NCT00513903

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
954

participants targeted

Target at P50-P75 for phase_3 cardiovascular-diseases

Timeline
Completed

Started Mar 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 9, 2007

Completed
7 months until next milestone

Study Start

First participant enrolled

March 1, 2008

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

August 19, 2014

Status Verified

August 1, 2014

Enrollment Period

4.3 years

First QC Date

August 7, 2007

Last Update Submit

August 18, 2014

Conditions

Cardiovascular DiseasesLung Diseases

Keywords

Pulmonary DiseasesContinuity of Pharmacy Care

Outcome Measures

Primary Outcomes (4)

  • ADEs

    Measured 30 and 90 days after hospital discharge

  • Medication appropriateness

    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

    Measured 30 and 90 days after hospital discharge

  • Cost-effectiveness of the minimal or enhanced treatment compared to usual care

    Measured 30 and 90 days after hospital discharge

Secondary Outcomes (5)

  • Number of medications

    Measured 30 and 90 days after hospital discharge

  • Complete medication list

    Measured 30 and 90 days after hospital discharge

  • Community physician and pharmacist surveys

    Measured 90 days after participant's hospital discharge

  • Medication adherence

    Measured 30 and 90 days after hospital discharge

  • 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

Study Arms (3)

Minimal intervention

ACTIVE COMPARATOR

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

Enhanced intervention

EXPERIMENTAL

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

Behavioral: Enhanced Intervention

Control

NO INTERVENTION

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

Interventions

Minimal interventionBEHAVIORAL

Minimal intervention patients will be seen by a clinical pharmacist during the hospitalization period to improve continuity of pharmacy care following hospital discharge.

Minimal intervention
Enhanced InterventionBEHAVIORAL

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.

Enhanced intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Iowa

Iowa City, Iowa, 52242, United States

Location

Related Publications (5)

  • 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.

    PMID: 18714110BACKGROUND

  • 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.

    PMID: 24515550RESULT

  • 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.

    PMID: 23988600RESULT

  • 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.

    PMID: 23307540RESULT

  • 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.

    PMID: 25234932DERIVED

MeSH Terms

Conditions

Cardiovascular DiseasesLung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

  • Barry L. Carter, PharmD

    University of Iowa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2007

First Posted

August 9, 2007

Study Start

March 1, 2008

Primary Completion

July 1, 2012

Study Completion

October 1, 2012

Last Updated

August 19, 2014

Record last verified: 2014-08

Locations

US(1)