ABSTRACT
BACKGROUND: Caregivers of patients with severe acute brain injuries (SABI) that lead to coma and require intensive care unit (ICU) treatment often experience chronic emotional distress. To address this need, we developed the Coma Family (COMA-F) program, a mindfulness-based resiliency intervention for these caregivers. OBJECTIVE: We will conduct an open pilot trial of COMA-F (National Institutes of Health Stage IA). Here we describe our study protocol and proposed intervention content. METHODS: We will enroll 15 caregivers of patients with SABIs during their loved one's hospital course from 3 enrollment centers. A clinical psychologist will deliver the COMA-F intervention (6 sessions) over Zoom (Zoom Video Communications, Inc) or in person. We will iterate COMA-F after each caregiver completes the intervention and an exit interview. English-speaking adults who have emotional distress confirmed by the clinical team and are the primary caregivers of a patient with SABI are eligible. The adult patient must have been admitted to the neuro-ICU for SABI and (1) have had a Glasgow Coma Scale score below 9 while not intubated or an inability to follow meaningful commands while intubated at any point during their hospitalization for >24 hours due to SABI; (2) will be undergoing either tracheostomy or percutaneous endoscopic or surgical gastrostomy tube placement or have already received one or both; and (3) have a prognosis of survival >3 months. We will identify eligible caregivers through screening patients' medical records and through direct referrals from clinicians in the neuro-ICU. During the intervention we will teach caregivers mind-body and resilience skills, including deep breathing, mindfulness, meditation, dialectical thinking, acceptance, cognitive restructuring, effective communication, behavioral activation, and meaning-making. Caregivers will complete self-report assessments (measures of emotional distress and resilience) before and after the intervention. Primary outcomes are feasibility (recruitment, quantitative measures, adherence, and therapist fidelity) and acceptability (treatment satisfaction, credibility, and expectancy). We will conduct brief qualitative exit interviews to gather feedback on refining the program and study procedures. We will examine frequencies and proportions to determine feasibility and acceptability and will analyze qualitative exit interview data using thematic analysis. We will also conduct 2-tailed t tests to explore signals of improvement in emotional distress and treatment targets. We will then conduct an explanatory-sequential mixed methods analysis to integrate quantitative and qualitative data to refine the COMA-F manual and study procedures. RESULTS: This study has been approved by the institutional review board at 1 of the 3 enrollment centers (2023P000536), with approvals at the other 2 centers pending. We anticipate that the study will be completed by late 2024. CONCLUSIONS: We will use our findings to refine the COMA-F intervention and prepare for a feasibility randomized controlled trial. TRIAL REGISTRATION: ClinicalTrials.gov NCT05761925; https://clinicaltrials.gov/study/NCT05761925. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/50860.
ABSTRACT
OBJECTIVE: The objectives of this research were to investigate and compare general and pediatric dentists' subjective judgments of orthodontic case complexity and to determine how their perceptions of case complexity influence their decisions to refer the patient to an orthodontist. METHODS: Twenty pediatric dentists and 21 general dentists participated in the study. Pretreatment orthodontic records of 20 patients with a variety of malocclusions and a range of American Board of Orthodontics Discrepancy Index (DI) scores were used. Respondents were asked about their background and training in orthodontics. They were also asked to identify the subjective complexity of each case with the use of a 100-point visual analog scale (VAS) and whether they would refer the patient to an orthodontic specialist. A mixed-model multivariate data analysis was used to evaluate the subjective case complexity with the use of fixed factors such as DI score, type of panel member, experience, annual continuing education rate, and gender. Generalized linear mixed models were used to investigate the referral patterns of the general dentists and pediatric dentists. Level of significance was set at P < 0.05 for all statistical analyses. RESULTS: General dentists appeared to provide more overall orthodontic treatment than pediatric dentists; many general dentists provide limited orthodontic treatment and clear aligner therapy (P < 0.05). The perceived complexity score for cases was not significantly different between the 2 groups (P = 0.82). The association between DI score and perceived complexity was similar in both groups (P = 0.183) and there was a high correlation between DI and VAS score in the sample (r = 0.71; 95% Cl 0.38-0.87). Pediatric dentists had higher referral rates for cases with DI scores both below and above 20. Significant differences were noted between the pediatric and general dentists in the individual case referral decision as evaluated by the DI (P < 0.037) and VAS (P < 0.042) scores. CONCLUSIONS: General dentists provided more orthodontic care than the pediatric dentists. Both groups identified case complexity similarly, with only minor differences, but pediatric dentists had higher referral rates to orthodontic specialists regardless of the initial case complexity.
