Patient SatisfactionNCT02413775
Patient Survey as a Tool to Quality Assurance and Quality Improvement
An observational study of Patient Satisfaction, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
One goal of the investigators of the Department of Anesthesiology and Operative Intensive Care Medicine CCM/CVK, Charité - Universitätsmedizin Berlin is a continuous improvement in the quality of care to the patients. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Patient Satisfaction
- How many people
- 821 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2015to Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All Patients who underwent a procedure in anesthesia
Who may be able to join
- male and female patients who underwent a procedure in anesthesia and willing to take part in the Survey
- aged >= 1 years
Who cannot join
- unconscious patients,
- refusal by patient / parents
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology and Intensive Care Medicine CCM and CVK, Charité - University Medicine Berlin
Berlin, 13353
About this study
Official title: Patient Survey as a Tool to Quality Assurance and Quality Improvement - Department of Anesthesiology and Operative Intensive Care (CCM/CVK), Charité - Universitätsmedizin Berlin
One goal of the investigators of the Department of Anesthesiology and Operative Intensive Care Medicine CCM/CVK, Charité - Universitätsmedizin Berlin is a continuous improvement in the quality of care to the patients. One focus is the freezing preoperatively during surgery, and on the follow-up study to assess the perceived waiting times in the anesthesiology outpatient clinic.
The project aims to quality assurance and quality improvement of the Department of Anesthesiology and Operative Intensive Care Medicine CCM/CVK, Charité - Universitätsmedizin Berlin .
Read the detailed description
The primary objective of the survey is to assess the entire perioperative care with particular focus on the development of perceived waiting times in the anesthesiology outpatient clinic, re-evaluation of the preoperative freezing the preoperative thirst, pain, nausea and vomiting after surgery (PONV prophylaxis).
The survey will be repeated in a three-year interval (approximately 1000 - 2000 patients per survey) to monitor and improve the quality of the Department of Anesthesiology and Operative Intensive Care Medicine CCM/CVK, Charité - Universitätsmedizin Berlin from the patient point of view.
In order to achieve a meaningful data collection, a response rate of 50 percent should be achieved.
- Conditions
- Patient Satisfaction
- Medical subject headings
- Patient Satisfaction
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction
Patient satisfaction with the care provided by the staff of the Department of Operative Anesthesiology and Intensive Care Medicine CCM/CVK; Measurement of satisfaction: Yes/No/Partly
Measured: Time during hospital stay, an average of 2 weeks
Secondary outcomes (33)
Waiting time in the premedication visit
Measurement of waiting time: < 15 minutes, 15-30 minutes, 30-60 minutes, > 60 minutes
Measured: Time in the outpatient clinic of anesthesia, an average of 1 hour
Friendliness of the staff during the premedication visit
Measurement of friendliness: Yes/No/Partly
Measured: Time in the outpatient clinic of anesthesia, an average of 1 hour
Information provided during the premedication visit by the anesthetist
Measurement of Information: Yes/No/Partly
Measured: Time in the outpatient clinic of anesthesia, an average of 1 hour
Response to questions during the premedication visit
Response to questions is measured: Yes/No/Partly
Measured: Time in the outpatient clinic of anesthesia, an average of 1 hour
Fear reduction during the premedication visit
Fear reduction is measured: Yes/No/Partly
Measured: Time in the outpatient clinic of anesthesia, an average of 1 hour
Information provided during the premedication visit by educational films
Measurement of information by educational films: Yes/No/Partly/No film
Measured: Time in the outpatient clinic of anesthesia, an average of 1 hour
Compliance with the planned start of the operation
Measurement of compliance with the start of the operation: Yes/No
Measured: Time in the operation room before start of anesthesia, an average of 30 minutes
Friendliness of staff
Measurement of friendliness: Yes/No/Partly
Measured: Time in the operation room before start of anesthesia, an average of 30 minutes
Fear
Fear measured: Yes, very much/Yes, but not much/No fear /Partly
Measured: Time in the operation room before start of anesthesia, an average of 30 minutes
Thirst
Thirst measured: Yes, very much/Yes, but not much/No thirst/Partly
Measured: Time in the operation room before start of anesthesia, an average of 30 minutes
Pain
Pain measured: Yes, strong pain/Yes, but not strong/No pain/Can't remember
Measured: Time in the operation room before start of anesthesia, an average of 30 minutes
Sufficient pain treatment
Sufficient pain treatment measured: Yes, sufficiently treated/ Treated, but not sufficiently/Not treated/No pain/No treatment wanted/Partly
Measured: Time in the operation room before start of anesthesia, an average of 30 minutes
Shivering
Shivering is measured: Yes, strong/Yes, but not strong/No shivering/Partly
Measured: Time in the operation room before start of anesthesia, an average of 30 minutes
Sufficient therapy in case of shivering
Sufficient therapy in case of shivering is measured: Yes, sufficiently treated/ Treated, but not sufficiently/Not treated/No shivering/No treatment wanted/ Partly
Measured: Time in the operation room before start of anesthesia, an average of 30 minutes
Friendliness of staff
Friendliness is measured: Yes/No/Partly
Measured: Time in the intensive care unit or post anesthesia care unit, an average of 3 days
Post-operative nausea and vomiting (PONV)
Measurement of PONV: nausea/vomiting/nausea and vomiting/neither nor
Measured: Time in the intensive care unit or post anesthesia care unit, an average of 3 days
Sufficient therapy in case of PONV
Sufficient therapy is measured: Yes, sufficiently treated/ Treated, but not sufficiently/Not treated/No PONV/No treatment wanted/Partly
Measured: Time in the intensive care unit or post anesthesia care unit, an average of 3 days
Pain intensity
Pain intensity is measured by likert scale: strong, moderate, low, none
Measured: Time in the intensive care unit or post anesthesia care unit, an average of 3 days
Sufficient therapy in case of pain
Sufficient therapy is measured: Yes, sufficiently treated/ Treated, but not sufficiently/Not treated/No pain/No treatment wanted/Partly
Measured: Time in the intensive care unit or post anesthesia care unit, an average of 3 days
Shivering
Sufficient therapy in case of shivering is measured: Yes/No/Partly
Measured: Time in the intensive care unit or post anesthesia care unit, an average of 3 days
Sufficient therapy in case of shivering
Sufficient therapy in case of shivering is measured: Yes, sufficiently treated/ Treated, but not sufficiently/Not treated/No shivering/No treatment wanted/Partly
Measured: Time in the intensive care unit or post anesthesia care unit, an average of 3 days
Post-operative nausea and vomiting (PONV)
Measurement of PONV: nausea/vomiting/nausea and vomiting/neither nor
Measured: Time during hospital stay, an average of 2 weeks
Regional anaesthesia
Measured: Yes / No
Measured: Time during hospital stay, an average of 2 weeks
Satisfaction with regional anaesthesia
Measurement of satisfaction: Yes/No/Partly
Measured: Time during hospital stay, an average of 2 weeks
In case of need choosing of regional anaesthesia again
Measurement of choosing again: Yes/No/Perhaps
Measured: Time during hospital stay, an average of 2 weeks
Satisfaction of care through pain service
Measurement of care through pain service: Yes/No/Partly
Measured: Time during hospital stay, an average of 2 weeks
Recommendation of medical care (provided by the staff from the Department of Anesthesiology and Intensive Care CVK/CCM)
Measurement of recommendation: Yes/No/Partly
Measured: Time during hospital stay, an average of 2 weeks
Atmosphere
Measurement of atmosphere: calm/busy/can´t remember
Measured: Time in the intensive care unit or post anesthesia care unit, an average of 3 days
Postoperative fear
Measurement of fear: Yes, very much/Yes, but not much/No fear
Measured: Time in the intensive care unit or post anesthesia care unit, an average of 3 days
Postoperative pain
Pain intensity is measured by likert scale: strong, moderate, low, none
Measured: Time during hospital stay, an average of 2 weeks
Sufficient therapy in case of pain
Sufficient therapy is measured: Yes, sufficiently treated/ Treated, but not sufficiently/Not treated/No pain/No treatment wanted/Partly
Measured: Time during hospital stay, an average of 2 weeks
Postoperative patient controlled analgesia
Measurement: Yes/No/I don´t know
Measured: Time during hospital stay, an average of 2 weeks
Choosing of Patient controlled anesthesia
Question: Would you choose patient controlled anesthesia again? Answer: Yes/No/Maybe
Measured: Time during hospital stay, an average of 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionSep 2021
- Study completionSep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient SatisfactionStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 821 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia Spies, Charite University, Berlin, Germany
- Investigators
- Claudia Spies, MD, Prof., Study director, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02413775
- Sponsor's protocol ID
- QM-Patient survey
- Status last verified
- Jan 2024
- First submitted
- 31 Mar 2015
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Survey as a Tool to Quality Assurance and Quality Improvement - Department of Anesthesiology and Operative Intensive Care (CCM/CVK), Charité - Universitätsmedizin Berlin
- ClinicalTrials.gov ID
- NCT02413775
- Acronym / sponsor ID
- QM-Patient survey
- Conditions
- Patient Satisfaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 821 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- Sep 2021 (actual)
- Study completion
- Sep 2021 (actual)
- First posted
- 10 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
One goal of the investigators of the Department of Anesthesiology and Operative Intensive Care Medicine CCM/CVK, Charité - Universitätsmedizin Berlin is a continuous improvement in the quality of care to the patients. One focus is the freezing preoperatively during surgery, and on the follow-up study to assess the perceived waiting times in the anesthesiology outpatient clinic.
The project aims to quality assurance and quality improvement of the Department of Anesthesiology and Operative Intensive Care Medicine CCM/CVK, Charité - Universitätsmedizin Berlin .
