Patient-Centered Chronic Pain Care

NCT05256394 | Completed

• 2 other identifiers: IRB2021019311R18HS028584-01
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

This study will adapt and scale existing AHRQ-supported interoperable CDS for patient-centered chronic pain care. The objective of this project is to study the adaptation and implementation of an existing interoperable CDS tool for pain treatment shared decision making, with tailored implementation support, in primary care clinical settings. The central hypothesis is that tailored implementation support will increase CDS adoption and shared decision making.

Conditions

Chronic Pain; Opioid Use; Musculoskeletal Pain

Outcome Measures

Primary Outcomes (1)

• Adoption

  Rate of qualifying patients seen for whom CDS use is documented

  During the implementation trial (5 months total)

Secondary Outcomes (12)

• Reach

  During the implementation trial (5 months total)

• Shared decision making

  Immediately after the intervention

• Pain and function

  Baseline/pre-intervention, and at 1 and 3 months

• Any opioid prescription

  Baseline/pre-intervention, and at 1 and 3 months

• Opioid prescriptions ≥50 MME/day

  Baseline/pre-intervention, and at 1 and 3 months

Study Arms (2)

Pain Manager + tailored implementation support Pain Manager

ACTIVE COMPARATOR

Pain Manager is a decision support tool. All study clinics will begin the trial with Pain Manager integrated and available in their EHR. Consistent with the stepped-wedge design, intensive implementation support (e.g, administrative support, technical support)will be provided to two clinics at once by a multidisciplinary team.

Behavioral: Pain Manager + tailored implementation support

Pain Manager implementation in EHR

NO INTERVENTION

Pain Manager is a decision support tool. All study clinics will begin the trial with Pain Manager integrated and available in their EHR. The other 6 clinics will have no additional tailor support.

Interventions

Pain Manager + tailored implementation support BEHAVIORAL

Individualized training, technical assistance, and workflow assessments.

Pain Manager + tailored implementation support Pain Manager

Eligibility Criteria

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

You may qualify if:

• Primary care patients receiving care at a participating clinic
• Patients with chronic non-cancer musculoskeletal pain and with a recent history of opioid use

You may not qualify if:

• Due to the fact that the clinical decision support tool is currently available in English only, non-English speaking patients will not be eligible to participate

Sponsors & Collaborators

• University of Florida: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (1)

UF Health Family Medicine - Commonwealth

Jacksonville, Florida, 32254, United States

Location

Related Publications (1)

• Salloum RG, Bilello L, Bian J, Diiulio J, Paz LG, Gurka MJ, Gutierrez M, Hurley RW, Jones RE, Martinez-Wittinghan F, Marcial L, Masri G, McDonnell C, Militello LG, Modave F, Nguyen K, Rhodes B, Siler K, Willis D, Harle CA. Study protocol for a type III hybrid effectiveness-implementation trial to evaluate scaling interoperable clinical decision support for patient-centered chronic pain management in primary care. Implement Sci. 2022 Jul 15;17(1):44. doi: 10.1186/s13012-022-01217-4.

  PMID: 35841043 DERIVED

MeSH Terms

Conditions

Chronic Pain; Musculoskeletal Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases

Study Officials

• Christopher Harle, Ph.D.

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a stepped-wedge, cluster randomized trial using mixed methods to assess the multilevel determinants of CDS implementation success. The investigators will use both quantitative and qualitative data to provide a comprehensive understanding of the clinical context of the participating sites before and after the trial, and identify system, clinic and provider-level factors that may influence the implementation process. In summary, this is a complete, open-cohort stepped-wedge cluster-randomized design with 5 time periods (including the baseline), with each period spanning 1 month and 2 clinics switching from control to intervention at each of the 4 steps (for a total study duration of 5 months).

Study Record Dates

• First Submitted: January 28, 2022
• First Posted: February 25, 2022
• Study Start: January 13, 2025
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: November 4, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)