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

Primary Purpose

Cardiovascular Diseases, Lung Diseases

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Minimal intervention
Enhanced Intervention
Sponsored by
University of Iowa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiovascular Diseases focused on measuring Pulmonary Diseases, Continuity of Pharmacy Care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • The University of Iowa

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

No Intervention

Arm Label

Minimal intervention

Enhanced intervention

Control

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

ADEs
Medication appropriateness
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
Cost-effectiveness of the minimal or enhanced treatment compared to usual care

Secondary Outcome Measures

Number of medications
Complete medication list
Community physician and pharmacist surveys
Medication adherence
Barriers to patient adherence

Full Information

First Posted
August 7, 2007
Last Updated
August 18, 2014
Sponsor
University of Iowa
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT00513903
Brief Title
Expanding the Role of Pharmacists in Treating Persons With Cardiovascular or Lung Diseases
Acronym
IowaCOC
Official Title
Enhanced Continuity of Pharmacy Care for Cardiovascular or Pulmonary Diseases
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Iowa
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Lung Diseases
Keywords
Pulmonary Diseases, Continuity of Pharmacy Care

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
954 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Minimal intervention
Arm Type
Active Comparator
Arm Description
Minimal intervention group patients will be seen by a clinical pharmacist in the hospital but will not receive followup after hospital discharge.
Arm Title
Enhanced intervention
Arm Type
Experimental
Arm Description
Enhanced intervention patients will receive care from a clinical pharmacist during hospitalization and followup by phone after hospitalization.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control arm patients will not be seen by the clinical pharmacist.
Intervention Type
Behavioral
Intervention Name(s)
Minimal intervention
Intervention Description
Minimal intervention patients will be seen by a clinical pharmacist during the hospitalization period to improve continuity of pharmacy care following hospital discharge.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
ADEs
Time Frame
Measured 30 and 90 days after hospital discharge
Title
Medication appropriateness
Time Frame
Measured 30 and 90 days after hospital discharge by the Hanlon et al. Medication Appropriateness Index
Title
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
Title
Cost-effectiveness of the minimal or enhanced treatment compared to usual care
Time Frame
Measured 30 and 90 days after hospital discharge
Secondary Outcome Measure Information:
Title
Number of medications
Time Frame
Measured 30 and 90 days after hospital discharge
Title
Complete medication list
Time Frame
Measured 30 and 90 days after hospital discharge
Title
Community physician and pharmacist surveys
Time Frame
Measured 90 days after participant's hospital discharge
Title
Medication adherence
Time Frame
Measured 30 and 90 days after hospital discharge
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barry L. Carter, PharmD
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18714110
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.
Results Reference
background
PubMed Identifier
24515550
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.
Results Reference
result
PubMed Identifier
23988600
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.
Results Reference
result
PubMed Identifier
23307540
Citation
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/phar.1164.
Results Reference
result
PubMed Identifier
25234932
Citation
Farris KB, Carter BL, Xu Y, Dawson JD, Shelsky C, Weetman DB, Kaboli PJ, James PA, Christensen AJ, Brooks JM. Effect of a care transition intervention by pharmacists: an RCT. BMC Health Serv Res. 2014 Sep 18;14:406. doi: 10.1186/1472-6963-14-406.
Results Reference
derived

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

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