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Cardiovascular DiseasesPhase 3IowaCOCNCT00513903

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

A Phase 3 study testing Minimal intervention and Enhanced Intervention in people with Cardiovascular Diseases and Lung Diseases, run by University of Iowa at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cardiovascular Diseases, Lung Diseases
What is being tested?
Minimal intervention and Enhanced Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
954 participants
Where
1 siteUnited States
Study dates
Mar 2008to Oct 2012
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

United States1 site

  • The University of Iowa

    Iowa City, Iowa, 52242

Other trials in United States

About this study

Official title: Enhanced Continuity of Pharmacy Care for Cardiovascular or Pulmonary Diseases

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.

Read the 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.

Being tested
Minimal intervention, Enhanced Intervention
Keywords
Pulmonary Diseases, Continuity of Pharmacy Care
Medical subject headings
Cardiovascular Diseases, Lung Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Minimal interventionBehavioural

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

  • Enhanced InterventionBehavioural

    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.

Study groups in NCT00513903
Study groupRoleWhat they receive
Minimal interventionActive comparatorMinimal intervention group patients will be seen by a clinical pharmacist in the hospital but will not receive followup after hospital discharge.
Receives: Behavioral: Minimal intervention
Enhanced interventionExperimentalEnhanced intervention patients will receive care from a clinical pharmacist during hospitalization and followup by phone after hospitalization.
Receives: Behavioral: Enhanced Intervention
ControlNo interventionControl arm patients will not be seen by the clinical pharmacist.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ADEs

    Measured: Measured 30 and 90 days after hospital discharge

  2. Medication appropriateness

    Measured: Measured 30 and 90 days after hospital discharge by the Hanlon et al. Medication Appropriateness Index

  3. 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: Measured 30 and 90 days after hospital discharge

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

    Measured: Measured 30 and 90 days after hospital discharge

Secondary outcomes (5)

  1. Number of medications

    Measured: Measured 30 and 90 days after hospital discharge

  2. Complete medication list

    Measured: Measured 30 and 90 days after hospital discharge

  3. Community physician and pharmacist surveys

    Measured: Measured 90 days after participant's hospital discharge

  4. Medication adherence

    Measured: Measured 30 and 90 days after hospital discharge

  5. Barriers to patient adherence

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2007 (estimated)
  2. Study startMar 2008
  3. Primary completionJul 2012
  4. Study completionOct 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
954 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00513903
Sponsor's protocol ID
498
Other IDs
R01HL082711, R01HL082711-01A2
Acronym
IowaCOC
Status last verified
Aug 2014
First submitted
7 Aug 2007
Last updated
19 Aug 2014
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 18714110

  • 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.

    PubMed 24515550

  • 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.

    PubMed 23988600

  • 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.

    PubMed 23307540

  • 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.

    PubMed 25234932

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Minimal intervention and Enhanced Intervention in people with Cardiovascular Diseases and Lung Diseases, run by University of Iowa at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ADEs (time frame: Measured 30 and 90 days after hospital discharge). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00513903, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2014.

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