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Signature Informed Consent for Long-Term Opioid Therapy in Patients With Cancer: Perspectives of Patients and
Karleen F Giannitrapani1, Soraya Fereydooni2, Azin Azarfar3
1Center for Innovation to Implementation (Ci2i), VA Palo Alto Health Care System, Stanford University School of Medicine, Palo Alto, California, USA.
Context:
Signature informed consent (SIC) is a part of a Veterans Health Administration ethics initiative for patient education and shared decision making with long-term opioid therapy (LTOT). Historically, patients with cancer-related pain receiving LTOT are exempt from this process.
Objectives:
Our objective is to understand patients' and providers' perspectives on using SIC for LTOT in patients with cancer-related pain.
Methods:
Semistructured interviews with 20 opioid prescribers and 20 patients who were prescribed opioids at two large academically affiliated Veterans Health Administration Medical Centers. We used a combination of deductive and inductive approaches in content analysis to produce emergent themes.
Results:
Potential advantages of SIC are that it can clarify and help patients comprehend LTOT risks and benefits, provide clear upfront boundaries and expectations, and involve the patient in shared decision making. Potential disadvantages of SIC include time delay to treatment, discouragement from recommended opioid use, and impaired trust in the patient-provider relationship. Providers and patients have misconceptions about the definition of SIC. Providers and patients question if SIC for LTOT is really informed consent. Providers and patients advocate for strategies to improve comprehension of SIC content. Providers had divergent perspectives on exemptions from SIC. Oncologists want SIC for LTOT to be tailored for patients with cancer.
Conclusion:
Provider and patient interviews highlight various aspects about the advantages and disadvantages of requiring SIC for LTOT in cancer-related pain. Tailoring SIC for LTOT to be specific to cancer-related concerns and to have an appropriate literacy level are important considerations.
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