Chronic Pain, Musculoskeletal Pain, Opioid Use
Conditions
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.
Interventions
BEHAVIORALPain Manager + tailored implementation support
Individualized training, technical assistance, and workflow assessments.
Sponsors
Agency for Healthcare Research and Quality (AHRQ)
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adoption | During the implementation trial (5 months total) | Rate of qualifying patients seen for whom CDS use is documented |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Shared decision making | Immediately after the intervention | SDM-Q-9 questionnaire: 9-item Shared Decision Making Questionnaire |
| Pain and function | Baseline/pre-intervention, and at 1 and 3 months | PEG-3: 3-item scale that measures pain on average, its interference with enjoyment of life, and with general activity |
| Any opioid prescription | Baseline/pre-intervention, and at 1 and 3 months | Binary measure of treatment choice that increases opioid-related risks |
| Opioid prescriptions ≥50 MME/day | Baseline/pre-intervention, and at 1 and 3 months | Binary measure of treatment choice that increases opioid-related risks |
| Opioid prescriptions ≥90 MME/day | Baseline/pre-intervention, and at 1 and 3 months | Binary measure of treatment choice that increases opioid-related risks |
| Reach | During the implementation trial (5 months total) | Rate of clinic encounters where CDS is documented |
| Prescriptions for non-opioid pain medications | Baseline/pre-intervention, and at 1 and 3 months | Binary measure recommended by the CDC to decrease opioid-related risks |
| Prescriptions for non-pharmacologic pain treatments | Baseline/pre-intervention, and at 1 and 3 months | Binary measure recommended by the CDC to decrease opioid-related risks |
| Urine drug screen orders | Baseline/pre-intervention, and at 1 and 3 months | Binary measure recommended by the CDC to decrease opioid-related risks |
| Naloxone prescriptions | Baseline/pre-intervention, and at 1 and 3 months | Binary measure recommended by the CDC to decrease opioid-related risks |
| Prescription or referral for medication-assisted therapy (MAT) | Baseline/pre-intervention, and at 1 and 3 months | Binary measure recommended by the CDC to decrease opioid-related risks |
| Benzodiazepine prescription concurrent with opioid prescription | Baseline/pre-intervention, and at 1 and 3 months | Binary measure of treatment choice that increases opioid-related risks |
Countries
United States
Outcome results
None listed