Cardiovascular Diseases Clinical Trial
— IowaCOCOfficial title:
Enhanced Continuity of Pharmacy Care for Cardiovascular or Pulmonary Diseases
Verified date | August 2014 |
Source | University of Iowa |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 954 |
Est. completion date | October 2012 |
Est. primary completion date | July 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | The University of Iowa | Iowa City | Iowa |
Lead Sponsor | Collaborator |
---|---|
University of Iowa | National Heart, Lung, and Blood Institute (NHLBI) |
United States,
Anderegg SV, Demik DE, Carter BL, Dawson JD, Farris K, Shelsky C, Kaboli P. Acceptance of recommendations by inpatient pharmacy case managers: unintended consequences of hospitalist and specialist care. Pharmacotherapy. 2013 Jan;33(1):11-21. doi: 10.1002/ — View Citation
Carter BL, Farris KB, Abramowitz PW, Weetman DB, Kaboli PJ, Dawson JD, James PA, Christensen AJ, Brooks JM. The Iowa Continuity of Care study: Background and methods. Am J Health Syst Pharm. 2008 Sep 1;65(17):1631-42. doi: 10.2146/ajhp070600. — View Citation
Farley TM, Shelsky C, Powell S, Farris KB, Carter BL. Effect of clinical pharmacist intervention on medication discrepancies following hospital discharge. Int J Clin Pharm. 2014 Apr;36(2):430-7. doi: 10.1007/s11096-014-9917-x. Epub 2014 Feb 11. — View Citation
Israel EN, Farley TM, Farris KB, Carter BL. Underutilization of cardiovascular medications: effect of a continuity-of-care program. Am J Health Syst Pharm. 2013 Sep 15;70(18):1592-600. doi: 10.2146/ajhp120786. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | ADEs | Measured 30 and 90 days after hospital discharge | Yes | |
Primary | Medication appropriateness | Measured 30 and 90 days after hospital discharge by the Hanlon et al. Medication Appropriateness Index | Yes | |
Primary | 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 | Measured 30 and 90 days after hospital discharge | Yes | |
Primary | Cost-effectiveness of the minimal or enhanced treatment compared to usual care | Measured 30 and 90 days after hospital discharge | No | |
Secondary | Number of medications | Measured 30 and 90 days after hospital discharge | No | |
Secondary | Complete medication list | Measured 30 and 90 days after hospital discharge | Yes | |
Secondary | Community physician and pharmacist surveys | Measured 90 days after participant's hospital discharge | No | |
Secondary | Medication adherence | Measured 30 and 90 days after hospital discharge | Yes | |
Secondary | Barriers to patient adherence | 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 | No |
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