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Design considerations for a remote randomized multi-site clinical trial evaluating an e-health self-management program for chronic pain patients receiving opioid therapy.

Publication ,  Journal Article
Winhusen, T; Wilson, M; Dolor, RJ; Theobald, J; Lewis, D; Regan, SL; Vonder Meulen, MB
Published in: Contemp Clin Trials
February 2021

Based on the adverse consequences and inadequate evidence of effectiveness for long-term opioid therapy (LOT), the CDC developed recommendations to decrease the use of LOT and morphine equivalent dose (MED) for patients receiving LOT. However, the majority of these patients report that opioid medication is significantly beneficial for pain management and are hesitant to reduce/decrease its use. Compounding the problem is poor access to non-pharmacologic therapies for many patients due to insurance reimbursement structures and limited pain-service availability. EMPOWER is an intent-to-treat, two-arm, open-label, randomized controlled trial evaluating a web-based self-management chronic pain program (E-Health) that has been found to reduce self-reported MED, while also decreasing pain, in two randomized controlled trials. Approximately 400 chronic pain patients receiving LOT at a daily average prescribed MED ≥ 20 mg at one of two U.S. healthcare systems, located in North Carolina and Ohio, will be randomized in a 1:1 ratio to treatment as usual (TAU) or TAU plus E-Health (E-Health+). TAU consists of LOT from a prescribing clinician. E-Health+ participants are provided with a 4-month E-Health subscription (active treatment phase). All participants will complete web-based self-report measures at baseline, the end of the active treatment phase, and 6-months post-active treatment. Opioid prescription information will be collected from the participants' electronic health record (EHR) from baseline through 6 months post-active treatment. This paper describes design considerations for this unique trial which is conducted completely remotely, with no in-person visits, and utilizes the EHR for participant identification and primary outcome collection.

Duke Scholars

Published In

Contemp Clin Trials

DOI

EISSN

1559-2030

Publication Date

February 2021

Volume

101

Start / End Page

106245

Location

United States

Related Subject Headings

  • Telemedicine
  • Self-Management
  • Public Health
  • Pain Management
  • Humans
  • General Clinical Medicine
  • Chronic Pain
  • Analgesics, Opioid
  • 42 Health sciences
  • 32 Biomedical and clinical sciences
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Winhusen, T., Wilson, M., Dolor, R. J., Theobald, J., Lewis, D., Regan, S. L., & Vonder Meulen, M. B. (2021). Design considerations for a remote randomized multi-site clinical trial evaluating an e-health self-management program for chronic pain patients receiving opioid therapy. Contemp Clin Trials, 101, 106245. https://doi.org/10.1016/j.cct.2020.106245
Winhusen, Theresa, Marian Wilson, Rowena J. Dolor, Jeff Theobald, Daniel Lewis, Saundra L. Regan, and Mary Beth Vonder Meulen. “Design considerations for a remote randomized multi-site clinical trial evaluating an e-health self-management program for chronic pain patients receiving opioid therapy.Contemp Clin Trials 101 (February 2021): 106245. https://doi.org/10.1016/j.cct.2020.106245.
Winhusen, Theresa, et al. “Design considerations for a remote randomized multi-site clinical trial evaluating an e-health self-management program for chronic pain patients receiving opioid therapy.Contemp Clin Trials, vol. 101, Feb. 2021, p. 106245. Pubmed, doi:10.1016/j.cct.2020.106245.
Winhusen T, Wilson M, Dolor RJ, Theobald J, Lewis D, Regan SL, Vonder Meulen MB. Design considerations for a remote randomized multi-site clinical trial evaluating an e-health self-management program for chronic pain patients receiving opioid therapy. Contemp Clin Trials. 2021 Feb;101:106245.
Journal cover image

Published In

Contemp Clin Trials

DOI

EISSN

1559-2030

Publication Date

February 2021

Volume

101

Start / End Page

106245

Location

United States

Related Subject Headings

  • Telemedicine
  • Self-Management
  • Public Health
  • Pain Management
  • Humans
  • General Clinical Medicine
  • Chronic Pain
  • Analgesics, Opioid
  • 42 Health sciences
  • 32 Biomedical and clinical sciences