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Improving medication safety for patients with chronic renal impairment in general practice
ISRCTN ISRCTN02900734
DOI 10.1186/ISRCTN02900734
ClinicalTrials.gov identifier
EudraCT number
Public title Improving medication safety for patients with chronic renal impairment in general practice
Scientific title
Acronym TP 1
Serial number at source 01GK0302
Study hypothesis In comparison with the control group, the intervention will result in a higher proportion of correctly adjusted drugs in patients with chronic renal impairment.
Lay summary Not provided at time of registration
Ethics approval Approved by Ethics Committee of Johann Wolfgang Goethe University on the 18th September 2006.
Study design Cluster-randomised controlled trial; we randomised 23 General Practitioner (GP) practices in the intervention and 23 practices in the control group.
Countries of recruitment Germany
Disease/condition/study domain Chronic renal impairment (grade III or higher)
Participants - inclusion criteria Patient level:
1. Patients with established chronic renal impaiment grade III or higher (creatinine clearance below 50 ml/min)
2. Patients at risk of developing chronic renal impairment (70 years or older with hypertension = risk group)

Practice level:
1. Use of computer during consultation
2. Use of computer for prescribing medications
Participants - exclusion criteria Patient level:
1. Terminally ill patients
2. Patients with dialysis treatment

Practice level:
Routine use of an electronic support system for dose adaption in patients with chronic renal impairment.
Anticipated start date 21/02/2007
Anticipated end date 13/02/2008
Status of trial Completed
Patient information material
Target number of participants 400 patients
Interventions Each participating practice attended one of four consecutive introductory meetings and was randomised to the intervention or control group. The practices are told to recruit ten suitable patients during a period of four weeks after the meeting. The date on which the data sheets for these ten patients arrive at our institute (= T0) will be registered as the start of the six-month follow-up period. Six months later, each practice will be asked to provide data sheets for the same patients (= T1).

Intervention:
Introduction of an electronic support system for dose adjustment of drugs (software DOSING) plus information package about chronic renal impairment for doctors and patients for six months.

Control:
Care as usual.
Primary outcome measure(s) Number of medications which have not been correctly adjusted to patient's renal function, measured at baseline (T0) and again after six months (T1).
Secondary outcome measure(s) 1. Number of patients in risk group with recently measured creatinine, measured at baseline (T0) and again after six months (T1)
2. Assessment of feasibility and usefulness of the tested electronic support system by participating General Practices (GP's), measured at baseline (T0) and again after six months (T1)
Sources of funding German Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung [BMBF]) (Germany) (ref: 01GK0302) - notification of February 7, 2006
Trial website
Publications 1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22953792
Contact name Mrs  Antje  Erler
  Address Institute for General Practice
Johann Wolfgang Goethe University
Theodor-Stern-Kai 7
  City/town Frankfurt
  Zip/Postcode D-60590
  Country Germany
  Email erler@allgemeinmedizin.uni-frankfurt.de
Sponsor German Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung [BMBF]) (Germany)
  Address Hannoversche Strasse 28-30
  City/town Berlin
  Zip/Postcode 10115
  Country Germany
  Sponsor website: http://www.bmbf.de/en/index.php
Date applied 29/03/2007
Last edited 23/05/2013
Date ISRCTN assigned 30/05/2007
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