Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (MISSION) (QUE 15-284)
Conditions: Co-Occurring Disorders, Homelessness, Substance Abuse Disorder, Mental Illness
Sponsor: VA Office of Research and Development

Maintaining Independence and Sobriety through Systems Integration, Outreach, and 
Networking 
NCT02942979 
Document Date: 8/10/2021 
 
 
 

Study Protocol and Statistical Analysis Plan 
Study Design  
This study involved a multi-site, randomized, hybrid type III modified stepped-wedge 
implementation-effectiveness trial in seven homeless programs at two VA Medical Centers 
(VAMCs) serving homeless Veterans with co-occurring mental health and substance use 
problems (Curran et al., 2012). Instead of starting all intervention and control sites together, the 
design staggered introduction of the Facilitation strategy. We selected a stepped-wedge design 
to compare Maintaining Independence and Sobriety through Systems Integration Outreach and 
Networking-Veterans Edition (MISSION-Vet) uptake under two staff level intervention 
conditions: Implementation as Usual versus Facilitation and to help identify and control for 
secular trends better than parallel-groups’ randomized controlled trials (Curran et al., 2015). In 
our study, both sites received six months of Implementation as Usual and crossed over to 
Facilitation for another six months. In addition, to further the existing literature supporting 
MISSION-Vet outcomes, this trial also enabled us to extract existing data from the VA Electronic 
Medical Record to examine treatment engagement among those receiving MISSION-Vet. The 
hypothesis of this project was that Facilitation would yield better adoption and fidelity to 
MISSION-Vet among sites compared to Implementation as Usual. The project was deemed 
quality improvement and received an exempt status by the Institutional Review Board at the 
Bedford, Massachusetts VAMC according to the VA Program Guide 1200.21 (Department of 
Veterans Affairs, 2019).  
MISSION-Vet Intervention  
MISSION-Vet is a multicomponent care coordination and linkage intervention to address 
the needs of homeless Veterans with co-occurring mental health and substance use problems 
and can be flexibly used within many of the VA homeless programs. In brief, MISSION-Vet is 
delivered by a master’s level social work case manager, and a peer specialist, the latter of 
which is someone with prior lived experience with homelessness, substance use and mental 

health issues. The MISSION-Vet team delivers the following five treatment components: critical 
time intervention (CTI), dual recovery therapy (DRT), peer support, vocational and educational 
support, and trauma-informed care, all guided by Housing First and harm reduction philosophies 
that emphasize low barrier services for clients (Susser et al., 1997; Ziedonis & Stern, 2001; 
Chinman et al., 2010; Bond et al., 2008; Najavits, 2012; Tsemberis et al., 2004). One of the core 
components of MISSION-Vet is CTI (Susser et al., 1997). CTI is an empirically supported 
assertive community treatment approach intended to reduce the risk of homelessness by 
enhancing continuity of support for individuals with mental illness during the transition from 
institutions such as inpatient psychiatry units, residential treatment programs and homeless 
residences to community living (Herman & Mandiberg, 2010). The primary focus of CTI is on 
housing placement and support. The next component is DRT which consists of 13 
psychoeducational sessions delivered by the case manager. DRT helps educate Veterans on 
the impacts of substance use, mental illness, and harmful behavior, offering exercises and tools 
to aid in recovery. The third component is Peer Support which includes 11 Peer-Led sessions 
that help Veterans engage in sobriety and mental health stability services with a “buddy” who 
offers role modeling and empowerment. In addition to the structured psychoeducational 
sessions designed to empower Veterans to engage in treatment, both the case manager and 
peer specialist also offer unstructured community outreach sessions to engage clients in care 
and link Veterans to other needed community support. The personal relationship and support 
provided by someone who “has been there” also bolsters the effectiveness of the other 
interventions. The fourth component is vocational and education support which helps Veterans 
find and maintain employment. MISSION-Vet includes educational supports to help Veterans 
understand and utilize benefits such as the Post-9/11 GI Bill, navigate enrollment and 
registration processes, and further and sustain their educational goals. Lastly, MISSION-Vet 
uses a trauma-informed care approach. MISSION-Vet Case Managers and P Specialists are 
trained to screen for trauma-related symptoms and refer to treatment providers when more 

intense treatment is needed. They are also trained to provide ongoing support for Veterans who 
are receiving treatment from a specialized PTSD program or to serve Veterans who do not 
require specialized PTSD services.  MISSION-Vet was offered for approximately 2-hours a 
week for 6-months, and service delivery was guided by a Treatment Manual (Smelson et al., 
2011a). Veterans could also receive a MISSION-Vet Workbook that includes assignments 
reinforcing recovery (Smelson et al., 2011b). 
Participation Sites 
Site Composition 
 
