MEPS-Pain: Personalized Pain Self-management Planning by and for Veterans Pilot Study

Chronic Low Back Pain Clinical Trial

— MEPS-Pain  

Official title:

Evidence-Based Multidimensional Pain Self-Management Planning: Personalized by and for Veterans Via Web-Based Application

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04075487
• Other study ID #: A3169-P
• Secondary ID: I21RX003169-01A1
• Status: Completed
• Phase: N/A
• Start date: June 21, 2022
• Est. completion date: July 31, 2023

Study information

• Verified date: August 2023
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Chronic low back pain is the #1 cause of disability and low quality of life in Veterans. Pain is a huge burden- stealing enjoyment, fulfillment, and time. Sometimes surgery, injections, or medications can help but sometimes not. Although no one solution fixes chronic low back pain, there are many treatments that can reduce pain impact and restore quality of life. These treatments involve: movement, psychology, mind-and-body therapies, sleep, and environmental factors. The challenge is how to best coordinate these treatments for chronic low back pain. The investigators have built a prototype mobile application that delivers the latest information to Veterans so they can work with healthcare providers to build their own pain self-management plans. With this new tool, the Veteran has data at hand and chooses their preferred pain self-management activities, making a coordinated plan that can be shared with their healthcare team. The investigators' goal is giving Veterans the knowledge and power to 'plan the work and work the plan' for chronic low back pain: restoring value, fulfillment, and meaning.

Description:

Chronic low back pain is highly prevalent in Veterans, and is often resistant to pharmacological management so that non-pharmacological management is required. For many patients, the most effective approach is comprehensive pain management incorporating multiple therapies addressing: physical, mental, mind-body, sleep, safety, and environmental needs. The ultimate outcome is the development of a coordinated multidimensional evidence-based plan for pain self-management (C-MEPPS) tailored to each patient. This approach, while effective, is highly resource intensive and severely constrained by cost and health system factors.

The investigators' goal is a mobile web-based application (App) that provides immediate feedback to Veterans seeking to develop their own pain self-management plan. This will represent a novel, scalable, Veteran-driven solution to chronic low back pain aligned with VA strategic objectives 'online navigator tools.empowers Veterans to make decisions.' The investigators are focused on transferring knowledge about evidence-base practices into the primary care context to help Veterans and their healthcare providers manage pain effectively- before it gets worse. The investigators have already developed the App prototype utilizing User-Centered Design principles to optimize the user experience. Our first aim is to develop and pilot test a web-based App for Veterans, including older Veterans and women Veterans, designed to empower each in pain self-management planning: providing access and data-driven guidance about evidence-based multidimensional behavior change. The investigators' second aim is to gather pilot data targeting patient-centered and rehabilitative outcomes such as: increased activity, more sleep time, decreased pain interference and better quality of life; through use of the App and engagement in pain self-management planning.

This project brings together the expertise of skilled exercise physiologists, experienced pain and sleep clinical psychologists, pain specialists, clinical educators, geriatricians, women's health providers, and technology design experts to create a powerful new pipeline for knowledge transfer to patients and providers. Grounded in whole health and integrative approaches, nursing principles, pharmacy practices, physical therapy, and nutrition are also included in the App. The investigators are working as an interprofessional pain-focused team to put the best-available information about non-pharmacological treatments for pain into the hands of Veterans and their primary care providers. The investigators' vision is to improve the lives of Veterans with chronic low back pain, improving access to knowledge and resources and giving Veterans the power to plan their own path to better, more fulfilling living despite chronic low back pain.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Veterans receiving care at the VAMHCS

• frequent or persistent low back pain (> 3 months)

• pain >4 on a 0-10 numeric rating scale

• willing to participate in trial of non-pharmacological therapies for pain

• ability to speak, read, and write as needed for study

• stable treatment

Exclusion Criteria:

• Veterans with cognitive or visual impairment limiting the ability to engage in self-directed self-management planning

• anticipated surgery or pain procedure during the expected study period

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

Other:
• Web-module for patient education and planning
Our goal is a mobile web-based application (App) that provides immediate feedback to Veterans seeking to develop their own pain self-management plan

Locations

Country	Name	City	State
United States	Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	VA Maryland Health Care System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient-Reported Outcomes Measurement Information System (PROMIS) pain interference	Pain interference utilizing PROMIS short form 6b; Maximum score 30 (bad outcome), minimum score 6 (good outcome).	8 weeks
Other	Patient-Reported Outcomes Measurement Information System (PROMIS) sleep disturbance	Patient-Reported Outcomes Measurement Information System (PROMIS) sleep disturbance 4a; Maximum score 20 (bad outcome), minimum score 4 (good outcome).	8 weeks
Other	Patient-Reported Outcomes Measurement Information System (PROMIS) Self Efficacy Managing symptoms	Patient-Reported Outcomes Measurement Information System (PROMIS) Self Efficacy Managing symptoms 4a; Maximum score 20 (good outcome), minimum score 4 (bad outcome).	8 weeks
Primary	Use of tablet-based application (App) for creation of pain self-management plan	The investigators will assess user experience with the App, assessing actual use to create a pain self-management plan. Plans will be assessed for appropriateness by pain clinician using a 0 to 10 scale: 0 meaning plan was not created, 1-10 rating quality of pain self-management plan on a scale of 1 being a 'worst imaginable' plan, 10 being a 'best imaginable' plan.	8 weeks
Primary	Tablet-based application (App) for pain self-management planning: patient experience via System usability scale	The investigators will assess user experience with the App, usability with SUS, modified for App.; Maximum score 50 (good outcome), minimum score 10 (poor outcome).	8 weeks
Primary	Use of tablet-based application (App), patient experience via qualitative interview responses	The investigators will assess user experience with the App, using qualitative interview responses interview responses to semi-structured interview questions.	8 weeks
Primary	Pain intensity	DOD-VA Pain instrument; Maximum score 10 (bad outcome), minimum score 1 (good outcome).	8 weeks
Primary	Tablet-based application (App) use for pain self-management planning: total clicks	Total daily clicks in the App; Maximum score unknown (good outcome), minimum score 0 (bad outcome).	8 weeks
Primary	Tablet-based application (App) use for pain self-management planning: daily logging of activities	Average number activities logged per day in the App; Maximum score unknown (good outcome), minimum score 0 (bad outcome).	8 weeks