Briefly describe a specific question, or set of related questions, about a health care test or treatment that this program should consider.

• Treatment approaches to avoid early mortality and morbidity, which may be due to psychiatric manifestations, including suicide, as well as the result of earlier onset or greater likelihood of general medical conditions (e.g., diabetes, obesity, cardiac disease, sleep apnea, HIV and other infectious diseases). One nominator noted that morbidity and early mortality may be due to psychiatric manifestations, including suicide, as well as the result of earlier onset or greater likelihood of general medical conditions (e.g., diabetes, obesity, cardiac disease, sleep apnea, HIV and other infectious diseases).

Does your question include a comparison of different health care approaches? (If no, your topic will still be considered.)

yes

If yes, explain the specific technologies, devices, drugs, or interventions you would like to see compared:

• Compare the effectiveness of different treatment approaches including integrating mental health care and primary care, improving consumer self-care, or a combination of integration and self-care. This could also include comparing various types of integrated care, such as co-locating mental health providers in primary care versus primary care providers in mental health treatment settings. New technologies could be used to enhance monitoring and communication about symptoms and track progress. Such technologies include but are not limited to telemedicine, therapeutic interactive voice response systems (Helzer et al. J Gen Intern Med. 2010 Apr; 25(4):340-4) or internet based therapies or self-learning approaches.
• Compare the effectiveness of meds alone versus meds and psychosocial treatment in underserved or specific groups.
• Compare the effectiveness of older versus newer psychotropic medications used at typical doses on long term outcomes (positive and negative outcomes).
• Compare the effectiveness of combinations of psychotropic pharmacologic interventions.
• Compare the effectiveness of bundled programs of antipsychotic medications with various bundled psychosocial interventions (partial treatment, supported work, care programs designed to empower oriented consumer groups, residential care, and family intervention).
• Compare versions of ACT treatment, including the client created alternative ACT-PACE from the National Empowerment Center.
• Compare the effectiveness of interventions targeting modifiable factors such as physical exercise, mental exercise, and nutrition (including daily caloric intake) on health outcomes for people with SMI.
• Compare the effectiveness of various tobacco cessation strategies on the quit rate for individuals with SMI.
• Compare tobacco utilization by gender, age group, race or ethnicity across various mental health and substance use diagnoses so high risk profiles can be created.
• It would also be possible to ex

What patients or group(s) of patients does your question apply to? (Please include specific details such as age range, gender, coexisting diagnoses, and indications for therapy.)

Patients with Serious Mental Illness (SMI)

Are there subgroups of patients that your question might apply to? (For example, an ethnic group, stage or severity of a disease.)

• Underserved or specific groups
• Pregnant women
• Racial, ethnic, and cultural subgroups (One nominator noted that different racial/ethnic/cultural subgroups may have different preferences for types of treatment. Subgroups of patients (e.g., based on personality traits, specific symptom profiles, co-occurring disorders, gene-based vulnerabilities) may also show preferential responses to particular treatment. Comparisons of treatment effectiveness should aim to match specific treatments to specific patients insofar as is possible.
• SMI and coexisting substance abuse
• Gender
• Age groups
• It may be helpful to look specifically at subgroups of individuals who have chronic mental illness as well as specific commonly co-occurring conditions or symptoms (e.g., smoking, substance use, high risk of suicide or aggression) and determine whether particular treatment approaches are associated with differential benefits (or risks).

Describe the health-related benefits you are interested in. (For example, improvements in patient symptoms or problems from treatment or diagnosis.)

• Social support and patient knowledge of risks associated with medication use, specifically diabetes, heart disease, weight gain and obesity-related health outcomes. (One nominator commented that social support seems distinct from knowledge about medications. It also seems less relevant as an outcome for these interventions. Issues such as diabetes, heart disease and weight need to be addressed as independent outcomes and not simply in terms of education about these potential side effects.)
• Improved quality of life
• Patient satisfaction
• Positive health and Positive psychosocial outcomes
• Positive health outcomes
• Improved symptom course including the course of symptoms in an acute episode or the entire longitudinal course and trajectory of illness
• Reduction in direct and indirect costs
• Improved overall physical health
• Decreased use of alcohol and other substances (and and rates of misuse/abuse/dependence)
• Delayed onset of medical complications associated with tobacco use
• Other health outcomes, including dental health. Poor dental care can be associated with health problems and medications can result in dental complications including bruxism and xerostomia (with an associated increase in decay and peridontitis).

Describe any health-related risks, side effects, or harms that you are concerned about.

Morbidity and mortality, specifically:

• Side effects of medication use including weight gain and risk of diabetes, heart disease, and other health problems that may result from obesity
• Suicide
• Tardive dyskinesia
• Poor health and psychosocial health outcomes
• Poor symptom course
• Sleep apnea- it has an increasing prevalence among those with mental illness, can contribute to early mortality, has implications for treatment (e.g., avoiding of sedating medications) and is often under-recognized and untreated.

