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Study protocol testing toolkit versus usual care for implementation of screening, brief intervention, referral to treatment in hospitals: a phased cluster randomized approach.

ABSTRACT: BACKGROUND:Alarming rates of unhealthy alcohol, non-prescription drug, and tobacco use highlight the preventable health risks of substance abuse and the urgent need to activate clinicians to recognize and treat risky use. Screening, brief intervention, and referral to treatment (SBIRT) is an efficacious and effective processes to identify, reduce and prevent risky use of substances. This paper describes a study protocol testing implementation of a toolkit to enhance use of SBIRT in acute care settings to recognize and address patient risky alcohol, drug, and tobacco use. METHODS:This study uses a phased cluster randomized mixed method design to test nurse-led implementation of an SBIRT toolkit on one medical-surgical unit at 14 acute care hospitals (critical access, community and academic health centers). Medical surgical units will be randomly assigned to implement the SBIRT toolkit (engagement and communication, assessment, planning, training, and evaluation tools) or a wait-list usual care control group that begins implementation 6 months later. Primary endpoints are documentation of SBIRT delivery in randomly selected electronic medical records at baseline, 6 months and 12 months after group 1 implementation (61 records per unit per time period, N?=?2562). Two surveys will be administered to unit nurses: smoking cessation activities will be assessed at baseline and SBIRT use will be assessed on randomly-selected days after implementation. In addition, site coordinators will complete a baseline capacity assessment, an implementation fidelity survey post-implementation, and a structured interview at the end of the study. Multilevel mixed-effects effects logistic and linear models will be used to analyze use of SBIRT and cost outcomes. DISCUSSION:This study will guide subsequent SBIRT implementation, dissemination, and spread across rural, community and urban healthcare systems throughout the state and beyond. The long-term objective is to activate clinicians to recognize, intervene and refer people with risky substance use to improve health and decrease substance use disorders. Trial registration ClinicalTrials.gov NCT03560076.

SUBMITTER: Newhouse R

PROVIDER: S-EPMC6307302 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature

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Study protocol testing toolkit versus usual care for implementation of screening, brief intervention, referral to treatment in hospitals: a phased cluster randomized approach.

Newhouse Robin R Janney Michelle M Gilbert Anne A Agley Jon J Bakoyannis Giorgos G Ferren Melora M Mullins C Daniel CD Johantgen Meg M Schwindt Rhonda R Thoele Kelli K

Addiction science & clinical practice 20181227 1

<h4>Background</h4>Alarming rates of unhealthy alcohol, non-prescription drug, and tobacco use highlight the preventable health risks of substance abuse and the urgent need to activate clinicians to recognize and treat risky use. Screening, brief intervention, and referral to treatment (SBIRT) is an efficacious and effective processes to identify, reduce and prevent risky use of substances. This paper describes a study protocol testing implementation of a toolkit to enhance use of SBIRT in acute ...[more]

PMID: 30587235

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Project description:ImportanceEarly intervention for substance use is critical to improving adolescent outcomes. Studies have found promising results for Screening, Brief Intervention, and Referral to Treatment (SBIRT), but little research has examined implementation.ObjectiveTo compare SBIRT implementation in pediatric primary care among trained pediatricians, pediatricians working in coordination with embedded behavioral health care practitioners (BHCPs), and usual care (UC).Design, setting, and participantsThe study is a 2-year (November 1, 2011, through October 31, 2013), nonblinded, cluster randomized, hybrid implementation and effectiveness trial examining SBIRT implementation outcomes across 2 modalities of implementation and UC. Fifty-two pediatricians from a large general pediatrics clinic in an integrated health care system were randomized to 1 of 3 SBIRT implementation arms; patients aged 12 to 18 years were eligible.InterventionsTwo modes of SBIRT implementation, (1) pediatrician only (pediatricians trained to provide SBIRT) and (2) embedded BHCP (BHCP trained to provide SBIRT), and (3) UC.Main outcomes and measuresImplementation of SBIRT (primary outcome), which included assessments, brief interventions, and referrals to specialty substance use and mental health treatment.ResultsThe final sample included 1871 eligible patients among 47 pediatricians; health care professional characteristics did not differ across study arms. Patients in the pediatrician-only (adjusted odds ratio [AOR], 10.37; 95% CI, 5.45-19.74; P < .001) and the embedded BHCP (AOR, 18.09; 95% CI, 9.69-33.77; P < .001) arms had higher odds of receiving brief interventions compared with patients in the UC arm. Patients in the embedded BHCP arm were more likely to receive brief interventions compared with those in the pediatrician-only arm (AOR, 1.74; 95% CI, 1.31-2.31; P < .001). The embedded BHCP arm had lower odds of receiving a referral compared with the pediatrician-only (AOR, 0.58; 95% CI, 0.43-0.78; P < .001) and UC (AOR, 0.65; 95% CI, 0.48-0.89; P = .006) arms; odds of referrals did not differ between the pediatrician-only and UC arms.Conclusions and relevanceThe intervention arms had better screening, assessment, and brief intervention rates than the UC arm. Patients in the pediatrician-only and UC arms had higher odds of being referred to specialty treatment than those in the embedded BHCP arm, suggesting lingering barriers to having pediatricians fully address substance use in primary care. Findings also highlight age and ethnic groups less likely to receive these important services.Trial registrationClinicaltrials.gov Identifier: NCT02408952.

Project description:Guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) implementation framework, a National Institutes of Health-sponsored study compared the nurse-administered Tobacco Tactics intervention to usual care. A prior paper describes the effectiveness of the Tobacco Tactics intervention. This subsequent paper provides data describing the remaining constructs of the RE-AIM framework.This pragmatic study used a mixed methods, quasi-experimental design in five Michigan community hospitals of which three received the nurse-administered Tobacco Tactics intervention and two received usual care. Nurses and patients were surveyed pre- and post-intervention. Measures included reach (patient participation rates, characteristics, and receipt of services), adoption (nurse participation rates and characteristics), implementation (pre-to post-training changes in nurses' attitudes, delivery of services, barriers to implementation, opinions about training, documentation of services, and numbers of volunteer follow-up phone calls), and maintenance (continuation of the intervention once the study ended).Reach: Patient participation rates were 71.5 %. Compared to no change in the control sites, there were significant pre- to post-intervention increases in self-reported receipt of print materials in the intervention hospitals (n?=?1370, p?<?0.001). Adoption: In the intervention hospitals, all targeted units and several non-targeted units participated; 76.0 % (n?=?1028) of targeted nurses and 317 additional staff participated in the training, and 92.4 % were extremely or somewhat satisfied with the training.Nurses in the intervention hospitals reported increases in providing advice to quit, counseling, medications, handouts, and DVD (all p?<?0.05) and reported decreased barriers to implementing smoking cessation services (p?<?0.001). Qualitative comments were very positive ("user friendly," "streamlined," or "saves time"), although problems with showing patients the DVD and charting in the electronic medical record were noted. Maintenance: Nurses continued to provide the intervention after the study ended.Given that nurses represent the largest group of front-line providers, this intervention, which meets Joint Commission guidelines for treating inpatient smokers, has the potential to have a wide reach and to decrease smoking, morbidity, and mortality among inpatient smokers. As we move toward more population-based interventions, the RE-AIM framework is a valuable guide for implementation.ClinicalTrials.gov, NCT01309217.

