Empowered Relief Delivered by Nurses (ERA)

Addressing Pain Care Inequities With Empowered Relief Delivered by ASPMN Nurses: A Randomized Controlled Trial

This study will investigate effects of a psychoeducation pain management skills intervention on adults with persistent pain by training a cohort of American Society for Pain Management Nursing (ASPMN) nurses to deliver and it [Empowered Relief (ER)], as a single-session video-conferenced program. The primary objective is to evaluate the effects of ASPMN nurse-provided ER versus waitlist control (WLC) on pain catastrophizing, pain bothersomeness, pain intensity, pain interference, sleep disturbance, physical function, depression, anxiety, and social isolation for patients with persistent pain. Secondarily, feasibility and acceptability of the ER program will be assessed through recruitment and retention data and qualitative satisfaction data.

Study Overview

• Status: Recruiting
• Conditions: Pain, Chronic
• Intervention / Treatment: Other: Empowered Relief

Detailed Description

Design: This study will be conducted as a randomized controlled trial comparing effects of ER to a WLC of participants with persistent pain when ER is provided by ER-trained ASPMN nurses. The secondary aims of feasibility and acceptability will use qualitative descriptive methods.

Participants: Participants (N=170) will be adults aged 18 and above years with self- reported or clinically diagnosed persistent pain. Participants will be recruited at clinical sites identified by ER-trained nurses and can be self or clinician referred. Participants will complete an online eligibility form to screen for inclusion and exclusion criteria. Inclusion criteria: pain >3 months more than half the time, English fluency, ability to attend a one-time web-based class and complete web-based surveys, age > 18 years. Exclusion criteria: Previous participation in ER class, cognitive impairment, non-English speaking, or psychological factors that would preclude comprehension of material or full participation in the study as determined by the investigators.

Procedures: Twenty ASPMN nurses will receive ER training facilitated by Stanford Pain Relief Innovations Lab. ER- trained nurse providers will be ASPMN-member nurses of any clinical background. ASPMN nurses will be invited to apply to become a trainer with the following expectations: ability to fully participate in a live, online, 2-day ER instructor training, able to fluently complete instructor training and deliver the ER program in English, commitment to deliver 1-3 live, online, 2-hour ER programs for patient participants, and willingness to complete post-program surveys after each session they deliver reporting on number of participants and any barriers encountered. Recruitment will occur through ASPMN-related mechanisms of communication, including its website, national officers and directors, newsletter, research group, national committees, chapter leadership and listserv.

After meeting eligibility criteria and completing informed consent, study participants will be asked to complete a baseline survey of demographics and health variables (as outlined in Table 1) and then randomized 1:1 to one of two unblinded study groups: ER and WLC. Participants randomized to the ER group will complete a HIPAA compliant, password protected Zoom ER class delivered by an ER-trained ASPMN nurse. A crossover intervention class will be offered to those patient participants randomized to WLC once the ER group has completed their class and follow up assessments, estimated at 2 months post intervention.

• Study Type: Interventional
• Enrollment (Estimated): 170
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Holly Watson, MSN; Phone Number: 614-204-4929; Email: holly409@icloud.com

Study Locations

• United States
  • Washington
    • Spokane, Washington, United States, 99201
      • Recruiting
      • Washington State University
      • Contact: Marian Wilson, PhD; Phone Number: 509-324-7443; Email: marian.wilson@wsu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• age > 18 years
• pain >3 months more than half the time
• English fluency
• ability to attend a one-time web-based class and complete web-based surveys.

Exclusion criteria:

• Previous participation in ER class
• cognitive impairment
• non-English speaking
• psychological factors that would preclude comprehension of material or full participation in the study as determined by the investigators.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Empowered Relief treatment; Participants randomized to the ER group will complete a HIPAA compliant, password protected 2-hour Zoom ER class delivered by an ER-trained ASPMN nurse.	Other: Empowered Relief; psycho-educational pain skills training; Other Names: ER
Other: Wait-list Control; Participants randomized to the Wait-list Control group will continue their usual pain care for 2 months and complete surveys to compare with the experimental treatment group. After serving as controls, they will be invited to attend the 2-hour Zoom ER class delivered by an ER-trained ASPMN nurse.	Other: Empowered Relief; psycho-educational pain skills training; Other Names: ER

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain Catastrophizing	Measured by self-report	Participants will be assessed at baseline, and then at 2, 4, and 8 week timepoints for change over time.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain Intensity	0-10 Pain severity scale	Participants will be assessed at baseline, and then at 2, 4, and 8 week timepoints for change over time.

Collaborators and Investigators

• Sponsor: Washington State University
• Collaborators: American Society for Pain Management Nursing
• Investigators: Principal Investigator: Marian Wilson, PhD, Washington State University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: June 17, 2023
• First Submitted That Met QC Criteria: June 27, 2023
• First Posted (Actual): July 7, 2023

Study Record Updates

• Last Update Posted (Actual): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 4, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 20013-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Can be requested from principal investigator
• IPD Sharing Time Frame: After publication
• IPD Sharing Access Criteria: Use for secondary analysis
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No