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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Iowa
ClinicalTrials.gov Identifier:
NCT00513903
First received: August 7, 2007
Last updated: August 18, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Cardiovascular Diseases
Lung Diseases
Behavioral: Minimal intervention
Behavioral: Enhanced Intervention
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Enhanced Continuity of Pharmacy Care for Cardiovascular or Pulmonary Diseases

Resource links provided by NLM:


Further study details as provided by University of Iowa:

Primary Outcome Measures:
  • ADEs [ Time Frame: Measured 30 and 90 days after hospital discharge ] [ Designated as safety issue: Yes ]
  • Medication appropriateness [ Time Frame: Measured 30 and 90 days after hospital discharge by the Hanlon et al. Medication Appropriateness Index ] [ Designated as safety issue: Yes ]
  • 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 [ Time Frame: Measured 30 and 90 days after hospital discharge ] [ Designated as safety issue: Yes ]
  • Cost-effectiveness of the minimal or enhanced treatment compared to usual care [ Time Frame: Measured 30 and 90 days after hospital discharge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of medications [ Time Frame: Measured 30 and 90 days after hospital discharge ] [ Designated as safety issue: No ]
  • Complete medication list [ Time Frame: Measured 30 and 90 days after hospital discharge ] [ Designated as safety issue: Yes ]
  • Community physician and pharmacist surveys [ Time Frame: Measured 90 days after participant's hospital discharge ] [ Designated as safety issue: No ]
  • Medication adherence [ Time Frame: Measured 30 and 90 days after hospital discharge ] [ Designated as safety issue: Yes ]
  • Barriers to patient adherence [ Time Frame: 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 ] [ Designated as safety issue: No ]

Enrollment: 954
Study Start Date: March 2008
Study Completion Date: October 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Minimal intervention
Minimal intervention group patients will be seen by a clinical pharmacist in the hospital but will not receive followup after hospital discharge.
Behavioral: Minimal intervention
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.
Behavioral: Enhanced Intervention
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.
No Intervention: Control
Control arm patients will not be seen by the clinical pharmacist.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00513903

Locations
United States, Iowa
The University of Iowa
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
University of Iowa
Investigators
Principal Investigator: Barry L. Carter, PharmD The University of Iowa
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Iowa
ClinicalTrials.gov Identifier: NCT00513903     History of Changes
Other Study ID Numbers: 498, R01HL082711, R01 HL082711-01A2
Study First Received: August 7, 2007
Last Updated: August 18, 2014
Health Authority: United States: Federal Government

Keywords provided by University of Iowa:
Pulmonary Diseases
Continuity of Pharmacy Care

Additional relevant MeSH terms:
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 25, 2014