Clinical trial NCT04075487: MEPS-Pain: Personalized Pain Self-management Planning by and for Veterans Pilot Study
Official title: Evidence-Based Multidimensional Pain Self-Management Planning: Personalized by and for Veterans Via Web-Based Application
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Keywords: Low back pain
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: VA Maryland Health Care System
First posted: 2019-08-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pilot study of feasibility and user experience of minimal risk App for pain self-management intervention.
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Use of tablet-based application (App) for creation of pain self-management plan
timeFrame: 8 weeks
measure: Tablet-based application (App) for pain self-management planning: patient experience via System usability scale
timeFrame: 8 weeks
measure: Use of tablet-based application (App), patient experience via qualitative interview responses
timeFrame: 8 weeks
measure: Pain intensity
timeFrame: 8 weeks
measure: Tablet-based application (App) use for pain self-management planning: total clicks
timeFrame: 8 weeks
measure: Tablet-based application (App) use for pain self-management planning: daily logging of activities
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) pain interference
timeFrame: 8 weeks
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) sleep disturbance
timeFrame: 8 weeks
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Self Efficacy Managing symptoms
timeFrame: 8 weeks
Locations:
city: Baltimore
country: United States
facility: Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
state: Maryland
Study officials:
affiliation: Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
name: Beth B. Hogans, MD
role: PRINCIPAL_INVESTIGATOR
References: