Reducing Opioid Use for Chronic Pain With a Group-Based Intervention: A Randomized Clinical Trial.

Importance: Opioid use for chronic nonmalignant pain can be harmful. Objective: To test whether a multicomponent, group-based, self-management intervention reduced opioid use and improved pain-related disability compared with usual care. Design, Setting, and Participants: Multicentered, randomized clinical trial of 608 adults taking strong opioids (buprenorphine, dipipanone, morphine, diamorphine, fentanyl, hydromorphone, methadone, oxycodone, papaveretum, pentazocine, pethidine, tapentadol, and tramadol) to treat chronic nonmalignant pain. The study was conducted in 191 primary care centers in England between May 17, 2017, and January 30, 2019. Final follow-up occurred March 18, 2020. Intervention: Participants were randomized 1:1 to either usual care or 3-day-long group sessions that emphasized skill-based learning and education, supplemented by 1-on-1 support delivered by a nurse and lay person for 12 months. Main Outcomes and Measures: The 2 primary outcomes were Patient-Reported Outcomes Measurement Information System Pain Interference Short Form 8a (PROMIS-PI-SF-8a) score (T-score range, 40.7-77; 77 indicates worst pain interference; minimal clinically important difference, 3.5) and the proportion of participants who discontinued opioids at 12 months, measured by self-report. Results: Of 608 participants randomized (mean age, 61 years; 362 female [60%]; median daily morphine equivalent dose, 46 mg [IQR, 25 to 79]), 440 (72%) completed 12-month follow-up. There was no statistically significant difference in PROMIS-PI-SF-8a scores between the 2 groups at 12-month follow-up (-4.1 in the intervention and -3.17 in the usual care groups; between-group difference: mean difference, -0.52 [95% CI, -1.94 to 0.89]; P = .15). At 12 months, opioid discontinuation occurred in 65 of 225 participants (29%) in the intervention group and 15 of 208 participants (7%) in the usual care group (odds ratio, 5.55 [95% CI, 2.80 to 10.99]; absolute difference, 21.7% [95% CI, 14.8% to 28.6%]; P < .001). Serious adverse events occurred in 8% (25/305) of the participants in the intervention group and 5% (16/303) of the participants in the usual care group. The most common serious adverse events were gastrointestinal (2% in the intervention group and 0% in the usual care group) and locomotor/musculoskeletal (2% in the intervention group and 1% in the usual care group). Four people (1%) in the intervention group received additional medical care for possible or probable symptoms of opioid withdrawal (shortness of breath, hot flushes, fever and pain, small intestinal bleed, and an overdose suicide attempt). Conclusions and Relevance: In people with chronic pain due to nonmalignant causes, compared with usual care, a group-based educational intervention that included group and individual support and skill-based learning significantly reduced patient-reported use of opioids, but had no effect on perceived pain interference with daily life activities. Trial Registration: isrctn.org Identifier: ISRCTN49470934.

Development and testing of an opioid tapering self-management intervention for chronic pain: I-WOTCH.

OBJECTIVES: To describe the design, development and pilot of a multicomponent intervention aimed at supporting withdrawal of opioids for people with chronic non-malignant pain for future evaluation in the Improving the Wellbeing of people with Opioid Treated CHronic pain (I-WOTCH) randomised controlled trial. DESIGN: The I-WOTCH intervention draws on previous literature and collaboration with stakeholders (patient and public involvement). Intervention mapping and development activities of Behaviour Change Taxonomy are described. SETTING: The intervention development was conducted by a multidisciplinary team with clinical, academic and service user perspectives. The team had expertise in the development and testing of complex health behaviour interventions, opioid tapering and pain management in primary and secondary care, I.T programming, and software development-to develop an opioid tapering App. PARTICIPANTS: The I-WOTCH trial participants are adults (18 years and over) with chronic non-malignant pain using strong opioids for at least 3 months and on most days in the preceding month. OUTCOMES: A multicomponent self-management support package to help people using opioids for chronic non-malignant pain reduce opioid use. INTERVENTIONS AND RESULTS: Receiving information on the impact of long-term opioid use, and potential adverse effects were highlighted as important facilitators in making the decision to reduce opioids. Case studies of those who have successfully stopped taking opioids were also favoured as a facilitator to reduce opioid use. Barriers included the need for a 'trade-off to fill the deficit of the effect of the drug'. The final I-WOTCH intervention consists of an 8-10 week programme incorporating: education; problem-solving; motivation; group and one to one tailored planning; reflection and monitoring. A detailed facilitator manual was developed to promote consistent delivery of the intervention across the UK. CONCLUSIONS: We describe the development of an opioid reduction intervention package suitable for testing in the I-WOTCH randomised controlled trial. TRIAL REGISTRATION NUMBER: ISRCTN49470934.

Testing a support programme for opioid reduction for people with chronic non-malignant pain: the I-WOTCH randomised controlled trial protocol.

INTRODUCTION: Chronic non-malignant pain has a major impact on the well-being, mood and productivity of those affected. Opioids are increasingly prescribed to manage this type of pain, but with a risk of other disabling symptoms, when their effectiveness has been questioned. This trial is designed to implement and evaluate a patient-centred intervention targeting withdrawal of strong opioids in people with chronic pain. METHODS AND ANALYSIS: A pragmatic, multicentre, randomised controlled trial will assess the clinical and cost-effectiveness of a group-based multicomponent intervention combined with individualised clinical facilitator led support for the management of chronic non-malignant pain against the control intervention (self-help booklet and relaxation compact disc). An embedded process evaluation will examine fidelity of delivery and investigate experiences of the intervention. The two primary outcomes are activities of daily living (measured by Patient-Reported Outcomes Measurement Information System Pain Interference Short Form (8A)) and opioid use. The secondary outcomes are pain severity, quality of life, sleep quality, self-efficacy, adverse events and National Health Service (NHS) healthcare resource use. Participants are followed up at 4, 8 and 12 months, with a primary endpoint of 12 months. Between-group differences will indicate effectiveness; we are looking for a difference of 3.5 points on our pain interference outcome (scale 40 to 77). We will undertake an NHS perspective cost-effectiveness analysis using quality adjusted life years. ETHICS AND DISSEMINATION: Full approval was given by Yorkshire & The Humber - South Yorkshire Research Ethics Committee on 13 September, 2016 (16/YH/0325). Appropriate local approvals were sought for each area in which recruitment was undertaken. The current protocol version is 1.6 date 19 December 2018. Publication of results in peer- reviewed journals will inform the scientific and clinical community. We will disseminate results to patient participants and study facilitators in a study newsletter as well as a lay summary of results on the study website. TRIAL REGISTRATION NUMBER: ISRCTN49470934; Pre-results.

Building Connections: Using Integrated Administrative Data to Identify Issues and Solutions Spanning the Child Welfare and Child Support Systems.

We analyze the role of newly integrated data from the child support and child welfare systems in seeding a major policy change in Wisconsin. Parents are often ordered to pay child support to offset the costs of their children's stay in foster care. Policy allows for consideration of the "best interests of the child." Concerns that charging parents could delay or disrupt reunification motivated our analyses of integrated data to identify the impacts of current policy. We summarize the results of the analyses and then focus on the role of administrative data in supporting policy development. We discuss the potential and limitations of integrated data in supporting cross-system innovation and detail a series of complementary research efforts designed to support implementation.

Permanency and the Educational and Economic Attainment of Former Foster Children in Early Adulthood.

Foster children are at disproportionate risk of adverse outcomes throughout the life course. Public policy prioritizes permanency (exiting foster care through reunification with birth parents, adoption, or legal guardianship) as means of promoting healthy development and wellbeing for foster youth, but little empirical evidence indicates that permanency, including its most preferred form-reunification-promotes positive outcomes. Using multi-system, statewide longitudinal administrative data, we employed logistic and mixed-effects regression to examine educational attainment and earnings among former foster youth in early adulthood. We included a variety of sociodemographic and economic controls to reduce selection bias. We found that youth who did not attain permanency (those who aged out of care) had significantly higher odds of graduating high school and enrolling in college than reunified youth and youth who exited to guardianship, and similar odds as adopted youth. Earnings were similar across groups. Among aged-out (but not reunified) youth, odds of high school graduation and average earnings were higher for those who spent more time in foster care prior to age 18. Notably, some findings were sensitive to the categorization of youth who ran away from care. Overall, results suggest that permanency alone is insufficient to promote foster youths' educational and economic attainment.

Families at the Intersection of the Criminal Justice and Child Protective Services Systems.

In this article, we first describe the incidence and prevalence of incarceration and CPS involvement in the United States. Second, we outline the reasons that the same individuals and families may be at risk for involvement in both systems and review the limited existing research examining links between incarceration and CPS involvement. Third, we use unique longitudinal data from Wisconsin, spanning from 2004 to 2012, to describe intergenerational and intragenerational overlap in the two systems. Specifically, we calculate (1) the proportion of all CPS-involved children who have an incarcerated parent; (2) the proportion of incarcerated adults who have a CPS-involved child; (3) the proportion of incarcerated young men and women who were involved in the CPS system as adolescents; and (4) the proportion of CPS-involved adolescents who subsequently became incarcerated. We conclude with a discussion of potential directions for future research as well as implications for practice and policy.

Children's academic achievement and foster care.

BACKGROUND AND OBJECTIVES: Poor school outcomes for children in out-of-home placement (OHP) raise concerns about the adequacy of child welfare and educational policy for this vulnerable population. We analyzed the relation between OHP and academic achievement, focusing on reading and math achievement in grades 3 through 8. METHODS: Linked administrative data were used for our analytic sample comprising 529 597 child-year observations for 222 049 children who experienced OHP or were in a comparison group. Three models were estimated: a pooled ordinary least squares regression that considered placement status and test scores net of the full set of control variables; an identical model that added the previous year's test scores as an additional control; and a final model that included child-specific fixed effects. RESULTS: Children in OHP settings had achievement test scores at least 0.6 SD below average. However, we found similar deficits across children with past, current, and future exposure to OHP and, in our preferred model, OHP (past, current, or future placement) had no statistically discernible relation with either reading or math achievement. CONCLUSIONS: OHP by itself is not significantly related to school achievement; however, evidence reveals consistently low average math and reading achievement among children involved with Child Protective Services.