Patient-Centered Chronic Pain Care

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Scaling Interoperable Clinical Decision Support for Patient-Centered Chronic Pain Care

Conditions
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Chronic Pain, Opioid Use, Musculoskeletal Pain

Intervention / Treatment
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* Behavioral: Pain Manager + tailored implementation support


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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 3 months and 2 clinics switching from control to intervention at each of the 4 steps (for a total study duration of 15 months).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pain Manager + tailored implementation support Pain Manager<br>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<br>* Individualized training, technical assistance, and workflow assessments.<br>|
| No Intervention: Pain Manager implementation in EHR<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adoption | Rate of qualifying patients seen for whom CDS use is documented | During the implementation trial (15 months total) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reach | Rate of clinic encounters where CDS is documented | During the implementation trial (15 months total) | 
| Shared decision making | SDM-Q-9 questionnaire: 9-item Shared Decision Making Questionnaire | 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 |