We are conducting an Institutional Review Board (IRB)-approved trial of telephone-based collaborative care for treating PD/GAD at 4 primary care practices within the University of Pittsburgh Medical Center. The practices participated in our earlier trial of collaborative care for PD/GAD9
and share a common commercially available EMR (EpicCare® Ambulatory Electronic Medical Record, Madison, WI). They include the University’s main urban faculty practice, and one rural and two suburban practices.
Primary care physicians (PCPs) view their patients’ medical information on computer workstations placed in each examination room. The EMR has an integral messaging system that permits PCPs and practice staff to communicate with each other and to document care. Electronic reminders prompt physicians to provide preventive and chronic illness care based on patient age, sex, and medical diagnoses entered into coded EMR fields.
Before the start of patient recruitment into both trials, we conducted training to familiarize PCPs with anxiety and mood disorders, and to inform them of our study procedures. Both trials utilized similar telephone-based collaborative care strategies10
and PCPs received instruction on recognizing anxiety and mood disorders and a copy of our locally adapted treatment guidelines for PD and GAD.10
Before activating our electronic reminders, we provided PCPs with guidance on how to respond to the EMR prompts.
Waitroom Recruitment Strategy
A study recruiter stationed in a practice waiting room administered the PRIME-MD patient questionnaire (PQ)11
to screen patients for the presence of an anxiety disorder. We required that patients with a positive PQ screen have: (a) no obvious dementia, psychotic illness, or unstable medical condition; (b) two or fewer positive responses on the CAGE alcohol screening questionnaire12
embedded within the PQ; and (c) no language or other communication barrier. If so, the recruiter obtained written consent to administer the PRIME-MD Anxiety Module.11
If the patient met DSM-IV criteria for PD and/or GAD, the recruiter confirmed the patient: (a) was not in active treatment with a mental health professional; (b) had no history of bipolar disorder; and (c) had no plans to leave the study practice within the following year. If confirmed, the recruiter consented the patient for our telephone follow-up procedure to determine the severity of their anxiety symptoms. We required at least a moderate level of anxiety symptoms as defined by a score ≥14 on the structured interview guide for the Hamilton Anxiety Rating Scale (SIGH-A)13
or ≥7 on the Panic Disorder Severity Scale (PDSS).14
We designed our EMR prompt to expose the PCP to a reminder about our study at the time of the clinical encounter for patients aged 18–64 with anxiety, generalized anxiety, panic, or depression entered into their electronic problem list, or if the physician coded one of these syndromes as the encounter diagnosis (Fig. ). We included depression as a trigger given its 40–50% comorbidity with anxiety, and PCPs greater likelihood to recognize and document mood disorders than anxiety disorders.15,16
The alert was suppressed if bipolar and psychotic disorders were on the electronic problem list. We did not enroll any patients into our trial before activation of our alerts.
Figure 1 EpicCare screenshot of a HIPAA-compliant “Best Practice Alert” reminder informing the PCP about our study. The clinician clicks on the “BestPractice SmartSet” hyperlink (at bottom) to send a referral for our screening procedure. (more ...)
We designed our alert to be Health Insurance Portability and Accountability Act (HIPAA)-compliant; instructing PCPs to seek patient permission before forwarding contact information to a study recruiter (Fig. ). Our research team was unaware of any patient’s identity until the PCP obtained oral consent to release this information. To facilitate our electronic approach, the IRB permitted PCPs to obtain a patient’s verbal consent rather than a signed HIPAA consent to release contact information.
After obtaining verbal consent, the PCP mouse-clicked a hyperlink within the alert that automatically entered the referral on an order list for the encounter. Once the PCP signed the order, an electronic “referral” containing the patient’s name and telephone number was forwarded to a “pool address” from which our research team then attempted to contact the patient. We programmed the prompt to turn off for a 180-day period after the referral, and permanently for patients who enrolled into our trial. However, the alert continued to trigger at subsequent visits if the PCP did not respond to the prompt.
The PCP could also initiate an electronic referral for any patient after obtaining consent by sending an electronic message to our pool address. We periodically reminded PCPs of this easily remembered address during routine training sessions, and through study-specific marketing materials (e.g., pens, mugs, and newsletters).
Within two business days after the PCP encounter, a research assistant telephoned the patient to describe our study, confirm preliminary eligibility criteria, and answer questions. If the patient remained potentially eligible to participate, they met with our study staff in the clinic to provide signed consent and confirm eligibility using similar criteria as our waitroom recruitment strategy.
We compared baseline sociodemographic, diagnostic, and symptom severity variables by recruitment strategy using t tests for continuous data and chi-square analyses for categorical data.