Efficacy of BETTER transitional care intervention for diverse patients with traumatic brain injury and their families: Study protocol of a randomized controlled trial.

OBJECTIVE: The purpose of this study is to examine the efficacy of BETTER (Brain Injury, Education, Training, and Therapy to Enhance Recovery) vs. usual transitional care management among diverse adults with traumatic brain injury (TBI) discharged home from acute hospital care and families. METHODS: This will be a single-site, two-arm, randomized controlled trial (N = 436 people, 218 patient/family dyads, 109 dyads per arm) of BETTER, a culturally- and linguistically-tailored, patient- and family-centered, TBI transitional care intervention for adult patients with TBI and families. Skilled clinical interventionists will follow a manualized protocol to address patient/family needs. The interventionists will co-establish goals with participants; coordinate post-hospital care, services, and resources; and provide patient/family education and training on self- and family-management and coping skills for 16 weeks following hospital discharge. English- and Spanish-speaking adult patients with mild-to-severe TBI who are discharged directly home from the hospital without inpatient rehabilitation or transfer to other settings (community discharge) and associated family caregivers are eligible and will be randomized to treatment or usual transitional care management. We will use intention-to-treat analysis to determine if patients receiving BETTER have a higher quality of life (primary outcome, SF-36) at 16-weeks post-hospital discharge than those receiving usual transitional care management. We will conduct a descriptive, qualitative study with 45 dyads randomized to BETTER, using semi-structured interviews, to capture perspectives on barriers and facilitators to participation. Data will be analyzed using conventional content analysis. Finally, we will conduct a cost/budget impact analysis, evaluating differences in intervention costs and healthcare costs by arm. DISCUSSION: Findings will guide our team in designing a future, multi-site trial to disseminate and implement BETTER into clinical practice to enhance the standard of care for adults with TBI and families. The new knowledge generated will drive advancements in health equity among diverse adults with TBI and families. TRIAL REGISTRATION: NCT05929833.

The impact of clinical pharmacy services on pneumococcal vaccine frequency and appropriateness in a family medicine clinic.

OBJECTIVE: To evaluate the impact of an ambulatory clinical pharmacy service (inclusive of immunization needs assessments) on the frequency and appropriateness of pneumococcal vaccine administration in a family medicine clinic. METHODS: This cohort study had an observational and retrospective design and included patients who received pneumococcal vaccines at a family medicine clinic in a medically underserved area in Southwestern Pennsylvania across a 42-month period from January 1, 2015, to June 30, 2018. The outcome measures included the administration and appropriateness of pneumococcal 13-valent conjugate (PCV13) and pneumococcal 23-valent polysaccharide (PPSV23) vaccines across 3 time cohorts including before, during, and after the establishment of a clinical pharmacy service. RESULTS: A total of 457 pneumococcal vaccines were administered, including 198 (43.3%) PCV13 and 259 (56.7%) PPSV23, across all time cohorts. Overall vaccine administration per month increased by 143% with the introduction of a dedicated clinical pharmacy service, including a 270% increase for PCV13 and an 87% increase for PPSV23. A strong correlation was found between recommendations made and doses administered for both pneumococcal vaccines (r = 0.89; P < 0.003). Across the entire time frame, PPSV23 administrations were appropriate in more than 96% of instances, whereas the appropriateness of PCV13 administrations were statistically significantly improved after the introduction of a fully dedicated clinical pharmacy service (58.5% vs. 90.8%; P < 0.05). The appropriateness of vaccine administration remained high even after the reduction of clinical pharmacy services. CONCLUSION: Clinical pharmacy service implementation in a family medicine clinic was associated with increased pneumococcal vaccine administration and increased appropriateness of PCV13 administrations.