Sharon McCarthy

Purpose. This randomized phase 2 study sought to assess the treatment effect of a finite duration of apalutamide with and without androgen deprivation therapy (ADT) in biochemically recurrent prostate cancer (BCR PC). Materials and Methods. Patients with BCR PC after primary definitive therapy and prostate-specific antigen (PSA) doubling time ≤12 months were randomized to open-label apalutamide (240 mg/d) alone, apalutamide plus ADT, or ADT alone (1 : 1:1 ratio) for 12 months followed by a 12-month observation period (NCT01790126). Mean changes from baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) at 12 months (primary endpoint) and other prespecified assessments of health-related quality of life (HRQoL), PSA nadir, time to PSA progression, time to testosterone recovery, recovered testosterone >150 ng/dL without PSA progression at 24 months, and molecular markers were evaluated. Results. In 90 enrolled patients (apalutamide plus ADT (n = 31), apalutamide (n = 29), ADT (n = 30)), FACT-P at 12 months was not significantly different between apalutamide, ADT and apalutamide, and ADT groups. Addition of apalutamide to ADT prolonged time to PSA progression but this change did not reach statistical significance (hazard ratio (HR): 0.56, 95% confidence interval (CI): 0.23–1.36, ); time to testosterone recovery was similar in the ADT-containing groups. In apalutamide plus ADT, apalutamide, and ADT groups, 37.9%, 37.0%, and 19.2% of patients, respectively, had testosterone >150 ng/dL at 24 months without confirmed PSA progression. Of the few biomarkers expressed in blood, EPHA3 was significantly associated with shorter time to PSA progression ( ) in the overall population. Conclusions. HRQoL was similar in patients treated with apalutamide alone, ADT alone, or their combination, although apalutamide plus ADT did not demonstrate statistically significant noninferiority in change from baseline in overall HRQoL. The aggregated efficacy and safety outcomes support further evaluation of apalutamide plus ADT in BCR PC.

Background: Serious mental illness (SMI) affects 4.6% of the American population. While treatments are available, adherence to specific regimens is often suboptimal. Multiple organizations, such as the Substance Abuse and Mental Health Services Administration (SAMHSA), have called for more options that improve accessibility and engagement to treatment among individuals with SMI. This study protocol answers such calls by testing the effectiveness of peer specialists—individuals with SMI trained to use their experience to help others with SMI—in delivering social skills training (SST) and cognitive behavioral social skills training (CBSST), evidence-based treatments effective at engaging individuals with SMI to make behavioral and cognitive changes. Peer specialists have been shown to be adept at engaging those with SMI in treatment; however, their ability to deliver these structured treatments is unknown. Methods: This study is a randomized, hybrid 1, research assistant-blinded, superiority trial. A total of 252 veterans with SMI will be recruited and randomized to one of three arms: CBSST-Peer vs. SST-Peer vs. treatment as usual. Participants randomized to CBSST-Peer or SST-Peer will participate in a 20-week group-based intervention that meets weekly for a 60-min class. All participants will complete 4 study assessments at baseline, 10 weeks, 20 weeks, and 32 weeks. A multidimensional battery of functional outcomes will be used with the Independent Living Skills Survey (ILSS) as the primary outcome measure. Post-study completion, veterans who participated in the CBSST-Peer or SST-Peer arms will randomly be invited to participate in focus groups, and peer specialists will complete interviews to further assess the effectiveness of each intervention. Discussion: Improving care and outcomes for individuals with SMI is a national priority. To improve care, it is imperative to think about new ways to improve engagement and accessibility to care. This study provides an innovative solution to this problem by evaluating how two different types of treatment, delivered by peer specialists, compare to usual care. The results of the study will allow for the expansion of treatment options that improve access and engagement among veterans with SMI.

