PAIN OUT: Improvement in Postoperative PAIN OUTcome (PAIN-OUT)
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| ClinicalTrials.gov Identifier: NCT02083835 |
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Recruitment Status :
Recruiting
First Posted : March 11, 2014
Last Update Posted : May 24, 2018
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| Condition or disease |
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| Post-operative Pain |
PAIN OUT offers a large registry as well as a system for benchmarking and feedback of outcome quality and decision support in acute pain conditions. It collects demographic, clinical and outcome data, using a validated assessment tool available in multiple languages.
The registry part of the project aims at performing population-based research. Furthermore, its infrastructure allows for the conduct of prospective studies comparing the effectiveness of processes of care.
The benchmark part of the project provides the medical community with a unique, user-friendly system to improve treatment of patients with postoperative pain. A web-based information system, featuring two main functions, was developed:
- a feedback and benchmarking system which provides participating sites with continuously updating data and analyses about the quality of care they provide compared to other institutions and allows identification of best clinical practice.
- a knowledge library which provides clinicians with easily accessible and regularly updated summaries of evidence-based recommendations tailored to specific post-operative situations.
From 2016 on, sub-projects in Mexico, China and several European countries have started. This programs take place over a period of two years during which collaborators carry out a Quality Improvement project in their hospital using methodology provided by PAIN OUT. This includes collection of baseline data in a first phase, analysis of findings according to a protocol provided by PAIN OUT, review of findings and developement of improvement measures, implementation of the improvements and assessment of outcomes after a second phase of data collection.
| Study Type : | Observational [Patient Registry] |
| Estimated Enrollment : | 200000 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 12 Months |
| Official Title: | Improvement in Postoperative Pain Outcome |
| Actual Study Start Date : | January 2009 |
| Estimated Primary Completion Date : | December 2030 |
| Estimated Study Completion Date : | December 2030 |
| Group/Cohort |
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post-surgical patients
post-surgical patients > 18 years
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pediatric patients post-op day 1
pediatric patients > 4 years on post-op day 1 (sub-project QUIPSI - PAIN OUTinfant)
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- Assessment of postoperative pain treatment [ Time Frame: first postoperative day ]
- patients' perception of pain treatment outcome [ Time Frame: first postoperative day ]
- worst pain since surgery
- least pain since surgery
- time in pain
- interference of pain with activities
- affect of pain on mood and emotions
- pain therapy side effects
- pain relief
- wish for more treatment
- information on treatment
- participation in decisions
- satisfaction
- non-medical treatment methods
- pre-hospital existence of pain
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| Ages Eligible for Study: | 4 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Inclusion Criteria:
- >= 18 years or >= 4 years for sub-project QUIPSI/PAIN OUTinfant
- patient is post-op day 1
- patient is at least 6 hours on the ward
- patient has given consent
Exclusion Criteria:
- patient cannot communicate
- patient is cognitively impaired
- patient is asleep
- patient is too ill
- patient does not want to fill in the questionnaire
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02083835
| Contact: Winfried Meissner, Prof. Dr. | +49 3641 9323353 | winfried.meissner@med.uni-jena.de |
| Germany | |
| Jena University Hospital | Recruiting |
| Jena, Germany, 07747 | |
| Contact: Winfried Meissner, Prof. +49 3641 9323353 | |
| Study Director: | Winfried Meissner, Prof. | University of Jena |
Additional Information:
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Prof. Dr. Winfried Meissner, apl. Prof. Dr. med. Winfried Meissner, University of Jena |
| ClinicalTrials.gov Identifier: | NCT02083835 History of Changes |
| Other Study ID Numbers: |
FP7 223590 |
| First Posted: | March 11, 2014 Key Record Dates |
| Last Update Posted: | May 24, 2018 |
| Last Verified: | May 2018 |
Keywords provided by Prof. Dr. Winfried Meissner, University of Jena:
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post-operative pain paitent reported outcomes quality improvement |
Additional relevant MeSH terms:
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Pain, Postoperative Pain Neurologic Manifestations Nervous System Diseases |
Postoperative Complications Pathologic Processes Signs and Symptoms |