Long term opioid therapy (LTOT) has come under increasing scrutiny with the growth in opioid prescribing. Concerns include the social and personal costs of opioid overuse and our limited knowledge with respect to long term benefits. Whether we should be concerned about the harms of opioid use in cancer is unclear. The therapeutic outlook for cancer is changing due to progress in disease treatment and earlier diagnosis, making the question of how to manage chronic cancer pain and the risk-benefit ratio of LTOT for persons with cancer increasingly relevant. Cancer advances raise the hopeful possibility of living much longer, but are accompanied by consequences including persistent or ongoing pain resulting from cancer itself and cancer treatments.
In VHA, providers who prescribe LTOT for chronic non-cancer pain must use signature informed consent to inform patients about risks and benefits of the therapy as well as to delineate expectations for safe use and other policies and procedures. There is no informed consent required for prescribing opioids to patients with cancer. Signature opioid informed consent (SOIC) may foster better decisions by enhancing provider transparency and patient understanding. SOIC may improve patients' understanding of risks and benefits of LTOT and may improve providers' approach to prescribing. SOIC could impact the Veteran-provider relationship, Veterans' knowledge, attitudes, and intentions, and provider prescribing practices. Effective SOIC should align opioid prescribing with evidence about LTOT outcomes and with Veterans' goals, values, and preferences.
There is a need to understand the role of chronic opioid use for cancer pain, and whether SOIC improves patient understanding of potential benefits and risks that impact cancer patients' safety. The Opioid CHOICE Study set out to evaluate the appropriateness of excluding Veterans with cancer from SOIC, and how the SOIC process impacted treatment decisions and communication for Veterans and providers. Opioids CHOICE aimed to:
Aim 1 - 1) Assemble a nationally representative cohort of Veterans receiving LTOT stratified by cancer status to describe their demographic and clinical characteristics and treatment patterns. 2) Compare those with and without cancer with regard to a) serious opioid-related adverse events, b) pain outcomes, and c) use of SOIC using iMED.
Aim 2 - Qualitatively evaluate provider and Veteran perceptions of SOIC for LTOT.
Aim 1: We identified a large retrospective cohort of approximately 1 million Veterans with incident LTOT over the period of 2010-2017, including Veterans with and without cancer, and observed the cohort over time for outcomes related to patterns of opioid receipt, serious opioid-related adverse events and pain intensity. To inform future SOIC implementation, we examined the proportion of Veterans with and without cancer who already have SOIC documented using iMED consent and the Veteran and facility characteristics associated with completion. Trends in SOIC completion and trends in serious opioid-related adverse events will be analyzed to inform a population-level examination of the possible benefits of SOIC.
Cohort inclusion and exclusion criteria:
Inclusion criteria: 1) 18 years of age and older at time of incident LTOT; 2) Receipt of VA care (e.g., 2 outpatient visits or 1 inpatient admission the year before cohort entry; and 3) Receipt of LTOT, defined as at least 90 consecutive days of opioid therapy allowing for up to 30-day gaps between medication fills. Exclusions: 1) Veterans with incident LTOT within 90 days of the end of the observation period; 2) Veterans enrolled in Medicare or contract hospice within 30 days of cohort entry where LTOT is likely for end-of-life care; 3) Opioid therapy for the treatment of opioid use disorder and in the setting of hospice care because neither pertains to SOIC policy.
Aim 2: We recruited veteran and provider participants from primary care and oncology settings at sites at both VA Connecticut and VA Palo Alto Healthcare Systems. Preliminary work supported both primary care and oncology clinics as important settings for cancer care. We identified Veterans using Aim 1 administrative data (CDW/VA CCR) indicators of new prescriptions and SOIC conversations and mailed an opt-out letter. Those who did not opt-out were called by a Research Assistant to complete informed consent for research. If verbal consent was obtained, we scheduled a phone interview with the Veteran. We contacted providers via email to ascertain willingness to participate in the study. Team members with training and experience using semi-structured interview guides conducted provider interviews either in person or over the phone.
