Examples of Successful Proposals

The Use of Psychotropic Medication Among Children & Adolescents

Specific Aims and Objectives

To develop an R01 application to the National Institute of Mental Health examining the use of psychotropic medications among children and adolescents. The application would address a series of research questions at the nexus of evidence-based treatment guidelines, quality of care, managed care and service delivery in the 'real world'.

Given recent reports of rising use of these medications among children and in light of research suggesting that the wrong children may receive them (Angold et al., 2000; Vitiello, 2000), the use and impact of psychotropic medications-especially in "real world" settings--is of vital public policy importance and central to the mission of the CYFC. While basic epidemiological evidence is available for attention disorders and other conditions, relatively little is known about the use and implications of these treatments in real-world settings. The Multi-Modal Treatment study (and related research), for example, established that stimulants are quite effective in reducing the symptoms of ADHD (Jensen, 2001). However, the use of medications in that study adhered closely to treatment guidelines. In particular, considerable effort was taken to titrate dosage, and medication management was aggressive. The limited evidence available suggests that treatment in the real world often departs from this ideal.

This application would begin a research partnership between researchers at Penn State (at both the University Park campus and the College of Medicine) and researchers at Kaiser Permanente (KP), America's largest not_for_profit health maintenance organization. KP serves over eight million members in 9 states and the District of Columbia. Using clinical records and insurance claims, the proposed project would examine a series of questions concerning the treatment of emotional and behavioral problems and the role of medications in that treatment; the relationship between quality of care and evidence-based treatment guidelines; and the role of managed care.

The requested funding would be used to develop an application examining the experiences of over 150,000 children and adolescents in Colorado and surrounding states. The project would draw on both insurance claims as well as electronic medical records. The former would provide information on the use of psychotropics as well as of other mental health and medical services. KP also maintains an electronic medical records system that would provide information on clinical outcomes as well as some insight into the clinician's decision-making process. KP maintains a database of provider characteristics as well. Given the large number of providers involved (over 450), these data will allow the research team to evaluate the role of provider characteristics and practice patterns in explaining the use of medications and its relationship to the use of other services (e.g, inpatient care).

The proposed project would develop an application to examine a series of questions about the use of psychotropic medications among children and adolescents treated in real-world settings. These include C How are psychotropic medications used by children and adolescents? What percentage of children and adolescents uses these medications? At what age are these medications first prescribed? How long do children and adolescents remain on these medications?

• What factors predict which children receive psychotropic medications? Is the use of these medications more common in urban than in rural areas?

• How closely does the use of medications conform to treatment guidelines? What factors predict concordance/discordance with treatment guidelines? For example, which factors predict the receipt and timing of followup visits after children or adolescents are prescribed psychotropic medications?

• How is concordance/discordance related to subsequent service use? Is the use of medication management associated with lower levels of subsequent service use (e.g., inpatient care)?

• How are provider characteristics related to the use of medications? For example, are timely followup visits more likely with behavioral health specialists than with pediatricians?

• How does the use of medications affect subsequent medical costs? Is there any evidence of cost offset? Does the relationship between medication use and subsequent medical costs moderated by medication management?

• How do the answers to these questions depend on the characteristics of the managed care plans involved? Is medication management, for example, less likely when providers are paid under a strict capitation plan? How does the use of formularies affect prescription patterns?

• How do the answers to these questions vary

  • across racial and ethnic groups?
  • by gender?
  • across rural and urban areas?
  • between children and adolescents with and without comorbid conditions, such as conduct disorder?
• Can these differences between explained by characteristics of the managed care plan? Quality of care and adherence to treatment guidelines? Service availability? Provider characteristics?

While much of this proposal discusses attention-related disorders, we also would examine similar questions for children receiving anti-depressants. We will compare and contrast the answers to the questions identified above across conditions (e.g., one would expect the role of drug formularies to have a greater impact in the case of depression relative to attention-related disorders).

