Optimized medication care for older hospitalized patients
Less is More: Optimized Pharmacotherapy with Improved CoNtinuity of CarE in HospitaLized OLder PeOple
This study is testing a new team-based approach to medication care for hospitalized patients aged 70 and older to see if it helps reduce the chances of them being readmitted due to medication issues.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2576 (estimated) |
| Ages | 70 Years and up |
| Sex | All |
| Sponsor | Radboud University Medical Center Academic / other |
| Locations | 16 sites (Nijmegen, Gelderland and 15 other locations) |
| Trial ID | NCT05899114 on ClinicalTrials.gov |
What this trial studies
This cluster randomized controlled trial aims to compare transitional multidisciplinary pharmacotherapeutic care (TMPC) with usual care for patients aged 70 and older who are hospitalized with polypharmacy. The study focuses on reducing drug-related readmissions (DRreAs) through a structured approach that includes pharmacotherapeutic analysis, multidisciplinary discussions, and personalized care plans. Participants will receive TMPC in hospitals assigned to the intervention group, while outcomes will be assessed over the first 30 days post-hospitalization to evaluate effectiveness and cost-efficiency.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 70 years or older who are taking five or more medications and have been admitted to the hospital through the emergency department.
Not a fit: Patients who are not taking multiple medications or those with a life expectancy of less than three months may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of drug-related readmissions and improve the quality of care for older patients.
How similar studies have performed: Previous studies have shown varying success with structured medication reviews, but this study's focus on a multidisciplinary approach in high-risk patients is a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 70 years or older * Polypharmacy, the use of 5 or more regular medications, defined as authorised medications with registration numbers, used for more than 30 days. Topical preparations are excluded from this definition. * Admitted to hospital through the ED (which comprises both the general emergency department and the cardiac emergency department) * Length of hospitalisation more than 24 hours * Completed medication verification * DRA prediction percentage of 23.0% or higher Exclusion Criteria: * No informed consent by patient or a legal representative * Participation in an interfering clinical trial * Elective hospital admission * Direct admission to the ICU (when medication verification as usual can't be executed, and therefore inclusion of patients as described in 10.2 is not possible) * A life expectancy of less than 3 months, which includes patients with palliative treatment at home, direct admission to palliative care or palliative care planned within 24 hours after index hospital admission. * Patient or legal representative not able to speak Dutch. * Follow-up of patient primarily by secondary caregivers. This refers to situations where the secondary caregiver is in the lead of the medication list of the patient instead of the GP or elderly care physician, for example in the following patient groups: * patients receiving intensive oncologic therapy * patients in an organ- or stem cell transplantation procedure * patients receiving intensive (chronic) psychiatric care, such as patients admitted to a medical psychiatric unit * patients on dialysis
Where this trial is running
Nijmegen, Gelderland and 15 other locations
- Canisius Wilhelmina Ziekenhuis — Nijmegen, Gelderland, Netherlands (Recruiting)
- Radboudumc — Nijmegen, Gelderland, Netherlands (Recruiting)
- Amphia ziekenhuis — Breda, Noord Brabant, Netherlands (Recruiting)
- Catharina Ziekenhuis — Eindhoven, Noord Brabant, Netherlands (Recruiting)
- Amsterdam UMC - location VUMC — Amsterdam, Noord-Holland, Netherlands (Recruiting)
- Amsterdam UMC- location AMC — Amsterdam, Noord-Holland, Netherlands (Recruiting)
- Zaans Medisch Centrum — Zaandam, Noord-Holland, Netherlands (Recruiting)
- Ziekenhuisgroep Twente — Almelo, Overijssel, Netherlands (Recruiting)
- Deventer Ziekenhuis — Deventer, Overijssel, Netherlands (Recruiting)
- Meander Medisch Centrum Amersfoort — Amersfoort, Utrecht, Netherlands (Recruiting)
- Erasmus Medisch Centrum Rotterdam — Rotterdam, Zuid Holland, Netherlands (Recruiting)
- Haga Ziekenhuis — Den Haag, Zuid-Holland, Netherlands (Recruiting)
- Leiden Universitair Medisch Centrum — Leiden, Zuid-Holland, Netherlands (Recruiting)
- Universitair Medisch Centrum Groningen — Groningen, Netherlands (Recruiting)
- Diakonessenhuis — Utrecht, Netherlands (Recruiting)
- Universitair Medisch Centrum Utrecht — Utrecht, Netherlands (Recruiting)
Study contacts
- Principal investigator: Kees Kramers, Prof. Dr. — Radboud University Medical Center
- Study coordinator: Sjacky Cooijmans, MSc
- Email: limoncello@zorgevaluatienederland.nl
- Phone: +31 (0)24 361 36 91
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.