Expanding the Role of Pharmacists in Treating Persons With Cardiovascular or Lung Diseases (IowaCOC)
|Cardiovascular Diseases Lung Diseases||Behavioral: Minimal intervention Behavioral: Enhanced Intervention||Phase 3|
|Study Design:||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|
- ADEs [ Time Frame: Measured 30 and 90 days after hospital discharge ]
- Medication appropriateness [ Time Frame: 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 [ Time Frame: Measured 30 and 90 days after hospital discharge ]
- Cost-effectiveness of the minimal or enhanced treatment compared to usual care [ Time Frame: Measured 30 and 90 days after hospital discharge ]
- Number of medications [ Time Frame: Measured 30 and 90 days after hospital discharge ]
- Complete medication list [ Time Frame: Measured 30 and 90 days after hospital discharge ]
- Community physician and pharmacist surveys [ Time Frame: Measured 90 days after participant's hospital discharge ]
- Medication adherence [ Time Frame: Measured 30 and 90 days after hospital discharge ]
- 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 ]
|Study Start Date:||March 2008|
|Study Completion Date:||October 2012|
|Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00513903
|United States, Iowa|
|The University of Iowa|
|Iowa City, Iowa, United States, 52242|
|Principal Investigator:||Barry L. Carter, PharmD||The University of Iowa|