This work would provide the team with an opportunity to develop a program of research in this area. In particular, over time, the work described here could be expanded to look at children and adolescents nationwide (through the HMO research network, a nationwide consortium of HMO's, of which KP is a member) and into other populations, such as children in foster care or the juvenile justice system.

Background and Rationale

Recent evidence suggests rising use of psychotropic medications among children and adolescents. Within these trends are striking (and in some cases, growing) gender and racial/ethnic differences.

Beyond basic epidemiological evidence, the literature provides little evidence as to how real-world providers use psychotropic medications. The little literature that is available raises troubling questions. In a community study, Angold et al. (2001) report that the majority of individuals who received stimulants were never reported by their parents to have any impairing ADHD symptoms. One explanation for this disjuncture is an over-reliance by managed care organizations (and capitated providers) to rely on low-cost therapies involving medications (rather than longer, most costly behavioral therapies and other alternatives).

These issues highlight the need for research on the use of medications by community providers and their link to quality of care and treatment outcomes.

Rising Use of Medications

The use of psychotropic medication to treat children and adolescents with ADHD has increased significantly over the past decade (Safer, 1997; Safer and Krager, 1988, 1994; Safer et al., 1996). Increases in the use of clonidine and methylphenidate account for most of the increase in psychotropic medications prescribed to children. The increase in prescription rates has been associated with a child's age, gender, race, geographical location, and provider. Between 1991 and 1995, use of clonidine increased twenty-eight-fold among preschoolers (Zito, Safer et al. 2000). Although methylphenidate use among preschoolers (ages 2-4) and children ages 5-14 grew substantially during this time, 15- to 19-year-olds experienced the greatest increase in use (311%) (Zito, et al, 2000).

Gender Differences Service Use

Studies on gender differences in ADHD have examined prevalence, symptomatology, the risk of comorbid disorders, and referral bias. Findings support the hypothesis of a gender effect on assignment of ADHD diagnoses; boys are three times as likely as girls to receive an ADHD diagnosis (Angold and Costello, 1997; Zito, Safer, dosReis, Magder, and Riddle, 1997; Wasserman, Slora, Fleiming, and Kessel, 1998). However, consensus in regards to symptomatology has not been established. While some studies found that ADHD girls had lower ratings of inattention, hyperactivity, and externalizing problems compared to ADHD boys (Gershon, 2002; Newcorn, Halperin et al., 2001), other studies found the opposite relationship (Biederman, Mick et al. 2002) or no gender difference (Horn, Wagner et al., 1989; Gaub and Carlson, 1997). Other studies found ADHD girls presented greater intellectual impairment (Gaub and Carlson, 1997; Gershon 2002) and lower interpersonal problems (Gershon 2002); (Newcorn, Halperin et al. 2001) while ADHD boys displayed greater impairment in the speed of processing information (Rucklidge and Tannock 2001). A gender effect was not found for academic performance, fine motor skills, parental education, parental depression, or self_perception (Gaub and Carlson, 1997; Horn, et al, 1989). The literature indicates similar inconsistencies in regards to the effect of gender on the risk of comorbid disorders. ADHD girls were shown to be at less risk for comorbid depression, conduct disorder, and oppositional defiant disorder than ADHD boys (Biederman et al., 2002) but reported greater impairment for anxiety, distress, and depression and are considered to be at greater risk of psychological impairment (Rucklidge and Tannock, 2001). Finally, studies note that lower rates of symptom manifestation may place ADHD girls at greater risk of unfavorable referral bias (Biederman et al., 2002; Gaub and Carlson, 1997).

Racial-Ethnic Differences in Service Use

In a national study examining mental health service use and spending in 1987 and 1996, Caucasians were found to be much more likely to seek help for mental health or substance abuse problems and to use psychotropic medications than all other racial/ethnic groups in both years (Zuvekas, 2001). Caucasians were also found to have the fastest rate of growth in use between 1987 and 1996.

Real-World Treatment Involving Medications is Less than Ideal

Concern regarding the widespread adoption of medicating children and adolescents with ADHD led to the creation of medication management guidelines by the American Academy of Pediatrics. That group recommended that the guidelines be applied to any child receiving medication and that treatment include a period of medication adjustment to achieve the desired behavioral outcome (titration), follow-up visits post-titration, and behavioral and/or psychological counseling. However, studies examining the concordance of follow-up visits post-titration indicate that approximately twenty percent of children on stimulants do not receive the recommended follow-up (Kelleher et al., 1989; Hoagwood 2000 Feb; Hoagwood 2000 October). Family practitioners were less likely (45.7%) to provide specific follow-up compared to psychiatrists (88.5%) and pediatricians (79%) (Hoagwood, Jensen et al. 2000a; Hoagwood 2000b). Follow-up counseling also did not meet the recommended guidelines and varied according to provider type. Pediatricians provided more general health counseling (45.4%) than psychiatrists (1.9%) (Hanwood 2000b) to patients receiving stimulants, while psychiatrists provided more psychotherapy than pediatricians (10.1%) and family practitioners (2.4%) (Hanwood 2000b).

Relevance to the CYFC

The proposed project builds on two of the four CYFC themes. In the area of "Family Change", the project would examine the link between "the restructuring of health and mental health care delivery systems (e.g., managed care)" and the well-being of children and adolescents. The project also would illumine the unique challenges facing service delivery systems in rural areas, an element of the theme, "Rural Communities in an Urban Society".

The project also would work toward building links between the University Park campus and the medical school. As discussed below, the project could involve a broader set of researchers at the University Park campus. Possible collaborators include Dennis Scanlon, a faculty member in Health Policy and Administration, with expertise in managed care and the measurement of health care quality. Another possibility is Marriane Hillmeier, a new CYFC hire in HPA, whose research focuses on racial and ethnic differences in children's health.

Anticipated Outcomes

The product of this effort will be an application submitted to NIMH in the spring of 2003. Over the long term, this project would result in increased collaboration between the UP campus and the College of Medicine.

Timeline

The project will result in a NIMH application to be submitted in the Spring or Summer of 2003. The assistantship would be used to fund a HPA student in the Fall and Spring of 2003.

Personnel

The principal investigator, E. Michael Foster, is an associate professor of Health Policy and Administration (HPA) and of Demography. Foster would supervise the entire process and would assist in developing a research plan that would include the appropriate analytical techniques. He would supervise the writing of the NIMH application.

Collaborating investigators:

• Dr. Arne Beck is the Research and Development Director in the Rocky Mountain Division, and Assistant Clinical Professor in the Department of Preventive Medicine and Biometrics at the University of Colorado Health Sciences Center. Dr. Beck will advise the project on substantive, clinical issues as well as facilitate data access.
• Stuart Kaplan, M.D., is professor and Director of Child and Adolescent Psychiatry Residency Training, in the Department of Psychiatry at the Pennsylvania State College of Medicine. Dr. Kaplan has published extensively on pediatric psychopharmaco-epidemiology. He would provide consultation on the clinical issues and would assist in developing a research plan, particularly in the area of the impact of treatment guidelines.
• Others. During the coming year, we would hope to involve other Penn State faculty members. Possible collaborators include Dennis Scanlon, a faculty member in Health Policy and Administration, with expertise in managed care and the measurement of health care quality. Another possibility is Marriane Hillmeier, a new CYFC hire in HPA, whose research focuses on racial and ethnic differences in children's health.

Funding With Justification

CYFC seed funds would support the NIMH application by funding a graduate student to:

• assist with the necessary literature reviews;
• working with Dr. Beck to assemble KP materials to be used in the preliminary studies section of the grant;
• explore the possibility of supplementing the KP data with additional data on service availability (using, for example, the Area Resource File) and
• help in developing a conceptual, multi-level model linking the various forces shaping the use of medications. These forces occur at the level of the individual, the family, the school, the managed care plan and the local community (including the availability and preferences of service providers).

Also requested is funding for Foster to make one trip to Colorado to meet with Dr. Beck.

Last modified: 09/27/06 | Contact Webmaster