Individual Education on Rational Drug Use in Primary Healthcare for Patients on Long-Term Medication

The Impact of Individual Education on Rational Drug Use in Primary Care for Patients on Long-Term Medication: an Intervention Study

Irrational medication use is a common problem in Turkiye and worldwide. Educational interventions are essential to promote rational drug use. This study was conducted to evaluate the effect of individual education on rational drug use given to individuals aged 45-74 years with at least one continuously used medication who applied to a primary health care institution on their rational drug use level. The hypothesis of the study was that individual training on rational drug use given to individuals using medication continuously is effective in increasing rational drug use.

Study Overview

• Status: Completed
• Conditions: Medication Adherence; Patient Compliance; Drug Utilization Review
• Intervention / Treatment: Other: Educational intervention

Detailed Description

Incorrect, unnecessary, ineffective and high-cost drug use is a significant problem all over the world. The adherence of patients to the treatment recommended by the healthcare professional depends on the improvement of their knowledge, attitudes and behaviours about rational drug use (RDU) in the correct direction. There is a need for educational interventions that will increase the knowledge and awareness of the society on this matter and encourage RDU. This study was conducted in Hacettepe University Faculty of Medicine, Family Medicine Training Unit to evaluate the effect of RDU education in individuals aged 45-74 years who were continuously taking medication. In this non-randomised matched controlled intervention study, participants who met the criteria were non-randomly divided into two groups (research and control arm). Firstly, volunteers for the research arm started to be included in the study. According to the distribution of gender, age groups and education levels of the research arm, a one-to-one matching was made to the control arm in terms of these qualifications. In this way, the effects of three possible confounding variables for the two arms were controlled through group matching. In the first visit, data were collected from the research and control arms with questionnaire forms including sociodemographic information and the Rational Drug Use Scale (RDUS). In the first visit after the completion of the questionnaire form, each individual in the research arm was given individual-patient education on rational drug use and patient brochure by the researcher. The control arm received no educational intervention and was not given a brochure at the first visit. The final visit was conducted with both the research and control arms 3 months after the first visit of each individual. The effect of the educational intervention on RDU was evaluated with the RDUS. In this visit, the individuals in the control arm were also given a patient brochure in line with the 'principle of equality'.

• Study Type: Interventional
• Enrollment (Actual): 365
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey
    • Hacettepe University Faculty of Medicine, Department of Family Medicine, Family Medicine Training Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Taking at least one medication continuously (Individuals with taking at least one medication that 'has been used every day for a minimum of 3 months and should be used for at least 1 year' were defined as 'continuous medication users'. Patients' declarations of continuous medication use were verified through the Family Medicine Information System).
• To be between 45-74 years old
• Not being dependent on another individual in terms of medication use
• Being co-operative and orientated (The Mini Mental Test is routinely administered to individuals over the age of 65 who are registered in the Family Medicine Training Unit and the results of this test can be seen in the Family Medicine Information System. In our study, those with normal scores (between 24-30 points) were considered to be co-operative and orientated).
• To be at least primary school graduate
• To agree to participate in the study

Exclusion Criteria:

• Not to have a medication that is used continuously
• Under 45 years of age or 75 years of age or older
• Being a cancer patient in active treatment
• Being pregnant or breastfeeding
• Having a severe psychiatric disorder
• Uncooperative or disorientated
• Not having completed primary school education
• Getting help from another person for the use of medicines
• In the recruitment of volunteers for the control arm to the 36 groups formed according to the distribution of gender, age groups and education levels of the research arm, the absence of a participant suitable for the characteristics of the group (In order to stabilise the effect of possible confounding variables between the two arms, each participant in the research arm was matched one-to-one with the participants in the control arm in terms of three sociodemographic variables. In the recruitment of volunteers to the control arm, if there was no participant matched to the age group, gender and education level of the participant in the research arm, the participants who were last included in the study in the research arm and could not be matched were excluded from the study).
• Development of a medical condition that prevented participation in the final visit within the three-month follow-up period

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Research Arm; Individuals in this arm were given individual education on rational drug use by the researcher at the first visit. 'Individual Training Presentation on Rational Drug Use' consisting of visual and written content was used for patient education intervention. After the education, 'Rational Drug Use Patient Brochure' was given to all participants in this arm.	Other: Educational intervention; In this study, 3 intervention tools were developed by the researchers. The first of these, 'Rational Drug Use Trainer Guide', was used for trainer training and standardisation of the education given to patients. The sample rational drug use presentations prepared by the Ministry of Health, Turkiye Medicines and Medical Devices Agency, Department of Rational Drug Use were combined in terms of content, enriched with information obtained from the literature and developed for the use of family physicians working in primary health care institutions in their clinical practices. 'Rational Drug Use Individual Education Presentation' was prepared by the researchers in line with the 'Rational Drug Use Trainer Guide'. It has been prepared in a format suitable for individual education presentation with the most concise and understandable content suitable for use during primary healthcare service delivery. 'Rational Drug Use Patient Brochure' was prepared by the researchers in a similar content.
No Intervention: Control Arm; No educational intervention was made in the control arm and no brochure was given at the first visit. In line with the principle of equality, participants in this arm were given a patient brochure at the end of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The effect of individual education on rational drug use status	Rational drug use status of the participants was measured with the Rational Drug Use Scale (RDUS). The RDUS consists of 21 questions and a single dimension. In this 5-point Likert-type scale, the answers for each item are never (1 point), rarely (2 points), sometimes (3 points), often (4 points) and always (5 points). Only the 17th item in the scale is reverse scored. After the reverse scoring process, the 'total scale score' is calculated by summing the scores of all items of the scale. As the total score obtained from RDUS increases, rational drug use also increases. This scale was applied to both arms in both first visit and final visit, and the effect of the educational intervention was evaluated through this scale.	3 months after the first visit of each individual with both the research and control arm

Collaborators and Investigators

• Sponsor: Gülşah Onur
• Investigators: Principal Investigator: Gülşah Onur, Research Assistant Dr., Hacettepe University Faculty of Medicine, Department of Family Medicine; Study Director: Duygu Ayhan Başer, Assoc. Prof., Hacettepe University Faculty of Medicine, Department of Family Medicine; Principal Investigator: Bahar (Güçiz) Doğan, Prof., Hacettepe University Institute of Public Health

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Actual): January 12, 2024
• Study Completion (Actual): April 16, 2024

Study Registration Dates

• First Submitted: November 20, 2024
• First Submitted That Met QC Criteria: November 20, 2024
• First Posted (Estimated): November 22, 2024

Study Record Updates

• Last Update Posted (Estimated): November 22, 2024
• Last Update Submitted That Met QC Criteria: November 20, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: aging; medication adherence; family practice; noncommunicable diseases; rational drug use; controlled clinical trials
• Other Study ID Numbers: HUTF-FM-GODAB-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No