During May, which is Mental Health Month, we’d like to take the opportunity to highlight the importance of patient-centered clinical research aimed at improving the lives of people with mental illness. Seeking better ways to prevent, diagnose, or treat mental illnesses is a major focus of PCORI’s research funding and patient and community engagement activities. Often, people suffering from a mental illness and their families don’t know how or where to ask for help. And when they do seek help, they often find little information available about which treatments are likely to work best for an individual patient.

Reaching Out to Patients

PCORI is supporting several projects focused on helping individuals and communities to identify and address mental health problems. One such project was recently funded under the Eugene Washington PCORI Engagement Awards program, which supports more active integration of patient, other stakeholder, and research communities in the research process.

This community-based project addresses disparities in integrated health care for African Americans with serious mental illness. An advisory board composed of patients, family members, healthcare providers, and other stakeholders will develop a curriculum to inform Chicago-area healthcare agencies about community-based participatory research. The board will then train two groups of patients and other community members to engage in all aspects of the participatory research process. The advisory board will select two smaller teams, which will each identify a problem related to healthcare access for African Americans with mental illness and develop a plan to address it. The board will disseminate the products of this project using both local and national networks.

Engaging Patients in Care Decisions

Even individuals who have been able to access mental illness care often have trouble finding treatment that meets their specific needs. PCORI is supporting projects focused on improving access to mental health services through patient empowerment, by increasing participation in decision making.

A Pennsylvania project is comparing two ways of improving patient-provider communication to provide patients with serious mental illness more input into treatment choices. In one approach, the clinician bases changes in medication on information that patients provide in standardized surveys that ask about their symptoms and side effects. In the other, the patient answers questions with the assistance of a trained peer. The result is a report that the patient and clinician use during the treatment visit.

The researchers are looking to compare these two approaches by measuring outcomes that matter most to patients with severe mental illness. To date, the study has recruited over 2,400 Medicaid-enrolled patients who receive treatment at one of 15 community mental health centers across the state. Each study site is randomly assigned to one or the other communication approach. The project’s Stakeholder Advisory Board has provided input at every stage of the study, such as recommending effective ways to present online data collection to participants, helping to guide recruitment strategies, and training research assistants to be sensitive to patients’ verbal and nonverbal cues.

Evaluating Treatment Options

There are effective treatment options for most mental disorders. Often, however, the problem facing patients and clinicians is choosing the best treatment for that patient’s characteristics, including preferences, and addressing treatment side effects. PCORI has recently funded several studies addressing this challenge.

A New York project is comparing the effectiveness of two treatment options for attention-deficit/hyperactivity disorder (ADHD) in primarily Hispanic and African-American adolescents, half of whom have substance use problems. Outpatient behavioral therapists will provide either a behavioral treatment (called Changing Academic Support in the Home for Adolescents with ADHD) alone or the behavioral treatment plus a medication decision-assist tool (called the Medication Integration Protocol). The research team will consider treatment effects on counseling attendance, medication use, behavioral problems, substance use, and quality of life. To make sure that the interventions are patient centered, the team regularly engages with teens diagnosed with ADHD, their families, school officials and other family advocates, therapists, and supervisors from counseling centers.

Improving Care Delivery

PCORI also aims to improve access to and delivery of effective treatments for all patients. For instance, PCORI is funding technologically focused studies as well as projects designed to improve care delivery starting with the patient-provider relationship and continuing to the community level.

One California project is testing a telehealth approach customized for integrating developmental, behavioral, and mental health services into pediatric primary care in low-income, urban communities. If scarce specialty providers deliver services remotely from a central location, many children can gain ready and sustainable access to those specialists through their small, local primary care clinics.

In this project, parents in the multi-stakeholder working group expressed concerns about unduly burdening parents who have just learned that their child has a serious mental health problem. The working group suggested that parents at that time wouldn’t be in a good frame of mind to decide whether to participate in a trial with individual randomization. In response, the research team adapted its study design so that each clinic will be randomly assigned to either the telehealth approach or usual care (a study design termed a “cluster randomized trial”). Thus, each clinic will provide the same type of treatment to all its families.

These are a sampling of projects that PCORI is supporting related to mental health knowledge, access, treatment, and services. The importance of mental health is also reflected in the topics on PCORI’s list of priority topics for its Pragmatic Clinical Studies initiative. Among the high-priority topics are autism, suicide, and integration of mental and behavioral health services into primary care for both the general population and for people at risk for disparities in health care and outcomes.

Other mental health issues are currently in PCORI’s topic-prioritization process that leads to targeted funding announcements. PCORI multi-stakeholder advisory panels have highly prioritized major depression, bipolar disorder, and attention-deficit hyperactivity disorder, in addition to autism, suicide, and integration of mental and behavioral health services into primary care. 

We look forward to keeping you informed as PCORI’s mental health projects progress toward answering questions important to patients, their caregivers, and others in the healthcare community.

Note - We would like to thank the following contributors to this blog post: Sarah Chew, Bridget Gaglio, Alex Hartzman, Katie Hughes, Beth Kosiak, Shivonne Laird, and Mychal Weinert.