Clinical trial NCT05256394: Patient-Centered Chronic Pain Care
Official title: Scaling Interoperable Clinical Decision Support for Patient-Centered Chronic Pain Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Pain
Opioid Use
Musculoskeletal Pain
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2022-02-25
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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).
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: This study will adapt and scale the use of existing AHRQ-supported interoperable CDS that aids patient-centered chronic pain treatment decision making. The research will generate critical evidence on scalable strategies to implement and evaluate interoperable CDS in real-world settings across different types of EHRs. The pragmatic trial will enhance the reach of interoperable CDS to more diverse populations. Together, these efforts will lead to important new technology and evidence that patients, clinicians, and health systems can use to improve care for millions of Americans who suffer from pain and other chronic conditions.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Adoption
timeFrame: During the implementation trial (5 months total)
Secondary outcomes:
measure: Reach
timeFrame: During the implementation trial (5 months total)
measure: Shared decision making
timeFrame: Immediately after the intervention
measure: Pain and function
timeFrame: Baseline/pre-intervention, and at 1 and 3 months
measure: Any opioid prescription
timeFrame: Baseline/pre-intervention, and at 1 and 3 months
measure: Opioid prescriptions ≥50 MME/day
timeFrame: Baseline/pre-intervention, and at 1 and 3 months
measure: Opioid prescriptions ≥90 MME/day
timeFrame: Baseline/pre-intervention, and at 1 and 3 months
measure: Benzodiazepine prescription concurrent with opioid prescription
timeFrame: Baseline/pre-intervention, and at 1 and 3 months
measure: Prescriptions for non-opioid pain medications
timeFrame: Baseline/pre-intervention, and at 1 and 3 months
measure: Prescriptions for non-pharmacologic pain treatments
timeFrame: Baseline/pre-intervention, and at 1 and 3 months
measure: Urine drug screen orders
timeFrame: Baseline/pre-intervention, and at 1 and 3 months
measure: Naloxone prescriptions
timeFrame: Baseline/pre-intervention, and at 1 and 3 months
measure: Prescription or referral for medication-assisted therapy (MAT)
timeFrame: Baseline/pre-intervention, and at 1 and 3 months
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: UF Health Family Medicine - Commonwealth
state: Florida
Study officials:
affiliation: University of Florida
name: Christopher Harle, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.