Drug counselling to improve the taking of short-term antibiotics as prescribed
| ISRCTN | ISRCTN82062391 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN82062391 |
| Secondary identifying numbers | KFI/2020 |
- Submission date
- 12/12/2020
- Registration date
- 22/12/2020
- Last edited
- 29/09/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Medication adherence usually refers to whether patients take their medications as prescribed (eg, twice daily), as well as whether they continue to take a prescribed medication. An earlier study showed that drug adherence information provided in pharmacies by pharmacy staff takes about 2 to 3 minutes and is usually delivered in a hurry and unstructured. Drug counselling between providers and patients takes longer and is very rare, and has never been done in some pharmacies. The researchers have developed a modified counselling model to help improve pharmaceutical counselling services. The aim of this study is to test the effect of this model.
Who can participate?
Adult patients who come to the pharmacy to buy antibiotics.
What does the study involve?
Patients at the pharmacy who are willing to take part in the study are randomly allocated to receive either advice as usual, or a 15-minute drug counselling session with pharmacy staff to explain the name of the drug, what it is for, dosage, frequency of use, duration of use, possible symptoms, and how to store the medicine in detail.
What are the possible benefits and risks of participating?
There are no expected benefits or risks for participants.
Where is the study run from?
Community pharmacies in Bali (Indonesia)
When is the study starting and how long is it expected to run for?
September 2020 to April 2021
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
I Gusti Ayu Rai Widowati
gekrai@angligan.com
Contact information
Scientific
Cokroaminoto Street, 410
Denpasar Bali
80116
Indonesia
 ORCID ID |
0000-0001-5847-4813 |
|---|---|
| Phone | +62 (0)8113905181 |
| gekrai@angligan.com |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Modification of pharmaceutical counseling enhances patient adherence with short-term antibiotics use compared with conventional drug information |
| Study acronym | MPH |
| Study objectives | The modified counseling enhances adherence with short-term antibiotic use in pharmacy patients. |
| Ethics approval(s) | Approved 26/10/2020, Research Ethics Committee, Faculty of Medicine, Udayana University (Pulau Serangan Street, Denpasar, Bali, 80114, Indonesia; +62 (0)361 227911-15; no email provided) ref: 2144/UNUN.14.2.2.VII.14/LT/2020 |
| Health condition(s) or problem(s) studied | Patient adherence to short-term antibiotics |
| Intervention | A baseline survey is conducted to measure the level of knowledge and attitudes of short-term antibiotic use in pharmacy patients. Participants are randomly allocated to the intervention group and the comparison group. The randomization process is carried out by block-randomization with 1 day intervals, for example Monday is the intervention group, Tuesday is the comparison group and so on. The intervention of modified counselling consists of explaining to the patient the name of the drug, indication, dosage, frequency of use, duration of use, possible symptoms, and how to store the medicine in detail. The intervention is conducted by a trained pharmacist assistant in a private room. The duration of follow-up is based on when the drug is consumed by the patient, ranging from 3-7 days depending on the amount of drug given in the doctor's prescription. In the comparison group, the patient is given conventional drug information by the pharmacist's assistant on duty. For baseline data, the researchers conduct a self-administered questionnaire with pharmacist patients, then for adherence measurements they use a telephone call to interview the participants. |
| Intervention type | Behavioural |
| Primary outcome measure | Patients adherence measured using Morisky Medication Adherence Scale -8 by telephone questionnaire when the drug is predicted to run out, 3-7 days from the time the patient came to the pharmacy to buy the drug |
| Secondary outcome measures | Problems arising in patient adherence or non-adherence to antibiotic therapy and the opinions of various parties on the implementation of the modified pharmaceutical counseling, collected by telephone interviews with patients (3-7 days from the time the patient came to the pharmacy to buy the drug) and interviews with service providers (at the pharmacy during the participant recruitment) and policyholders (at any convenient time and place during the data collection by appointment) |
| Overall study start date | 21/09/2020 |
| Completion date | 30/04/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 300 |
| Total final enrolment | 300 |
| Key inclusion criteria | 1. Aged ≥18 years 2. Come to the pharmacy to buy antibiotics by prescription 3. Willing to become respondents by agreeing to the informed consent |
| Key exclusion criteria | Patients who are doctors, nurses, midwives and other health workers |
| Date of first enrolment | 01/12/2020 |
| Date of final enrolment | 15/03/2021 |
Locations
Countries of recruitment
- Indonesia
Study participating centres
Denpasar Bali
80114
Indonesia
Denpasar Bali
80113
Indonesia
Denpasar Bali
80114
Indonesia
Karangasem Bali
80811
Indonesia
Sponsor information
University/education
Faculty of Medicine
PB. Sudirman Street
Denpasar Bali
80114
Indonesia
| Phone | +62 (0)361 223797 |
|---|---|
| info@unud.ac.id | |
| Website | http://www.unud.ac.id/eng/ |
"ROR" |
https://ror.org/035qsg823 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/09/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/09/2022 | 29/09/2022 | Yes | No |
Editorial Notes
29/09/2022: Publication reference added.
17/05/2022: The intention to publish date has been changed from 01/08/2021 to 01/09/2022.
19/04/2021: The total final enrolment was added.
01/03/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 28/02/2021 to 15/03/2021.
2. The intention to publish date was changed from 01/04/2021 to 01/08/2021.
21/12/2020: Trial's existence confirmed by Research Ethics Committee, Faculty of Medicine, Udayana University.
