Collaborative care programs for pregnant and postpartum individuals with opioid use disorder: Organizational characteristics of sites participating in the NIDA CTN0080 MOMs study.

INTRODUCTION: Pregnant individuals with substance use disorders face complex issues that may serve as barriers to treatment entry and retention. Several professional organizations have established recommendations on comprehensive, collaborative approaches to treatment to meet the needs of this population, but information on real-world application is lacking. Sites participating in the NIDA CTN0080 "Medication treatment for Opioid use disorder in expectant Mothers (MOMs)"-a randomized clinical trial of extended release compared to sublingual buprenorphine among pregnant and postpartum individuals (PPI)-were selected, in part, because they have a collaborative approach to treating PPI with opioid use disorder (OUD). However, organizational differences among sites and how they implement expert recommendations for collaborative care could impact study outcomes. METHODS: Prior to study launch at each of the 13 MOMs sites, investigators used the Pregnancy and Addiction Services Assessment (PAASA) to collect information about organizational factors. Input from a team of addiction, perinatal, and economic evaluation experts guided the development of the PAASA. Investigators programmed the PAASA into a web-based data system and summarized the resultant site data using descriptive statistics. RESULTS: Study sites represented four US census regions. Most sites were specialty obstetrics & gynecology (OB/GYN) programs providing OUD services (n = 9, 69.2 %), were affiliated with an academic institution (n = 11, 84.6 %), and prescribed buprenorphine in an ambulatory/outpatient setting (n = 11, 84.6 %); all sites offered access to naloxone. Sites reported that their population was primarily White, utilized public insurance, and faced numerous psychosocial barriers to treatment. Although all sites offered many services recommended by expert consensus groups, they varied in how they coordinated these services. CONCLUSIONS: By providing the organizational characteristics of sites participating in the MOMs study, this report assists in filling the current gap in knowledge regarding similar programs providing services to PPI with OUD. Collaborative care programs such as those participating in MOMs are uniquely positioned to participate in research to determine the most effective models of care and to determine how research can be integrated into those clinical care settings.

Association of methadone dose with substance use and treatment retention in pregnant and postpartum women with opioid use disorder.

BACKGROUND: In non-pregnant individuals being treated for opioid use disorder (OUD) with methadone, doses ≥60mg per day are associated with improved treatment retention and decreased illicit opioid use. Although methadone remains the first line treatment for OUD in pregnant women, there are no studies replicating this finding in pregnancy. METHODS: We conducted a retrospective cohort study of 189 pregnant women treated with methadone for OUD from 2006 to 2013. Chart data collected included demographics, pregnancy dates, methadone doses, and urine drug screen (UDS) results. RESULTS: Treatment retention at delivery was significantly higher for subjects taking ≥60mg of methadone (90.1% v. 74.1% p<0.005), as was treatment retention at 60days postpartum (71.6% v. 37.0%, p<0.0001). Percent of UDS results negative for illicit substances during pregnancy was also significantly higher for subjects taking ≥60mg (71.5% v. 58.0%, p<0.04). There was no significant difference in UDS results in the first 60days postpartum (63.9% v. 68.1%). Generalized linear models showed a significant positive relationship between methadone dose and treatment retention at delivery (p<0.02) and at 60days postpartum (p<0.004) as well as a significant positive relationship between length of time in treatment and treatment retention at delivery (p<0.04) and at 60days postpartum (p<0.007). Maternal age and percent of negative UDS results were not predictive of treatment retention in either model and there was no significant interaction effect between methadone dose and percent negative UDS results. CONCLUSIONS: In this cohort, women taking ≥60mg of methadone during pregnancy were more likely to remain in treatment and to provide urine samples negative for illicit drugs. Multivariate modeling suggested a dose dependent response across the entire dose range, rather than a threshold effect at 60mg.

Risk factors for opioid overdose and awareness of overdose risk among veterans prescribed chronic opioids for addiction or pain.

