Adaptation of a Mobile Interactive Obesity Treatment Approach for Early Severe Mental Illness: Protocol for a Mixed Methods Implementation and Pilot Randomized Controlled Trial.

BACKGROUND: Obesity is common in individuals with severe mental illness (SMI), contributing to a significantly shortened lifespan when compared to the general population. Available weight loss treatments have attenuated efficacy in this population, underscoring the importance of prevention and early intervention. OBJECTIVE: Here, we describe a type 1 hybrid study design for adapting and pilot-testing an existing mobile health intervention for obesity prevention in individuals with early SMI and Class I or early-stage obesity, defined as a BMI of 30-35. METHODS: An existing, evidence-based interactive obesity treatment approach using low-cost, semiautomated SMS text messaging was selected for adaptation. Community mental health clinics and Clubhouse settings in Eastern Missouri and South Florida were identified to participate. This study has the following 3 aims. First, using the Enhanced Framework for Reporting Adaptations and Modifications to Evidence-based interventions, contextual aspects of the clinical and digital treatment environments are identified for adaptation, considering 5 main stakeholder groups (clinical administrators, prescribing clinicians, case managers, nurses, and patients). Following a 2-week trial of unadapted SMS text messaging, Innovation Corps methods are used to discover needed intervention adaptations by stakeholder group and clinical setting. Second, adaptations to digital functionality and intervention content will be made based on themes identified in aim 1, followed by rapid usability testing with key stakeholders. A process for iterative treatment adaptation will be developed for making unplanned modifications during the aim 3 implementation pilot study. Individuals working in partner community mental health clinics and Clubhouse settings will be trained in intervention delivery. Third, in a randomized pilot and feasibility trial, adults with 5 years or less of treatment for an SMI diagnosis will be randomized 2:1 to 6 months of an adapted interactive obesity treatment approach or to an attentional control condition, followed by a 3-month extension phase of SMS text messages only. Changes in weight, BMI, and behavioral outcomes, as well as implementation challenges, will be evaluated at 6 and 9 months. RESULTS: Institutional review board approval for aims 1 and 2 was granted on August 12, 2018, with 72 focus group participants enrolled; institutional review board approval for aim 3 was granted on May 6, 2020. To date, 52 participants have been enrolled in the study protocol. CONCLUSIONS: In this type 1 hybrid study design, we apply an evidence-based treatment adaptation framework to plan, adapt, and feasibility test a mobile health intervention in real-world treatment settings. Resting at the intersection of community mental health treatment and physical health promotion, this study aims to advance the use of simple technology for obesity prevention in individuals with early-stage mental illness. TRIAL REGISTRATION: ClinicalTrials.gov NCT03980743; https://clinicaltrials.gov/ct2/show/NCT03980743. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/42114.

Impact of the CATIE findings on state mental health policy.

The authors, who are medical directors of three state mental health agencies and members of the Medical Directors' Council of the National Association of State Mental Health Program Directors (NASMHPD), describe the impact on public mental health policy of the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE). Before publication of the CATIE results, the preponderance of information indicated substantial and broad-ranging advantages of second-generation antipsychotics over first-generation agents. State mental health authorities focused on improving access to and increasing utilization of the newer agents. In many states, expenditures for these agents accounted for 10% of the total pharmacy budget of the Medicaid program. After CATIE, state policy makers have had to take a more critical look at the data and formulate more nuanced approaches. The authors summarize policy recommendations of the NASMHPD Medical Directors' Council, which reviewed efficacy studies of antipsychotics and formulated a position statement. The recommendations cover three broad areas of policy. First, neither complete open access for all patients at all times nor a uniform fail-first trial of a first-generation antipsychotic is an optimal approach. A more nuanced middle ground is necessary. Second, excessive emphasis on the cost of second-generation antipsychotics has led to a lack of focus on optimizing use of all antipsychotic medication in usual practice. More research and management attention must be focused on improving how these medications are prescribed for individual patients. Third, more resources should be invested in clinical trials that more clearly and accurately reflect current practice.

When is antipsychotic polypharmacy supported by research evidence? Implications for QI.

