Meeting the Needs of Participants In Clinical Research: An Evaluation of the NYSPI Social Work Consultation Service

Background and Purpose: Advances in mental health treatment are often made through clinical trials, in which individuals from a clinical population volunteer in exchange for financial compensation or for “free” treatment. In clinical research, participants are not simply subjects, but have dual roles as patient-participants, while researchers have dual roles as provider-investigators (Litton & Miller, 2010). Research with psychiatric patient-participants, a vulnerable population, must consider the needs of subjects above those of investigators, which may mean providing clinical services beyond those required by the protocol (Emanuel, Wendler, & Grady, 2000; Zion, Gillam, & Loff, 2000).The Social Work Consultation Service (SWCS) at New York State Psychiatric Institute (NYSPI) was developed to meet needs of research participants not met through typical clinical trials. Referrals were to be short-term and concrete, limited to three sessions with a social worker, in which participants were provided with resources or referrals to outside agencies. The present study provides a descriptive evaluation of how the service works, who it serves, what needs are addressed, and how successful it has been in meeting those needs.

Methods: Data were obtained via chart extraction for all NYSPI patients referred to SWCS over a 5-year period -- January 2006 to January 2011. Variables of interest focused on demographics, source and reasons for referral, success of the service, and amount of time expended for each patient. Descriptive data relating to time expended was divided according to whether or not the patient engaged in services (defined as having at least one appointment) and, if engaged, whether or not the service successfully addressed the presenting problem.

Results: 131 SWCS charts from the 5-year period were reviewed (2 had no usable information). Of the 129 with information, the age range served was 21 to 65 (mean = 45.1), with slightly more females (55%) receiving services. Most patients were either uninsured or on Medicaid, and were unmarried, separated, or divorced. Nearly 1/4 had minor children, but only half were considered primary caretakers for these children. Referrals came primarily from neuroscience, substance abuse, and general mental health research units. Referrals typically aimed to address concrete needs related to housing, entitlements, medical care, and mental health treatment. All except five referrals were deemed appropriate for the service. 41 patients never made further contact beyond the initial referral, although an average of 71 minutes was spent (e.g., contacting referral sources, etc.). Of the 88 participants who were engaged in services, 71 (81%) had their presenting issues successfully addressed, using an average of 257.68 minutes (13.28 contacts). 15 (17%) were not successfully helped despite substantial effort - an average of 199.00 minutes (11.07 contacts). There was missing data on this variable for 2 cases.

Conclusions and Implications: This evaluation confirms the need for additional services among research participants, and supports the efficacy of a time-limited social work service in addressing these needs. This not only improves the quality of care provided to a vulnerable population, but may also improve retention in clinical research by eliminating barriers to participation.