Detailed description
The primary objective of the survey is to assess the entire perioperative care with particular focus on the development of perceived waiting times in the anesthesiology outpatient clinic, re-evaluation of the preoperative freezing the preoperative thirst, pain, nausea and vomiting after surgery (PONV prophylaxis).
The survey will be repeated in a three-year interval (approximately 1000 - 2000 patients per survey) to monitor and improve the quality of the Department of Anesthesiology and Operative Intensive Care Medicine CCM/CVK, Charité - Universitätsmedizin Berlin from the patient point of view.
In order to achieve a meaningful data collection, a response rate of 50 percent should be achieved.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All Patients who underwent a procedure in anesthesia
Key inclusion criteria (2 listed)
- male and female patients who underwent a procedure in anesthesia and willing to take part in the Survey
- aged >= 1 years
Key exclusion criteria (2 listed)
- unconscious patients,
- refusal by patient / parents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient satisfaction
Time frame: Time during hospital stay, an average of 2 weeks
Patient satisfaction with the care provided by the staff of the Department of Operative Anesthesiology and Intensive Care Medicine CCM/CVK; Measurement of satisfaction: Yes/No/Partly
33 secondary outcomes
Waiting time in the premedication visit
Time frame: Time in the outpatient clinic of anesthesia, an average of 1 hour
Friendliness of the staff during the premedication visit
Time frame: Time in the outpatient clinic of anesthesia, an average of 1 hour
Information provided during the premedication visit by the anesthetist
Time frame: Time in the outpatient clinic of anesthesia, an average of 1 hour
Response to questions during the premedication visit
Time frame: Time in the outpatient clinic of anesthesia, an average of 1 hour
Fear reduction during the premedication visit
Time frame: Time in the outpatient clinic of anesthesia, an average of 1 hour
Information provided during the premedication visit by educational films
Time frame: Time in the outpatient clinic of anesthesia, an average of 1 hour
Compliance with the planned start of the operation
Time frame: Time in the operation room before start of anesthesia, an average of 30 minutes
Friendliness of staff
Time frame: Time in the operation room before start of anesthesia, an average of 30 minutes
Fear
Time frame: Time in the operation room before start of anesthesia, an average of 30 minutes
Thirst
Time frame: Time in the operation room before start of anesthesia, an average of 30 minutes
Pain
Time frame: Time in the operation room before start of anesthesia, an average of 30 minutes
Sufficient pain treatment
Time frame: Time in the operation room before start of anesthesia, an average of 30 minutes
Shivering
Time frame: Time in the operation room before start of anesthesia, an average of 30 minutes
Sufficient therapy in case of shivering
Time frame: Time in the operation room before start of anesthesia, an average of 30 minutes
Friendliness of staff
Time frame: Time in the intensive care unit or post anesthesia care unit, an average of 3 days
Post-operative nausea and vomiting (PONV)
Time frame: Time in the intensive care unit or post anesthesia care unit, an average of 3 days
Sufficient therapy in case of PONV
Time frame: Time in the intensive care unit or post anesthesia care unit, an average of 3 days
Pain intensity
Time frame: Time in the intensive care unit or post anesthesia care unit, an average of 3 days
Sufficient therapy in case of pain
Time frame: Time in the intensive care unit or post anesthesia care unit, an average of 3 days
Shivering
Time frame: Time in the intensive care unit or post anesthesia care unit, an average of 3 days
Sufficient therapy in case of shivering
Time frame: Time in the intensive care unit or post anesthesia care unit, an average of 3 days
Post-operative nausea and vomiting (PONV)
Time frame: Time during hospital stay, an average of 2 weeks
Regional anaesthesia
Time frame: Time during hospital stay, an average of 2 weeks
Satisfaction with regional anaesthesia
Time frame: Time during hospital stay, an average of 2 weeks
In case of need choosing of regional anaesthesia again
Time frame: Time during hospital stay, an average of 2 weeks
Satisfaction of care through pain service
Time frame: Time during hospital stay, an average of 2 weeks
Recommendation of medical care (provided by the staff from the Department of Anesthesiology and Intensive Care CVK/CCM)
Time frame: Time during hospital stay, an average of 2 weeks
Atmosphere
Time frame: Time in the intensive care unit or post anesthesia care unit, an average of 3 days
Postoperative fear
Time frame: Time in the intensive care unit or post anesthesia care unit, an average of 3 days
Postoperative pain
Time frame: Time during hospital stay, an average of 2 weeks
Sufficient therapy in case of pain
Time frame: Time during hospital stay, an average of 2 weeks
Postoperative patient controlled analgesia
Time frame: Time during hospital stay, an average of 2 weeks
Choosing of Patient controlled anesthesia
Time frame: Time during hospital stay, an average of 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia Spies, MD, Prof. study director
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patient Satisfaction, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction (time frame: Time during hospital stay, an average of 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2024.