This project was conducted at two VA Medical Centers (VAMCs; hereafter Sites A and 
B) and offered to staff at seven homeless programs (four locations at Site A and three locations 
at Site B) with the unit of measurement being the two VAMCs. The two VAMCs were selected 
because of the size and scope of the healthcare systems, geographic dispersion, and the rate 
of homelessness in the regions (Department of Veterans Affairs, 2014). Site A was in a large 
VA urban setting, serving approximately 83,000 unique Veterans annually with the highest-level 
complexity, and two on-site residential buildings, and two off-site buildings. Site B was a 
smaller suburban medium complexity VA serving approximately 18,000 unique Veterans 
annually, with one on-site and off-site residential building. Both Sites A and B had community-
based non-residential treatment which included housing placement, case management, 
linkages to mental health and substance use programing, but not MISSION-Vet. 
Recruitment 
 
There were two groups of participants in the study: staff and clients. The first group were 
the case managers and peer specialists delivering MISSION-Vet; staff participation was voluntary 
with no incentives provided. The second group were, Veterans (clients) being served by these 
staff in their respective VA homeless programs. Staff were encouraged to follow the 
recommended MISSION-Vet inclusion and exclusion criteria. This included: (1) enrolled in a VA 
homeless program at one of the implementation sites; (2) met Diagnostic and Statistical Manual of 

Mental Disorders, 5th Edition (American Psychiatric Association, 2013) diagnostic criteria or 
International Classification of Diseases, 10th Revision (World Health Organization, 2004) for 
current substance use or dependence disorder (e.g., alcohol, marijuana, cocaine) and a co-
occurring mental illness which includes anxiety, mood, or a psychotic spectrum disorder; and (3) 
was willing to participate in the service. 
Implementation Strategy 
Passive Implementation: Implementation as Usual  
Implementation as Usual for MISSION-Vet is comprised of a 1.5 hour webinar training 
which provides an overview of the MISSION-Vet approach, staff roles, as well as key 
information on how to access and use the MISSION-Vet Treatment Manual and Consumer 
Workbook. The manual is posted on the web and available inside the VA on the National Center 
for Homelessness among Veterans website or at missionmodel.org. The webinar was offered at 
least twice to case manager and peer specialist staff within the two VAMCs and seven 
programs to accommodate scheduling. It also presented how to use the MISSION-Vet service 
delivery fidelity measure, embedded within the VA medical record. This fidelity measure was 
used to capture the total number and type of MISSION-Vet sessions delivered, which served as 
our measures of MISSION-Vet uptake. 
As previously mentioned, MISSION-Vet includes the following resources developed and 
ready to use for this study:  
MISSION-Vet Treatment Manual: The manual is a “how-to” guide that describes the core 
components of the approach, including the delivery of CTI, the role of the MISSION-Vet team 
(case manager and peer specialist), the co-occurring mental health and substance use psycho-
educational sessions and suggestions for offering vocational, educational, and trauma-informed 
support delivered. The manual also includes a number of appendices with didactic materials to 
assist with service delivery. 

MISSION-Vet Consumer Workbook: The workbook serves as a resource for MISSION-Vet 
participants to help them integrate DRT and peer support concepts while also offering 
homework assignments to develop needed skills to maintain housing and other supports. In 
addition, the Consumer Workbook contains materials designed to increase a MISSION-Vet 
client’s internal motivation for and engagement in outpatient services.  
MISSION-Vet Fidelity Measure: Our fidelity measure quantifies all of the components involved in 
delivering MISSION services. It is embedded in the VA medical record and used by VA staff to 
determine model adherence. 
Implementation platform: Facilitation 
 
Following the initial training, there was a 6-month waiting period prior to the 6-months of 
Facilitation being offered to each of the seven programs at the two VAMCs. Facilitation is a 
comprehensive approach in which implementation experts partner with local staff to support 
implementation planning and to tailor adoption strategies to local contexts (Ajzen, 1977; 
Rosenheck, 2001). This approach builds capacity for implementing evidence-based programs 
by strengthening the knowledge, attitudes, and skills practitioners need to carry out evidence-
based program implementation. In this study Facilitation included external and internal 
facilitators working in tandem to support MISSION-Vet implementation. Specifically, external 
facilitators are external to the implementation site and have general expertise in implementation 
strategies and relevant clinical models and their evidence base. An internal facilitator is familiar 
with facility‐level organizational structures, procedures, and culture as well as the clinical 
processes within the system at the regional or local facility level. The external and internal 
facilitators work together to present sites with important design considerations and steps 
practitioners can follow to obtain positive results, and then provide practitioners with guidance 
necessary to complete those steps (i.e., to perform each task as close to the ideal as possible). 
The goal was to work with leadership and staff to integrate MISSION-Vet into routine 
operations, closing the gap between research and practice. Over time, the external facilitator 

transfers understanding of effective implementation activities to the internal facilitator and thus 
fosters introduction and retention of skills in the local organization. 
 
The external facilitators held bi-weekly meetings with local program staff executing 
MISSION-Vet to address implementation barriers, troubleshoot, and provide implementation 
fidelity reports, which included feedback on number and type of MISSION-Vet services 
delivered. External facilitators also provided regular feedback on the staff’s use of the fidelity 
measure within the VA medical record since this fidelity measure was used to construct our 
measure of implementation uptake. 
Measures 
Project measures captured information about implementation outcomes (both Facilitation 
and the implementation of MISSION-Vet), organizational readiness and VA health services 
utilization. Depending on the outcome, data were measured at the site, staff, and/or veteran 
level.  
Implementation Outcomes 
Consistent with recommendations for type III hybrid effectiveness-implementation 
designs, our primary outcome was MISSION-Vet uptake (as measured by number of MISSION-
Vet sessions delivered) during the Implementation as Usual versus Facilitation time periods 
(Curran et al., 2012) and the secondary aim was to assess clinical outcomes (health service 
utilization). For this comparison of IU versus IF timeframes, we used a standardized facilitation 
tracking sheet completed by the external facilitators at the site level that included date, length of 
time, parties involved, activity type (Ritchie et al., 2019).  
In addition, MISSION-Vet implementation was collected with a fidelity measure that was 
embedded in the Veterans’ electronic medical record using a specially created service tracking 
note template to quantify the type and amount of MISSION-Vet delivered (Chinman et al., 
2017). The MISSION-Vet Fidelity Measure tracks all the core elements of the MISSION-Vet 
treatment model, including Critical Time Intervention, DRT, Peer Support, vocational supports, 

and trauma-informed care for each individual veteran. The fidelity index consists of 78 items 
assessing the presence or absence of certain activities within MISSION-Vet and will be 
captured in veterans’ electronic medical records. Information captured in this note template 
included: which DRT sessions, peer support sessions, and Consumer Workbook exercises were 
completed; whether the MISSION-Vet Consumer workbook was provided; whether community 
activities were done with a Veteran (e.g., taken to appointment, NA/AA meetings, meetings with 
landlords); and referrals made to other services. Data on all veterans at all sites will be obtained 
from electronic medical records available in the VA’s Corporate Data Warehouse. 
Organizational Readiness 
An abbreviated version of the Organizational Readiness to Change Assessment (ORCA) 
context subscale and Jacobs’ Implementation Climate survey, was used to examine 
organizational readiness resulting in a 21-item 5-point Likert scale to get at site and staff level 
readiness (Helfrich et al., 2009; Jacobs et al., 2014). Higher scores indicate greater 
organizational readiness and implementation climate. Following MISSION-Vet training, staff 
were asked to complete the organizational readiness survey and demographic survey regarding 
their age, sex, role/position, and tenure in VA.  
Veteran Treatment Engagement 
Treatment engagement as an outcome was captured with Veterans’ medical records 
obtained from the VA Corporate Data Warehouse, which included number of MISSION-Vet 
contacts and other outpatient visits (mental health, substance use, medicine, primary care, 
emergency department, other, total). Each service utilization outcome was aggregated over the 
1-year period following the date of Veterans’ initial MISSION-Vet session. 
Semi-structured Interviews 
Semi-structured interviews were conducted for a formative and summative evaluation. 
The formative evaluation interviews elicited key stakeholders’ experiences with, and 
perspectives on MISSION-Vet training, barriers to and facilitators of implementing MISSION-Vet 

