Clinical trial NCT03834922: Providing Standardized Consented PROMs (Patient Reported Outcome Measures) for Improving Pain Treatment
Official title: PROMPT Providing Standardized Consented PROMs (Patient Reported Outcome Measures) for Improving Pain Treatment A Multicenter, Non-interventional, Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain, Postoperative
Keywords: Acute pain
Chronification of pain
Pain treatment
Pain management
Postoperative pain
Lead sponsor: University of Jena
Sponsor class: OTHER
Collaborators: name: Grünenthal GmbH
name: University Hospital Muenster
name: Hospital Ambroise Paré Paris
name: Novartis Pharmaceuticals
name: Hôpital Raymond Poincaré
name: University of Helsinki
name: University Hospital St Luc, Brussels
name: Oxford University Hospitals NHS Trust
name: University Hospital, Geneva
name: Orthopedic Center Santy, Lyon, France
name: University of Naples
name: Hospital Clínico Universitario de Valladolid
name: Cancer Center Porto, Portugal
name: Orthopedic Institute Banjika, Belgrade, Serbia
name: Cardiovascular Center Dedinje, Belgrade, Serbia
name: University of Homburg
name: Barts & The London NHS Trust
name: Insel Gruppe AG, University Hospital Bern
name: University Hospital Dresden
name: University Hospital Bergmannsheil Bochum
name: Infirmerie Protestante de Lyon
First posted: 2019-02-08
Enrollment: 3322
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing one of the following types of surgery: TKA, breast, sternotomy and endometriosis related surgery. Only female patients will be included in the Breast Surgery and Endometriosis group. For the other surgeries, there will not be a special preference in the distribution by sex or age for the recruitment.

Brief summary: PROMPT aims at improving management of acute and chronic pain by identifying a core set of PROMs (patient reported outcome measures) that are predictive indicators of treatment success in clinical practice and controlled trials. These will not only address pain intensities as well as the functional consequences of pain for individuals but also identify patients at risk of experiencing chronification of acute post-operative pain. Results will help health care professionals to individualize pain management, and thus improve the quality of life of pain patients.

Detailed description: In order to reach this objective, a non-interventional prospective data collection aiming at reaching a consensus on a core set of PROMs which reliably predict and/or measure success in acute and chronic pain treatments in real life conditions and identifying predictors for chronification of postoperative pain will be conducted (PROMPT NIT-1). Aim of the data collection is to evaluate the abilities of certain PROMs in assessing acute post-surgical pain outcomes in daily routine care of patients after four different surgical procedures: (total knee replacement, breast surgery, sternotomy and surgery related to endometriosis), and to validate selected risk factors for chronification prospectively.

Eligibility criteria: Inclusion Criteria:

* Patient is of consenting age (\>18 years old)
* Elective surgery
* Planned stay in hospital for the surgery
* First contact with the patient before surgery
* Patient agrees to participate

Exclusion Criteria:

* Patient is unable to give consent
* Cognitive impairment
* Questionnaire is not available in a language the patient is fluent in
* Patient not willing to answer the follow-up questionnaire

Primary outcomes:
measure: WP 2 - Acute pain: Sensitivity to change
timeFrame: 2019 - 2022
measure: WP 3 - Chronification of pain: Incidence of chronic post-surgical pain (CPSP)
timeFrame: 2019 - 2022
Secondary outcomes:
measure: Objective physical activity and sleep, measured with Actigraph devices
timeFrame: 01/2020 to 12/2021
measure: Association between other POD7 PROMs and activity/sleep
timeFrame: 01/2020 to 12/2021
measure: Association between peri-operative processes and activity/sleep
timeFrame: 01/2020 to 12/2021
measure: Is decreased activity a predictor for chronic postsurgical pain?
timeFrame: 01/2020 to 12/2021
measure: Do activity trajectories since surgery parallel trajectories of other outcomes?
timeFrame: 01/2020 to 12/2021
measure: Correlation of activity difference between POD5-7 and preop with POD7 oucomes
timeFrame: 01/2020 to 12/2021
measure: Association between ambient light intensity and outcomes on POD7
timeFrame: 01/2020 to 12/2021
Other outcomes:
Locations:
city: Jena
country: Germany
facility: Jena University Hospital
state: Thuringia
Study officials:
affiliation: Jena University Hospital
name: Winfried Meissner, Prof.
role: STUDY_CHAIR
affiliation: Grünenthal GmbH
name: Hiltrud Liedgens, Dr.
role: STUDY_CHAIR
affiliation: University Hospital Münster
name: Esther Pogatzki-Zahn, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Ambroise Paré Paris
name: Dominique Fletcher, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Novartis
name: Shaloo Pandhi
role: PRINCIPAL_INVESTIGATOR
References: