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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Other: Prospective data collection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Total knee arthroplasty<br>Patients undergoing total knee arthroplasty | Other: Prospective data collection<br>* No intervention. It's a prospective data collection.<br>|
| Sternotomy<br>Patients undergoing sternotomy | Other: Prospective data collection<br>* No intervention. It's a prospective data collection.<br>|
| Breast<br>Patients undergoing breast surgery | Other: Prospective data collection<br>* No intervention. It's a prospective data collection.<br>|
| Endometriosis<br>Patients undergoing endometriosis-related surgery | Other: Prospective data collection<br>* No intervention. It's a prospective data collection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Association between other POD7 PROMs and activity/sleep | Association between other POD7 PROMs and activity/sleep | 01/2020 to 12/2021 | 
| Association between peri-operative processes and activity/sleep | Association between peri-operative processes and activity/sleep | 01/2020 to 12/2021 | 
| 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 | 
| 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 | 
| 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 | 
| Association between ambient light intensity and outcomes on POD7 | Association between ambient light intensity and outcomes on POD7 | 01/2020 to 12/2021 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute pain, Chronification of pain, Pain treatment, Pain management, Postoperative pain