Rising overdose fatalities among U.S. veterans suggest veterans taking prescription opioids may be at risk for overdose. However, it is unclear whether veterans prescribed chronic opioids are aware of this risk. The objective of this study was to identify risk factors and determine awareness of risk for opioid overdose in veterans treated with opioids for chronic pain, using veterans treated with methadone or buprenorphine for opioid use disorder as a high-risk comparator group. In the current study, 90 veterans on chronic opioid medication, for either opioid use disorder or pain management, completed a questionnaire assessing risk factors, knowledge, and self-estimate of risk for overdose. Nearly all veterans in both groups had multiple overdose risk factors, although individuals in the pain management group had on average a significantly lower total number of risk factors than did individuals in the opioid use disorder group (5.9 versus 8.5, p < .0001). On average, participants treated for pain management scored slightly but significantly lower on knowledge of opioid overdose risk factors (12.1 versus 13.5, p < .01). About 70% of participants, regardless of group, believed their overdose risk was below that of the average American adult. There was no significant relationship between self-estimate of overdose risk and either number or knowledge of opioid overdose risk factors. Our results suggest that veterans in both groups underestimated their risk for opioid overdose. Expansion of overdose education to include individuals on chronic opioids for pain management and a shift in educational approaches to overdose prevention may be indicated.

Barriers to implementation of opioid overdose prevention programs in Ohio.

BACKGROUND: Nationally, overdose fatalities have reached epidemic proportions. Ohio has one of the highest overdose death rates in the country, as well as high rates of prescription opioid trafficking. METHODS: A cross-sectional self-report survey of opioid overdose prevention programs (OOPPs) in Ohio was conducted between August and October 2014 to characterize programs and ascertain barriers to successful implementation. A 91% response rate was achieved with 18 programs participating in the study. RESULTS: The first Ohio OOPP opened in August 2012, a second program opened in 2013, and the remaining programs began in 2014. All of the programs distribute nasal naloxone and provide overdose prevention education, and 89% (n = 16) provide overdose kits for free. Six OOPPs are funded by the Ohio Department of Health, 3 programs are funded by a local health foundation, and several other public and private funding sources were reported. The OOPPs have funding to distribute a combined total of 8,670 overdose kits and had distributed 1998 kits by October 2014. The OOPPs reported 149 overdose reversals. Fifteen programs (83%) reported implementation barriers that were categorized as stigma-, cost-, staffing-, legal, regulatory, and client-related problems. Legislative changes aimed at removing some of the obstacles to distribution and lay administration of naloxone have recently been enacted in Ohio. CONCLUSIONS: OOPPs have rapidly expanded in Ohio during the past 3 years. Although recent legislative changes have addressed some of the reported implementation barriers, stigma and the cost of naloxone remain significant problems.

Pharmacological Management of Opioid Use Disorder in Pregnant Women.

Opioid misuse during pregnancy is associated with negative outcomes for both mother and fetus due not only to the physiological effects of the drug but also to the associated social, medical and mental health problems that accompany illicit drug use. An interdisciplinary approach to the treatment of opioid use disorder during pregnancy is most effective. Ideally, obstetric and substance use treatment are co-located and ancillary support services are readily available. Medication-assisted treatment with methadone or buprenorphine is intrinsic to evidence-based care for the opioid-using pregnant woman. Women who are not stabilized on an opioid maintenance medication experience high rates of relapse and worse outcomes. Methadone has been the mainstay of maintenance treatment for nearly 50 years, but recent research has found that both methadone and buprenorphine maintenance treatments significantly improve maternal, fetal and neonatal outcomes. Although methadone remains the current standard of care, the field is beginning to move towards buprenorphine maintenance as a first-line treatment for pregnant women with opioid use disorder, because of its greater availability and evidence of better neonatal outcomes than methadone. However, there is some evidence that treatment dropout may be greater with buprenorphine relative to methadone.

Pharmacologic and behavioral interventions to improve cardiovascular risk factors in adults with serious mental illness: a systematic review and meta-analysis.

