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PainTracker Self-Manager: a Web-based Platform to Promote and Track Chronic Pain Self-management (PTSM)

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ClinicalTrials.gov Identifier: NCT03045081
Recruitment Status : Completed
First Posted : February 7, 2017
Results First Posted : November 12, 2019
Last Update Posted : November 12, 2019
Sponsor:
Collaborators:
Duke University
University of New Mexico
Information provided by (Responsible Party):
Mark Sullivan, University of Washington

Brief Summary:
To develop and test a web-based patient empowerment platform, PainTracker Self-Manager (PTSM), that can support integrated multimodal care in a variety of specialty and primary care settings. The investigators will adapt PainTracker, a web-based outcome and treatment tracking tool already deployed in multiple University of Washington clinics to create the PTSM self-management tool that helps assess, engage, activate, and support patients' efforts to self-manage their chronic pain in collaboration with their clinicians. PTSM design will be based on 4-phase patient engagement strategy derived from Acceptance and Commitment Therapy. Phase 1 focuses on achieving consensus on the clinical problem definition, treatment goals and timeline. Phase 2 focuses on promoting values-based action and acceptance of pain. Phase 3 focuses on providing skills in chronic pain self-management with close monitoring of patient reported outcomes and actigraphy. Phase 4 focuses on providing autonomy support to promote maintenance of self-management behaviors. Phase 5 involves generating a patient registry with the above data for use in quality improvement research. The investigators will engage patients, providers and investigators in designing PTSM, reviewing prototypes, and conducting usability testing. In a 6-month clinical trial, the investigators will compare 50 intervention patients from the UW Center for Pain Relief who receive PTSM to 50 historical control patients who have received the basic PainTracker. The primary outcome will be chronic pain self-efficacy, with secondary outcomes of: chronic pain acceptance, perceived efficacy in physician-patient interactions, and patient and provider satisfaction. Development of the PTSM platform will support the dissemination of the multimodal interdisciplinary care for chronic pain that is recommended in the National Pain Strategy, and may help chronic pain care meet the goals of the Triple Aim: better patient experience, better patient outcomes, with lower costs.

Condition or disease Intervention/treatment Phase
Chronic Pain Behavioral: PainTracker Self-Manager Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PainTracker Self-Manager: Development and Testing of a Web-based Platform to Promote and Track Chronic Pain Self-management and Other Treatment Outcomes
Study Start Date : April 2016
Actual Primary Completion Date : September 30, 2017
Actual Study Completion Date : September 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
No Intervention: Usual care
Patients receive outcome tracking tool, PainTracker, but no additional web-based support for self-management
Experimental: PainTracker Self-Manager
Patients are invited to complete the web-based PainTracker Self-Manager and interact with a nurse care manager who supports chronic pain self-management
Behavioral: PainTracker Self-Manager
Interactive web-based educational and assessment program supported by a nurse care manager




Primary Outcome Measures :
  1. Chronic Pain Self-efficacy [ Time Frame: 3 months and 6 months ]
    Pain self-efficacy questionnaire (PSEQ); scores range from 0 to 60, with higher scores meaning greater self-efficacy (i.e., better outcome)


Secondary Outcome Measures :
  1. Chronic Pain Acceptance [ Time Frame: 3 months and 6 months ]
    Chronic Pain Acceptance Questionnaire with 2 subscales: Activity Engagement and Pain Willingness. Scores on the "activity engagement" subscale range from 0 to 66; scores on the "pain willingness" subscale range from 0 to 54; higher scores denote greater chronic pain acceptance.

  2. Patient-physician Interactions [ Time Frame: 3 months and 6 months ]
    Perceived efficacy in patient-physician interactions (PEPPI). Sum scores range from 5 to 25 with higher scores denoting greater perceived efficacy in patient-physician interactions.

  3. Patient Satisfaction [ Time Frame: 3 months and 6 months ]
    Patient satisfaction with care process. Note that we elected to evaluate patient satisfaction with their pain treatment in general, as opposed to the PTSM process specifically, in order to compare satisfaction between the study groups. Patient satisfaction was rated on an 11-point rating scale from 0 "extremely dissatisfied" to 10 "extremely satisfied"; higher scores denote higher satisfaction with pain treatment.

  4. Provider Satisfaction [ Time Frame: 6 months ]
    Provider satisfaction with care process and PTSM

  5. Pain Severity, Enjoyment of Life Interference, General Activity Interference (PEG) [ Time Frame: 3 months and 6 months ]
    Pain and pain interference were evaluated using the 3-item PEG scale. The pain intensity item was rated on an 11-point numeric rating scale, from 0 "no pain" to 10 "pain as bad as you can imagine." Interference (with enjoyment of life and general activity) were rated from 0 "does not interfere" to 10 "completely interferes." The PEG total (mean) score ranges from 0 to 10, where higher scores denote greater pain intensity and interference.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All new patients receiving care at University of Washington's Center for Pain Relief (UWCPR) and planning ongoing pain care by providers at UWCPR (not one-time consults or procedure patients), with a diagnosis of one or more chronic pain disorders
  • *Note: Eligible patients will be invited to participate in the study after completing their second PainTracker pre-UWCPR visit assessment.

Exclusion Criteria:

  • Patients attending UWCPR for only a single session or for only evaluation
  • Patients participating in 6-week Pain Support Groups at UWCPR or Harborview Medical Center for the duration of the 6-month study
  • Unable to read and write English
  • Dementia or other significant cognitive impairment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03045081


Locations
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United States, Washington
University of Washington Center for Pain Relief
Seattle, Washington, United States, 98115
Sponsors and Collaborators
University of Washington
Duke University
University of New Mexico
Investigators
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Principal Investigator: Mark D Sullivan, MD University of Washington
  Study Documents (Full-Text)

Documents provided by Mark Sullivan, University of Washington:
Study Protocol  [PDF] March 21, 2018
Statistical Analysis Plan  [PDF] March 21, 2018
Informed Consent Form  [PDF] February 17, 2017


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Responsible Party: Mark Sullivan, Professor, Psychiatry and Behavioral Sciences, University of Washington
ClinicalTrials.gov Identifier: NCT03045081    
Other Study ID Numbers: 51541
First Posted: February 7, 2017    Key Record Dates
Results First Posted: November 12, 2019
Last Update Posted: November 12, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms