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

NCT03045081 | Completed Results

• 1 other identifier: 51541
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

• Chronic Pain Self-efficacy

  Pain self-efficacy questionnaire (PSEQ); scores range from 0 to 60, with higher scores meaning greater self-efficacy (i.e., better outcome)

  3 months and 6 months

Secondary Outcomes (5)

• Chronic Pain Acceptance

  3 months and 6 months

• Patient-physician Interactions

  3 months and 6 months

• Patient Satisfaction

  3 months and 6 months

• Provider Satisfaction

  6 months

• Pain Severity, Enjoyment of Life Interference, General Activity Interference (PEG)

  3 months and 6 months

Study Arms (2)

Usual care

NO INTERVENTION

Patients receive outcome tracking tool, PainTracker, but no additional web-based support for self-management

PainTracker Self-Manager

EXPERIMENTAL

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

Interventions

PainTracker Self-Manager BEHAVIORAL

Interactive web-based educational and assessment program supported by a nurse care manager

PainTracker Self-Manager

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• Duke University: collaborator
• University of New Mexico: collaborator

Study Sites (1)

University of Washington Center for Pain Relief

Seattle, Washington, 98115, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dale J. Langford, PhD; Research Assistant Professor
• Organization: University of Washington

dalejwl@uw.edu

2066160158

Study Officials

• Mark D Sullivan, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Psychiatry and Behavioral Sciences

Study Record Dates

• First Submitted: February 2, 2017
• First Posted: February 7, 2017
• Study Start: April 1, 2016
• Primary Completion: September 30, 2017
• Study Completion: September 30, 2017
• Last Updated: November 12, 2019
• Results First Posted: November 12, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)