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A cluster randomized Hybrid Type III trial testing an implementation support strategy to facilitate the use of an evidence-based practice in VA homeless programs.

ABSTRACT: The Housing and Urban Development-Veterans Affairs Supportive Housing (HUD-VASH) program is one of the largest initiatives to end Veteran homelessness. However, mental health and substance use disorders continue to reduce client stability and impede program success. HUD-VASH programs do not consistently employ evidence-based practices that address co-occurring mental health and substance use disorders. This paper presents a study protocol to evaluate the implementation of an evidence-based, co-occurring disorder treatment called Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking-Veterans Edition (MISSION-Vet) in HUD-VASH using an implementation strategy called Getting To Outcomes (GTO).In three large VA Medical Centers, this Hybrid Type III trial will randomize case managers and their clients by HUD-VASH sub-teams to receive either MISSION-Vet Implementation as Usual (IU-standard training and access to the MISSION-Vet treatment manuals) or MISSION-Vet implementation augmented by GTO. In addition to testing GTO, effectiveness of the treatment (MISSION-Vet) will be assessed using existing Veteran-level data from the HUD-VASH data monitoring system. This project will compare GTO and IU case managers and their clients on the following variables: (1) fidelity to the MISSION-Vet intervention; (2) proportion of time the Veteran is housed; (3) mental health, substance use, and functional outcomes among Veterans; and (4) factors key to the successful deployment of a new treatment as specified by the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) model.This project is an important step for developing an implementation strategy to increase adoption of evidence-based practice use in VA homeless programs, and to further examine efficacy of MISSION-Vet in HUD-VASH. This project has important implications for program managers, policy makers, and researchers within the homelessness field. VA Central IRB approval for this study was granted in October 2011. The three sites were trained on MISSION-Vet and GTO in the first half of 2013. The first GTO planning meetings began after training occurred, between January 2013 and November 2013, across the three sites. The data collection-via a fidelity measure embedded into the VA Computerized Patient Record System-began as each site initiated MISSION-Vet, between April 2013 and January 2014.ClinicalTrials.gov: NCT01430741.

SUBMITTER: Smelson DA

PROVIDER: S-EPMC4448312 | biostudies-literature | 2015 May

REPOSITORIES: biostudies-literature

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Project description:BackgroundIncorporating evidence-based integrated treatment for dual disorders into typical care settings has been challenging, especially among those serving Veterans who are homeless. This paper presents an evaluation of an effort to incorporate an evidence-based, dual disorder treatment called Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking-Veterans Edition (MISSION-Vet) into case management teams serving Veterans who are homeless, using an implementation strategy called Getting To Outcomes (GTO).MethodsThis Hybrid Type III, cluster-randomized controlled trial assessed the impact of GTO over and above MISSION-Vet Implementation as Usual (IU). Both conditions received standard MISSION-Vet training and manuals. The GTO group received an implementation manual, training, technical assistance, and data feedback. The study occurred in teams at three large VA Medical Centers over 2 years. Within each team, existing sub-teams (case managers and Veterans they serve) were the clusters randomly assigned. The trial assessed MISSION-Vet services delivered and collected via administrative data and implementation barriers and facilitators, via semi-structured interview.ResultsNo case managers in the IU group initiated MISSION-Vet while 68% in the GTO group did. Seven percent of Veterans with case managers in the GTO group received at least one MISSION-Vet session. Most case managers appreciated the MISSION-Vet materials and felt the GTO planning meetings supported using MISSION-Vet. Case manager interviews also showed that MISSION-Vet could be confusing; there was little involvement from leadership after their initial agreement to participate; the data feedback system had a number of difficulties; and case managers did not have the resources to implement all aspects of MISSION-Vet.ConclusionsThis project shows that GTO-like support can help launch new practices but that multiple implementation facilitators are needed for successful execution of a complex evidence-based program like MISSION-Vet.Trial registrationClinicalTrials.gov NCT01430741.

