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Pharmacist Role in HF Patients Transition of Care

Primary Purpose

Heart Failure

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pharmacist intervention
Sponsored by
Nova Southeastern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Heart Failure focused on measuring Heart Failure, HF, CHF, RCT, Self-efficacy, Pharmacy, Pharmacist, Transition of Care, Readmission

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Pharmacist intervention group

    usual care group

    Arm Description

    The intervention group will receive: A phone call 48h-72h after discharge from the hospital to ensure that the patient filled their prescriptions and started taking their medication. 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.

    The control group will receive the usual standard care available at West Kendall Baptist Hospital.

    Outcomes

    Primary Outcome Measures

    change in knowledge
    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.
    change in self-efficacy using a 16 items scale
    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.

    Secondary Outcome Measures

    hospital readmission rate
    hospital readmission rate
    hospital readmission rate
    number of emergency visits
    number of emergency visits
    number of emergency visits

    Full Information

    First Posted
    August 2, 2016
    Last Updated
    July 30, 2018
    Sponsor
    Nova Southeastern University
    Collaborators
    Baptist Health South Florida
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02874183
    Brief Title
    Pharmacist Role in HF Patients Transition of Care
    Official Title
    Pharmacist Role in HF Patients Transition of Care: Randomized Clinical Trial (RCT)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2018
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Collaborating site had difficulty with approval
    Study Start Date
    August 2016 (undefined)
    Primary Completion Date
    December 2016 (Anticipated)
    Study Completion Date
    December 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Nova Southeastern University
    Collaborators
    Baptist Health South Florida

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heart Failure
    Keywords
    Heart Failure, HF, CHF, RCT, Self-efficacy, Pharmacy, Pharmacist, Transition of Care, Readmission

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Pharmacist intervention group
    Arm Type
    Experimental
    Arm Description
    The intervention group will receive: A phone call 48h-72h after discharge from the hospital to ensure that the patient filled their prescriptions and started taking their medication. 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.
    Arm Title
    usual care group
    Arm Type
    No Intervention
    Arm Description
    The control group will receive the usual standard care available at West Kendall Baptist Hospital.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Pharmacist intervention
    Intervention Description
    Pharmacist counseling and follow-up phone calls
    Primary Outcome Measure Information:
    Title
    change in knowledge
    Description
    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.
    Time Frame
    at baseline, 30 days, 60 days and 90 days after hospital discharge
    Title
    change in self-efficacy using a 16 items scale
    Description
    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.
    Time Frame
    at baseline, 30 days, 60 days and 90 days after hospital discharge
    Secondary Outcome Measure Information:
    Title
    hospital readmission rate
    Time Frame
    30 days after hospital discharge
    Title
    hospital readmission rate
    Time Frame
    60 days after hospital discharge
    Title
    hospital readmission rate
    Time Frame
    90 days after hospital discharge
    Title
    number of emergency visits
    Time Frame
    30 days after hospital discharge
    Title
    number of emergency visits
    Time Frame
    60 days after hospital discharge
    Title
    number of emergency visits
    Time Frame
    90 days after hospital discharge

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    12657078
    Citation
    Coleman EA. Falling through the cracks: challenges and opportunities for improving transitional care for persons with continuous complex care needs. J Am Geriatr Soc. 2003 Apr;51(4):549-55. doi: 10.1046/j.1532-5415.2003.51185.x.
    Results Reference
    background
    PubMed Identifier
    18086926
    Citation
    Rosamond W, Flegal K, Furie K, Go A, Greenlund K, Haase N, Hailpern SM, Ho M, Howard V, Kissela B, Kittner S, Lloyd-Jones D, McDermott M, Meigs J, Moy C, Nichol G, O'Donnell C, Roger V, Sorlie P, Steinberger J, Thom T, Wilson M, Hong Y; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2008 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation. 2008 Jan 29;117(4):e25-146. doi: 10.1161/CIRCULATIONAHA.107.187998. Epub 2007 Dec 17. No abstract available. Erratum In: Circulation. 2010 Jul 6;122(1):e10. Kissela, Bret [corrected to Kissela, Brett].
    Results Reference
    background
    PubMed Identifier
    11867975
    Citation
    Aminzadeh F, Dalziel WB. Older adults in the emergency department: a systematic review of patterns of use, adverse outcomes, and effectiveness of interventions. Ann Emerg Med. 2002 Mar;39(3):238-47. doi: 10.1067/mem.2002.121523.
    Results Reference
    background
    PubMed Identifier
    24327590
    Citation
    Hawes EM, Maxwell WD, White SF, Mangun J, Lin FC. Impact of an outpatient pharmacist intervention on medication discrepancies and health care resource utilization in posthospitalization care transitions. J Prim Care Community Health. 2014 Jan 1;5(1):14-8. doi: 10.1177/2150131913502489. Epub 2013 Sep 17.
    Results Reference
    background
    PubMed Identifier
    22618976
    Citation
    Bellone JM, Barner JC, Lopez DA. Postdischarge interventions by pharmacists and impact on hospital readmission rates. J Am Pharm Assoc (2003). 2012 May-Jun;52(3):358-62. doi: 10.1331/JAPhA.2012.10172.
    Results Reference
    background
    PubMed Identifier
    24196278
    Citation
    Thomas R, Huntley AL, Mann M, Huws D, Elwyn G, Paranjothy S, Purdy S. Pharmacist-led interventions to reduce unplanned admissions for older people: a systematic review and meta-analysis of randomised controlled trials. Age Ageing. 2014 Mar;43(2):174-87. doi: 10.1093/ageing/aft169. Epub 2013 Nov 5.
    Results Reference
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