Pharmacist Role in HF Patients Transition of Care

July 30, 2018 updated by: Fatimah M. Sherbeny, PharmD,MS., Nova Southeastern University

Pharmacist Role in HF Patients Transition of Care: Randomized Clinical Trial (RCT)

To assess the effectiveness of pharmacist's provided education in HF patients, in improving patients' knowledge and self-efficacy, and to assess the impact of this intervention on the rate of hospital readmission and emergency visits at 30-days, 60-days and 90-days after discharge.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

"Transition of care" is one of the new disciplines that pharmacists have been involved-in within the healthcare system. It is a process where a patient's care is shifting from one setting to another. During this process, transitional care is designed to ensure continuity of patient care across different sites or across different levels of care within the same facility. For example, from Intensive Care Unit (ICU) to the ward, from hospital to home, or from hospital to rehab centers. Many stakeholders are involved in this process, and coordination between them is necessary to have successful one, in addition to logistical arrangements, and patient education. Otherwise, poor communication, inadequate patient education, and lack of access to healthcare services, will produce failure of having a smooth transition and could result in negative health outcomes including complications in the patient's disease status, emergency room visits or hospital readmissions. Not only that these negative health outcomes are affecting the patient, they are also negatively affecting the healthcare spending in the United States. For instance, inadequate care coordination and management of care transitions accounted for $25 to $45 billion in wasteful spending in 2011 through preventable adverse events and hospital readmissions. Therefore, cost containment and reducing the excessive spending in healthcare is an important aim of "transition of care", secondary to improving patient outcomes.

Pharmacist's role in Transition of care:

Pharmacists have the knowledge, training and expertise to play a major role in the transition of care process. They are involved in dispensing the patient's medications at the hospital, ensuring that the patient's medication chart is updated, identify any medication discrepancy, provide medication reconciliation, medication education, patient counseling at discharge and they could follow-up with the patients after discharge to check if they filled their prescription, what side effects are they having, and monitor their adherence to their treatment plan. These pharmacist's interventions have been applied, among other approaches, by hospitals to improve the quality of their services and minimize the rate of readmissions.

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Admitted HF patients at WKBH
  • Patients with primary or secondary diagnosis of HF
  • Discharged to Home
  • 18 years old or older

Exclusion Criteria:

  • ≥ 90 years old
  • Patients with major comorbidities such as cancer, end-stage kidney disease, and liver failure
  • Patients with memory problems such as dementia and Alzheimer's disease
  • Patients discharged to places other than home
  • Patients who are unable to understand or follow discharge instructions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Pharmacist intervention group

The intervention group will receive:

  1. A phone call 48h-72h after discharge from the hospital to ensure that the patient filled their prescriptions and started taking their medication.
  2. A phone call five to seven days after discharge to reinforce the education using the "teach back technique"1. Patients will be asked about their medications, what are they for, how to use them, and what side effects to watch for, based on the education and information that was provided to them at discharge.
Behavioral: Pharmacist intervention
Pharmacist counseling and follow-up phone calls
NO_INTERVENTION: usual care group
The control group will receive the usual standard care available at West Kendall Baptist Hospital.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in knowledge
Time Frame: at baseline, 30 days, 60 days and 90 days after hospital discharge
The investigators will measure patient's knowledge about heart failure using a 15 item questionnaire, at baseline (at recruitment) before they get the discharge counseling at West Kendall Baptist Hospital (WKBH), then the investigators will measure it again 30 days, 60 days, and 90 days after discharge to evaluate the change in the patient's knowledge and how much information did the patients retain after the discharge counseling.
at baseline, 30 days, 60 days and 90 days after hospital discharge
change in self-efficacy using a 16 items scale
Time Frame: at baseline, 30 days, 60 days and 90 days after hospital discharge
the investigators will measure patient's self-efficacy, using a 16 items scale, at baseline (at recruitment) before the patients get the discharge counseling at West Kendall Baptist Hospital (WKBH), then the investigators will measure it again 30 days, 60 days, and 90 days after discharge to evaluate the change in the patient's self-efficacy and ability to take care of themselves before and after they receive the discharge counseling and be educated about heart failure and how to manage it.
at baseline, 30 days, 60 days and 90 days after hospital discharge

Secondary Outcome Measures

Outcome Measure
Time Frame
hospital readmission rate
Time Frame: 30 days after hospital discharge
30 days after hospital discharge
hospital readmission rate
Time Frame: 60 days after hospital discharge
60 days after hospital discharge
hospital readmission rate
Time Frame: 90 days after hospital discharge
90 days after hospital discharge
number of emergency visits
Time Frame: 30 days after hospital discharge
30 days after hospital discharge
number of emergency visits
Time Frame: 60 days after hospital discharge
60 days after hospital discharge
number of emergency visits
Time Frame: 90 days after hospital discharge
90 days after hospital discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nova Southeastern University

Collaborators

Baptist Health South Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (ANTICIPATED)

December 1, 2016

Study Completion (ANTICIPATED)

December 1, 2016

Study Registration Dates

First Submitted

August 2, 2016

First Submitted That Met QC Criteria

August 16, 2016

First Posted (ESTIMATE)

August 22, 2016

Study Record Updates

Last Update Posted (ACTUAL)

August 1, 2018

Last Update Submitted That Met QC Criteria

July 30, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-052

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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