Appropriateness for EHC Program

Does your question include a health care drug, intervention, device, or technology available (or likely to be available) in the U.S.?

yes

Which priority area(s) and population(s) does this topic apply to? (check all that apply)

EHC Priority Conditions (updated in 2008)

• Cardiovascular disease, including stroke and hypertension
• Depression and other mental health disorders
• Diabetes mellitus
• Functional limitations and disability
• Obesity
• Substance abuse

AHRQ Priority Populations

• Low income groups
• Minority groups
• Women
• Elderly
• Individuals with special health care needs, including individuals with disabilities or who need chronic care or end-of-life health care

Federal Health Care Program

• Medicaid
• Medicare

Importance

Describe why this topic is important.

American adults living with SMI die about 25 years earlier than other Americans, largely owing to treatable medical conditions.1 In fact, many people with SMI do not seek any health care.2 Severity is strongly related to comorbidity; more than a quarter of all those with an SMI have two mental health diagnoses, and almost 50 percent have more than three mental health diagnoses.3 Thirty seven percent of people with alcohol disorders and 53 percent with other drug disorders have comorbid psychiatric conditions.4 Individuals with SMI are at much higher risk for suicide. For people with virtually every category of SMI, suicide is a leading cause of death, with lifetime risks ranging from 4 to 8 percent.5 SMI is the second leading cause of disability in the United States for ages 15 to 446 and accounts for between 5,000 and 10,000 disability-adjusted life years (DALYs) lost worldwide per year per 1 million population.

In 2000, the total economic burden of illness for depression was $83.1 billion in the United States. Of this total, $26.1 billion (31 percent) were direct treatment costs, $5.4 billion (7 percent) were suicide-related costs, and $51.5 billion (62 percent) were workplace costs.7 An estimated 2 to 15 percent of individuals who have been diagnosed with major depression die by suicide.8 (Although, earlier mortality is not purely an effect of the increased suicide rate but is due to many general medical causes including cardiac illness.) As described, the personal and societal costs of SMI are significant. They include earlier mortality, higher rates of suicide, significantly higher health care costs for employers and the government, added family caregiver burden, and associated substance abuse problems. Patients and families are also among those who absorb higher health costs in the form of copayments (for those with insurance) and full payment (typically at higher than insurance negotiated rates) for those without insurance.

There is concern about the pro

What specifically motivated you to ask this question? (For example, you are developing a clinical guideline, working with a policy with large uncertainty about the appropriate approach, costly intervention, new research you have read, items in the media you may have seen, a clinical practice dilemma you know of, etc.)

• NC DHHS wishes to fund and promote evidenced-based services. Our ability to reduce tobacco use is an important strategy in reducing medical complication, improving care, and reducing mortality and cost. Strategies for the SMI population are particularly relevant.
• These issues of the comparative effectiveness of specific treatments for serious mental illness are directly related to the practice guideline development efforts of the American Psychiatric Association. The high rates of early mortality among those with serious mental illness constitute a significant public health issue. Psychiatric and general medical interventions to reduce this risk of mortality and morbidity is essential, yet best practices for such interventions have not been well defined. Consequently, in clinical practice, insufficient attention has been given to unidentified and/or undertreated general medical and psychiatric symptoms and syndromes. If best practices could be delineated, then policies and health care delivery models could be adjusted to optimize care and outcomes for patients.

Does your question represent uncertainty for clinicians and/or policy-makers? (For example, variations in clinical care, controversy in what constitutes appropriate clinical care, or a policy decision.)

yes

If yes, please explain:

• Ideally it will assist in policy and payment for evidenced-based cessation services.

Potential Impact

How will an answer to your research question be used or help inform decisions for you or your group?

• Target interventions at high risk populations. Develop policy that promotes and funds best practices. Integrate into performance measures.
• Answers to these research questions will be able to inform the development of practice guideline recommendations for psychiatrists relating to the comparative effectiveness of these interventions.

Describe the timeframe in which an answer to your question is needed.

As soon as possible. This topic was prioritized during a series of stakeholder meetings focused on SMI, held July-August 2010.

Describe any health disparities, inequities, or impact on vulnerable populations your question applies to.

This need to be better understood. The gap in mortality between community samples and those with serious mental illness seems, as least in part, due to disparities in health care. Those with serious mental illness are by definition a vulnerable population. Many such individuals have co-occurring conditions, psychosocial difficulties or financial hardships that result in even more dramatic inequities in access to care or to specific interventions.

Nominator Information

Other Information About You: (optional)

Please choose a description that best describes your role or perspective: (you may select more than one category if appropriate)

• Target interventions at high risk populations. Develop policy that promotes and funds best practices. Integrate into performance measures.
• Answers to these research questions will be able to inform the development of practice guideline recommendations for psychiatrists relating to the comparative effectiveness of these interventions.

Are you making a suggestion as an individual or on behalf of an organization?

Organization

Please tell us how you heard about the Effective Health Care Program

1- RTI- UNC IEF topic nomination process; 2- The Practice Guidelines project of the American Psychiatric Association was asked for the name of someone to participate; my name was submitted.