Computerized Decision Support Tool for Pain Management in Primary Care

Study Overview
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Brief Summary
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Chronic pain is highly prevalent, compromises quality of life, and increases care utilization. Primary care providers are challenged to provide effective treatments, use opioid therapy appropriately, and address the adverse consequences of pain. Technology-enabled decision support tools may provide a means to improve pain management in primary care. The objective of this study was to evaluate a novel electronic health record (EHR)-based decision support tool-plus-education intervention for pain management in primary care.

Detailed Description
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This randomized, wait-list controlled trial evaluated a novel EHR-based system for pain management among patients with chronic pain in six practices of a Federally Qualified Health Center network in New York.

Official Title
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Pain Management in Primary Care: A Randomized Controlled Trial of a Computerized Decision Support Tool

Conditions
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Chronic Pain

Intervention / Treatment
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* Other: Early intervention
* Other: Delayed intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Treated at the Institute for Family Health Spoke English or Spanish Received one or more prescriptions for an opioid or nonopioid analgesic during the past three months Pain screening at the prior three office visits documented scores >3 on the 0-6 scale (FACES, Hicks et al., 2001). Willingness to complete questionnaires three times A commitment to return to the practice Reachable by phone No evidence of psychopathology or cognitive impairment severe enough to prevent informed consent or completing the survey instruments Exclusion Criteria: -

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early intervention<br>Three sites received the Pain Management Support System for Primary Care (PMSS-PC) integrated into the Electronic Health Record. | Other: Early intervention<br>* The Pain Management Support System for Primary Care (PMSS-PC) generated best practice alerts and gave clinicians access to a pain assessment template, measures of psychological distress and substance use, guidelines for drug and non-drug therapies, and facilitated referrals. At implementation, clinicians at the practices were offered in-person and virtual education through six webinars on best practices for pain.<br>|
| Other: Delayed intervention<br>Delayed wait-list control group. Three additional sites received the intervention 6 months after the first arm. | Other: Delayed intervention<br>* Delayed wait-list control group. The second arm involved three additional sites receiving the PMSS-PC intervention 6 months after the first arm. Initial outcomes from the PMSS-PC Experimental Intervention arm were compared to those of this Wait-list Control arm.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Worst Pain Intensity | Worst pain intensity score on the Brief Pain Inventory-Short Form. Scores range from 0-10, with higher scores indicating more severe worst pain intensity. | From baseline to 6 months following intervention implementation | 
| Average Pain Intensity | Average pain intensity score on the Brief Pain Inventory-Short Form. Scores range from 0-10, with higher scores indicating more severe average pain intensity. | From baseline to 6 months following intervention implementation | 
| Pain Interference with Function | Pain interference T-score, measured on the PROMIS Pain Interference Short Form. Higher scores indicate more pain interference with function. | From baseline to 6 months following intervention implementation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Worst Pain Intensity | Worst pain intensity score on the Brief Pain Inventory-Short Form. Scores range from 0-10, with higher scores indicating more severe worst pain intensity. | From 6 to 12 months following intervention implementation | 
| Average Pain Intensity | Average pain intensity score on the Brief Pain Inventory-Short Form. Scores range from 0-10, with higher scores indicating more severe average pain intensity. | From 6 to 12 months following intervention implementation | 
| Pain Interference with Function | Pain interference T-score, measured on the PROMIS Pain Interference Short Form. Higher scores indicate more pain interference with function. | From 6 to 12 months following intervention implementation | 
| Uptake of the PMSS-PC intervention tool | Use of the PMSS-PC decision support tool by primary care providers | From baseline to 12 months following intervention implementation |