BACKGROUND: Concurrent use of multiple standing antipsychotics (antipsychotic polypharmacy) is increasingly common among both inpatients and outpatients. Although this has often been cited as a potential quality-of-care problem, reviews of research evidence on antipsychotic polypharmacy have not distinguished between appropriate versus inappropriate use. METHODS: A MEDLINE search from 1966 to December 2007 was completed to identify studies comparing changes in symptoms, functioning, and/or side effects between patients treated with multiple antipsychotics and patients treated with a single antipsychotic. The studies were reviewed in two groups on the basis of whether prescribing was concordant with guideline recommendations for multiple-antipsychotic use. RESULTS: A review of the literature, including three randomized controlled trials, found no support for the use of antipsychotic polypharmacy in patients without an established history of treatment resistance to multiple trials of monotherapy. In patients with a history of treatment resistance to multiple monotherapy trials, limited data support antipsychotic polypharmacy, but positive outcomes were primarily found in studies of clozapine augmented with a second-generation antipsychotic. DISCUSSION: Research evidence is consistent with the goal of avoiding antipsychotic polypharmacy in patients who lack guideline-recommended indications for its use. The Joint Commission is implementing a core measure set for Hospital-Based Inpatient Psychiatric Services. Two of the measures address antipsychotic polypharmacy. The first measure assesses the overall rate. The second measure determines whether clinically appropriate justification has been documented supporting the use of more than one antipsychotic medication.

Psychiatry's Role in Improving the Physical Health of Patients With Serious Mental Illness: A Report From the American Psychiatric Association.

The American Psychiatric Association Integrated Care Workgroup recently convened an expert panel charged with addressing the role of psychiatry in improving the physical health of persons with serious mental illness. The group reviewed the peer-reviewed and gray literature and developed a set of recommendations grounded in this review. This column summarizes the panel's primary findings and recommendations to key stakeholders, including clinicians, health care organizations, researchers, and policy makers.

The Role of Clinical Setting and Management Approach in Metabolic Testing Among Youths and Adults Treated With Antipsychotics.

OBJECTIVE: This study compared metabolic screening among patients who received antipsychotic treatment at community mental health centers (CMHCs), with or without case management, and patients treated elsewhere. METHODS: Rates of glucose and lipid testing among youths and adults in Missouri Medicaid (N=9,473) who received antipsychotic treatment at CMHCs, with and without case management, were evaluated. Multivariable logistic regressions determined which characteristics were independently associated with metabolic testing. RESULTS: A total of 37.0% and 17.3% of youths and 68.7% and 34.9% of adults had glucose and lipid testing, respectively. Compared with treatment elsewhere, treatment at CMHCs, with or without case management, respectively, was associated with higher odds of glucose testing (youths, adjusted odds ratio [AOR]=1.68 and 1.89; adults, AOR=1.43 and 1.44) and lipid testing (youths, AOR=2.40 and 2.35; adults, AOR=1.97 and 1.48). CONCLUSIONS: CMHCs had higher rates of metabolic testing, possibly reflecting Missouri's efforts to promote testing in these settings.

The impact of the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) on prescribing practices: an analysis of data from a large midwestern state.

BACKGROUND: The Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) was a series of effectiveness trials. The results of these trials began publication in September 2005. Among other findings, these studies were interpreted to suggest that (1) second-generation antipsychotics might have fewer advantages over first-generation antipsychotics than had been generally thought; (2) among the agents assessed, olanzapine had the best efficacy outcome; and (3) after treatment failure with a second-generation antipsychotic, the most efficacious second-line medication is clozapine. To examine the actual impact on practice of these publications, we looked at change in physician prescribing behavior based on these 3 conclusions before and after publication of CATIE. METHOD: Rates of antipsychotic medication prescriptions to 51,459 patients with an ICD-9 code of 295 for schizophrenia were extracted from a Missouri Medicaid claims database. χ² Tests were used to compare the rates of prescribing antipsychotic medications before and after each of 3 key CATIE publications (time 1 was September 2005, time 2 was December 2006, and time 3 was April 2006). RESULTS: At all time points, we demonstrated a decrease in prescriptions by all prescribers for olanzapine (P < .0001). One year after time 1, we found an increase in prescriptions by all prescribers for aripiprazole (P < .0001). No statistically significant increases in clozapine prescribing were observed. Also, a small but statistically significant increase was seen in prescriptions of perphenazine (P < .02 at time 3). However, this increase occurred only for prescriptions written by psychiatrists and not other prescribers. CONCLUSIONS: We found some evidence in our sample that the publication of the results from CATIE had a small but statistically significant effect on prescribing habits of psychiatrists but not other physicians in our sample population. However, larger changes occurred in prescribing behavior that were largely unrelated to the CATIE trial. We propose a hypothesis to explain the direction of observed changes.

Effects of adopting a smoke-free policy in state psychiatric hospitals.

OBJECTIVE: The aim of this study was to investigate how adopting a smoke-free policy in state psychiatric hospitals affected key factors, including adverse events, smoking cessation treatment options, and specialty training for clinical staff about smoking-related issues. METHODS: Hospitals were surveyed in 2006 and 2008 about their smoking policies, smoking cessation aids, milieu management, smoking cessation treatment options, and aftercare planning and referrals for smoking education. Comparisons were made between hospitals that went smoke-free between the two time periods (N=28) and those that did not (N=42). RESULTS: Among hospitals that changed to a smoke-free policy, the proportion that reported adverse events decreased by 75% or more in three areas: smoking or tobacco use as a precursor to incidents that led to seclusion or restraint, smoking-related health conditions, and coercion or threats among patients and staff. Hospitals that did not adopt a smoke-free policy cited several barriers, including resistance from staff, patients, and advocates. CONCLUSIONS: Although staff were concerned that implementing a smoke-free policy would have negative effects, this was not borne out. Findings indicated that adopting a smoke-free policy was associated with a positive impact on hospitals, as evidenced by a reduction in negative events related to smoking. After adoption of a smoke-free policy, fewer hospitals reported seclusion or restraint related to smoking, coercion, and smoking-related health conditions, and there was no increase in reported elopements or fires. For hospitals adopting a smoke-free policy in 2008, there was no significant difference between 2006 and 2008 in the number offering nicotine replacement therapies or clinical staff specialty training. Results suggest that smoking cessation practices are not changing in the hospital as a result of a change in policy.

State mental health policy: mending Missouri's safety net: transforming systems of care by integrating primary and behavioral health care.

Missouri has begun a three-year pilot program across the state to integrate the primary care services provided by federally qualified health centers (FQHCs) and the behavioral health services provided by community mental health centers (CMHCs). This column describes the integration initiative, in which start-up funds were provided in 2008 to seven FQHC-CMHC partnerships (a total of $700,000 to each pair over 3.5 years). It reviews lessons learned during the first year of the project in bringing these two very different public systems of care together to mend the public health safety net.

Implementing practice guidelines: lessons from public mental health settings.

There is evidence that state-of-the-art psychiatric treatments are not being translated into community settings, resulting in the de facto denial of up-to-date psychiatric care for many Americans with mental illness. Although multiple models of evidence-based care exist, little is known about how to disseminate information regarding these models to clinicians in real-world practice. Suggested solutions have included the use of published practice guidelines, such as the American Psychiatric Association Practice Guidelines and the Expert Consensus Guidelines, or algorithm-based programs, such as the Texas Medication Algorithm Project. Unfortunately, the real-world utility of practice guidelines tends to be limited, because their implementation depends entirely on practitioner self-motivation. Similarly, the use of algorithm-based programs may be limited by their pervasive high specificity, practitioner resistance, and various patient misperceptions. Another solution is the implementation of evidence-based practices (EBPs), such as the Substance Abuse and Mental Health Services Administration (SAMHSA) EBPs. However, states' use of the SAMHSA EBPs has been hampered by misalignment of the funding structure, lack of information regarding EBPs, high costs to train and supervise staff, staff turnover, and a lack of resources. As a result, federal and clinical/professional agencies have called for a change in the nation's mental health care delivery system, supplying persuasive arguments for the economic and clinical superiority of integrated care models. One such model, the Missouri Medical Risk Management (MRM) Program for Medicaid Recipients with Schizophrenia, currently assists patients identified as being at high risk for adverse medical and behavioral outcomes. Preliminary results from the Missouri MRM Program are described.