Health Care Improvement Clinical Trial
Official title:
Impact of Clinical Pharmacy Service on Patient Care and Cost Saving
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.
Many studies have shown the positive impact of clinical pharmacy service on clinical,
economic and humanistic outcomes. This type of service may be highly important in saving
lives, improving patient outcomes, and decreasing treatment costs particularly in
resource-limited settings like Ethiopia with a double burden of communicable and
non-communicable diseases which need medication therapy. Though patients may experience a
number of problems related to drug therapy, no study is conducted in Ethiopia to show the
impact of clinical pharmacy service in alleviating such treatment related problems.
Therefore, this study aims to answer the following research questions.
impact of clinical pharmacy service in improving patient outcome and reducing cost of
treatment of chronic illness patients
impact of clinical pharmacy service in improving patient outcome and reducing cost of
treatment of hospitalized patients
Study site location and participants: this randomized controlled trial will be conducted at
Jimma University Specialized Hospital, Southwest Ethiopia.
Sample size calculation
The sample size for inpatients is calculated using the Open Epi online sample size
calculator software with the following assumptions:
With 80% power and significance level of 0.05 with a 95% confidence interval. Two tailed
test and a 1:1 ratio between intervention group and control group. The investigators used
the prevalence of drug related problem (primary outcome) to be 52% from previous reports in
Ethiopia.
The effect size is considered to be 1.5
Through calculation, the final sample size in each arm is 61 and considering a 20%
contingency for loss to follow up, 73 participants are needed in each group. Therefore, the
total sample size is 146.
For ambulatory patients, sample size is calculated using the prevalence of the three types
of drug related problems (indication, safety, and effectiveness) from previous studies. The
prevalence of effectiveness related drug related problem was reported to be 14%. The effect
size is determined to be 1.4 and all other parameters are considered similar to the above.
Through calculation, 215 patients are needed in each group. Considering a 10% loss for
follow up, the total sample size is 473 in the two groups.
Randomization and concealing allocation
Randomization will be completed by Statistical Package for the Social Science version 21
generated algorithm. Treating assignments kept in sealed opaque envelopes with only number
labeled will be opened after patients give their informed consents. The assigned research
assistant will distribute envelopes and record patients in each group enrollment and patient
assignment.
Blinding: research assistants of the trial who are responsible for outcome recording will be
blinded to treatment assignment.
Intervention:
Pharmacy Intervention group
For Hospitalized Patients:
Four full timer pharmacists trained on clinical pharmacy (ward Pharmacists) will be assigned
to 8-15 patients each at medical ward to provide clinical pharmacy service.
Two full timer postgraduate year two clinical pharmacy students will be assigned to medical
ward A Male and medical ward B female.
Two clinical pharmacists from school of pharmacy will also be assigned to each ward.
For Ambulatory Patients;
Two post graduate year II clinical pharmacy students will be assigned to outpatient
department of ambulatory care clinic.
The assigned pharmacy professionals will sit with the physician and make therapeutic
decisions in consultation with the physician, develop therapeutic plan and give patient
education and document into the documentation form.
Control Group
Patients in the control group will get the standard care by physicians and nurses.
Measurement
Primary outcomes
Interventions by Pharmacy professionals
For hospitalized patients, all interventions made by pharmacy professionals will be
documented on pharmacy professional activity documentation forms. Data collectors will
abstract all the relevant data from the document. The data that will be abstracted by data
collectors are:
Identified drug therapy problems and interventions made to resolve drug therapy problems.
Suggestions on prevention and avoidance of medication errors.
Cost of medicines and pharmaceuticals.
Cost of hospitalization including cost of laboratory investigations.
Patient educations given during hospital stay and at discharge for hospitalized patients.
Recommendations made for laboratory investigation and treatment monitoring done.
Patient education at hospital for ambulatory patients.
Secondary outcomes
Length of hospital stay
In hospital mortality
Patient knowledge about the drug at discharge
Inpatient satisfaction with the health care service provided
For ambulatory patients,
Primary outcome
Identified drug therapy problems and interventions made to resolve drug therapy problems.
Cost of medicines
Secondary outcomes
Patient knowledge about the prescribed medicines
Statistical analysis: Statistical software Statistical Package for the Social Science 21
will be used for analysis. Variables with p value<0.05 will be considered statistically
significant.
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research