Health Care ImprovementTGPIONEERNCT02861677
Impact of Clinical Pharmacy Service on Patient Care and Cost Saving
A study testing pharmaceutical care in people with Health Care Improvement, run by Jimma University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Health Care Improvement
- What is being tested?
- pharmaceutical care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 576 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years old,
- Patients admitted to internal medicine ward,
- Ambulatory patients with the following non-communicable diseases:
- diabetes mellitus,
- hypertension,
- heart failure,
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- 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.
Who cannot join
- 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.
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- Patients admitted with stroke.
- Chronic illness ambulatory patients with the following conditions:
- Patients not willing to participate.
- Women with gestational diabetes.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the detailed description
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.
- Conditions
- Health Care Improvement
- Being tested
- pharmaceutical care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pharmaceutical careOther
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | The control group will receive the usual medical care by physicians and nurses |
| Intervention group | Experimental | the intervention group will receive clinical pharmacy services Receives: Other: pharmaceutical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of drug therapy problems
Measured: through study completion, an average of 8 weeks
The number of medication errors
Measured: through study completion, an average of 8 weeks
Cost of medicines
Measured: through study completion, an average of 8 weeks
Secondary outcomes (2)
Length of hospital stay
Measured: through study completion, an average of 8 weeks
In hospital mortality
Measured: through study completion, an average of 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionSep 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Care ImprovementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 576 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jimma University
- Sponsor type
- University, hospital or other
- Collaborators
- MSH/SIAPS-Ethiopia
- Responsible party
- Principal investigator, Tigestu Alemu, Jimma University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02861677
- Sponsor's protocol ID
- Rpge/502/2016
- Acronym
- TGPIONEER
- Status last verified
- Aug 2016
- First submitted
- 1 Aug 2016
- Last updated
- 10 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Clinical Pharmacy Service on Patient Care and Cost Saving
- ClinicalTrials.gov ID
- NCT02861677
- Acronym / sponsor ID
- TGPIONEER / Rpge/502/2016
- Conditions
- Health Care Improvement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 576 participants (estimated)
- Lead sponsor
- Jimma UniversityUniversity, hospital or other
- Collaborators
- MSH/SIAPS-Ethiopia
- Study start
- Aug 2016
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 10 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –The control group will receive the usual medical care by physicians and nurses |
| Intervention group | Experimental | Other: pharmaceutical carethe intervention group will receive clinical pharmacy services |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥18 years old,
- Patients admitted to internal medicine ward,
- Ambulatory patients with the following non-communicable diseases:
Key exclusion criteria (10 listed)
- Hospitalized medical inpatients with the following conditions.
- Drop outs:
- Patients not willing to participate.
- Women with gestational diabetes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pharmaceutical care | Other | Intervention group |
Primary outcome
The number of drug therapy problems
Time frame: through study completion, an average of 8 weeks
The number of medication errors
Time frame: through study completion, an average of 8 weeks
Cost of medicines
Time frame: through study completion, an average of 8 weeks
2 secondary outcomes
Length of hospital stay
Time frame: through study completion, an average of 8 weeks
In hospital mortality
Time frame: through study completion, an average of 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing pharmaceutical care in people with Health Care Improvement, run by Jimma University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tigestu Desse, MSc (+251923533706, tgfrekidan16@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of drug therapy problems (time frame: through study completion, an average of 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2016.