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

University of Iowa

Status and phase: Completed; Phase 3

Conditions: Lung Diseases; Cardiovascular Diseases

Treatments: Behavioral: Minimal intervention; Behavioral: Enhanced Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00513903

R01HL082711-01A2 (U.S. NIH Grant/Contract)

R01HL082711 (U.S. NIH Grant/Contract)

498

Details and patient eligibility

About

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.

Full 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.

Enrollment: 954 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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954 participants in 3 patient groups

Minimal intervention

Active Comparator group

Description:

Minimal intervention group patients will be seen by a clinical pharmacist in the hospital but will not receive followup after hospital discharge.

Treatment:

Behavioral: Minimal intervention

Enhanced intervention

Experimental group

Description:

Enhanced intervention patients will receive care from a clinical pharmacist during hospitalization and followup by phone after hospitalization.

Treatment:

Behavioral: Enhanced Intervention

Control

No Intervention group

Description:

Control arm patients will not be seen by the clinical pharmacist.