compared to usual care
Prazo: Measured 30 and 90 days after hospital discharge
Measured 30 and 90 days after hospital discharge

Medidas de resultados secundários

Medida de resultado
Prazo
Number of medications
Prazo: Measured 30 and 90 days after hospital discharge
Measured 30 and 90 days after hospital discharge
Complete medication list
Prazo: Measured 30 and 90 days after hospital discharge
Measured 30 and 90 days after hospital discharge
Community physician and pharmacist surveys
Prazo: Measured 90 days after participant's hospital discharge
Measured 90 days after participant's hospital discharge
Medication adherence
Prazo: Measured 30 and 90 days after hospital discharge
Measured 30 and 90 days after hospital discharge
Barriers to patient adherence
Prazo: Measured at baseline by scores on the following questionnaires: self-efficacy, cognitive impairment (Pfeiffer Mental Status Questionnaire), medication management skills and the Katz index of activities of daily living
Measured at baseline by scores on the following questionnaires: self-efficacy, cognitive impairment (Pfeiffer Mental Status Questionnaire), medication management skills and the Katz index of activities of daily living

Colaboradores e Investigadores

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

Patrocinador

Investigadores

  • Investigador principal: Barry L. Carter, PharmD, University of Iowa

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 março de 2008

Conclusão Primária (Real)

1 de julho de 2012

Conclusão do estudo (Real)

1 de outubro de 2012

Datas de inscrição no estudo

Enviado pela primeira vez

7 de agosto de 2007

Enviado pela primeira vez que atendeu aos critérios de CQ

7 de agosto de 2007

Primeira postagem (Estimativa)

9 de agosto de 2007

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

19 de agosto de 2014

Última atualização enviada que atendeu aos critérios de controle de qualidade

18 de agosto de 2014

Última verificação

1 de agosto de 2014

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • 498
  • R01HL082711 (Concessão/Contrato do NIH dos EUA)
  • R01HL082711-01A2 (Concessão/Contrato do NIH dos EUA)

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