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

Prof. Dr. Winfried Meissner3,322 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

3,322

Conditions

Pain, Postoperative

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 2019 - 2022

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.

Time frame: 2019 - 2022

Secondary Outcomes

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;