NCT02861677

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
576

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2016

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 1, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 10, 2016

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

August 10, 2016

Status Verified

August 1, 2016

Enrollment Period

1 month

First QC Date

August 1, 2016

Last Update Submit

August 9, 2016

Conditions

Health Care Improvement

Outcome Measures

Primary Outcomes (3)

  • The number of drug therapy problems

    through study completion, an average of 8 weeks

  • The number of medication errors

    through study completion, an average of 8 weeks

  • Cost of medicines

    through study completion, an average of 8 weeks

Secondary Outcomes (2)

  • Length of hospital stay

    through study completion, an average of 8 weeks

  • In hospital mortality

    through study completion, an average of 8 weeks

Study Arms (2)

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

Other: pharmaceutical care

Interventions

pharmaceutical careOTHER
Intervention group

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Pharmaceutical Services

Intervention Hierarchy (Ancestors)

Health ServicesHealth Care Facilities Workforce and Services

Central Study Contacts

Tigestu Desse, MSc

CONTACT

+251923533706tgfrekidan16@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer and clinical pharmacist

Study Record Dates

First Submitted

August 1, 2016

First Posted

August 10, 2016

Study Start

August 1, 2016

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

August 10, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share