The Improve Drug Therapy Trial
| ISRCTN | ISRCTN14052916 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14052916 |
- Submission date
- 25/02/2025
- Registration date
- 27/02/2025
- Last edited
- 26/03/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Medication reviews involve structured patient interviews and a systematic evaluation of medication history to optimise drug use by identifying and addressing drug-related problems (DRPs). DRPs include dosage errors, duplicate prescriptions, adherence issues, lack of effectiveness, potential drug-drug interactions (pDDIs), side effects, storage issues, and patient-reported concerns. Implementing medication reviews in community pharmacies may help mitigate the burden of polypharmacy. This study is the first randomised, patient- and assessor-blind trial investigating the effects of structured medication reviews (Type 2a) in outpatients with polypharmacy.
Who can participate?
Patients aged over 18 years with an intake of eight or more systemically available drugs (in case of combination products, eight or more active ingredients, also including over-the-counter drugs, especially if they are on the list of interaction-relevant over-the-counter drugs)
What does the study involve?
Medication review type 2a focuses on prescribed medication and consists of an assessment of DRPs and personalised recommendations to improve DRPs (both oral and written). The study involves up to three study visits: in the intervention group patients receive one (baseline) or two (baseline + month 3 to 4) medication reviews with a follow-up assessment of drug-related problems after 6 to 9 months. In the control group patients receive an assessment of drug-related problems without any recommendations to improve (baseline) and one “full” medication review with recommendations (months 3 to 4) with a follow-up assessment of drug-related problems after 6 to 9 months.
What are the possible benefits and risks of participating?
Patient benefits:
1. Improved understanding of their treatment through pharmacist-led reviews.
2. Identification of contraindications or serious DRPs, prompting immediate intervention through consultation with treating physicians or clinical pharmacologists.
3. Optimised drug treatment and personalised therapy discussions.
4. All pharmacist recommendations were reviewed with treating physicians to ensure the best possible patient care.
Where is the study run from?
Medical University of Vienna (Austria)
When is the study starting and how long is it expected to run for?
January 2021 to June 2024
Who is funding the study?
1. Austrian Chamber of Pharmacists
2. Austrian Federation of Social Insurances
Who is the main contact?
Christian Schoergenhofer, christian.schoergenhofer@meduniwien.ac.at
Contact information
Principal Investigator
Waerhinger Gürtel 18-20
Vienna
1090
Austria
 ORCID ID |
0000-0002-2286-1077 |
|---|---|
| Phone | +43 (0)14040029810 |
| christian.schoergenhofer@meduniwien.ac.at |
Scientific
Waehringer Gürtel 18-20
Vienna
1090
Austria
| ORCID ID |
0009-0003-8288-8591 |
|---|---|
| Phone | +43 (0)14040029810 |
| thorsten.bischof@meduniwien.ac.at |
Public
Spitalgasse 31
Vienna
1090
Austria
| Phone | +43 (0)40414100 |
|---|---|
| stefan.deibl@apothekerkammer.at |
Study information
| Study design | Prospective multi-centre randomized-controlled patient and observer-blind parallel-group study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community, Pharmacy |
| Study type | Other, Prevention, Screening, Safety |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Effects of a community pharmacy-based structured medication review on drug-related problems and patient-reported outcomes in all-comers with polypharmacy: a randomised, controlled, double-blind, parallel-group trial |
| Study objectives | The aim of this study is to investigate the prevalence of drug-related problems in outpatients with polypharmacy, and the effects of medication reviews on drug-related problems. |
| Ethics approval(s) |
Approved 27/01/2022, Ethics committee of the Medical University of Vienna (Borschkegasse 8b/6, Vienna, 1090 Wien, Austria; +43 (0)14040021470; ethik-kom@meduniwien.ac.at), ref: 2029/2021 |
| Health condition(s) or problem(s) studied | Polypharmacy |
| Intervention | According to the Pharmaceutical Care Network Europe (PCNE) definition, medication reviews are structured patient interviews with systematic evaluations of their medication history with the aim of optimising their drug use by identifying drug-related problems (DRPs) and recommending interventions to improve health outcomes. At baseline, pharmacists conducted a medication review, interviewing patients and assessing drug-related problems (DRPs)—a summative measure of potential pharmacotherapy issues. Patients were randomised (1:1) via an interactive web-response system to either: Intervention group: Pharmacists addressed DRPs and provided recommendations to patients. Control group: DRPs were documented but not addressed - patients did not receive recommendations to address them. After 3 to 4 months, a blinded independent pharmacist reassessed DRPs, maintaining study blinding until this point. Subsequently, all patients received personalised recommendations—for the second time in the intervention group and for the first time in the control group. Follow-up: An optional third appointment after 6 to 9 months allowed all patients a final DRP assessment. |
| Intervention type | Behavioural |
| Primary outcome measure | Drug-related problems assessed using a structured medication review type 2a (questionnaire) at baseline, after 3 to 4 months, and after 6 to 9 months |
| Secondary outcome measures | 1. Therapy adherence assessed using a structured medication review type 2a (questionnaire) at baseline, after 3 to 4 months, and after 6 to 9 months 2. Health literacy was assessed using a structured medication review type 2a (questionnaire) at baseline, after 3 to 4 months, and after 6 to 9 months 3. The effects of one structured medication review type 2a at months 3 to 4 compared to two structured medication reviews type 2a at baseline and month 3 to 4 on drug-related problems (questionnaire) 4. The number of drug-related problems assessed using a structured medication review type 2a (questionnaire) at baseline, after 3 to 4 months, and after 6 to 9 months 5. The number of medications and active ingredients assessed using a structured medication review type 2a (questionnaire) at baseline, after 3 to 4 months, and after 6 to 9 months 6. Relative and absolute frequency of contraindications or severe drug-related problems that require intervention by clinical pharmacologists/clinical pharmacists or treating physicians, assessed using a structured medication review type 2a (questionnaire) at baseline, after 3 to 4 months, and after 6 to 9 months 7. Associations of gender, age, and number of medications/active ingredients at baseline with the number of drug-related problems assessed using a structured medication review type 2a at baseline Added 26/03/2025: 1. Descriptive statistics of patients participating in part 2 of the study per group and presentations of reasons why the study was terminated before part 1 2. Absolute and relative number of contributors to drug-related problems (e.g., double prescriptions, dosing errors, etc) and the impact of a structured medication review type 2a (questionnaire) on these parameters at baseline, after 3 to 4 months, and after 6 to 9 months 3. Change in drug-related problems (or contributors) within each group from baseline to month 3 to 4 or month 6 to 9 using a structured medication review type 2a (questionnaire) will be analysed with non-parametric, pairwise comparisons |
| Overall study start date | 01/01/2021 |
| Completion date | 01/06/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 150 Years |
| Sex | Both |
| Target number of participants | 200 |
| Total final enrolment | 220 |
| Key inclusion criteria | 1. Patients with intake of ≥8 systemically available drugs (in case of combination products, ≥8 active ingredients, also including over-the-counter drugs, especially if they are on the list of interaction relevant over the counter drugs) 2. Patients >18 years of age 3. Patients signing informed consent |
| Key exclusion criteria | 1. Patients not willing to adhere to the study’s requirements 2. Patients unable to understand the nature and purpose of the study 3. Previous participation in a structured medication review type 2a |
| Date of first enrolment | 01/06/2022 |
| Date of final enrolment | 01/01/2024 |
Locations
Countries of recruitment
- Austria
Study participating centres
Vienna
1100
Austria
Vienna
1220
Austria
Vienna
1140
Austria
Vienna
1100
Austria
Vienna
1210
Austria
Vienna
1160
Austria
Vienna
1110
Austria
Vienna
1100
Austria
Vienna
1210
Austria
Sponsor information
Industry
Waehringer Gürtel 18-20
Vienna
1090
Austria
| Phone | +43 (0)14040029810 |
|---|---|
| klin-pharmakologie@meduniwien.ac.at | |
| Website | https://klinische-pharmakologie.meduniwien.ac.at |
"ROR" |
https://ror.org/05n3x4p02 |
Funders
Funder type
Other
No information available
No information available
Results and Publications
| Intention to publish date | 01/04/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The manuscript is finished and ready for submission to a peer-reviewed journal. |
| IPD sharing plan | The dataset generated during the study will be available upon request to the corresponding author (Christian Schoergenhofer, MD, PhD, christian.schoergenhofer@meduniwien.ac.at) |
Editorial Notes
26/03/2025: Secondary outcome measures updated.
25/02/2025: Study's existence confirmed by the ethics committee of the Medical University of Vienna.
