Improving medication safety for patients with chronic renal impairment in general practice
| ISRCTN | ISRCTN02900734 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN02900734 |
| Secondary identifying numbers | 01GK0302 |
- 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
Scientific
Institute for General Practice
Johann Wolfgang Goethe University
Theodor-Stern-Kai 7
Frankfurt
D-60590
Germany
| erler@allgemeinmedizin.uni-frankfurt.de |
Study information
| Study design | Cluster-randomised controlled trial; we randomised 23 General Practitioner (GP) practices in the intervention and 23 practices in the control group. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Quality of life |
| 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 | 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 measures | 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) |
| Overall study start date | 21/02/2007 |
| Completion date | 13/02/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 400 patients |
| 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
D-60590
Germany
Sponsor information
German Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung [BMBF]) (Germany)
Government
Government
Hannoversche Strasse 28-30
Berlin
10115
Germany
| Website | http://www.bmbf.de/en/index.php |
|---|---|
"ROR" |
https://ror.org/04pz7b180 |
Funders
Funder type
Government
German Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung [BMBF]) (Germany) (ref: 01GK0302) - notification of February 7, 2006
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
