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Suggested Citation:"Summary." National Academies of Sciences, Engineering, and Medicine. 2023. Review of Four CARA Programs and Preparing for Future Evaluations. Washington, DC: The National Academies Press. doi: 10.17226/26831.
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Summary

The opioid epidemic has been recognized as a national emergency (Gostin et al., 2017; HHS, 2021, 2023). In 2021, the Substance Abuse and Mental Health Services Administration (SAMHSA) reported that nearly 22 percent of people aged 12 or older used an illicit drug in the past year, which is a higher percentage than in prior years (SAMHSA, 2018b, 2021). Deaths due to prescription drugs, synthetic opioids, and heroin have increased substantially over the past decade (NIDA, 2022). Particularly notable has been the more recent increase in deaths due to illicitly manufactured fentanyl and its analogs (CDC, 2018a; NIDA, 2022). The use of opioids with other drugs, such as benzodiazepines, stimulants, or alcohol, has also increased dramatically (CDC, 2018a, 2019, 2020b). The COVID-19 pandemic has compounded this substance use disorder (SUD) epidemic; on December 17, 2020, the Centers for Disease Control and Prevention (CDC) released a Health Alert Network Advisory to alert the nation that an unprecedented rise in fatal drug overdoses across the United States was occurring, which has worsened significantly during the COVID-19 pandemic (CDC, 2020a); this trend has continued (SAMHSA, 2021).1

COMPREHENSIVE ADDICTION AND RECOVERY ACT

To help address the challenges of overdose deaths and opioid use disorder and to expand access to evidence-based treatment, the Comprehensive Addiction and Recovery Act (CARA; P.L. 114-198) was signed into law on

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1 Text in this section is reprinted from the second report in this series (NASEM, 2021).

Suggested Citation:"Summary." National Academies of Sciences, Engineering, and Medicine. 2023. Review of Four CARA Programs and Preparing for Future Evaluations. Washington, DC: The National Academies Press. doi: 10.17226/26831.
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July 22, 2016.2 CARA is extensive legislation intended to address many aspects of the opioid epidemic, including prevention, treatment, recovery, law enforcement and criminal justice reform, and overdose reversal. It authorizes more than $181 million each year in new federal funding to address the opioid epidemic. It mandates the implementation of programs and services to address opioid use across the United States to address addiction and recovery.3 Among those efforts was the authorization of four programs to be overseen by SAMHSA. The four CARA grant programs described in this report, while focused primarily on opioids, also occasionally include treatment and recovery services for co-occurring SUDs.4

The CARA legislation also mandated a role for the National Academy of Sciences in Section 701, Grant accountability and evaluations. However, it was not until 2 years later, with the passage of the Consolidated Appropriations Act of 20185 that appropriations were granted requesting a study of the four SAMHSA programs in CARA, to be conducted by the National Academies of Sciences, Engineering, and Medicine (the National Academies).

THE FOUR CARA PROGRAMS

Two of the CARA grant programs—the State Pilot Grant Program for Treatment for Pregnant and Postpartum Women (PPW-PLT) and Building Communities of Recovery (BCOR)—are administered by the Center for Substance Abuse Treatment (CSAT).

The other two grant programs—Improving Access to Overdose Treatment (OD Treatment Access) and First Responder Training (FR-CARA)—are focused on preventing overdose and are administered by the Center for Substance Abuse Prevention (CSAP). See Tables S-1 and S-2 for a summary of the four programs.6

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2 See https://www.congress.gov/bill/114th-congress/senate-bill/524/text (accessed March 13, 2020).

3 See https://www.cadca.org/comprehensive-addiction-and-recovery-act-cara (accessed March 13, 2020).

4 Text in this paragraph is reprinted from the second report in this series (NASEM, 2021).

5 See https://www.govinfo.gov/content/pkg/CPRT-115HPRT29457/pdf/CPRT-115HPRT29457.pdf (accessed February 15, 2023).

6 Text in this section, including the two tables on the following pages, is reprinted from the second report in this series (NASEM, 2021).

Suggested Citation:"Summary." National Academies of Sciences, Engineering, and Medicine. 2023. Review of Four CARA Programs and Preparing for Future Evaluations. Washington, DC: The National Academies Press. doi: 10.17226/26831.
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REPORT SERIES STATEMENT OF TASK

The first CARA grants were awarded in 2017, and the second cohorts were awarded in 2018. SAMHSA entered into a contract with the National Academies in July 2018, after implementation had begun. The committee’s Statement of Task is in Box S-1.

In the first report, the committee reviewed the reporting metrics selected by SAMHSA for the four CARA grant programs, and recommended changes or additions. For the second report, intended to provide an update on grantee progress, the committee reviewed data collected through the reporting materials that grantees submitted to SAMHSA. The conclusions of that report centered largely around the limitations of the reporting materials provided by SAMHSA. The conclusions noted (NASEM, 2021):

The committee concludes, based on information provided by SAMHSA, that grantees providing data have shown at least some progress in planning and implementing the four Comprehensive Addiction and Recovery Act programs under review. The degree of implementation and progress and the nature of supporting data vary across programs, grantees, and specific activities; data were not provided on all grantees.

Suggested Citation:"Summary." National Academies of Sciences, Engineering, and Medicine. 2023. Review of Four CARA Programs and Preparing for Future Evaluations. Washington, DC: The National Academies Press. doi: 10.17226/26831.
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TABLE S-1 Summary of BCOR and PPW-PLT Programs

Program Eligible Applicants Awards and Project Period Funding Restrictions Program Purpose
BCOR Recovery community organizations (RCOs) that are domestic private nonprofit entities in states, territories, or tribes (must be controlled and managed by members of the addiction recovery community) 2017 awards: 8 (up to $200,000 each)

2018 awards: 18 (up to $200,000 each)

Up to 3 years
No more than 20% of the federal funding may be allocated to data collection performance measurement, and performance assessment.

Must receive at least 50% of funds from nonfederal sources with a 100% matching requirement.
The purpose of this program is to “mobilize resources within and outside of the recovery community to increase the prevalence and quality of long-term recovery support from substance abuse and addiction.

These grants are intended to support the development, enhancement, expansion, and delivery of recovery support services (RSS) as well as promotion of and education about recovery.”
PPW-PLT Single state agencies for substance abuse 2017 awards: 3 ($1,100,000 each)

2018 awards: 3 (up to $1,100,000 each)

Up to 3 years
No more than 15% of the federal funding may be allocated to data collection performance measurement, and performance assessment.

A minimum of 75% of federal funds must be directed toward service provision; no more than 25% may go toward infrastructure or capacity building.
The purpose of this program is to “enhance flexibility in the use of funds designed to support family-based services for pregnant and postpartum women with a primary diagnosis of a substance use disorder, including opioid disorders; help state substance abuse agencies address the continuum of care, including services provided to women in nonresidential-based settings; and promote a coordinated, effective and efficient state system managed by state substance abuse agencies by encouraging new approaches and models of service delivery.”

Through this program, SAMHSA seeks to “reduce the misuse of alcohol and other drugs, increase engagement in treatment services, increase retention in the appropriate level and duration of services, and increase access to the use of medications approved by the U.S. Food and Drug Administration (FDA) in combination with counseling to treat drug addiction.”a

a The committee prefers the use of the terms substance use disorder (SUD) and opioid use disorder (OUD); “addiction” will be used when directly quoting grantees or SAMHSA. SOURCES: The information in this table is pulled directly from the initial Funding Opportunity Announcements for PPW-PLT (SAMHSA, 2017b) and BCOR (SAMHSA, 2017a). The information in the Awards and Projects column comes from the Individual Grant Awards page for PPW-PLT (SAMHSA, 2017h, 2018g) and BCOR (SAMHSA, 2017g, 2018f).

Suggested Citation:"Summary." National Academies of Sciences, Engineering, and Medicine. 2023. Review of Four CARA Programs and Preparing for Future Evaluations. Washington, DC: The National Academies Press. doi: 10.17226/26831.
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Program Activities
Required Activity
  • “Support the development, expansion, and enhancement of community and statewide recovery support services.”

Allowable Activities

  • “Build connections through infrastructure building between recovery networks, between recovery care organizations, and with other RSS.
  • Reduce the stigma associated with drug and alcohol addiction.
  • Conduct public education and outreach on issues relating to drug and alcohol addiction and recovery.”
Required Activities
  • “Facilitate the availability of family-based treatment and recovery support services.
  • Develop a needs assessment using statewide epidemiological data (where available if a needs assessment effort is already in place, work with the local, state, or tribal epidemiological outcomes workgroup to enhance and supplement the current process and its findings); it should identify gaps in services furnished to pregnant and postpartum women along the continuum of care with a primary diagnosis of substance use disorder, including opioid use disorders.
  • Develop and implement a state strategic plan or enhance an existing plan to ensure sustained partnerships across public health and other systems that will result in short and long-term strategies to support family-based treatment services along the continuum of care for pregnant and postpartum women.”

Allowable Activities

  • “Adopt and/or enhance computer system, management information system (MIS), electronic health records (EHRs), etc., to document and manage client needs, care processes, integration with related support services, and outcomes.
  • Train or develop the workforce to help state staff or community provider employees to identify mental health or substance abuse or provide effective services consistent with the purpose of the grant program.
  • Develop policy to support needed services system improvements (e.g., rate-setting activities, establishment of standards of care, adherence to the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care, development/revision of credentialing, licensure, or accreditation requirements).”
Suggested Citation:"Summary." National Academies of Sciences, Engineering, and Medicine. 2023. Review of Four CARA Programs and Preparing for Future Evaluations. Washington, DC: The National Academies Press. doi: 10.17226/26831.
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TABLE S-2 Summary of OD Treatment Access and FR-CARA Programs

Program Eligible Applicants Awards and Project Period Funding Restrictions Program Purpose
OD Treatment Access Federally qualified health centers (FQHCs); opioid treatment programs; practitioners dispensing narcotic drugs 2017 awards: 1 (up to $1,000,000 each)

2018 awards: 5 (up to $200,000 each)

Up to 5 years
No more than 20% of total award may be used for (1) purchasing or distributing drugs or devices to treat overdose and (2) offsetting copayments or other cost sharing for such drugs or devices.

No more than 20% of the total award can be used for data collection, performance measurement, and performance assessment.
The purpose of the program is to “expand access to FDA [Food and Drug Administration] approved drugs or devices for emergency treatment of known or suspected opioid overdose.”
FR-CARA States; tribes and tribal organizations; local governmental entities 2017 awards: 21 (between $250,000 and $800,000 each)

2018 awards: 27c (between $250,000 and $800,000 each)

Up to 4 years
No more than 20% of the federal funding may be used for data collection, performance measurement, and performance assessment expenses. No more than 10% may be used for administrative costs. The purpose of this program is to “allow first responders and members of other key community sectors to administer a drug or device approved or cleared under the Federal Food, Drug, and Cosmetic Act for emergency treatment of a known or suspected opioid overdose.”

a See the toolkit at https://store.samhsa.gov/product/Opioid-Overdose-Prevention-Toolkit/SMA18-4742 (accessed March 13, 2020).

b The committee prefers the term “survivors”; however, “victims” will be used when directly quoting SAMHSA.

c SAMHSA initially awarded funding to 28 grantees in this year. One of the original grantees rescinded (see section “FR-CARA Program Description”).

SOURCES: The information in this table is pulled directly from the Funding Opportunity Announcements for OD Treatment Access (SAMHSA, 2017d) and FR-CARA (SAMHSA, 2017c). The information in the Awards and Projects column comes from the Individual Grant Awards pages for OD Treatment Access (SAMHSA, 2017f, 2018e) and FR-CARA (SAMHSA, 2017e, 2018d).

Suggested Citation:"Summary." National Academies of Sciences, Engineering, and Medicine. 2023. Review of Four CARA Programs and Preparing for Future Evaluations. Washington, DC: The National Academies Press. doi: 10.17226/26831.
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Program Activities
Required Activities
  • “Establish a program for prescribing a drug or device approved by the FDA for treatment of known or suspected opioid overdose.
  • Train and provide resources for health care providers and pharmacists on the prescribing of such drugs or devices.
  • Establish protocols to connect patients who have experienced a drug overdose with appropriate treatment, including medications, counseling, or behavioral therapies.
  • Develop a plan for sustaining the program after federal support has ended.
  • Use the SAMHSA Opioid Overdose Prevention Toolkita as a guide to develop and implement a comprehensive prevention program to reduce the number of prescription drug/opioid overdose–related deaths and adverse events.”

