Providing Standardized Consented PROMs (Patient Reported Outcome Measures) for Improving Pain Treatment

Pain, Postoperative Clinical Trial

— PROMPT  

Official title:

PROMPT Providing Standardized Consented PROMs (Patient Reported Outcome Measures) for Improving Pain Treatment A Multicenter, Non-interventional, Prospective Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03834922
• Other study ID #: 777500-IMI-PainCare PROMPT
• Status: Completed
• Start date: September 24, 2019
• Est. completion date: June 30, 2022

Study information

• Verified date: November 2022
• Source: University of Jena
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3322
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Other:
• Prospective data collection
No intervention. It's a prospective data collection.

Locations

Country	Name	City	State
Germany	Jena University Hospital	Jena	Thuringia

Sponsors (22)

Lead Sponsor

Collaborator

Prof. Dr. Winfried Meissner

Barts & The London NHS Trust, Cancer Center Porto, Portugal, Cardiovascular Center Dedinje, Belgrade, Serbia, Grünenthal GmbH, Hôpital Raymond Poincaré, Hospital Ambroise Paré Paris, Hospital Clínico Universitario de Valladolid, Infirmerie Protestante Lyon, Novartis Pharmaceuticals, Orthopedic Center Santy, Lyon, France, Orthopedic Institute Banjika, Belgrade, Serbia, Oxford University Hospitals NHS Trust, University Hospital Bergmannsheil Bochum, University Hospital Dresden, University Hospital Inselspital, Berne, University Hospital Muenster, University Hospital St Luc, Brussels, University Hospital, Geneva, University of Helsinki, University of Homburg, University of Naples

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	WP 2 - Acute pain: Sensitivity to change	For WP2, the primary endpoint will be pain intensity at day 3 (NRS Scale from 0 to 10, 0 being no pain, 10 being worst pain imaginable). This primary endpoint (PROMs) will be used to assess sensitivity to change from POD3 to POD1.	2019 - 2022
Primary	WP 3 - Chronification of pain: Incidence of chronic post-surgical pain (CPSP)	For WP3, the primary end point will be the incidence of moderate to severe CPSP (Numeric rating scale = 3/10) at 6 months using the average pain on the Brief Pain Inventory Questionnaire.	2019 - 2022
Secondary	Objective physical activity and sleep, measured with Actigraph devices	Correlation of physical activity data (average no. of steps of days 5 to 7) with PRO "physical function" on day 7;	01/2020 to 12/2021
Secondary	Association between other POD7 PROMs and activity/sleep	Association between other POD7 PROMs and activity/sleep	01/2020 to 12/2021
Secondary	Association between peri-operative processes and activity/sleep	Association between peri-operative processes and activity/sleep	01/2020 to 12/2021
Secondary	Is decreased activity a predictor for chronic postsurgical pain?	Is decreased activity a predictor for chronic postsurgical pain on POM6?	01/2020 to 12/2021
Secondary	Do activity trajectories since surgery parallel trajectories of other outcomes?	Do activity trajectories since surgery parallel trajectories of other outcomes?	01/2020 to 12/2021
Secondary	Correlation of activity difference between POD5-7 and preop with POD7 oucomes	Correlation of activity difference between POD5-7 and preop with POD7 oucomes	01/2020 to 12/2021
Secondary	Association between ambient light intensity and outcomes on POD7	Association between ambient light intensity and outcomes on POD7	01/2020 to 12/2021