Ethical and Regulatory Concerns in Pragmatic Clinical Trial Monitoring and Oversight.

The implementation of pragmatic clinical trials (PCTs) can be accompanied by unique regulatory challenges. In this paper, we describe the experience and management of regulatory noncompliance during a 25-site acute care PCT. During the trial, the study team conducted a comprehensive audit of all enrollment forms (informed consent and Health Insurance Portability and Accountability Act authorization forms) and related study documentation. A review of 997 participants' enrollment forms identified 138 (13.8%) that required reporting to the institutional review board due to noncompliance. To prevent subsequent noncompliance, the study team developed and introduced a revised participant tracking system, reviewed all enrollment documentation, and retrained sites regarding study procedures. Based on these experiences, we developed a set of recommendations for future PCTs to ensure both operational success and regulatory compliance.

Pragmatic Quality Assessment of Brief Health Behavior Change Interventions: Evidence for Criterion-Related Validity of the Behavior Change Counseling Index.

BACKGROUND: Healthcare providers frequently engage patients in conversations about health behavior change and are encouraged to use patient-centered approaches, such as Motivational Interviewing. Training in and sustainment of these skills are known to require feedback based on actual or role-played patient encounters. The behavior change counseling index (BECCI) is a pragmatic measure to assess healthcare providers' patient-centered behavior change counseling skills that was developed as an alternative to resource-intensive "gold standard" measures, which are difficult to use in routine practice. We are not aware of any studies that examine the criterion-related validity of this measure using an alternative gold standard measure. We examined the criterion-related validity of the BECCI as rated by a simulated patient actor immediately after a brief behavior change intervention role-play using objective ratings on the motivational interviewing treatment integrity (MITI) scale. METHODS: We conducted a secondary analysis of data from a 25-site clinical trial of screening and intervention for posttraumatic stress disorder and comorbidities with patients at level I trauma centers in the USA. Participants were 64 providers representing diverse professional roles trained to deliver a multi-component intervention with study patients. As part of the training, providers role-played counseling a patient to reduce risky alcohol use with a simulated patient actor. These 20-min role-plays were conducted by telephone and audio recorded. Immediately after the role-play, the simulated patient actor rated the quality of the providers' patient-centered behavior change counseling skills using the BECCI. A third-party expert MITI rater later listened to the audio recordings of the role-plays and rated the quality of the providers' patient-centered behavior change counseling skills using the MITI 3.1.1. RESULTS: All correlations observed were statistically significant. The overall BECCI score correlated strongly (≥ 0.50) with five of the six MITI scores and moderately (0.33) with MITI percent complex reflections. CONCLUSIONS: This study provides evidence of criterion-related validity of the BECCI with a sample of healthcare providers representing a range of professional roles. Simulated patient actor rating using the BECCI is a pragmatic approach to assessing the quality of brief behavior change interventions delivered by healthcare providers.

Task-shifting to improve the reach of mental health interventions for trauma patients: findings from a pilot study of trauma nurse training in patient-centered activity scheduling for PTSD and depression.

Despite high rates of posttraumatic stress disorder (PTSD) and depression among traumatically injured patients, engagement in session-based psychotherapy early after trauma is limited due to various service utilization and readiness barriers. Task-shifting brief mental health interventions to routine trauma center providers is an understudied but potentially critical part of the continuum of care. This pilot study assessed the feasibility of training trauma nurses to engage patients in patient-centered activity scheduling based on a Behavioral Activation paradigm, which is designed to counteract dysfunctional avoidance/withdrawal behavior common among patients after injury. Nurses (N = 4) and patients (N = 40) were recruited from two level II trauma centers. A portion of a one day in-person workshop included didactics, demonstrations, and experiential activities to teach brief intervention delivery. Nurses completed pre- and posttraining standardized patient role-plays prior to and two months after training, which were coded for adherence to the intervention. Nurses also completed exit interviews to assess their perspectives on the training and addressing patient mental health concerns. Findings support the feasibility of training trauma nurses in a brief mental health intervention. Task-shifting brief interventions holds promise for reaching more of the population in need of posttrauma mental health care.

Technology Use, Preferences, and Capacity in Injured Patients at Risk for Posttraumatic Stress Disorder.

OBJECTIVE: This investigation comprehensively assessed the technology use, preferences, and capacity of diverse injured trauma survivors with posttraumatic stress disorder (PTSD) symptoms. METHOD: A total of 121 patients participating in a randomized clinical trial (RCT) of stepped collaborative care targeting PTSD symptoms were administered baseline one-, three-, and six-month interviews that assessed technology use. Longitudinal data about the instability of patient cell phone ownership and phone numbers were collected from follow-up interviews. PTSD symptoms were also assessed over the course of the six months after injury. Regression analyses explored the associations between cell phone instability and PTSD symptoms. RESULTS: At baseline, 71.9% (n = 87) of patients reported current cell phone ownership, and over half (58.2%, n = 46) of these patients possessed basic cell phones. Only 19.0% (n = 23) of patients had no change in cell phone number or physical phone over the course of the six months postinjury. In regression models that adjusted for relevant clinical and demographic characteristics, cell phone instability was associated with higher six-month postinjury PTSD symptom levels (p < 0.001). CONCLUSIONS: Diverse injured patients at risk for the development of PTSD have unique technology use patterns, including high rates of cell phone instability. These observations should be strongly considered when developing technology-supported interventions for injured patients with PTSD.