Project description:BackgroundDepression is a leading cause of disability worldwide. African American adults, compared to White adults, are half as likely to be screened for depression in primary care settings. Disparities in depression screening contribute to poor clinical outcomes, as African Americans with depression are more disabled and sicker longer compared to Whites. African American churches are trusted settings that provide access to supports for depression. Indeed, in the first study of its kind, the investigators found that 20% of adults in African American churches screened positive for depression using the Patient Health Questionnaire-9 (PHQ-9). However, no subjects with a positive screen (PHQ-9 ≥ 10) accepted a treatment referral when offered by research personnel. Community Health Workers, who are trusted paraprofessionals from the target community, may bridge the gap between depression screening and treatment. The investigators have trained and certified 112 Community Health Workers from 45 African American churches in New York City to deliver an evidence-based intervention called Screening, Brief Intervention, and Referral to Treatment (SBIRT). Thus, the aim of the current study is to test the impact of Community Health Worker-delivered depression screening in Black churches on engagement with clinical services.MethodsUsing a hybrid type 1 effectiveness-implementation design, we propose a 2-arm, mixed-methods cluster randomized controlled trial. Church study sites will be randomized to either SBIRT (intervention arm) or referral as usual (usual care arm). This trial will be conducted with 600 church members across 30 churches (300 intervention; 300 usual care). Our primary outcome is treatment engagement, defined as attending a depression-related clinical visit. Secondary outcomes will be changes in Mental Health-Related Quality of Life and depressive symptoms at 3 and 6 months post-screening. Lastly, we will conduct a concurrent, mixed-methods (qualitative-quantitative) process evaluation to assess contextual facilitators and barriers of screening and referral.DiscussionThis is the first randomized trial of a church-placed, community health worker-delivered intervention for depression in African American populations. This study may provide a novel and effective approach to increasing depression identification and treatment linkage in economically disadvantaged populations with high depression rates.Trial registrationClinicalTrials.gov NCT04524767 . Registered on 21 August 2020.

Project description:BackgroundUnhealthy alcohol use is a major contributor to the global burden of disease and injury. The US Preventive Services Task Force has recommended alcohol screening and intervention in general medical settings since 2004. Yet less than one in six US adults report health care professionals discussing alcohol with them. Little is known about methods for increasing implementation; different staffing models may be related to implementation effectiveness. This implementation trial compared delivery of alcohol screening, brief intervention and referral to specialty treatment (SBIRT) by physicians versus non-physician providers receiving training, technical assistance, and feedback reports.MethodsThe study was a cluster randomized implementation trial (ADVISe [Alcohol Drinking as a Vital Sign]). Within a private, integrated health care system, 54 adult primary care clinics were stratified by medical center and randomly assigned in blocked groups of three to SBIRT by physicians (PCP arm) versus non-physician providers and medical assistants (NPP and MA arm), versus usual care (Control arm). NIH-recommended screening questions were added to the electronic health record (EHR) to facilitate SBIRT. We examined screening and brief intervention and referral rates by arm. We also examined patient-, physician-, and system-level factors affecting screening rates and, among those who screened positive, rates of brief intervention and referral to treatment.ResultsScreening rates were highest in the NPP and MA arm (51 %); followed by the PCP arm (9 %) and the Control arm (3.5 %). Screening increased over the 12 months after training in the NPP and MA arm but remained stable in the PCP arm. The PCP arm had higher brief intervention and referral rates (44 %) among patients screening positive than either the NPP and MA arm (3.4 %) or the Control arm (2.7 %). Higher ratio of MAs to physicians was related to higher screening rates in the NPP and MA arm and longer appointment times to screening and intervention rates in the PCP arm.ConclusionFindings suggest that time frames longer than 12 months may be required for full SBIRT implementation. Screening by MAs with intervention and referral by physicians as needed can be a feasible model for increasing the implementation of this critical and under-utilized preventive health service within currently predominant primary care models.Trial registrationClinical Trials NCT01135654.

Project description:Importance:Most smoking cessation (SC) clinics are costly, passive, and underused. Objective:To compare the SC effect of a combined intervention involving brief, model-guided SC advice plus active referral to SC services (active referral group) with those of brief, model-guided SC advice only (brief advice group) and general SC advice only (control group). Design, Setting, and Participants:A single-blind, 3-arm, pragmatic cluster randomized clinical trial was conducted including 1226 adult daily smokers in the general Hong Kong community proactively recruited to participate in the Quit-to-Win Contest held in 2015. The study was conducted from June 20 to September 24, 2015. Participants were randomly allocated to the active referral (n = 402), brief advice (n = 416), and control (n = 408) groups. Intention-to-treat analysis was used. Interventions:Brief telephone counseling was offered to the active referral and brief advice groups at 1 and 2 months. Interventions were delivered by SC ambassadors who had undergone a short training period. Main Outcomes and Measures:The primary outcome was the self-reported past 7-day point prevalence of abstinence (PPA) at 6 months. The secondary outcomes were carbon monoxide level-validated abstinence, smoking reduction, and SC service use. Results:Participants included 991 (80.8%) men; mean (SD) age was 42.0 (14.8) years. The response rate was 68.2% at 3 and 72.3% at 6 months. The corresponding PPAs were 18.9% and 17.2% in the active referral group-higher than in the brief advice (8.9% and 9.4%; both P ≤ .001) or control (14.0% and 11.5%; P = .03 at 6 months) groups. Compared with the other 2 groups, the active referral group had significantly higher validated abstinence rates (10.2% at 3 months and 9.0% at 6 months, all P < .05) with odds ratios of 2.84 (95% CI, 1.57-5.15) and 2.61 (95% CI, 1.46-4.68) at 3 months, and 1.85 (95% CI, 1.06-3.23) and 1.81 (95% CI, 1.04-3.16) at 6 months in the brief advice and control groups, respectively. The SC service use rate was significantly higher in the active referral group (25.1%) than in either brief advice (2.4%) or control (3.4%) groups at 6 months (P < .001). Conclusions and Relevance:An intervention involving brief advice and active referral delivered to smokers in the community by volunteers can increase quitting in places where SC services are available but underused. Trial Registration:clinicaltrials.gov Identifier: NCT02539875.