OBJECTIVE: Individuals with serious mental illness have high rates of cardiovascular disease (CVD) risk factors and mortality. This systematic review was conducted to evaluate pharmacologic and behavioral interventions to reduce CVD risk in adults with serious mental illness. DATA SOURCES: MEDLINE, EMBASE, PsycINFO, ClinicalTrials.gov, and Cochrane Database of Systematic Reviews were searched from January 1980 to July 2012 for English language studies. Examples of search terms used include schizophrenia, bipolar disorder, antipsychotics, weight, glucose, lipid, and cardiovascular disease. STUDY SELECTION: Two reviewers independently screened citations and identified 33 randomized controlled trials of at least 2 months' duration that enrolled adults with serious mental illness and evaluated pharmacologic or behavioral interventions targeting weight, glucose, or lipid control. DATA EXTRACTION: Reviewers extracted data, assessed applicability, and evaluated study quality; the team jointly graded overall strength of evidence. RESULTS: We included 33 studies. Most studies targeted weight control (28 studies). Compared with control groups, weight control was improved with behavioral interventions (mean difference = -3.13 kg; 95% CI, -4.21 to -2.05), metformin (mean difference = -4.13 kg; 95% CI, -6.58 to -1.68), anticonvulsive medications topiramate and zonisamide (mean difference = -5.11 kg; 95% CI, -9.48 to -0.74), and adjunctive or antipsychotic switching to aripiprazole (meta-analysis not possible). Evidence was insufficient for all other interventions and for effects on glucose and lipid control. The small number of studies precluded analyses of variability in treatment effects by patient characteristics. CONCLUSIONS: Few studies have evaluated interventions addressing 1 or more CVD risk factors in people with serious mental illness. Glucose- and lipid-related results were mainly reported as secondary outcome assessments in studies of weight-management interventions. Comparative effectiveness studies are needed to test multimodal strategies, agents known to be effective in nonserious mental illness populations, and antipsychotic-management strategies.

A systematic review of community opioid overdose prevention and naloxone distribution programs.

Community-based opioid overdose prevention programs (OOPPs) that include the distribution of naloxone have increased in response to alarmingly high overdose rates in recent years. This systematic review describes the current state of the literature on OOPPs, with particular focus on the effectiveness of these programs. We used systematic search criteria to identify relevant articles, which we abstracted and assigned a quality assessment score. Nineteen articles evaluating OOPPs met the search criteria for this systematic review. Principal findings included participant demographics, the number of naloxone administrations, percentage of survival in overdose victims receiving naloxone, post-naloxone administration outcome measures, OOPP characteristics, changes in knowledge pertaining to overdose responses, and barriers to naloxone administration during overdose responses. The current evidence from nonrandomized studies suggests that bystanders (mostly opioid users) can and will use naloxone to reverse opioid overdoses when properly trained, and that this training can be done successfully through OOPPs.

Development and implementation of an opioid overdose prevention program within a preexisting substance use disorders treatment center.

This case study of the development and implementation of an opioid overdose prevention program is based on an actual clinic's experience, but information about the clinic, including details of implementation and outcome measures, has been changed. Four experts reflect on the medical, administrative, peer-support, community, and evaluation aspects of this case. This discussion highlights challenges and important considerations in the creation of programs to address the ever-increasing risk for opioid overdose.

A survey of stakeholder knowledge, experience, and opinions of advance directives for mental health in Virginia.

An innovative Virginia health care law enables competent adults with serious mental illness to plan for treatment during incapacitating crises using an integrated advance directive with no legal distinction between psychiatric or other causes of decisional incapacity. This article reports results of a survey of 460 individuals in five stakeholder groups during the initial period of the law's implementation. All respondents held favorable views of advance directives for mental health care. Identified barriers to completing and using advance directives varied by group. We conclude that relevant stakeholders support implementation of advance directives for mental health, but level of baseline knowledge and perception of barriers vary. A multi-pronged approach will be needed to achieve successful implementation of advance directives for mental health.

Assisted outpatient treatment in New York: regional differences in New York's assisted outpatient treatment program.

