Condition category
Surgery
Date applied
15/04/2008
Date assigned
11/07/2008
Last edited
09/06/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

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 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

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

Trial setting

Hospitals

Trial 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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/10/2007

Overall trial end date

09/06/2010

Reason abandoned

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

Patient

Age group

Adult

Gender

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

Trial 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

http://www.charite.de/

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes