Short-Term Use of Antibiotics and Adherence Level
Condition: Acute Infection
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): Routine care by the dispensing pharmacist; Pharmaceutical education/counseling about prescribed antibiotic
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Patients in the control group received routine care by the dispensing pharmacist and seen by research assistant for data collection only; Patient in the intervention group was provided with pharmaceutical education about his/her prescribed antibiotic by the trained clinical pharmacist. 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.
Intervention MeSH terms: Anti-Bacterial Agents
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research