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Request for Proposals - DSM-5 Field Trial Site Recruitment (4/4/2010) 

Important Notice to Applicants for DSM-5 Field Trials in Large, Academic Settings

This RFP is posted for informational purposes only. The deadline for receipt of proposals for DSM-5 Field Trials has now passed and the application period has closed.

 

Below is a general description of the APA's Request for Proposals (RFP) for DSM-5 Field Trial site recruitment. A detailed summary of information needed from respondants to this RFP can be found by clicking here.

1.1  INTRODUCTION/BACKGROUND

The DSM-5 Task Force is requesting proposals from academic and large general psychiatric, mental health specialty, and medical specialty settings to participate in the field trials of proposed DSM-5 diagnostic criteria, cross-cutting dimensional measures, and diagnostic-specific severity measures.  Our objective is to assure that these proposed changes are subjected to rigorous and empirically sound field trials before DSM is released for general clinical and research use. As such, the American Psychiatric Association (APA) plans to field test the clinical utility, feasibility, reliability, and, where possible, validity of selected DSM-5 draft diagnostic criteria and associated dimensional measures across a variety of clinical settings. The initial phase of these field trials is set to begin in the summer of 2010 and continue through February 2011. The disorders selected for study in field trials include those with high public health significance and/or those with significant proposed changes to the diagnostic criteria.  A list of the diagnoses planned for testing in the field trials can be found by clicking here.  We are limiting this first round of contracted sites to locations in the U.S. and Canada but will consider international sites for the second wave of field trials.  However, if international sites believe that they have the resources to carry out this wave 1 protocol, we will be happy to discuss how we can facilitate their participation. 

 

An additional field trial in routine clinical practice settings covering all DSM-5 disorders will be conducted separately with a focus on clinical utility and feasibility but without a test-retest or validity component. This additional field trial will enroll a randomly selected sample of individual multidisciplinary clinicians as well as a sample who volunteer to participate.  International participation will be feasible for the volunteer component of this “Practice Research Network” protocol, which will start later in the fall of 2010. The detailed protocol for this version of the field trial is available upon request.

 

These first wave of DSM-5 Field Trials will be conducted in 8-10 academic or other large clinical settings across the U.S. and Canada using a standardized protocol developed by the DSM-5 Research Group.  The field trials will utilize a stratified sampling design with stratification based on the patients’ DSM-IV primary Axis I or Axis II diagnosis. For a disorder that is new to DSM-5, stratum will be defined by a combination of relevant DSM-IV diagnoses and symptoms, as documented by the treating clinician on the Patient Recruitment/Screening Form. The Patient Recruitment/Screening Form inquires about the patient's diagnosis, whether the patient is currently symptomatic, whether the patient has any past or current self-injurious ideation or attempts, and other age-specific and relevant factors (such as temper tantrums in children). Consecutive new and existing patients entering the clinical setting for their initial or routine follow-up visits, which occur during the 4 ½ month recruitment period for the field trials, and who are found to be symptomatic during the visit, will be sampled into a diagnostic group or a control group.  There will be a minimum of 2 to a maximum of 5 diagnostic groups (i.e., D2-D5) and one control group (i.e., Other) examined at any single site. Each potential site should examine the diagnostic distribution of patients in its setting to assess which disorders the site would be able to study in this field trial. Each diagnostic group will need 50 patients, which includes a combined sample of 50 new and existing patients.  The control group will comprise 50 randomly selected patients from among the pool of new and existing patients who are not diagnosed with any of the diagnoses of interest at that particular site.  Therefore, each participating site in the study will require final sample sizes of 150-300 patients. 

 

The timeline for the study including the period of pre-data collection will be 9 months (from June 1, 2010 to February 28, 2011).  The pre-data collection period will involve site preparation, staff training, and applying for IRB approval of the study.  Therefore, information on the site’s feasibility of acquiring rapid IRB approval is needed. Each enrolled patient will have three study visits, which will occur over a period of 2-4 months. After a baseline study visit, all enrolled patients will be re-examined at least 4 hours but not more than 2 weeks after the baseline study visit by a different clinician to enable the assessment of the test-retest reliability of the diagnostic criteria and dimensional measures, and 4-12 weeks later by the treating clinician to assess the sensitivity to change of the dimensional measures.  To facilitate data management and enhance the feasibility of the study, all data collection will be done using a Web-based electronic data collection system.