Project description:Aim This project evaluated the effectiveness of screening brief intervention and referral for treatment (SBIRT) in primary care in Abu Dhabi to manage patients with problematic substance use. This study aimed to determine whether: (i) training primary care physicians on the SBIRT model increased the identification of patients using substances at a harmful, hazardous or dependent level; (ii) training improved physicians' knowledge, attitudes and beliefs in self-efficacy in managing substance use.BackgroundSubstance use is increasing in the United Arab Emirates yet there has been no formal primary care intervention. SBIRT was considered an appropriate model given its endorsement by the WHO.MethodsA controlled trial (two intervention and two matched control clinics) was undertaken. Intervention physicians (n=17) were trained in SBIRT. Physicians' attitudes were measured before and after training and eight months after implementation. Target recruitment was 900 patients. Inclusion criteria were: consenting UAE national, ⩾18 years, using the 'walk-in' primary care clinic. Patient data was collected by physician-administered questionnaire. Prevalence of drug use was measured through electronic patient records. Findings A total of 906 patients were screened, aged 18-82 years and 496 (55%) were female. Of these, 5.7% reported use of amphetamine, 3.9% alcohol, 3.3%, sedatives, 1.7% opioids and 1.1% cannabis. In all, 21 people had a moderate/high ASSIST score and received a brief intervention, but did not attend follow-up; three high-risk people were referred for specialist treatment. Physicians' attitudes towards patients with problematic substance use and providing treatment improved after training, but returned to pre-training levels after eight months. Including the 21 individuals identified from intervention screening, the prevalence of substance use increased to 0.208% (95% CI 0.154-0.274), significantly higher than in control clinics (P<0.001). In conclusion, physicians were generally positive towards SBIRT and SBIRT increased recorded drug related conditions at a practice level. However, poor patient attendance at follow-up requires investigation.

Project description:BackgroundSnakebite is a global health problem that predominantly occurs in rural areas. In Sri Lanka, the majority of snakebite patients first present to smaller rural primary hospitals. Improving care delivered at rural hospitals has the potential to reduce morbidity and mortality from snakebites.ObjectiveIn this study, we evaluated whether an educational intervention would increase compliance with national snakebite treatment guidelines in primary hospitals.MethodsThe hospitals were randomized into educational intervention (n = 24) and control groups (n = 20). The intervention hospitals received a brief educational intervention based on Sri Lankan Medical Association (SLMA) guidelines on the management of snakebites. Control hospitals had free access to the guidelines but no additional promotion. Four outcomes were assessed: pre- and post-test knowledge at the completion of a one-day workshop of educational intervention (intervention group only); improvement in the quality of the patient's medical records; appropriateness of transfers to higher hospitals; and quality of overall management graded by a blinded expert. The data was collected over a period of 12 months.ResultsAll case notes of snakebite hospital admissions were reviewed. There were 1021 cases in the intervention group hospitals and 1165 cases in the control hospitals. Four hospitals in the intervention group and three hospitals in the control group did not have snakebite admissions and were excluded from the cluster analysis. The absolute quality of care was high in both groups. Post-test knowledge was improved (p < 0.0001) following the intervention group's educational workshop. There was no statistical difference between the two groups in terms of clinical data documentation in hospital notes (scores, p = 0.58) or transfer appropriateness (p = 0.68)-both of which were significantly different from the guidelines.ConclusionEducation of primary hospital staff improved the immediate knowledge gained but did not improve record-keeping or the appropriateness of inter-hospital patient transfer.Trial registrationThe study was registered with Sri Lanka Medical Associations' clinical trial registry. Reg. No SLCTR -2013-023. Registered: 30/07/2013.

