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

18 août 2014 mis à jour par: 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.

Aperçu de l'étude

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

954

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • Iowa
      • Iowa City, Iowa, États-Unis, 52242
        • The University of Iowa

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: 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.
Expérimental: 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.
Aucune intervention: Control
Control arm patients will not be seen by the clinical pharmacist.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Délai
ADEs
Délai: Measured 30 and 90 days after hospital discharge
Measured 30 and 90 days after hospital discharge
Medication appropriateness
Délai: 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
Délai: 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
Délai: Measured 30 and 90 days after hospital discharge
Measured 30 and 90 days after hospital discharge

Mesures de résultats secondaires

Mesure des résultats
Délai
Number of medications
Délai: Measured 30 and 90 days after hospital discharge
Measured 30 and 90 days after hospital discharge
Complete medication list
Délai: Measured 30 and 90 days after hospital discharge
Measured 30 and 90 days after hospital discharge
Community physician and pharmacist surveys
Délai: Measured 90 days after participant's hospital discharge
Measured 90 days after participant's hospital discharge
Medication adherence
Délai: Measured 30 and 90 days after hospital discharge
Measured 30 and 90 days after hospital discharge
Barriers to patient adherence
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Les enquêteurs

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

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 mars 2008

Achèvement primaire (Réel)

1 juillet 2012

Achèvement de l'étude (Réel)

1 octobre 2012

Dates d'inscription aux études

Première soumission

7 août 2007

Première soumission répondant aux critères de contrôle qualité

7 août 2007

Première publication (Estimation)

9 août 2007

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

19 août 2014

Dernière mise à jour soumise répondant aux critères de contrôle qualité

18 août 2014

Dernière vérification

1 août 2014

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • 498
  • R01HL082711 (Subvention/contrat des NIH des États-Unis)
  • R01HL082711-01A2 (Subvention/contrat des NIH des États-Unis)

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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