Aims To identify barriers and facilitators associated with initial implementation of a US alcohol and other substance use Screening, Brief Intervention, and Referral to Treatment (SBIRT) grant program, and to identify modifications in program design that addressed implementation challenges. Design A mixed-method approach used quantitative and qualitative data, including SBIRT provider ratings of implementation barriers and facilitators, staff interview responses and program documentation. Setting Multiple sites within the first seven programs funded in a national demonstration program in the United States. Participants One hundred and two SBIRT providers were surveyed; 221 SBIRT stakeholders and staff were interviewed. Measurements Mean ratings of barriers and facilitators were calculated using provider survey responses. An inductive content analysis of interview responses identified factors perceived to support and challenge implementation; program modifications that occurred over time were recorded. Findings Providers rated pre-selected implementation facilitators higher than barriers. Content analysis of interview responses revealed six themes: committed leaders; intra-and inter-organizational communication/collaboration; provider buy-in and model acceptance; contextual factors; quality assurance; and grant requirements. Over time, programs tended to: adopt more efficient 'pre-screen' item sets; screen for risk factors in addition to alcohol/substance use; use contracted specialists to deliver SBIRT services; conduct services in high-volume emergency department and trauma center settings; and implement on-site and telephonic treatment delivery. Conclusions Screening, Brief Intervention and Referral to Treatment program implementation in the United States is facilitated by committed leadership and the use of substance use specialists, rather than medical generalists, to deliver services. Many implementation challenges can be addressed by an adequate start-up phase focused on comprehensive education and training, and on the development of intra-and inter-organizational communication and collaboration; opinion leader support; and practitioner and host site buy-in.
Aims To assess the sustainability of Screening, Brief Intervention and Referral to Treatment (SBIRT) services after cessation of initial start-up funding. Design Descriptive study with quantitative and qualitative data collected from 34 staff participants from six grantees (comprising 103 sites) funded previously through a large, federally supported SBIRT program. Setting Primary care out-patient clinics and hospitals in the United States. Participants Thirty-four granteerelated staff members, including administrators, evaluators, key stakeholders and SBIRT service providers from six grantees. Measurements Changes to levels and types of service delivery activities after federal funding stopped, alternative sources of funding and obstacles to delivery of services. Findings Of the 103 original sites in the six SBIRT grantee programs, 69 sites continued providing services in some capacity (same as before, reduced, modified or expanded). Most of the 69 sites (67%) adapted and redesigned the delivery of SBIRT services post-initial grant funding. In addition, new sites were added after grant funding ended, bringing the total number of sites to 88. Analysis of participant responses identified four primary factors that influenced SBIRT sustainability: presence of champions, funding availability, systemic change and SBIRT practitioner characteristics. Conclusions Almost 70% of the Screening, Brief Intervention and Referral to Treatment (SBIRT) services in the United States funded initially through a federal program were able to sustain operations after federal funding ceased and some expanded SBIRT services beyond the original sites. The key factors related to sustainability were securing new funding, having champions, adapting and making system changes and managing program staffing challenges.
After the placebo-controlled extension of the pivotal US trial of glatiramer acetate for the treatment of relapsing multiple sclerosis ended, 208 participants entered an open-label, long-term treatment protocol Magnetic resonance imaging (MRI) was added to the planned evaluations of these subjects to determine the consequences of long-term treatment on MRI-defined pathology and evaluate its clinical correlates. Of the 147 subjects that remained on long-term follow-up, adequate images were obtained on 135 for quantitative MRI analysis. The initial imaging sessions were performed between June 1998 and January 1999 at 2,447 +/- 61 days (mean +/- standard deviation) after the subject's original randomization. Clinical data from a preplanned clinical visit were matched to MRI within 3 +/- 51 days. At imaging, 66 patients originally randomized to placebo (oPBO) in the pivotal trial had received glatiramer acetate for 1,476 +/- 63 days, and 69 randomized to active treatment with glatiramer acetate (oGA) were on drug for 2,433 +/- 59 days. The number of documented relapses in the 2 years prior to entering the open-label extension was higher in the group originally randomized to placebo (oPBO=1.86 +/- 1.78, oGA=1.03 +/- 1.28; P=0.002). The annualized relapse rate observed during the open-label study was similar for both groups (oPBO=0.2 7, +/- 0.45 oGA=0.28 +/- 0.40), but the reduction in rate from the placebo-controlled phase was greater for those beginning therapy with GA (oPBO reduced by 0.66 +/- 0.71, oGA reduced by 0.23 +/- 0.58; P=0.0002). One or more gadolinium enhancing lesions were found in 27.4% of all patients (number of distinct enhancements=1.16 +/- 2.52, total enhanced tissue volume=97 +/- 26 microl). The risk of having an enhancement was higher in those with relapses during the open-label extension (odds ratio 4.65, 95% confidence interval (CI) 2.0 to 10.7; P=0.001). The odds for finding an enhancement was 2.5 times higher for those patients originally randomized to placebo (CI 1.1 to 5.4; P=0.02) compared to those always on glatiramer acetate. MRI-metrics indicative of chronic pathology, particularly measures of global cerebral tissue loss (atrophy), were uniformly worse for those originally on placebo. These observations enrich our long-term follow up of the clinical consequences of treatment with glatiramer acetate to include its apparent effects on MRI-defined pathology. They show that the effect of glatiramer acetate on enhancements is definite, but modest, consistent with the drug's described mechanisms of action, and that a delay in initiating treatment results in progression of MRI-measured pathology that can be prevented.
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