Background: The Veterans Health Administration (VHA) developed the Stratification Tool for Opioid Risk Mitigation (STORM) dashboard to assist in identifying Veterans at risk for adverse opioid overdose or suicide-related events. In 2018, a policy was implemented requiring VHA facilities to complete case reviews of Veterans identified by STORM as very high risk for adverse events. Nationally, facilities were randomized in STORM implementation to four arms based on required oversight and by the timing of an increase in the number of required case reviews. To help evaluate this policy intervention, we aimed to (1) identify barriers and facilitators to implementing case reviews; (2) assess variation across the four arms; and (3) evaluate associations between facility characteristics and implementation barriers and facilitators. Method: Using the Consolidated Framework for Implementation Research (CFIR), we developed a semi-structured interview guide to examine barriers to and facilitators of implementing the STORM policy. A total of 78 staff from 39 purposefully selected facilities were invited to participate in telephone interviews. Interview transcripts were coded and then organized into memos, which were rated using the −2 to + 2 CFIR rating system. Descriptive statistics were used to evaluate the mean ratings on each CFIR construct, the associations between ratings and study arm, and three facility characteristics (size, rurality, and academic detailing) associated with CFIR ratings. We used the mean CFIR rating for each site to determine which constructs differed between the sites with highest and lowest overall CFIR scores, and these constructs were described in detail. Results: Two important CFIR constructs emerged as barriers to implementation: Access to knowledge and information and Evaluating and reflecting. Little time to complete the CASE reviews was a pervasive barrier. Sites with higher overall CFIR scores showed three important facilitators: Leadership engagement, Engaging, and Implementation climate. CFIR ratings were not significantly different between the four study arms, nor associated with facility characteristics. Plain Language Summary: The Veterans Health Administration (VHA) created a tool called the Stratification Tool for Opioid Risk Mitigation dashboard. This dashboard shows Veterans at risk for opioid overdose or suicide-related events. In 2018, a national policy required all VHA facilities to complete case reviews for Veterans who were at high risk for these events. To evaluate this policy implementation, 78 staff from 39 facilities were interviewed. The Consolidated Framework for Implementation Research (CFIR) implementation framework was used to create the interview. Interview transcripts were coded and organized into site memos. The site memos were rated using CFIR's −2 to +2 rating system. Ratings did not differ for four study arms related to oversight and timing. Ratings were not associated with facility characteristics. Leadership, engagement and implementation climate were the strongest facilitators for implementation. Lack of time, knowledge, and feedback were important barriers.

BackgroundThe Veterans Health Administration (VHA) developed the Stratification Tool for Opioid Risk Mitigation (STORM) dashboard to assist VHA clinicians in identifying Veterans at risk for adverse opioid overdose or suicide-related events. In 2018, a national policy was implemented requiring providers at all VHA facilities to complete case reviews of Veterans identified by STORM as very high risk for adverse events. Nationally, facilities were randomized by the type of oversight required when sufficient case reviews were not completed and also by the timing of an increase in the number of required case reviews. As part of a comprehensive assessment of this policy intervention, we aimed to 1) identify barriers and facilitators to implementing case reviews as required in the policy; 2) assess variation across the four arms of the study; and 3) evaluate associations between facility characteristics and implementation barriers and facilitators.MethodsUsing the Consolidated Framework for Implementation Research (CFIR), we developed a semi-structured interview guide to examine barriers to and facilitators of implementing the STORM policy. Staff from 40 purposefully selected facilities who were involved in implementation were invited to participate in telephone interviews. Interview transcripts were coded and then organized into memos, which were numerically rated using the -2 to +2 CFIR rating system for each construct. Descriptive statistics were used to evaluate the mean ratings on each CFIR construct, the associations between ratings and study arm, and three facility characteristics (size, rurality, and level of academic detailing) associated with CFIR ratings. We used the mean CFIR rating for each site to determine which constructs differed between the sites with highest and lowest overall CFIR scores, and these constructs were described in detail. ResultsInterviews with 78 staff at 39 VHA facilities identified a slightly positive (+0.2) overall mean CFIR rating. CFIR ratings were not significantly different between the four study arms, nor associated with facility characteristics. Overall, two important barriers to implementation were CFIR constructs Access to knowledge and information and Evaluating and reflecting. Having time to complete the reviews was a pervasive barrier. Sites with higher overall CFIR scores showed three important facilitators: Leadership engagement, Engaging, and Implementation climate. ConclusionAlthough there was variability in implementation barriers and facilitators across facilities, these were unrelated to study arms and facility characteristics. Leadership, resources, and overall implementation climate were the strongest facilitators of policy implementation.

Background: Over 1100 veterans work in the Veterans Health Administration (VHA) as peer specialists (PSs)—those with formal training who support other veterans with similar diagnoses. A White House Executive Action mandated the pilot reassignment of VHA PSs from their usual placement in mental health to 25 primary care Patient Aligned Care Teams (PACTs) in order to broaden the provision of wellness services that can address many chronic illnesses. An evaluation of this initiative was undertaken to assess the impact of outside assistance on the deployment of PSs in PACTs, as implementation support is often needed to prevent challenges commonly experienced when first deploying PSs in new settings. Methods: This study was a cluster-randomized hybrid II effectiveness-implementation trial to test the impact of minimal implementation support vs. facilitated implementation on the deployment of VHA PSs in PACT over 2 years. Twenty-five Veterans Affairs Medical Centers (VAMCs) were recruited to reassign mental health PSs to provide wellness-oriented care in PACT. Sites in three successive cohorts (n = 7, 10, 8) over 6-month blocks were matched and randomized to each study condition. In facilitated implementation, an outside expert worked with site stakeholders through a site visit and regular calls, and provided performance data to guide the planning and address challenges. Minimal implementation sites received a webinar and access to the VHA Office of Mental Health Services work group. The two conditions were compared on PS workload data and veteran measures of activation, satisfaction, and functioning. Qualitative interviews collected information on perceived usefulness of the PS services. Results: In the first year, sites that received facilitation had higher numbers of unique veterans served and a higher number of PS visits, although the groups did not differ after the second year. Also, sites receiving external facilitation started delivering PS services more quickly than minimal support sites. All sites in the external facilitation condition continued in the pilot into the second year, whereas two of the sites in the minimal assistance condition dropped out after the first year. There were no differences between groups on veterans’ outcomes—activation, satisfaction, and functioning. Most veterans were very positive about the help they received as evidenced in the qualitative interviews. Discussion: These findings demonstrate that external facilitation can be effective in supporting the implementation of PSs in primary care settings. The lack of significant differences across conditions after the second year highlights the positive outcomes associated with active facilitation, while also raising the important question of whether longer-term success may require some level of ongoing facilitation and implementation support. Trial registration: This project is registered at ClinicalTrials.gov with number NCT02732600 (URL: https://clinicaltrials.gov/ct2/show/NCT02732600).

Background: The behavioral model of health service use identified health needs, service preferences (predispositions), and service availability (enabling factors) as important predictors, but research has not conceptualized consistently each type of influence nor identified their separate effects on use of substance abuse and mental health services or their value in predicting service outcomes. Objectives: To test hypotheses predicting use of substance abuse and mental health services and residential stability and evaluate peer specialists’ impact. Research Design: Randomized trial of peer support added to standard case management in VA-supported housing program (Housing and Urban Development-VA Supportive Housing program). Subjects: One hundred sixty-six dually diagnosed Veterans in Housing and Urban Development-VA Supportive Housing program in 2 cities. Measures: Average VA service episodes for substance abuse and mental illness; residential instability; preferences for alcohol, drug, and psychological services; extent of alcohol, drug, and psychological problems; availability of a peer specialist. Results: Self-assessed health needs, mediated by service preferences, and assignment to a peer specialist predicted use of VA behavioral health services and residential stability, as did chronic medical problems, sex, and race. Conclusions: The behavioral model identifies major predictors of health service use and residential stability, but must recognize the mediating role of service preferences, the differing effects of alcohol and drug use, the unique influences of social background, and the importance of clinical judgment in needs assessment. Service availability and residential stability can be increased by proactive efforts involving peer specialists even in a health care system that provides services without a financial barrier.

Although peer specialists play an increasing role in mental health service delivery, little is known about the best program structures for maximizing effective service delivery. This study reports on qualitative data from a larger study on peer specialists working with veterans in a Veterans Affairs homelessness program who were dually diagnosed with substance abuse and mental health concerns. Peer specialists were trained to deliver a recovery support program that is carried out weekly over 9 months and includes 20 structured sessions using a workbook and 20 unstructured, individually planned sessions. A sample of 20 veterans who were in the program were interviewed, along with 8 case managers and 3 peer specialists involved with the program. Interview transcripts were coded for 3 elements of program structure: time, content, and delivery. Results show that the program structure allowed flexibility for individual needs and that the workbook sessions were useful. Veterans ascribed value to the peer specialist delivering the content, compared to working alone on the material. Deliberate use of unstructured time with the peer specialist was seen as reducing isolation, increasing community integration, and encouraging recovery activities. The weekly, dependable nature of the program was seen as highly positive, whereas the 9-month duration was seen as too short. All groups interviewed expressed satisfaction with the program, although the case managers reported some reservations related to supervision and boundaries. Results suggest that, compared to completely structured or unstructured approaches that are common for peer specialist services, a middle level of structure for peer specialist programs could be a useful alternative.

Mitigating the risks of adverse outcomes from opioids is critical. Thus, the Veterans Affairs (VA) Healthcare System developed the Stratification Tool for Opioid Risk Management (STORM), a dashboard to assist clinicians with opioid risk evaluation and mitigation. Updated daily, STORM calculates a “risk score” of adverse outcomes (e.g., suicide-related events, overdoses, overdose death) from variables in the VA medical record for all patients with an opioid prescription and displays this information along with documentation of recommended risk mitigation strategies and non-opioid pain treatments. In March 2018, the VA issued a policy notice requiring VA Medical Centers (VAMCs) to complete case reviews for patients whom STORM identifies as very high-risk (i.e., top 1% of STORM risk scores). Half of VAMCs were randomly assigned notices that also stated that additional support and oversight would be required for VAMCs that failed to meet an established percentage of case reviews. Using a stepped-wedge cluster randomized design, VAMCs will be further randomized to conduct case reviews for an expanded pool of patients (top 5% of STORM risk scores vs. 1%) starting either 9 or 15 months after the notice was released, creating four natural arms. VA commissioned an evaluation to understand the implementation strategies and factors associated with case review completion rates, whose protocol is described in this report. This mixed-method study will include an online survey of all VAMCs to identify implementation strategies and interviews at a subset of facilities to identify implementation barriers and facilitators. The survey is based on the Expert Recommendations for Implementing Change (ERIC) project, which engaged experts to create consensus on 73 implementation strategies. We will use regression models to compare the number and types of implementation strategies across arms and their association with case review completion rates. Using questions from the Consolidated Framework for Implementation Research, we will interview stakeholders at 40 VAMCs with the highest and lowest adherence to opioid therapy guidelines. By identifying which implementation strategies, barriers, and facilitators influence case reviews to reduce opioid-related adverse outcomes, this unique implementation evaluation will enable the VA to improve the design of future opioid safety initiatives. This project is registered at the ISRCTN Registry with number ISRCTN16012111 . The trial was first registered on 5/3/2017.

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. 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. 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. 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. Clinicaltrials.gov, registration number: NCT01430741 , registered July 26, 2011.

Over 1100 Veterans work in the Veterans Health Administration (VHA) as peer specialists (PSs). PSs are Veterans with formal training who provide support to other Veterans with similar diagnoses, primarily in mental health settings. A White House Executive Action mandated the pilot reassignment of VHA PSs from mental health to 25 primary care Patient Aligned Care Teams (PACT) in order to broaden the provision of wellness services that can address many chronic illnesses. An evaluation of this initiative was undertaken to assess the impact of outside assistance on the deployment of PS in PACT, as implementation support is often needed to prevent challenges commonly experienced when first deploying PSs in VHA settings. We present the protocol for this cluster-randomized hybrid type II trial to test the impact of standard implementation (receive minimal assistance) vs. facilitated implementation (receive outside assistance) on the deployment of VHA PSs in PACT. A VHA Office of Mental Health Services work group is recruiting 25 Veterans Affairs Medical Centers to reassign a mental health PSs to provide wellness-oriented care in PACT. Sites in three successive cohorts (n = 8, 8, 9) beginning over 6-month blocks will be matched and randomized to either standard or facilitated implementation. In facilitated implementation, an outside expert works with site stakeholders through a site visit, regular calls, and performance data to guide the planning and address challenges. Standard implementation sites will receive a webinar and access the Office of Mental Health Services work group. The two conditions will be compared on PS workload data, fidelity to the PS model of service delivery, team functioning, and Veteran measures of activation, satisfaction, and functioning. Qualitative interviews will collect information on implementation barriers and facilitators. This evaluation will provide critical data to guide administrators and VHA policy makers on future deployment of PSs, as their role has been expanding beyond mental health. In addition, development of novel implementation strategies (facilitation tailored to PSs) and the use of new tools (peer fidelity) can be models for monitoring and supporting deployment of PSs throughout VHA. ClinicalTrials.gov, NCT02732600 (URL: https://clinicaltrials.gov/ct2/show/NCT02732600 )