as well as to identify particular areas to target for Facilitation. Summative evaluation interviews 
identified stakeholder’s experiences with Facilitation and needed adaptations to MISSION-Vet 
as well as veteran experiences with MISSION-Vet. 
All semi-structured interviews were conducted by phone. Interview questions focused on 
evaluating the implementation of Facilitation, Implementation as Usual, and MISSION-Vet with 
particular focus on barriers to Facilitation, perceptions of strengths and weaknesses of 
MISSION-Vet for this population and setting, and leadership support for implementation in VA. 
The goal of the qualitative portion of this project was to get an understanding of what staff 
thought about MISSION-Vet itself and for researchers to understand the organizational context 
and then to identify barriers and facilitators to implementation of MISSION-Vet so that these 
areas can be addressed through Facilitation once it is activated. 
Statistical Analysis Plan  
Our analytic strategy involved four components that align with the four study aims. 
Specifically, we examined: 1) pre-implementation organizational readiness; 2) IF process, 
including IF events; 3) MISSION-Vet implementation in the IU and IF time periods; and 4) 
association between MISSION-Vet and VA health services. Because the number of trained 
providers to deliver MISSION-Vet and the number of Veterans who received it at the seven 
homeless programs was too small for meaningful program comparison, our analysis focuses on 
a comparison between the two VAMCs (Sites A and B) rather than the seven individual 
programs when making comparisons for all measures of interest. 
First, we examined organizational readiness using descriptive statistics and conducted 
comparisons of organizational readiness between the Sites A and B and by staff type (case 
manager vs. peer specialist), staff age, staff sex, and duration of employment with the VA using 
non-parametric Wilcoxon and Kruskal-Wallis tests. Second, we used descriptive statistics to 
examine IF events, including number, duration, and type of IF activities. Third, and similarly, we 
used descriptive statistics to examine implementation of MISSION-Vet. We summarize 

information about the number and type of MISSION-Vet sessions provided overall, at the 
Veteran-level, and by VAMC. We also examined provision of MISSION-Vet separately by staff 
type (i.e., whether a case manager or peer specialist). Additionally, to assess the potential 
impact of IF on MISSION-Vet, we examined how the overall provision of MISSION-Vet changed 
over time both before and after the start of IF using descriptive measures of the number of 
MISSION-Vet sessions provided at each site by month. Our intent was to estimate the 
intervention effect using a statistical model in line with established practices for stepped wedge 
designs. However, because neither of the two sites provided any MISSION-Vet services in the 
IF period, there was no variation in the outcome of interest during this time thus rendering it 
impractical to estimate such a model. We therefore use descriptive statistics to examine the 
impact of IF on the provision of MISSION-Vet services. 
Fourth, we examined the relationship between receipt of MISSION-Vet and Veteran-
level measures of engagement in clinical service (i.e., VA inpatient and outpatient services). To 
do so, we estimated a series of bivariate linear regression models in which our service utilization 
measures (i.e., number of outpatient and inpatient visits, by type, in the year after a Veteran’s 
initial MISSION-Vet session) served as the outcomes of interest and the number of MISSION-
Vet sessions in the year following a Veteran’s initial MISSION-Vet session served as the 
predictor of interest in all models. 
Qualitative Analysis 
Each interview will be recorded and transcribed verbatim. A codebook will be developed 
with a priori codes based on Consolidated Framework for Implementation Research 
(Damschroder et al., 2009) along with emergent thematic coding (Boyatzis, 1998). For the 
formative evaluation, interviews will be coded and analyzed to synthesize data on organizational 
strengths and weaknesses and to identify key areas for the Facilitation strategy to target. The 
same process will be followed with the summative evaluation. The summative evaluation will 

enable us to identify the differences and similarities experienced by participants both within LA 
sites and across the sites. These similarities and differences within and across sites will serve 
as a key “lessons learned” for subsequent efforts to facilitate use of MISSION-Vet across a 
larger number of sites in the VA. 
 
 
 

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