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

Prof. Dr. Winfried Meissner

Status: Completed

Conditions: Pain, Postoperative

Treatments: Other: Prospective data collection

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03834922

777500-IMI-PainCare PROMPT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,322 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

3,322 participants in 4 patient groups

Total knee arthroplasty

Description:

Patients undergoing total knee arthroplasty

Treatment:

Other: Prospective data collection

Sternotomy

Description:

Patients undergoing sternotomy

Treatment:

Other: Prospective data collection

Breast

Description:

Patients undergoing breast surgery

Treatment:

Other: Prospective data collection

Endometriosis

Description:

Patients undergoing endometriosis-related surgery

Treatment:

Other: Prospective data collection