Patient Voices in Chronic Pain
Opioid overuse in the treatment of chronic noncancer pain has emerged in the past decade as a nationwide public health crisis. More than 100 million people in the U.S. suffer from chronic pain, but the narrow-minded focus on treatment of pain has led to high rates of opioid prescribing, as evidenced by a doubling in the number of primary care visits culminating in a prescription from the 1990s to early 2000s.
This has coincided with an increase in opioid use disorders and overdoses. In 2007, almost 30,000 unintentional drug overdoses occurred in the U.S., or one death every 19 minutes.
Efforts to address opioid overuse must consider the biopsychosocial illness experience beyond the physical symptom of pain and incorporate the patient perspective. Present communication challenges between patients and primary care providers pose a significant barrier to more effective and personally relevant management of chronic pain.
This study will assess two strategies: clinical decision support, and patient and activation tools, which are detailed in the next section, to close these gaps and better align expectations. These approaches are widely used and evidence-based but have never been put to a head-to-head test. We are therefore conducting a pragmatic, randomized trial to determine the comparative effectiveness of these two interventions.
Clinical decision support (CDS)
One arm of this study is physician-oriented and will evaluate the use of clinical decision support tools in preventing opioid misuse. As part of the Choosing Wisely campaign to reduce waste in healthcare and avoid risks associated with unnecessary treatment, national medical specialty societies issued specific evidence-based recommendations. Cedars-Sinai previously operationalized more than 180 of these guidelines as alerts within the electronic health record, including alerts directed at optimizing opioid prescribing.
This study will specifically examine the effectiveness of the following existing alerts:
- Prescription or refill of long-acting or extended-release opioids
- Identification of patients at risk for opioid-related harms
- Co-prescribing of benzodiazepines and opioids
These are designed to remind physicians at the point of care to evaluate appropriate opioid use, assess outcomes for health-related quality of life and consider treatment alternatives. Use of CDS to prompt a discussion of risks and benefits with patients has the potential to enhance informed decision-making and is likely to result in greater satisfaction with the treatment decision.
Patient education and activation tools (PEATs)
For the second intervention, which is patient-facing, subjects will receive educational tools and materials that are widely used in chronic pain management. Several systematic reviews have demonstrated their effectiveness, particularly in improving patient-provider dialogue and communication behaviors.
Notably, patient education and activation tools not only prime patients for their visits, but also induce providers to introduce more themes during the conversation. For this study, we chose two PEATs to distribute with input from our patient advocate partners: "Patient Management: Which Treatment is Right for You" and "Preparing for Your Health Care Visit."
The former, developed by consumer advocacy organization Consumer Reports, presents detailed information about opioids and alternatives, including nonpharmacological treatments for chronic pain. It specifically discusses addiction risks, side effects and long-term effectiveness of opioids.
The second patient tool was created by the American Chronic Pain Association and is designed to elicit patient preferences, questions and concerns about health-related quality of life. In addition, it incorporates health domains such as sleep, endurance and concentration.
The PEATs will be distributed via the patient portal in the electronic health record prior to office visits with a primary care provider and are intended to help patients prepare for their visit. The goal is to promote shared decision-making, which involves a two-way discussion of treatment aims, preferences and values with the provider.
This is another means of addressing the appropriateness of opioid prescriptions for patients with chronic pain, particularly those who are at high risk for drug interactions or addiction, or for whom opioids may not be effective for long-term pain relief.
We will compare the effectiveness of the two interventions in patients with an opioid prescription of six weeks or longer. Primary outcomes of this study are pain interference — how pain interferes with a patient's daily life — and satisfaction with patient-physician communication.
It is important not to overlook pain interference, which our patient partners identified as particularly meaningful, because a single-minded focus on reducing inappropriate opioid prescribing could do harm if we prevent opioid use in appropriate circumstances. Secondary outcomes are overall health-related quality of life and high-risk prescribing, defined as prescriptions over 90 morphine milligram equivalents and co-prescribing of benzodiazepines and opioids.
To measure these outcomes, we will pull data from a variety of sources, including the electronic health record, CDS analytics and questionnaires delivered through the patient portal. The web-based questionnaires will allow us to collect data directly from patients in the form of patient-reported outcomes related to pain interference and health-related quality of life.
This will enable us to capture information on whether our interventions resulted in unintended consequences when reducing opioid use without substituting other pain management strategies. We will be using a Patient-Reported Outcome Measurement Information System (PROMIS®) questionnaire from the National Institutes of Health, as well as the Combined Outcome Measure for Risk Communication and Treatment Decision-Making Effectiveness (COMRADE) questionnaire.
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Cedars-Sinai Center for Outcomes Research and Education
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Los Angeles, CA 90048