Project description:BACKGROUND:Evidence-based treatment for co-occurring disorders is needed within programs that serve homeless Veterans to assist with increasing engagement in care and to prevent future housing loss. A specialized co-occurring disorders treatment engagement intervention called Maintaining Independence and Sobriety Through Systems Integration, Outreach and Networking - Veterans Edition (MISSION-Vet) was implemented within the Housing and Urban Development - Veterans Affairs Supportive Housing (HUD-VASH) Programs with and without an implementation strategy called Getting To Outcomes (GTO). While implementation was modest for the GTO group, no one adopted MISSION in the non-GTO group. This paper reports Veteran level outcome data on treatment engagement and select behavioral health outcomes for Veterans exposed to the MISSION-Vet model compared to Veterans without access to MISSION-Vet. METHODS:This hybrid Type III trial compared 81 Veterans in the GTO group to a similar group of 87 Veterans with mental health and substance use disorders from the caseload of staff in the non-GTO group. Comparisons were made on treatment engagement, negative housing exits, drug and alcohol abuse, inpatient hospitalizations, emergency department visits and income level over time, using mixed-effect or Cox regression models. RESULTS:Treatment engagement, as measured by the overall number of case manager contacts with Veterans and others (e.g. family members, health providers), was significantly higher among Veterans in the GTO group (B?=?2.30, p?=?.04). Supplemental exploratory analyses between Veterans who received "higher" and "lower" intensity MISSION-Vet services in the GTO group failed to show differences in alcohol and drug use, inpatient hospitalization and emergency department use. CONCLUSIONS:Despite modest MISSION-Vet fidelity among staff treating Veterans in the GTO group, differences were found in treatment engagement. However, this study failed to show differences in alcohol use, drug use, mental health hospitalizations and negative housing exits over time among those Veterans receiving higher intensity MISSION-Vet services versus low intensity services. This project suggests that MISSION-Vet could be used in HUD-VASH to increase engagement among Veterans struggling with homelessness, a group often disconnected from care. TRIAL REGISTRATION:Clinicaltrials.gov, registration number: NCT01430741 , registered July 26, 2011.

Project description:BackgroundThe Veterans Health Administration (VA) Grant and Per Diem case management "aftercare" program provides 6 months of case management for homeless-experienced veterans (HEVs) undergoing housing transitions. To standardize and improve aftercare services, we will implement critical time intervention (CTI), an evidence-based, structured, and time-limited case management practice. We will use two strategies to support the implementation and sustainment of CTI at 32 aftercare sites, conduct a mixed-methods evaluation of this implementation initiative, and generate a business case analysis and implementation playbook to support the continued spread and sustainment of CTI in aftercare.MethodsWe will use the Replicating Effective Programs (REP) implementation strategy to support CTI implementation at 32 sites selected by our partners. Half (n=16) of these sites will also receive 9 months of external facilitation (EF, enhanced REP). We will conduct a type 3 hybrid cluster-randomized trial to compare the impacts of REP versus enhanced REP. We will cluster potential sites into three implementation cohorts staggered in 9-month intervals. Within each cohort, we will use permuted block randomization to balance key site characteristics among sites receiving REP versus enhanced REP; sites will not be blinded to their assigned strategy. We will use mixed methods to assess the impacts of the implementation strategies. As fidelity to CTI influences its effectiveness, fidelity to CTI is our primary outcome, followed by sustainment, quality metrics, and costs. We hypothesize that enhanced REP will have higher costs than REP alone, but will result in stronger CTI fidelity, sustainment, and quality metrics, leading to a business case for enhanced REP. This work will lead to products that will support our partners in spreading and sustaining CTI in aftercare.DiscussionImplementing CTI within aftercare holds the potential to enhance HEVs' housing and health outcomes. Understanding effective strategies to support CTI implementation could assist with a larger CTI roll-out within aftercare and support the implementation of other case management practices within and outside VA.Trial registrationThis project was registered with ClinicalTrials.gov as "Implementing and sustaining Critical Time Intervention in case management programs for homeless-experienced Veterans." Trial registration NCT05312229 , registered April 4, 2022.

Project description:BackgroundBroadly disseminating and implementing evidence-based psychotherapies with high fidelity, particularly cognitive behavioral therapy (CBT), has proved challenging for many health-care systems, including the Department of Veterans Affairs, especially in primary care settings such as small or remote clinics. A computer-based tool (based on the coordinated anxiety learning and management (CALM) program) was designed to support primary care-based mental health providers in delivering CBT. The objectives of this study are to modify the CALM tool to meet the needs of mental health clinicians in veterans affairs (VA) community-based outpatient clinics (CBOCs) and rural "veterans", use external facilitation to implement CBT and determine the effect of the CALM tool versus a manualized version of CALM to improve fidelity to the CBT treatment model, and conduct a needs assessment to understand how best to support future implementation of the CALM tool in routine care.Methods/designFocus groups will inform the redesign of the CALM tool. Mental health providers at regional VA CBOCs; CBT experts; VA experts in implementation of evidence-based mental health practices; and veterans with generalized anxiety disorder, panic disorder, social anxiety disorder, posttraumatic stress disorder, "with or without" depression will be recruited. A hybrid type III design will be used to examine the effect of receiving CBT training plus either the CALM tool or a manual version of CALM on treatment fidelity. External facilitation will be used as the overarching strategy to implement both CBT delivery methods. Data will also be collected on symptoms of the targeted disorders. To help prepare for the future implementation of the CALM tool in VA CBOCs, we will perform an implementation need assessment with mental health providers participating in the clinical trial and their CBOC directors.DiscussionThis project will help inform strategies for delivering CBT with high fidelity in VA CBOCs to veterans with anxiety disorders and PTSD with or without depression. If successful, results of this study could be used to inform a national rollout of the CALM tool in VA CBOCs including providing recommendations for optimizing the adoption and sustained use of the computerized CALM tool among mental health providers in this setting.Trial registrationClinicalTrials.gov, NCT02488551.

Project description:Guidelines are often slowly adapted into clinical practice. However, actively supporting healthcare professionals in evidence-based treatment may speed up guideline implementation. Danish low back pain (LBP) guidelines focus on primary care treatment of LBP, to reduce referrals from primary care to secondary care. The primary aim of this project was to reduce secondary care referral within 12 weeks by a multifaceted implementation strategy (MuIS).In a cluster randomised design, 189 general practices from the North Denmark Region were invited to participate. Practices were randomised (1:1) and stratified by practice size to MuIS (28 practices) or a passive implementation strategy (PaIS; 32 practices). Included were patients with LBP aged 18 to 65 years who were able to complete questionnaires, had no serious underlying pathology, and were not pregnant. We developed a MuIS including outreach visits, quality reports, and the STarT Back Tool for subgrouping patients with LBP. Both groups were offered the usual dissemination of guidelines, guideline-concordant structuring of the medical record, and a new referral opportunity for patients with psycho-social problems. In an intention-to-treat analysis, the primary and secondary outcomes pertained to the patient, and a cost-effectiveness analysis was performed from a healthcare sector perspective. Patients and the assessment of outcomes were blinded. Practices and caregivers delivering the interventions were not blinded.Between January 2013 and July 2014, 60 practices were included, of which 54 practices (28 MuIS, 26 PaIS) included 1101 patients (539 MuIS, 562 PaIS). Follow-up data for the primary outcome were available on 100 % of these patients. Twenty-seven patients (5.0 %) in the MuIS group were referred to secondary care vs. 59 patients (10.5 %) in the PaIS group. The adjusted odds ratio (AOR) was 0.52 [95 % CI 0.30 to 0.90; p?=?0.020]. The MuIS was cost-saving £-93.20 (£406.51 vs. £499.71 per patient) after 12 weeks. Conversely, the MuIS resulted in less satisfied patients after 52 weeks (AOR 0.50 [95 % CI 0.31 to 0.81; p?=?0.004]).Using a MuIS changed general practice referral behaviour and was cost effective, but patients in the MuIS group were less satisfied. This study supports the application of a MuIS when implementing guidelines.ClinicalTrials.gov, NCT01699256.

Project description:BackgroundPost-9/11 veterans who enroll in VA health care frequently present with suicidal ideation and/or recent suicidal behavior. Most of these veterans are not screened on their day of enrollment and their risk goes undetected. Screening for suicide risk, and associated mental health factors, can lead to early detection and referral to effective treatment, thereby decreasing suicide risk. eScreening is an innovative Gold Standard Practice with evidence to support its effectiveness and implementation potential in transition and care management (TCM) programs. We will evaluate the impact of eScreening to improve the rate and speed of suicide risk screening and referral to mental health care compared to current screening methods used by transition care managers. We will also evaluate the impact of an innovative, multicomponent implementation strategy (MCIS) on the reach, adoption, implementation, and sustained use of eScreening.MethodsThis is an eight-site 4-year, stepped-wedge, mixed-method, hybrid type-II implementation trial comparing eScreening to screening as usual while also evaluating the potential impact of the MCIS focusing on external facilitation and Lean/SixSigma rapid process improvement workshops in TCM. The aims will address: 1) whether using eScreening compared to oral and/or paper-based methods in TCM programs is associated with improved rates and speed of PTSD, depression, alcohol, and suicide screening & evaluation, and increased referral to mental health treatment; 2) whether and to what degree our MCIS is feasible, acceptable, and has the potential to impact adoption, implementation, and maintenance of eScreening; and 3) how contextual factors influence the implementation of eScreening between high- and low-eScreening adopting sites. We will use a mixed methods approach guided by the RE-AIM outcomes of the Practical Robust Implementation and Sustainability Model (PRISM). Data to address Aim 1 will be collected via medical record query while data for Aims 2 and 3 will be collected from TCM staff questionnaires and qualitative interviews.DiscussionThe results of this study will help identify best practices for screening in suicide prevention for Post-9/11 veterans enrolling in VA health care and will provide information on how best to implement technology-based screening into real-world clinical care programs.Trial registrationClinicalTrials.gov : NCT04506164; date registered: August 20, 2020; retrospectively registered.

Project description:BackgroundAnxiety is a common mental health problem seen in primary care. However, its management in clinical practice varies greatly. Clinical practice guidelines (CPGs) have the potential to reduce variations and improve the care received by patients by promoting interventions of proven benefit. However, uptake and adherence to their recommendations can be low.Method/designThis study involves a community based on cluster randomized trial in primary healthcare centres in the Madrid Region (Spain). The project aims to determine whether the use of implementation strategy (including training session, information, opinion leader, reminders, audit, and feed-back) of CPG for patients with anxiety disorders in primary care is more effective than usual diffusion. The number of patients required is 296 (148 in each arm), all older than 18 years and diagnosed with generalized anxiety disorder, panic disorder, and panic attacks by the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV). They are chosen by consecutive sampling. The main outcome variable is the change in two or more points into Goldberg anxiety scale at six and twelve months. Secondary outcome variables include quality of life (EuroQol 5D), and degree of compliance with the CPG recommendations on treatment, information, and referrals to mental health services. Main effectiveness will be analyzed by comparing the patients percentage improvement on the Goldberg scale between the intervention group and the control group. Logistic regression with random effects will be used to adjust for prognostic factors. Confounding factors or factors that might alter the effect recorded will be taken into account in this analysis.DiscussionThere is a need to identify effective implementation strategies for CPG for the management of anxiety disorders present in primary care. Ensuring the appropriate uptake of guideline recommendations can reduce clinical variation and improve the care patients receive.Trial registrationISRCTN: ISRCTN83365316.

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A cluster randomized Hybrid Type III trial testing an implementation support strategy to facilitate the use of an evidence-based practice in VA homeless programs.

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