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Impact of Clinical Pharmacy Service on Patient Care and Cost Saving (TGPIONEER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02861677
Recruitment Status : Unknown
Verified August 2016 by Tigestu Alemu, Jimma University.
Recruitment status was:  Not yet recruiting
First Posted : August 10, 2016
Last Update Posted : August 10, 2016
Sponsor:
Collaborator:
MSH/SIAPS-Ethiopia
Information provided by (Responsible Party):
Tigestu Alemu, Jimma University

Brief Summary:

Background: Pharmacists have been proven to improve patient outcomes, medication adherence, glycemic control, reduce blood pressure, low-density lipoprotein, health care costs and length of hospital stay, and enhance quality of life.

Objective: to measure the impact of clinical pharmacy service on patient care and cost saving of patients at inpatient wards and ambulatory care clinics of Jimma University Specialized Hospital.

Methods: single center Randomized Controlled Trial will be conducted. Participants will be assigned to either pharmacy professionals' intervention group or non-intervention (control) group based on computer generated random number. The study will be done from July 26 to September 15, 2016. The total sample size is calculated with Open Epi online sample size calculator with 95% CI and 80% power. The total sample size is found to be 146 for inpatients and 473 for outpatients. Linear regression, student's t-test, logistic regression and chi-square test will be used for statistical analysis. Variables with p<0.05 will be considered statistically significant.


Condition or disease Intervention/treatment Phase
Health Care Improvement Other: pharmaceutical care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 576 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Impact of Clinical Pharmacy Service on Patient Care and Cost Saving
Study Start Date : August 2016
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control group
The control group will receive the usual medical care by physicians and nurses
Experimental: Intervention group
the intervention group will receive clinical pharmacy services
Other: pharmaceutical care



Primary Outcome Measures :
  1. The number of drug therapy problems [ Time Frame: through study completion, an average of 8 weeks ]
  2. The number of medication errors [ Time Frame: through study completion, an average of 8 weeks ]
  3. Cost of medicines [ Time Frame: through study completion, an average of 8 weeks ]

Secondary Outcome Measures :
  1. Length of hospital stay [ Time Frame: through study completion, an average of 8 weeks ]
  2. In hospital mortality [ Time Frame: through study completion, an average of 8 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥18 years old,
  • Patients admitted to internal medicine ward,
  • Ambulatory patients with the following non-communicable diseases:

    • diabetes mellitus,
    • hypertension,
    • heart failure,
    • ischemic heart disease,
    • rheumatoid heart diseases,
    • chronic kidney disease,
    • venous thromboembolism,
    • asthma, chronic obstructive pulmonary disease, and epilepsy who have been on treatment for at least three months.

Exclusion Criteria:

  • Hospitalized medical inpatients with the following conditions.
  • Drop outs:

    • Patients leaving against medical advice, die and abscond within 72 hours of admission.
    • Patients not willing to participate.
    • Patients who may be transferred from intensive care unit to internal medicine ward.
    • Patients who may be transferred from other wards to internal medicine ward.
    • Patients admitted with stroke.

Chronic illness ambulatory patients with the following conditions:

  • Patients not willing to participate.
  • Women with gestational diabetes.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02861677


Contacts
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Contact: Tigestu Desse, MSc +251923533706 tgfrekidan16@gmail.com

Sponsors and Collaborators
Jimma University
MSH/SIAPS-Ethiopia
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Responsible Party: Tigestu Alemu, Lecturer and clinical pharmacist, Jimma University
ClinicalTrials.gov Identifier: NCT02861677    
Other Study ID Numbers: Rpge/502/2016
First Posted: August 10, 2016    Key Record Dates
Last Update Posted: August 10, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No