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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00513903
Recruitment Status : Completed
First Posted : August 9, 2007
Last Update Posted : August 19, 2014
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of Iowa

Brief Summary:
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 or disease Intervention/treatment Phase
Cardiovascular Diseases Lung Diseases Behavioral: Minimal intervention Behavioral: Enhanced Intervention Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 954 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Enhanced Continuity of Pharmacy Care for Cardiovascular or Pulmonary Diseases
Study Start Date : March 2008
Actual Primary Completion Date : July 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Diseases
U.S. FDA Resources

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. ADEs [ Time Frame: Measured 30 and 90 days after hospital discharge ]
  2. Medication appropriateness [ Time Frame: Measured 30 and 90 days after hospital discharge by the Hanlon et al. Medication Appropriateness Index ]
  3. 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 ]
  4. Cost-effectiveness of the minimal or enhanced treatment compared to usual care [ Time Frame: Measured 30 and 90 days after hospital discharge ]

Secondary Outcome Measures :
  1. Number of medications [ Time Frame: Measured 30 and 90 days after hospital discharge ]
  2. Complete medication list [ Time Frame: Measured 30 and 90 days after hospital discharge ]
  3. Community physician and pharmacist surveys [ Time Frame: Measured 90 days after participant's hospital discharge ]
  4. Medication adherence [ Time Frame: Measured 30 and 90 days after hospital discharge ]
  5. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00513903

United States, Iowa
The University of Iowa
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
University of Iowa
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Barry L. Carter, PharmD The University of Iowa

Publications of Results:
Other Publications:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University of Iowa Identifier: NCT00513903     History of Changes
Other Study ID Numbers: 498
R01HL082711 ( U.S. NIH Grant/Contract )
R01HL082711-01A2 ( U.S. NIH Grant/Contract )
First Posted: August 9, 2007    Key Record Dates
Last Update Posted: August 19, 2014
Last Verified: August 2014

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

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