OBJECTIVE: This study sought to describe the implementation of "Kendra's Law" in New York State and examine regional differences in the application of the program. METHODS: Between February 2007 and April 2008, interviews were conducted with 50 key informants across New York State. Key informants included assisted outpatient treatment (AOT) county coordinators, county directors of community services, judges, attorneys from the Mental Hygiene Legal Service (MHLS), psychiatrists, treatment providers, peer advocates, family members, and other referred individuals. Additional analyses were conducted using AOT program administrative and evaluation databases and client history data. RESULTS: From program inception in 1999 through 2007, a total of 8,752 initial AOT orders and 5,684 renewals were granted. Notable regional differences were found in the use of two distinct models of AOT: AOT First and Enhanced Voluntary Services First. Regional differences were also found in how the AOT program was implemented and administered. Other variations stemmed from the court proceedings themselves, the continuity and interest of the presiding judge, and the attitudes of the MHLS attorneys. CONCLUSIONS: Many regional adaptations of the AOT program were found. Many were the result of lack of guidance in implementing Kendra's Law. Policy makers may want to consider whether the law should change to allow for these differences or whether additional support from a central source is warranted to ensure more uniformity in the implementation of AOT and thus the fairness of its application across the state.

Continuing medication and hospitalization outcomes after assisted outpatient treatment in New York.

OBJECTIVE: This study examined whether persons with mental illness who undergo a period of involuntary outpatient commitment continue to receive prescribed medications and avoid psychiatric hospitalization after outpatient commitment ends. METHODS: Data on Medicaid pharmacy fills and inpatient treatment were used to describe patterns of medication possession and hospitalization for persons with mental illness after they received assisted outpatient treatment (AOT) in New York between 1999 and 2007 (N=3,576). Multivariable time-series analysis was used to compare post-AOT periods to pre-AOT periods. RESULTS: For former AOT recipients, sustained improvements in rates of medication possession and hospitalization in the post-AOT period varied according to the length of time spent in court-ordered treatment. When the court order for AOT was for six months or less, improved medication possession rates and reduced hospitalization were sustained in the post-AOT period only when intensive case coordination services (assertive community treatment, intensive case management, or both) were kept in place. However, when the court order was for seven months or more, improved medication possession rates and reduced hospitalization outcomes were sustained even when the former AOT recipients were no longer receiving intensive case coordination services. CONCLUSIONS: Benefits of involuntary outpatient commitment, as indicated by improved rates of medication possession and decreased hospitalizations, were more likely to persist after involuntary outpatient commitment ends if it is kept in place longer than six months.

Assessing outcomes for consumers in New York's assisted outpatient treatment program.

OBJECTIVE: This study examined whether New York State's assisted outpatient treatment (AOT) program, a form of involuntary outpatient commitment, improves a range of policy-relevant outcomes for court-ordered individuals. METHODS: Administrative data from New York State's Office of Mental Health and Medicaid claims between 1999 and 2007 were linked to examine whether consumers under a court order for AOT experienced reduced rates of hospitalization, shorter hospital stays, and improvements in other outcomes. Multivariable analyses controlling for relevant covariates were used to examine the likelihood that AOT produced these effects. RESULTS: On the basis of Medicaid claims and state reports for 3,576 AOT consumers, the likelihood of psychiatric hospital admission was significantly reduced by approximately 25% during the initial six-month court order (odds ratio [OR]=.77, 95% confidence interval [CI]=.72-.82) and by over one-third during a subsequent six-month renewal of the order (OR=.59, CI=.54-.65) compared with the period before initiation of the court order. Similar significant reductions in days of hospitalization were evident during initial court orders and subsequent renewals (OR=.80, CI=.78-.82, and OR=.84, CI=.81-.86, respectively). Improvements were also evident in receipt of psychotropic medications and intensive case management services. Analysis of data from case manager reports showed similar reductions in hospital admissions and improved engagement in services. CONCLUSIONS: Consumers who received court orders for AOT appeared to experience a number of improved outcomes: reduced hospitalization and length of stay, increased receipt of psychotropic medication and intensive case management services, and greater engagement in outpatient services.

Robbing Peter to pay Paul: did New York State's outpatient commitment program crowd out voluntary service recipients?

OBJECTIVE: This study examined whether New York State's assisted outpatient treatment (AOT) program disadvantaged voluntary service recipients by directing services toward court-ordered individuals. METHODS: Administrative data from the New York State Office of Mental Health were linked with Medicaid claims from 1999 through 2007 to compare trends in utilization of enhanced outpatient services by involuntary and voluntary service recipients with serious mental illness. Multivariable time series analysis was used to examine the likelihood that voluntary care seekers (N=3,295) either did not initiate or did not receive assertive community treatment or intensive case management during any month as a function of the number of AOT orders in the system. RESULTS: New York State appropriated new resources for enhanced community-based mental health services to implement AOT. During the first three years of the AOT program, most of the expansion in enhanced services was directed toward individuals under court-ordered treatment, which appears to have affected voluntary care seekers by lowering their odds of initiating enhanced services and raising their odds of having these services discontinued or no longer receiving them. However, after the first three years of AOT, enhanced service provision expanded steadily among both voluntary and involuntary recipients. CONCLUSIONS: In tandem with New York's AOT program, enhanced services increased among involuntary recipients, whereas no corresponding increase was initially seen for voluntary recipients. In the long run, however, overall service capacity was increased, and the focus on enhanced services for AOT participants appears to have led to greater access to enhanced services for both voluntary and involuntary recipients.

Changes in guideline-recommended medication possession after implementing Kendra's law in New York.

OBJECTIVE: This study examined changes in possession of guideline-recommended medication among three groups of New York State Medicaid enrollees with severe mental illness: those who received an involuntary outpatient commitment order, voluntary enhanced services, or neither of these interventions. METHODS: An observational study was conducted with New York State Medicaid claims data for enrollees with bipolar, schizophrenia, or schizoaffective disorders in New York City, Long Island, and the Hudson River regions from 2000 to 2005 (N=7,762). With adjustment for clinical and demographic characteristics, logistic regression models predicted the probability of a monthly medication possession ratio (MPR) ≥ 80% for medications recommended by expert guidelines or by the U.S. Food and Drug Administration for the indicated psychiatric diagnosis. Separate models were fit by region and for patients who ever received assisted outpatient treatment (AOT), voluntary enhanced services but never AOT, or neither treatment. RESULTS: In all three regions, for all three groups, the predicted probability of an MPR ≥ 80% improved over time (AOT improved by 31-40 percentage points, followed by enhanced services, which improved by 15-22 points, and "neither treatment," improving 8-19 points). Some regional differences in MPR trajectories were observed. CONCLUSIONS: After New York implemented AOT and increased community resources for enhanced services, guideline-recommended medication possession improved among Medicaid enrollees with severe mental illness--even among those who never received these interventions or services. However, further study is needed to understand why there were different regional trajectories and why some groups did not gain similarly across regions.

Reductions in arrest under assisted outpatient treatment in New York.

OBJECTIVE: Individuals with serious mental illness have a relatively high risk of criminal justice involvement. Assisted outpatient treatment (AOT) is a legal mechanism that mandates treatment for individuals with serious mental illness who are unlikely to live safely in the community without supervision and who are also unlikely to voluntarily participate in treatment. Under an alternative arrangement, some individuals for whom an AOT order is pursued sign a voluntary service agreement in lieu of a formal court order. This study examined whether AOT recipients have lower odds of arrest than persons with serious mental illness who have not yet initiated AOT or signed a voluntary service agreement. METHODS: Interview data from 2007 to 2008 from an evaluation of AOT in New York State were matched with arrest records from 1999 to 2008 for 181 individuals and analyzed using multivariable logistic regression. RESULTS: The odds of arrest for participants currently receiving AOT were nearly two-thirds lower (OR=.39, p<.01) than for individuals who had not yet initiated AOT or signed a voluntary service agreement. The odds of arrest among individuals currently under a voluntary service agreement (OR=.64) were not significantly different than for individuals who had not yet initiated either arrangement. The adjusted predicted probabilities of arrest in any given month were 3.7% for individuals who had not yet initiated AOT or a voluntary agreement, 1.9% for individuals currently on AOT, and 2.8% for individuals currently under a voluntary agreement. CONCLUSIONS: AOT may be an important part of treatment efforts to reduce criminal justice involvement among people with serious mental illness.

Medication preferences and adherence among individuals with severe mental illness and psychiatric advance directives.

OBJECTIVE: Psychiatric advance directives allow patients with severe mental illness to document their preferences for particular medications. This study investigated the role of psychiatric advance directives in treatment choice and medication adherence. METHODS: A total of 123 persons with severe mental illness recorded medication preferences in psychiatric advance directives. The authors compared medication preferences to prescribed medications over 12 months, determined concordance between preferred and prescribed medications, and examined the effect of concordance on medication adherence at 12 months. RESULTS: Participants requested a median of two medications in their psychiatric advance directives (range from zero to six) and refused a median of one medication (range from zero to ten). Between baseline and follow-up there was a 27% increase in the number of medications prescribed that had been requested on the psychiatric advance directive (Wilcoxon matched pairs, p<.001). After correction for the number of medications listed in the psychiatric advance directive, a 10% increase in concordance remained significant (p<.001). Being prescribed at least one medication requested in the psychiatric advance directive predicted higher medication adherence at 12 months, after the analysis controlled for relevant covariates (odds ratio=7.8, 95% confidence interval=1.8-34.0). CONCLUSIONS: Providing information about medication preferences in psychiatric advance directives may increase prescribing of patient-preferred medications even in noncrisis settings. Patients who were prescribed medications that they requested in advance were significantly more likely to adhere to medications, supporting the benefit of patient participation in medication choice. Psychiatric advance directives appear to be a clinically useful conduit for communicating patient medication preferences.

Characteristics of representative payeeship involving families of beneficiaries with psychiatric disabilities.

OBJECTIVE: Although the Social Security Administration frequently assigns family members to serve as representative payees for relatives with psychiatric disabilities, few studies have examined characteristics associated with these payee arrangements or the perceptions of the individuals involved in them. METHODS: One hundred participants (50 dyads of consumers with psychiatric disabilities and their representative payees from their family) were interviewed for data on perceived benefits and problems of the payeeship, knowledge of payee guidelines, the consumer-payee relationship, arithmetic and money management skills, and payeeship characteristics. RESULTS: Most consumers and payees believed that payeeship led to greater living stability; however, 36% of consumers and 50% of payees reported disagreement and conflict. Some consumers thought payeeship reduced their autonomy, although payees were less aware of this. Consumers and payees showed gaps in knowledge of payeeship, with only 28% correctly recognizing that payeeship did not last indefinitely. Both groups showed deficiencies in money management skills and basic arithmetic abilities; in these domains, there were no significant differences between payees and consumers. Risk of conflict was elevated when consumers had better money management skills and when payees had not completed high school. CONCLUSIONS: Although payeeship was beneficial, the data revealed potential problems in skills and knowledge about representative payeeship among consumers and payees. Efforts by policy makers and clinicians to increase collaboration between payees and consumers and to improve accurate knowledge of payeeship could help address its downsides.

Effect of patients' reasons for refusing treatment on implementing psychiatric advance directives.

OBJECTIVE: Clinicians have raised concerns that psychiatric advance directives may be used to refuse all treatment. However, people writing psychiatric advance directives can explicitly state their reasoning underlying treatment decisions. This study examined whether patients' reasons for refusing treatment influenced clinician decision making about implementing psychiatric advance directives. METHODS: A total of 597 mental health professionals completed a questionnaire that presented two scenarios: one in which the patient wrote a psychiatric advance directive refusing all medication because of paranoid delusions and one in which the patient wrote a psychiatric advance directive refusing all medication because of concerns about side effects. RESULTS: Twenty-two percent of clinicians reported that they would respect the former psychiatric advance directive, whereas 72% reported that they would respect the latter. After multivariate regression was used, the reason for treatment refusal remained the single significant predictor of clinicians' decision to honor a patient's psychiatric advance directive. CONCLUSIONS: Results show reasons for treatment refusal in psychiatric advance directives are likely to affect clinicians' decisions to implement the directives.