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Impact of Clinical Pharmacy Services on Medication Cost and Hospitalization Rates in Hemodialysis Patients

Primary Purpose

End Stage Renal Disease

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Behavioral Patient care
Sponsored by
University of New Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for End Stage Renal Disease focused on measuring Document the number, type, and severity of DRPs, in HD patients., Determine the rates and categorization of, DRPs-associated hospitalizations in HD patients., Document the number and types of pharmaceutical, Care Interventions., Determine the outcomes of pharmaceutical care, Intervention, Determine the rate of acceptance of pharmaceutical, Care Interventions ., Assign significance rank to pharmaceutical, Determine annual drug cost in HD patients., Determine drug cost associated for treatment, of each HD patient comorbidity., Determine Quality of Life (QoL) using a renal, -specific instrument

Eligibility Criteria

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

Inclusion Criteria: Patients are eligible for inclusion in the study if they have been on HD for greater than three months, greater than 18 years of age, those who plan to be continuously enrollment in therapy at the same dialysis center throughout the duration of the study. Informed consent will be obtained on eligible patients. The study is to be approved by the Human Research Review Committee prior to initiation. Exclusion Criteria: Patients will be excluded if they have been on HD for less than three months, decline the opportunity to participate, or are less than 18 years of age.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    No Intervention

    Arm Label

    Behavioral Patient Care

    Arm Description

    Chart review

    Outcomes

    Primary Outcome Measures

    Reduction in at home medications
    Behavioral: Patent care

    Secondary Outcome Measures

    Full Information

    First Posted
    July 9, 2008
    Last Updated
    July 17, 2023
    Sponsor
    University of New Mexico
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05952388
    Brief Title
    Impact of Clinical Pharmacy Services on Medication Cost and Hospitalization Rates in Hemodialysis Patients
    Official Title
    Impact of Clinical Pharmacy Services on Medication Cost and Hospitalization Rates in Hemodialysis Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    PI left the institution
    Study Start Date
    January 2003 (Actual)
    Primary Completion Date
    January 2003 (Actual)
    Study Completion Date
    January 2003 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of New Mexico

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the effects of pharmaceutical care interventions in the ambulatory hemodialysis patients over a one-year period. Cost containment occurs through pharmaceutical care interventions designed to identify and ameliorate drug-related problems (DRPs), improve the cost-effectiveness of therapeutic regimens and prevent hospitalizations.
    Detailed Description
    Approximately 350,000 end-stage renal disease (ESRD) patients in the United States utilized over $17.9 billion Medicare dollars in 1999. The ESRD population and cost is projected to double by 2010. ESRD patients have a mean of 5 comorbidities per patient and are prescribed a median of eight medications. The average monthly medication cost per patient is approximately $1,200.00. For every dollar spent on medication an additional $1.77 is spent on drug-related problems (DRPs). Dialysis patients are at high risk for DRPs. It is unknown if continued pharmacist intervention in hemodialysis patients will improve patient care, reduce medication utilization and cost, and prevent hospitalization as seen in other populations. The purpose of this study is to investigate the impact of continued pharmacist intervention in ambulatory hemodialysis patients.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    End Stage Renal Disease
    Keywords
    Document the number, type, and severity of DRPs, in HD patients., Determine the rates and categorization of, DRPs-associated hospitalizations in HD patients., Document the number and types of pharmaceutical, Care Interventions., Determine the outcomes of pharmaceutical care, Intervention, Determine the rate of acceptance of pharmaceutical, Care Interventions ., Assign significance rank to pharmaceutical, Determine annual drug cost in HD patients., Determine drug cost associated for treatment, of each HD patient comorbidity., Determine Quality of Life (QoL) using a renal, -specific instrument

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Behavioral Patient Care
    Arm Type
    No Intervention
    Arm Description
    Chart review
    Intervention Type
    Other
    Intervention Name(s)
    Behavioral Patient care
    Other Intervention Name(s)
    Chart review
    Intervention Description
    chart review
    Primary Outcome Measure Information:
    Title
    Reduction in at home medications
    Description
    Behavioral: Patent care
    Time Frame
    through study completion, an average of 1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients are eligible for inclusion in the study if they have been on HD for greater than three months, greater than 18 years of age, those who plan to be continuously enrollment in therapy at the same dialysis center throughout the duration of the study. Informed consent will be obtained on eligible patients. The study is to be approved by the Human Research Review Committee prior to initiation. Exclusion Criteria: Patients will be excluded if they have been on HD for less than three months, decline the opportunity to participate, or are less than 18 years of age.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Amy B Pai, Pharm.D
    Organizational Affiliation
    University of New Mexico
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Impact of Clinical Pharmacy Services on Medication Cost and Hospitalization Rates in Hemodialysis Patients

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