Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05293977 |
| Other study ID # |
536/2019 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 3, 2020 |
| Est. completion date |
December 15, 2021 |
Study information
| Verified date |
March 2022 |
| Source |
Jordan University of Science and Technology |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Objectives: To evaluate the impact of educational intervention on antibiotic short-term
adherence .
Methods: A prospective randomized controlled study was conducted in a tertiary hospital in
Jordan. Adult patients who had an acute infection diagnosis and were prescribed antibiotic
pills for short term (< 30 day) at home were included in the study. Patients were recruited
and randomly allocated into one of the two groups; control and intervention. Each patient in
the intervention group was provided with pharmaceutical education about prescribed
antibiotic.
Description:
A prospective, single blinded, randomized controlled study was conducted at King Abdullah
University Hospital (KAUH) in Jordan. The study was carried out during Aug 2020 till Sep
2021. The primary outcome determined in this study was the impact of pharmaceutical care on
the level of short-term adherence among adult patients. An ethical approval was granted from
Institutional Review Board in Jordan University of Science and Technology (Ref number
15/126/2019). A sample of 279 patients per each group was required to detect 15% difference
in adherence level between intervention and control group at 95% statistical power and at 5%
significant level.
All eligible adult patients attending outpatient clinics at KAUH were invited to participate
in the study. Adult patients (≥18-year-old) who had an acute infection diagnosis confirmed by
a consultant and were prescribed antibiotic pills for short course treatment (< 30 day) at
home were included in the study. Those patients who were immunocompromised or used
antibiotics for prophylactic indications were excluded. A trained clinical pharmacist
(research assistant) interviewed the patients in the waiting area of hospital pharmacy to
collect the basic information about the prescribed antibiotics and indications. Written
informed consents were obtained from all recruited patients.
Patients were recruited and randomly allocated into one of the two groups (ratio 1:1);
ordinary care (control) group and intervention group. Randomization using a simple technique
was adopted; even number was assigned for intervention and odd number for control. Each
patient in the intervention group was verbally provided with pharmaceutical
education/counseling about his/her prescribed antibiotic. The research assistant was
responsible for randomization, enrolment and assignment of patients into study groups
(intervention Vs control), providing pharmaceutical education about prescribed antibiotics
for intervention group and follow up phone calls for both groups. The patients themselves did
not know whether they were enrolled in the intervention or control group. To prepare the
education about antibiotics, the 10 most commonly prescribed antibiotics were determined in
advance from hospital records: Amoxicillin or Amoxicillin/Clavulanic acid, Ciprofloxacin,
Levofloxacin, Azithromycin, Cefuroxime, Cephalexin, Clindamycin, Doxycycline, Metronidazole,
Trimethoprim/Sulfamethoxazole. Standard education points about antibiotics include (i)
mechanism of action and/or use, (ii) correct administration method, (iii) correct timing,
(iv) possible adverse effect and self-management intervention methods when faced with side
effects, (v) what to do in case of missing any dose. On the other hand, patients in the
control group received routine care by the dispensing pharmacist and seen by research
assistant for data collection only. The average time interview for patients was 20-25 min in
the intervention group Vs approximately 10 min in the control group.
At baseline, socio-demographics and clinical data of all participants were collected such as
age, gender, education, employment, family income, and presence of comorbid disease. In
addition, questions related to antibiotic use were asked to the patients in both groups such
as how many antibiotics were used, symptoms for using antibiotic, and duration/dosing/times
interval. Two days after completing the antibiotics course regimens, patients in both groups
were followed up by phone to measure adherence by asking them about i) any missing of
doses/days of the prescribed antibiotics (subjective method) and ii) number of
untaken/remaining pills (objective method). In addition, the patients were asked about
whether they use other resources for antibiotics information and the causes of missing
duration/doses. In the current study, the participants were labeled as non-adherent if they
failed to follow the duration and/ or number of daily doses as prescribed by the physician.
These measurements were used based on previous studies.
Data were analyzed using SPSS (version 23). Number (percentage) and median (interquartile
range, IQR) were calculated for categorical and continuous data respectively. Univariate
analysis was conducted using chi square for categorical variables and Mann Whitney test for
continuous data. Factors that were investigated for adherence included: study group, age,
gender, marital status, education, employment, income, comorbidity, total number of doses,
days antibiotic prescribed, frequency, use the prescribed antibiotic before, and looking at
information related to antibiotics. Variables with p value less than 0.25 in univariate
analysis were entered in multivariate logistic regression to calculate odds ratio (OR) and
95% confidence interval (95%CI). Intention to treat analysis approach was used in the current
study to consider missing data.