Potential sites can include general psychiatric clinics, diagnosis-specific specialty clinics, and medical specialty clinics. Final site selection will also be based on a number of requirements such as patient volume; clinician staffing (i.e., a minimum of 8 participating clinicians per site); the prevalence and types of mental disorders typically seen in the setting and whether they relate to the field trial disorders of interest; and whether the setting has a research infrastructure in place to accommodate the complexities of the study design outlined above.  For instance, multiple clinicians need to be available in participating sites to: i) enable the reliability component of the study, which requires at least 2 clinicians who have not seen the patient previously (3 clinicians for existing patients); ii) review each patient’s self-rated cross-cutting measures (e.g., PROMIS measures); and iii) provide DSM-5 diagnoses using a diagnostic criteria checklist, and associated symptom severity ratings at baseline and the first visit.  The existing research infrastructure at each participating site should preferably be able to retain the services of Research Coordinator time from existing staff, thereby reducing the need to hire a new untrained Research Coordinator at each site.  The Research Coordinators will be reimbursed on a combination of fixed (i.e., a set 0.5 to 1.0 full-time rate for the first half of the study) and variable costs basis (i.e., based on number of patients recruited and retained for the remainder of the study).

1.2  BUDGET AND PROJECT PERIOD

The funding for the field trial sites will be supported through contracts between the sites and the APA.  Funds awarded will be site-specific, dependent on the number of diagnoses being examined at the site, and hence, the numbers of patients that the site will have to recruit, enroll, and follow throughout the field trials.  Based on the number of diagnoses and the control group, any single site will need to enroll and follow a final sample of 150 (for 2 diagnoses plus control group) to 300 (for 5 diagnoses plus control group) patients throughout the study. The overall budget based on these patient numbers is estimated to range from $175,000.00 - $260,000.00 per site.  This overall budget will cover:

 

1.    Research Coordinator fixed cost at a 0.5 to 1.0 full-time rate for the first half of the study = $30,000.00 maximum (based on up to $80K/year rate) depending on the number of diagnoses being field tested at the particular site.  For instance, a site that has the capacity to field test 5 diagnoses plus enroll a control group of 50 patients, the Research Coordinator’s fixed cost for the first half of the study will be $30,000.  However, a site that only has the capacity to field test 2 diagnoses plus enroll a control group of 50 patients (i.e., total sample of 150), the Research Coordinator’s fixed cost for the first half of the study will be $15,000.  Within the first half of the study, the Research Coordinator will be actively involved in pre-data collection activities such as preparing the site for the study, completing the IRB application process, initial participant recruitment and consent, coordinating participating clinicians’ schedules, scheduling baseline study visits for consented participants, and enrollment of patients (since the recruitment period overlaps with the data collection period). 

 

2.    Research Coordinator variable cost at $30 per patient for the baseline visit and $60 per patient for each of the 2 follow-up visits.

3.    A 10% administrative cost.

4.    Clinician remuneration at $100 per patient per study visit.

5.    Patient remuneration at $40 per study visit.

6.    Miscellaneous costs of up to $1,500.00 per site, which include photocopying and printing.

7.    The APA will provide a study laptop and 4 tablets to each participating field trial site.

 

In addition to the clinician remuneration, each clinician will be listed as a field trial participant in DSM-5.  Each participating clinician who is a physician will be provided with CME credits for his or her participation.

1.3  APPLICATION PROCESS AND CONTACT INFORMATION

A letter of intent to submit a proposal, although non-binding and not mandatory, is recommended.  This letter should be submitted to the persons below by 5:00 p.m. on April 15, 2010, and should include the prospective study setting and potential disorders that could be studied at the site.  Applicants offering prospective sites must submit, in writing (by e-mail), an application which should include a detailed description of the ability of their respective sites to meet all requirements in the RFP that is available on request and posted on the www.DSM5.org Web site. The application should also include an outline of the disorders that can be tested in the particular site. All applicants should review the detailed field trial protocol that is available on request and posted here. This application is due at the APA by the close of business (5:00 p.m. EST) on Friday, May 7, 2010. The application must be submitted to both:

 

Name and Title:

 

 

 

Mailing Address:

 

 

 

 

Email Address:

 

Phone number:

 

Fax number:

William E. Narrow, M.D., M.P.H.

Associate Director, Division of Research, American Psychiatric Association

 

American Psychiatric Association

Suite 1825

1000 Wilson Blvd

Arlington VA  22209

 

 

wnarrow@psych.org

 

 

301-332-2807

 

 

703-907-1087

Diana E. Clarke, M.Sc., Ph.D.

Research Statistician, Division of Research, American Psychiatric Association

 

American Psychiatric Association

Suite 1825

1000 Wilson Blvd

Arlington VA  22209

 

 

dclarke@psych.org

 

 

703-907-8621

 

 

703-907-1087

 

If you have any questions regarding this RFP, please feel free to contact either Drs. Narrow or Clarke using the contact information above.