Contact information
Type
Scientific
Contact name
Prof Claudia Spies
ORCID ID
Contact details
Department of Anaesthesiology and Intensive Care Medicine
Charite - Universitatsmedizin Berlin
Augustenburger Platz 1
Berlin
D-13353
Germany
+49 (0)30 450 55 10 01
claudia.spies@charite.de
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Shared decision making in surgical patients
Acronym
PART-Studie
Study hypothesis
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
Study design
Prospective randomised controlled single-centre interventional study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet.
Condition
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
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).
Secondary outcome measures
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.
Overall study start date
01/10/2007
Overall study end date
09/06/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Written informed consent
2. German speaking
3. Patients of traumatology and surgery
4. Aged 18 years or older, either sex
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
280
Participant 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
Recruitment start date
21/04/2008
Recruitment end date
09/06/2010
Locations
Countries of recruitment
Germany
Study participating centre
Charite - Universitatsmedizin Berlin
Berlin
D-13353
Germany
Sponsor information
Organisation
Charite - University Medicine Berlin (Charite - Universitatsmedizin Berlin) (Germany)
Sponsor details
c/o Prof. Claudia Spies
Department of Anaesthesiology and Intensive Care Medicine
Augustenburger Platz 1
Berlin
13353
Germany
+49 (0)304 5055 1002
claudia.spies@charite.de
Sponsor type
Hospital/treatment centre
Website
ROR
Funders
Funder type
Hospital/treatment centre
Funder name
Charite - University Medicine Berlin (Charite - Universitatsmedizin Berlin) (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|