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Transsectoral optimisation of patient safety

Transsectoral optimisation of patient safety - TOP

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00025485
Enrollment
29160
Registered
2021-09-09
Start date
2021-11-24
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insured persons of the participating health insurance funds from the age of 18 who take five or more prescribed drugs and are initially hospitalised by the participating hospitals in an internal medicine ward, geriatrics, visceral surgery, vascular surgery, cardiac and thoracic surgery, orthopaedics as well as trauma surgery, neurology and urology during the study period.

Interventions

Group 1: Treatment as usual Group 2: Digitally supported medication therapy management process: Insured patients of the participating health insurance companies with polypharmacy are informed about th

Sponsors

Bergische Universität Wuppertal
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: All insured persons of the participating health insurance companies from the age of 18 who take five or more prescribed drugs and are initially admitted to an internal medicine ward, geriatrics, visceral surgery, vascular surgery, cardiac and thoracic surgery, orthopaedics as well as trauma surgery, neurology and urology by the participating hospitals during the study period are included. Inclusion in the study is consecutive. The study patients will be treated according to the group status of the respective hospital.

Exclusion criteria

Exclusion criteria: Patients undergoing oncological treatment are excluded, as they are regularly hospitalised due to treatment cycles.

Design outcomes

Primary

MeasureTime frame
The combined primary endpoint is whether TOP leads to a reduction in the mortality of hospitalised patients with polypharmacy (in hospital and up to 3 months after discharge) and/or the re-hospitalisation rate (within 3 months after discharge).

Secondary

MeasureTime frame
Proportion of patients receiving inappropriate prescriptions; Proportion of patients experiencing serious preventable adverse drug reactions in hospital or within 3 months of discharge; Use of emergency outpatient care; Health-related quality of life; Patient empowerment; Experienced continuity of (pharmaceutical) care; Patient satisfaction with medication information received; Adherence; Self-reported adverse drug events; Perceived patient safety. Health economic aspect: Cost-effectiveness and cost-utility of the intervention compared to standard care; Costs and benefits (financial, resources/time, intangible) of the intervention at the level of stakeholders.

Countries

Germany

Contacts

Public Contact; ;

AOK Nordost – Die Gesundheitskasse;BARMER

susanne.dolfen@nordost.aok.de;petra.kellermann-muehlhoff@barmer.de0800 265080-22261;0800-333004-992975

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026