Direct Patient Feedback on Postoperative Pain (DPF)

Smartphone Reported Direct Patient Feedback on Postoperative Pain That is Directly Passed on to Surgical Ward Nurses, Effects on Patient Reported Postoperative Pain Outcomes and Pharmaco-therapy. A Prospective, Randomized, Single-blinded, Controlled Tria

Postoperative pain is common, can be severe, has a negative impact on outcomes after surgery and brings along major economic costs for society. A substantial part of patients may develop persistent post-surgical pain. Severity and duration of pain after surgery appear to have a role in this process but the transition from acute postoperative pain to chronic pain is only partially understood.

Effective treatment of postoperative pain is hampered by several barriers, including the way measurement of pain and registration of pain-scores are carried out by nurses in clinical practice. Modern technology offers new opportunities for pain measurement and direct patient feedback on postoperative pain, during and also after clinical admission. We developed a smartphone application that allows clinical patients to report pain scores and other pain related outcomes on postoperative pain with their own telephone device. Patient reported pain scores > 3 on a Numeric Rating Scale (NRS) 0-10 are immediately passed on to the nurse who receives a message of the reported pain score. This can lead to earlier detection of pain and a more timely treatment resulting in improved patient reported outcomes on postoperative pain

Study Overview

• Status: Recruiting
• Conditions: Pain
• Intervention / Treatment: Behavioral: direct patient feedback

Detailed Description

Postoperative pain is common, can be severe, has a negative impact on outcomes after surgery and brings along major economic costs for society. A substantial part of patients may develop persistent post-surgical pain. Severity and duration of pain after surgery appear to have a role in this process but the transition from acute postoperative pain to chronic pain is only partially understood.

Effective treatment of postoperative pain is hampered by several barriers, including the way measurement of pain and registration of pain-scores are carried out by nurses in clinical practice. Modern technology offers new opportunities for pain measurement and direct patient feedback on postoperative pain, during and also after clinical admission. We developed a smartphone application that allows clinical patients to report pain scores and other pain related outcomes on postoperative pain with their own telephone device. Patient reported pain scores > 3 on a Numeric Rating Scale (NRS) 0-10 are immediately passed on to the nurse who receives a message of the reported pain score. This can lead to earlier detection of pain and a more timely treatment resulting in improved patient reported outcomes on postoperative pain

• Study Type: Interventional
• Enrollment (Anticipated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: marjolein haveman, dr; Phone Number: 0503616161; Email: m.e.haveman@umcg.nl

Study Locations

• Netherlands
  • Groningen, Netherlands, 9713EZ
    • Recruiting
    • University Medical Center Groningen
    • Contact: rob spanjersberg; Email: r.spanjersberg@umcg.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Participants have to be 18 years or older
• Participants need to undergo a clinical surgical procedure for one of the three medical specialties mentioned above.
• Participants must be admitted to one of the participating surgical wards directly following discharge from the post anesthetic care unit after surgery.
• Participants have to stay admitted to the wards at least till the next day after surgery.
• Participants have to be in the possession of a smartphone that is able to receive a SMS text message and can sent data to a web based server.
• Participants must master the Dutch language and provide their written informed consent on forehand.
• Participants answered the first questionnaire (APS-POQ-R part I) before surgery.

Exclusion Criteria:

A potential subject who meets any of the following criteria will be excluded from participation in this study:

• Patients who do not wish to participate.
• Patients that for physical or cognitive impairments are unable to participate.
• Patients who do not possess a smartphone.
• Patients who are transferred to another ward during hospital admission e.g. the intensive care unit the first night after surgery.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Applying a system in which patients undergoing surgery can report pain scores and other pain-related outcomes with their own smartphone, both during hospitalization and for three months after discharge. During clinical admission patient reported pain scores > 3 (NRS 0-10) in the intervention group are immediately passed on to the nurse who will receive a notification on a smartphone. In the control group the patients' pain scores are not sent to the nurse. After discharge, patients will report pain scores every two weeks for three months.	Behavioral: direct patient feedback; Participants in the intervention group report postoperative pain scores and other pain related outcomes with their own smartphone. Pain scores reported by smartphone > 3 (NRS 0-10) are immediately passed on to the nurse who will receive a notification on a smartphone. All patient reported pain-scores by smartphone are stored in a database that is not accessible to medical or nursing staff from the nursing ward.
No Intervention: control group; Participants in the control group report postoperative pain scores and other pain related outcomes with their own smartphone. Their reported pain-scores will not be surpassed to the nurses on the ward. All patient reported pain-scores by smartphone are stored in a database that is not accessible to medical or nursing staff from the nursing ward.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient reported time in severe pain	Patient reported time in severe pain per separate clinical admission day (8 a.m.-8 a.m.), as reported by APS-POQ-R.	every clinical admission day (8 a.m.-8 a.m.)

Collaborators and Investigators

• Sponsor: University Medical Center Groningen
• Investigators: Study Chair: marjolein haveman, UMCG

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2022
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): January 1, 2025

Study Registration Dates

• First Submitted: March 13, 2023
• First Submitted That Met QC Criteria: March 13, 2023
• First Posted (Actual): March 24, 2023

Study Record Updates

• Last Update Posted (Actual): March 24, 2023
• Last Update Submitted That Met QC Criteria: March 13, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: NL9697

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No