The COVID-19 pandemic is exacerbating the challenges faced by Veterans at risk for opioid overdose, including Veterans prescribed moderate-to-high dose long-term opioid therapy (LTOT), whose usual treatment resources and coping strategies may be inaccessible. The VHA's clinical practice guidelines recommend a Veteran-centered, team-based approach that includes (1) regular, individualized assessment of benefits and harms of LTOT; (2) reduction and discontinuation of LTOT when benefits no longer outweigh harms; (3) switch to buprenorphine (BUP) if opioid dependence with difficulty tapering or opioid use disorder (OUD) emerge; and (4) optimization of non-pharmacologic and non-opioid pain treatment. Opioid prescribers' duties and attention are shifted to COVID-related care, and many non-pharmacologic treatments such as exercise are difficult to access or unavailable, putting this vulnerable group is at disproportionately high risk. This substandard care could lead to worsened symptoms, treatment disengagement and even death, especially if indicated switches to BUP are delayed. The VHA must pivot quickly to deploy and evaluate virtual models of care for Veterans on high-risk LTOT that meet the dual challenges of maintaining social distancing and high quality of care.
The objectives of this project were to examine the feasibility and acceptability of Video-Telecare Collaborative Pain Management (VCPM) among 60 Veterans on risky LTOT using a quality improvement framework and develop decision aids for ascertaining patient preference for communication and care delivery and examine feasibility of virtual outcome assessment as part of clinical care.
This single-arm feasibility study was conducted in two VA sites. Eligible participants currently received LTOT for chronic pain at 50 mg morphine equivalent daily dose (MEDD). VCPM is a multi-component intervention consisting of already-established care processes and materials. First, the patient was mailed an informational packet prior to intake appointment. Second, using the collaborative medication management model established in VHA, the intake appointment was led by the Clinical Pharmacy Specialist (CPS) using a standardized intake evaluation. The CPS and physician designed a plan and presented the plan to the patient. If BUP switch was offered and accepted, the physician completed additional brief evaluations, including a history, medication review, treatment planning, and discussion of other VCPM components, using two-way audio-video visits (with telephone as a back-up). Participants completed scheduled follow-up phone visits on Days 4, 7 and 14 and at 1, 2, 3 months. The patient's preference of modality for information receipt (web, email, regular mail) and communication (video vs. telephone) guided decisions; we iteratively refined method to align with these preferences. Patients who continued with active intervention (based on shared decision-making with the clinical team) were maintained for 90 days.
Patient demographics and physical and mental health diagnoses were collected from inpatient and outpatient domains. Also, we collected opioid dose, prescriptions, and drug dispensing from outpatient pharmacy domains, and pain treatment variables from outpatient and lab chemistry data; outpatient pharmacy data; and outpatient procedure codes. We measured the feasibility and acceptability of the intervention overall, as well as each component; opioid reassessment, and BUP transition and maintenance. Overall, we examined the number of 1) referrals, 2) enrollment, 3) retention, and 4) data collection at follow-up. Feasibility and acceptability of opioid reassessment and buprenorphine switch and maintenance were based on the total number offered BUP. Although the project used shared decision-making with Veterans, the percent of patients who agree to transfer provides a realistic indicator of overall feasibility/acceptability. Additional measures included engagement (percent who complete tapering or BUP transition) and retention (percent maintaining prescription at 1 month).
Feasibility and acceptability measures were evaluated based on descriptive statistics of central tendency and distribution. We established a priori criteria for the primary outcomes of feasibility and acceptability of VCPM. These were established to provide criteria for whether a full-scale trial of VCPM would be warranted, substantial modification (removing or replacing components) would be required, or further evaluation should be terminated. These criteria were 1) a majority of patients (>50%) agreeing to recommended BUP transition, 2) >50% satisfaction, or 3) >50% sessions attended.
A total of 127 patients were sent introduction brochures for the project, with 104 initial contact calls. Our target for the initial CPS interview was 60, but we were only able to recruit 44 patients across the 2 sites, due to more patients declining the initial visit than expected.
Feasibility and Acceptability.
Several factors impacted our evaluation of the feasibility and acceptability of the Quality Improvement (QI) pilot. First, by its very nature, a QI study includes modification and adaptation of components to fit the clinical needs of the patients. Second, through the project we have learned that feasibility for this intervention is based on initial engagement (Recruitment/Engagement Feasibility) as well as longitudinal patient care (Treatment Feasibility) and that different factors impact these components. Our success with those components differed, leading to suggested modifications for future implementation. Third, the use of a shared decision-making model affected the appropriateness of a single outcome measure of feasibility. Through the process of implementing VCPM, we determined that successful opioid and pain outcome for patients who engaged in continued care with the team was primarily defined by a reduction in MEDD and improvement in pain functioning. Thus, successful clinical outcomes for these patients could include 1) transfer to a buprenorphine formulation, 2) initiation of Buprenorphine temporarily, followed by a return to LTOT at reduced MEDD, 3) tapering existing long-term opioids (including rotation of other non-opioid medications), and 4) reduction in MEDD through opioid rotation.
CPS Visit and Patient Engagement. Of the 104 initial contact calls, 49 (47%) declined the intervention, and an additional 6 could not be contacted following the initial call. Thus, although potential participants were selected based on criteria of received LTOT for chronic pain at 50 mg MEDD, more than half (60/104, 58%) did not complete the initial visit.
Of those who attended the initial virtual visit with the CPS a large percent (20/44, 45%) chose to continue their care with their PCP, rather than the VCPM team. For those cases, recommendations were shared with the PCP and care coordination was provided as needed. Only two patient refused CPS recommendations, and 3 were regarded as outside the care scope of VCPM. At present we do not know whether and to what extent these patients have reduced MEDD with their PCPs.
The large number of patients who declined the intervention and did not engage in care with the VCPM team indicates that recruitment/engagement feasibility for VCPM as implemented is low. Patient reluctance to engage in changes to LTOT is common among veterans and methods to address this reluctance is needed. An important component of this project was to develop video testimonials from successful VCPM patients to address prospective patient reluctance. The short timeframe of this study did not allow us to develop videos prior to VCPM implementation to evaluate their effectiveness in improving patient engagement. However, these resources are available for future implementation and evaluation of VCPM. We are also exploring the feasibility and acceptability of patient access to peer-support specialists with lived experience of opioid transition. In West Haven, patients can discuss the process of changing LTOT with a trained peer-support specialist. We are also exploring other methods to increase patient interest and engagement in LTOT change.
Longitudinal Clinical Outcomes - Treatment Feasibility. 19 patients chose to engage in longitudinal care with the VCPM team. 17/19 (89%) had improved outcomes as indicated by reductions in opioid MEDD and improved pain functioning. These findings indicate that the treatment feasibility of VCPM for patients who engaged in longitudinal clinical care was high with promising effectiveness. Ten of those achieved these outcomes through a Buprenorphine formulation, and the other 7 through opioid tapering and/or opioid rotation. One patient (initiated on Buprenorphine but stopped due to side effects) did not reduce MEDD but engaged in some additional non-pharmacologic treatment. One patient died after initiation with the VCPM team due to an unrelated event (suspected homicide). Of the 2 patients who initiated Buprenorphine but stopped due to side effects, neither experienced unexpected side effects.
Additional patient outcomes. 3-month follow-up surveys were initiated by 18 of the 19 patients who engaged in longitudinal care, with 16 completing all items. Ratings of current pain severity and interference were moderate (Mean = 6.0 and 6.0, SD = 2.0 and 2.6, respectively on a 0 to 10 scale). However, most patients (12/16) reported their pain severity for the past 3 months to be similar or better than prior to the intervention. Patients reported that VCPM was successful in helping with their pain (Mean = 7.0, SD = 3.8, 0 to 10 scale), with the majority (56%) reporting an 8 or above.
Acceptability - Patient Satisfaction. The majority of patients (12/16) engaged in VCPM reported that they would recommend VCPM to a friend who has a pain problem (Mean = 7.6, SD = 3.2, 0 to 10 scale). As part of the follow-up survey, patients completed a 5-item survey (1 to 5 scale from strongly disagree to strongly agree) on their rating of satisfaction and ease of use of virtual care based on the how they received their care (phone or video). Mean ratings for virtual care were high (4.3, SD = 0.5) indicating strong satisfaction with the virtual care component of VCPM.
Veterans who engage in VCPM are likely to reduce risks associated with long-term opioid therapy and improve functioning, while reducing risk of COVID-19 through virtual delivery. With improved engagement in VCPM could be quickly scaled both regionally and nationally.
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