Trial document





This trial has been registered retrospectively.
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  DRKS00026120

Trial Description

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Title

Medication reviews in geriatric patients in long-term care facilities

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Drug related problems, such as prescribing drugs in the wrong dosage or incorrect use of crushed tablets, can significantly compromise drug safety. Residents in long-term care facilities (nursing homes) are particularly vulnerable to clinical consequences that may result from these drug related problems. Therefore, the aim of this study is to investigate how medication reviews contribute to identify drug related problems among residents in three long-term care facilities, and subsequently to find and also implement solutions together with the physicians, nursing staff and supplying pharmacies involved.

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Brief Summary in Scientific Language

Medication reviews can successfully protect residents of long-term care facilities from drug related problems and the clinical consequences that may result, such as adverse drug events. However, there are few controlled studies that have examined the impact of actual medication changes on clinical patient-relevant outcomes.
Therefore, a controlled, prospective intervention study will be conducted in three long-term care facilities. In the intervention group, pharmaceutical medication reviews will be performed and subsequently specific solutions between physicians, nurses, and supplying pharmacies for identified drug related problems will be developed and, where necessary and appropriate, implemented. The control group receives usual care without a medication review. The impact on actual medication changes as well as clinical endpoints (falls, hospitalizations, and death) will be analyzed at two follow-up time points in both groups.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00026120
  •   2021/09/07
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  •   yes
  •   Approved
  •   231-13-03062013, Ethikkommission an der Medizinischen Fakultät der Universität Leipzig
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Secondary IDs

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Health Condition or Problem studied

  •   Drug related problems in the prescription and use of medication in geriatric patients.
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Interventions/Observational Groups

  •   Patients in the intervention group receive a one-time medication review, which is performed by a pharmacist and subsequently coordinated with the healthcare professionals involved. Drug related problems in the prescription of medications (e.g., double prescriptions, dosing problems, underuse) and in the use of medications (e.g., correct administration of medications) are examined, and the identified drug related problems are discussed with the participating physicians, nurses, or also the supplying pharmacies (depending on the area of responsibility) in an interdisciplinary exchange and, if necessary, measures are implemented, which are examined at two follow-up times (each at an interval of three months).
  •   Residents in the control group do not receive medication reviews.
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Characteristics

  •   Interventional
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  •   Other
  •   Open (masking not used)
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  •   Control group receives no treatment
  •   Other
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Medication changes (based on changes in resident's medication records).

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Secondary Outcome

Falls, hospital admissions, death.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2015/03/25
  •   200
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   65   Years
  •   no maximum age
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Additional Inclusion Criteria

Age ≥ 65, long-term/chronic medications ≥ 3, and multimorbidity with ≥ 3 comorbidities, written consent from the resident, or in the case of cognitive impairment, from the legally responsible party.

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Exclusion Criteria

No present consent to study participation; life expectancy of less than six months.

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Addresses

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    • Klinische Pharmazie Institut für Pharmazie Universität Leipzig
    • Mr.  Professor  Thilo  Bertsche 
    • Brüderstraße 32
    • 04103  Leipzig
    • Germany
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    • Klinische Pharmazie Institut für Pharmazie Universität Leipzig
    • Mr.  Professor  Thilo  Bertsche 
    • Brüderstraße 32
    • 04103  Leipzig
    • Germany
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    • Klinische Pharmazie Institut für Pharmazie Universität Leipzig
    • Mr.  Professor  Thilo  Bertsche 
    • Brüderstraße 32
    • 04103  Leipzig
    • Germany
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Sources of Monetary or Material Support

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    • Apothekerstiftung Westfalen-Lippe
    • Bismarckallee 25
    • 48151  Münster
    • Germany
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    • Dr. August und Dr. Anni Lesmüller Stiftung
    • Maria-Theresia-Straße 28
    • 81675  München
    • Germany
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    • Deutsche Apothekerstiftung ABDA
    • Postfach 080463
    • 10004  Berlin
    • Germany
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Status

  •   Recruiting complete, follow-up complete
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  •   2017/10/24
  •   211
  •   211
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Trial Publications, Results and other Documents

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