Improving medication safety for patients with chronic renal impairment in general practice

ISRCTN	ISRCTN02900734
DOI	https://doi.org/10.1186/ISRCTN02900734
Protocol serial number	01GK0302
Sponsor	German Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung [BMBF]) (Germany)
Funder	German Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung [BMBF]) (Germany) (ref: 01GK0302) - notification of February 7, 2006

Submission date: 29/03/2007
Registration date: 30/05/2007
Last edited: 23/05/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mrs Antje Erler
Scientific

Institute for General Practice
Johann Wolfgang Goethe University
Theodor-Stern-Kai 7
Frankfurt
D-60590
Germany

Email	erler@allgemeinmedizin.uni-frankfurt.de

Study information

Primary study design	Interventional
Study design	Cluster-randomised controlled trial; we randomised 23 General Practitioner (GP) practices in the intervention and 23 practices in the control group.
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	TP 1
Study objectives	In comparison with the control group, the intervention will result in a higher proportion of correctly adjusted drugs in patients with chronic renal impairment.
Ethics approval(s)	Approved by Ethics Committee of Johann Wolfgang Goethe University on the 18th September 2006.
Health condition(s) or problem(s) studied	Chronic renal impairment (grade III or higher)
Intervention	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.
Intervention type	Other
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).
Key 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)
Completion date	13/02/2008

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	400
Key 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
Key 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.
Date of first enrolment	21/02/2007
Date of final enrolment	13/02/2008

Locations

Countries of recruitment

Germany

Study participating centre

Institute for General Practice

Frankfurt
D-60590
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	06/09/2012		Yes	No