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 |
| Secondary identifying numbers | N/A |
- 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
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 |
|---|---|
| claudia.spies@charite.de |
Study information
| 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 |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 |
| Completion date | 09/06/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
D-13353
Germany
Sponsor information
Charite - University Medicine Berlin (Charite - Universitatsmedizin Berlin) (Germany)
Hospital/treatment centre
Hospital/treatment centre
c/o Prof. Claudia Spies
Department of Anaesthesiology and Intensive Care Medicine
Augustenburger Platz 1
Berlin
13353
Germany
| Phone | +49 (0)304 5055 1002 |
|---|---|
| claudia.spies@charite.de | |
| Website | http://www.charite.de/ |
"ROR" |
https://ror.org/001w7jn25 |
Funders
Funder type
Hospital/treatment centre
Charite - University Medicine Berlin (Charite - Universitatsmedizin Berlin) (Germany)
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 |
