Enhancement of patient's autonomy by active role training with operative patients: Patient Active Role Training

ISRCTN	ISRCTN19208427
DOI	https://doi.org/10.1186/ISRCTN19208427
Protocol serial number	N/A
Sponsor	Charite - University Medicine Berlin (Charite - Universitatsmedizin Berlin) (Germany)
Funder	Charite - University Medicine Berlin (Charite - Universitatsmedizin Berlin) (Germany)

Submission date: 15/04/2008
Registration date: 11/07/2008
Last edited: 09/06/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Claudia Spies
Scientific

Department of Anaesthesiology and Intensive Care Medicine
Charite - Universitatsmedizin Berlin
Augustenburger Platz 1
Berlin
D-13353
Germany

Phone	+49 (0)30 450 55 10 01
Email	claudia.spies@charite.de

Study information

Primary study design	Interventional
Study design	Prospective randomised controlled single-centre interventional study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Shared decision making in surgical patients
Study acronym	PART-Studie
Study objectives	The hypothesis is that patients with wish of autonomy, who will receive structured information, will have a better outcome measured by earlier fulfilled discharge criteria from the hospital influence on length of stay. On 04/01/2011 the following changes were made to the trial record: 1. The overall trial end date was changed from 30/05/2008 to 30/05/2010 2. The target number of participants was changed from 100 to 175. On 09/06/2015 the following changes were made to the trial record: 1. The overall trial start date was changed from 25/04/2008 to 01/10/2007. 2. The overall trial end date was changed from 30/05/2010 to 09/06/2010. 3. The target number of participants was changed from 175 to 280.
Ethics approval(s)	Ethics Committee of Charité - University Medicine Berlin, 18/03/2008
Health condition(s) or problem(s) studied	Indication for operation in traumatology and general surgery
Intervention	The inclusion of the patients takes place in the anaesthesiology premedication clinic. After the education, a computer assisted questionnaire will be performed. This questionnaire contains a special questionnaire of the preference of autonomy. If the score of the patient is above the median score the patient gets randomised. This so called 'active decision' group gets a booklet. This booklet contains informations of essential processes for the preparations before and after operations. In the control group the participants do not obtain any additional information. In both groups, pain, nil per os, mobilisation were recorded.
Intervention type	Procedure/Surgery
Primary outcome measure(s)	1. Analgesia 2. Post-operative nausea and vomiting, using the Visual Analogue Scale (VAS: 0 = no pain/no vomiting, 10 = unbearable pain/extreme vomiting) 3. Post-Anaesthesia Discharge Scoring System (PADSS) PADSS will be measured daily during the patient's study participation in the Charité hospital (longest time until the 5th day of hospital stay).
Key secondary outcome measure(s)	1. World Health Organization (WHO)-5 Well Being Index 2. Patient Involvement in Care Scale 3. Sense of coherence 4. Autonomy Perference Index The patients will be monitored and these parameters will be surveyed every day until they fulfill the hospital discharge criteria (measured by PADSS) up to hospital discharge at fifth of the patient's stay.
Completion date	09/06/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	280
Key inclusion criteria	1. Written informed consent 2. German speaking 3. Patients of traumatology and surgery 4. Aged 18 years or older, either sex
Key exclusion criteria	1. Patients who have no wish for shared decision 2. Accommodation in an institution due to an official or judicial order 3. No written consent from patient 4. Unwillingness to allow storage and sharing of anonymised disease data in the context of the clinical study 5. Aged less than 18 years 6. Member of staff of the Charité 7. No working knowledge of German 8. Planned sojourn on intensive care unit
Date of first enrolment	21/04/2008
Date of final enrolment	09/06/2010

Locations

Countries of recruitment

Germany

Study participating centre

Charite - Universitatsmedizin Berlin

Berlin
D-13353
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?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes