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

• Register: ISRCTN
• Last refreshed on: 17 October 2016
• Main ID: ISRCTN19208427
• Date of registration: 11/07/2008
• Prospective Registration: No
• Primary sponsor: Charite - University Medicine Berlin (Charite - Universitatsmedizin Berlin) (Germany)
• Public title: Enhancement of patient's autonomy by active role training with operative patients: Patient Active Role Training
• Scientific title: Shared decision making in surgical patients
• Date of first enrolment: 21/04/2008
• Target sample size: 280
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN19208427
• Study type: Interventional
• Study design: Prospective randomised controlled single-centre interventional study (Treatment)
• Phase: Not Specified

Countries of recruitment

Germany

Contacts

• Name: Claudia Spies

Key inclusion & exclusion criteria

Inclusion criteria: 1. Written informed consent
2. German speaking
3. Patients of traumatology and surgery
4. Aged 18 years or older, either sex
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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Indication for operation in traumatology and general surgery
Surgery
Traumatology and general surgery

Intervention(s)

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.

Primary Outcome(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).

Secondary Outcome(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.

Secondary ID(s)

N/A

Source(s) of Monetary Support

Charite - University Medicine Berlin (Charite - Universitatsmedizin Berlin) (Germany)