To understand how SOIC should be applied and to characterize the quality of communication around SOIC, we developed interview guides to query experiences and perceptions of both providers and Veterans with SOIC, opioids, pain management, and communication of risks and benefits. We also obtained their opinions on the use of SOIC and suggestions for potential improvements to that process. These interviews were audio-recorded, transcribed by a VA approved professional transcription service, and de-identified. The transcripts were reviewed by qualified team members and codes were developed for qualitative analysis using ATLAS.ti software. The team amended codes as needed through discussion of emerging themes and data interpretation. Coding was done using constant comparison.
Aim 1: We have conducted preliminary analyses using the final dataset, calculating rates of serious adverse events over the 8-year period (2010-2017, inclusive), stratified by cancer status. Preliminary findings will require careful validation but suggest in the case of some serious adverse events like overdose, rates were higher among patients with cancer than without. With respect to overdose, we found that rates markedly increased among patients with and without cancer at the time point marking the changeover from ICD-9 to ICD-10, suggesting a more expansive list of codes for overdose with ICD-10 or underuse of some overdose-related codes in ICD-9.
Aim 2: We completed semi-structured interviews with 20 patients and 20 providers (Palliative care, oncology, and primary care based advanced practice nurses (APRNs) and physicians) from two VA medical centers. Although providers participated, many more Veterans than expected declined to participate in interviews (52 Veterans, 6 providers). This was especially true of those who had recently undergone an SOIC conversation. While the research nature of the inquiry was clearly stated, Veterans who were willing to give a reason mentioned perceived scrutiny and concerns about losing access to opioids and analgesia.
Provider Results: 1) The appropriateness of SOIC depends on patient characteristics (stage, state, prognosis, age, mental health, and history of substance use). 2) Benefits of using SOIC can include patient awareness of medication safety ("benefit of the consent process is that they understand the downside, to avoid accidental overdosing"), patient activation ("it is helpful because it makes them feel a little responsible for how they manage the opiates"), and the opportunity for shared decision making. 3) Potential risks include: SOIC may be unnecessary ("With a patient with widely metastatic disease and poor prognosis of limited survival. the informed consent just sort of seems almost superfluous"), detrimental to access ([I don't like to have] conversation that in some way impedes [access to] the medicines they need") and represent a trade-off, in terms of provider time, to addressing other patient concerns. 4) Providers had divergent recommendations about when was the most appropriate time for SOIC (before any opioid, before LTOT, never). 5) Opioid consent processes should have parity with substances for other conditions: "if we're going to do it [SOIC] for opioids for cancer patients, then we should do it for warfarin for stroke patients." 6) SOIC for patients with cancer should be tailored and condition sensitive.
Patient Results: patients report that current cancer prognosis/symptoms/ related fears ("There are side effects [e.g. of chemotherapy] that scare me a lot more than the opioids' side effects"), personal experiences with substances (opioids, cannabis, previous addictions) witnessing opioid use and addiction experiences of family and close friends, and not being able to "afford being functionally impaired" by pain impact perceptions of the risks and benefits of opioids for their circumstance. Patients prefer to focus oncology visits on cancer treatment rather than opioid therapy. In lieu of using oncologist visit time, patients feel able to navigate dosing and tapering decisions with palliative care advanced practice nurses (APRNs) and clinical pharmacists.
The CHOICE Project will directly inform National Ethics Center and Patient Care Services application of VA Directive 1005 to Veterans with cancer. This project evaluated SOIC with a focus on concerns and outcomes that are meaningful to Veterans. In Aim 1, we evaluated the risks of LTOT among Veterans with cancer and compared them to the general population of Veterans on LTOT. Preliminarily, the rates of opioid-related adverse events among patients with cancer (relative to patients with non-cancer), especially overdose, supports the application of SOIC among patients with cancer. In Aim 2, Veteran and provider perspectives on cancer pain, opioid management, as well as SOIC revealed a variety of critical exclusions (e.g., advanced disease, use of SOIC when pain is acute or severe) and practices (e.g., use of non-physicians) will be needed to implement SOIC effectively.
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