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| ID | Type | Description | Link |
|---|---|---|---|
| 1R18HS028584-01 | U.S. AHRQ Grant/Contract | View source |
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| Name | Class |
|---|---|
| Agency for Healthcare Research and Quality (AHRQ) | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pain Manager + tailored implementation support | Behavioral | Individualized training, technical assistance, and workflow assessments. |
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| Measure | Description | Time Frame |
|---|---|---|
| Adoption | Rate of qualifying patients seen for whom CDS use is documented | During the implementation trial (5 months total) |
| Measure | Description | Time Frame |
|---|---|---|
| Reach | Rate of clinic encounters where CDS is documented | During the implementation trial (5 months total) |
| Shared decision making | SDM-Q-9 questionnaire: 9-item Shared Decision Making Questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Harle, Ph.D. | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UF Health Family Medicine - Commonwealth | Jacksonville | Florida | 32254 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35841043 | Derived | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Sep 19, 2022 | Oct 31, 2025 | ICF_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
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| Jul 8, 2026 |
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D059352 | Musculoskeletal Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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).
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| Immediately after the intervention |
| Pain and function | PEG-3: 3-item scale that measures pain on average, its interference with enjoyment of life, and with general activity | Baseline/pre-intervention, and at 1 and 3 months |
| Any opioid prescription | Binary measure of treatment choice that increases opioid-related risks | Baseline/pre-intervention, and at 1 and 3 months |
| Opioid prescriptions ≥50 MME/day | Binary measure of treatment choice that increases opioid-related risks | Baseline/pre-intervention, and at 1 and 3 months |
| Opioid prescriptions ≥90 MME/day | Binary measure of treatment choice that increases opioid-related risks | Baseline/pre-intervention, and at 1 and 3 months |
| Benzodiazepine prescription concurrent with opioid prescription | Binary measure of treatment choice that increases opioid-related risks | Baseline/pre-intervention, and at 1 and 3 months |
| Prescriptions for non-opioid pain medications | Binary measure recommended by the CDC to decrease opioid-related risks | Baseline/pre-intervention, and at 1 and 3 months |
| Prescriptions for non-pharmacologic pain treatments | Binary measure recommended by the CDC to decrease opioid-related risks | Baseline/pre-intervention, and at 1 and 3 months |
| Urine drug screen orders | Binary measure recommended by the CDC to decrease opioid-related risks | Baseline/pre-intervention, and at 1 and 3 months |
| Naloxone prescriptions | Binary measure recommended by the CDC to decrease opioid-related risks | Baseline/pre-intervention, and at 1 and 3 months |
| Prescription or referral for medication-assisted therapy (MAT) | Binary measure recommended by the CDC to decrease opioid-related risks | Baseline/pre-intervention, and at 1 and 3 months |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |