The I-WOTCH study; A RANDOMISED CONTROLLED TRIAL OF A GROUP BASED INTERVENTON TO SUPPORT OPIOID TAPERING
Problem
The harms of opioid use for chronic non-malignant pain are well documented. There is a pressing need for effective interventions to help people using opioids to taper safely. We did a randomised controlled trial to test whether a multi-component group-based self-management intervention can reduce opioid use and improve pain-related disability, compared to usual care.
Approach
We recruited people taking strong opioids for chronic non-malignant pain, on most days over the preceding three months, from general practices in England. We randomised participants to a three-day group intervention emphasising skill-based learning and education, supplemented by one-to-one support, delivered by a nurse and a lay person, or to usual care. We had two primary outcomes; the Patient-Reported Outcomes Measurement Information System Pain Interference Short Form (8A) (PROMIS-PI-SF-8A) and the proportion of participants who discontinued opioids at 12 months. Secondary outcomes included quality of life (measured by the EQ-5D). In depth process evaluation and qualitative interviews were completed.
Findings
Between July 2017 and January 2019 we recruited 608 participants with chronic non-malignant pain from 191 general practices; 81% had low back pain, 52% chronic widespread pain, and 93% multi-site pain. The median daily morphine equivalent dose was 46mg (IQR 25 to 79), 14% were using ≥ 120mg morphine equivalent dose per day. We delivered 35 group interventions at 25 community locations (median group size 9 (IQR 5 to 11)). There was no difference on the PROMIS-PI-SF-8A scores: mean difference, -0.52 [95% CI -1.94 to 0.89], p=0.15). At 12 months, 65/225 (29%) of intervention participants and 15/208 (7%) usual care participants had stopped opioids (odds ratio 5.55 [95% CI 2.80 to 10.99], absolute difference, 21.7% [95% CI, 14.8 to 28.6], p<0.001). Serious Adverse events occurred in 5% (16/303) and 8% (25/305) and respectively of usual care and intervention participants.
Consequences
The I-WOTCH intervention helped one in five additional people stop opioids with no adverse effect on perceived pain interference with daily life activities. We have developed an intervention which is deliverable in primary care. Please Note: The results are provided for review purposes only and in confidence. The results are currently under review for publication and not yet published. If the abstract is accepted for SAPC, please can I request that we are informed to give consent before the abstract and final results are published in any conference related material.