Project description:Rationale, aims, and objectivesDecisions about whether to refer or admit a patient to an intensive care unit (ICU) are clinically, organizationally, and ethically challenging. Many explicit and implicit factors influence these decisions, and there is substantial variability in how they are made, leading to concerns about access to appropriate treatment for critically ill patients. There is currently no guidance to support doctors making these decisions. We developed an intervention with the aim of supporting doctors to make more transparent, consistent, patient-centred, and ethically justified decisions. This paper reports on the implementation of the intervention at three NHS hospitals in England and evaluates its feasibility in terms of usage, acceptability, and perceived impact on decision making.MethodsA mixed method study including quantitative assessment of usage and qualitative interviews.ResultsThere was moderate uptake of the framework (28.2% of referrals to ICU across all sites during the 3-month study period). Organizational structure and culture affected implementation. Concerns about increased workload in the context of limited resources were obstacles to its use. Doctors who used it reported a positive impact on decision making, with better articulation and communication of reasons for decisions, and greater attention to patient wishes. The intervention made explicit the uncertainty inherent in these decisions, and this was sometimes challenging. The patient and family information leaflets were not used.ConclusionsWhile it is feasible to implement an intervention to improve decision making around referral and admission to ICU, embedding the intervention into existing organizational culture and practice would likely increase adoption. The doctor-facing elements of the intervention were generally acceptable and were perceived as making ICU decision making more transparent and patient-centred. While there remained difficulties in articulating the clinical reasoning behind some decisions, the intervention offers an important step towards establishing a more clinically and ethically sound approach to ICU admission.

Project description:BackgroundScreening, brief intervention, and referral to treatment (SBIRT) for risky substance use is infrequently included in routine healthcare in low-resourced settings. A SBIRT programme, adopted by the Western Cape provincial government within an alcohol harm reduction strategy, employed various implementation strategies executed by a diverse team to translate an evidence-based intervention into services at three demonstration sites before broader programme scale-up. This paper evaluates the implementation of this programme delivered by facility-based counsellors in South African emergency centres.MethodGuided by the Consolidated Framework for Implementation Research, this mixed methods study evaluated the feasibility, acceptability, appropriateness and adoption of this task-shared SBIRT programme. Quantitative data were extracted from routinely collected health information. Qualitative interviews were conducted with 40 stakeholders in the programme's second year.ResultsIn the first year, 13 136 patients were screened and 4 847 (37%) patients met criteria for risky substance use. Of these patients, 83% received the intervention, indicating programme feasibility. The programme was adopted into routine services and found to be acceptable and appropriate, particularly by stakeholders familiar with the emergency environment. These stakeholders highlighted the burden of substance-related harm in emergency centres and favourable patient responses to SBIRT. However, some stakeholders expressed scepticism of the behaviour change approach and programme compatibility with emergency centre operations. Furthermore, adoption was both facilitated and hampered by a top-down directive from provincial leadership to implement SBIRT, while rapid implementation limited effective engagement with a diverse stakeholder group.ConclusionThis is one of the first studies to address SBIRT implementation in low-resourced settings. The results show that SBIRT implementation and adoption was largely successful, and provide valuable insights that should be considered prior to implementation scale-up. Recommendations include ensuring ongoing monitoring and evaluation, and early stakeholder engagement to improve implementation readiness and programme compatibility in the emergency setting.

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Study protocol testing toolkit versus usual care for implementation of screening, brief intervention, referral to treatment in hospitals: a phased cluster randomized approach.

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Study protocol testing toolkit versus usual care for implementation of screening, brief intervention, referral to treatment in hospitals: a phased cluster randomized approach.

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