Allowable Activities

  • “Collaborate with health care providers and pharmacists to educate them on overdose dangers, and to recommend that they consider providing standing orders for FDA-approved overdose reversal drugs to patients and individuals who support persons at high risk for overdose.
  • Collaborate with pharmacies to distribute overdose reversal drugs or devices, if permitted by state law.
  • Provide public education on any state ‘Good Samaritan’ laws, such as those that permit bystanders to alert emergency responders to an overdose or to administer FDA-approved overdose reversal drugs without fear of civil or criminal penalties.”
Required Activities
  • “Make a drug or device approved or cleared under the Federal Food, Drug, and Cosmetic Act for emergency treatment of a known or suspected opioid overdose available to be carried and administered by first responders (FRs) and members of other key community sectors.
  • Train and provide resources for FRs and members of other key community sectors on carrying and administering such a drug or device.
  • Establish processes, protocols, and mechanisms for referral to appropriate treatment and recovery communities, which may include an outreach coordinator or team to connect individuals receiving opioid overdose reversal drugs to follow-up services.
  • Form or join an established advisory council.”

Allowable Activities

  • “Collaborate with health care providers to educate them on overdose dangers and recommend that they consider providing resources to overdose victimsb and families, including information on treatment and recovery.
  • Provide public education on any state ‘Good Samaritan’ laws, such as those that permit bystanders to alert emergency responders to an overdose or to administer FDA-approved overdose reversal drugs without fear of civil or criminal penalties.”
Suggested Citation:"Summary." National Academies of Sciences, Engineering, and Medicine. 2023. Review of Four CARA Programs and Preparing for Future Evaluations. Washington, DC: The National Academies Press. doi: 10.17226/26831.
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The committee concludes that it cannot determine whether these programs have had specific, identifiable impacts on people with substance use disorders. It is very possible that these programs have had a positive impact on people’s substance use and on their health and well-being, but the limitations of the information provided do not allow for confidence in such a determination.

The committee concludes that it cannot determine whether the Comprehensive Addiction and Recovery Act programs have had a positive impact on advancing systems change in substance use disorder prevention and treatment or in advancing systematic interagency collaboration. The lack of systematic, quantifiable, or descriptive data does not allow for such a determination.

INTERPRETATION OF THE STATEMENT OF TASK

In the second report in this series, the committee identified that the limitations in the data SAMHSA provided would limit its ability to address both of these tasks for the third and final report.7 In light of that fact, the final chapter of that report laid out proposals for how the committee might attempt to respond to these charges in a way that would be doable and useful to SAMHSA and Congress (NASEM, 2021). This section will provide a summary of the challenges, and how the committee has chosen to interpret the two charges for this third and final report.

Assessing Effectiveness

For the present report, SAMHSA provided similar information to what was provided for the second report for the CSAT programs. The agency supplied the committee with additional detail and free text responses from the CSAP program grantees mandatory reporting. The information provided was also more comprehensive of grantee experiences, given that, when the second report was under way, most grantees had just begun many of their activities. Many grantees had completed or were near completion of their grant by the time SAMHSA forwarded their reporting for this third report. However, given that it was the same type of information, many of the materials the committee received had the same limitations as in the second report; these limitations included but were not limited to aggregation of information across grantees, anonymization, and lack of inclusion of reporting from some grantees.

Nevertheless, the materials provided by SAMHSA were sufficient for the committee to describe, to some extent, the experience and processes

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7 For a full discussion of those limitations, see the second report in this series (NASEM, 2021).

Suggested Citation:"Summary." National Academies of Sciences, Engineering, and Medicine. 2023. Review of Four CARA Programs and Preparing for Future Evaluations. Washington, DC: The National Academies Press. doi: 10.17226/26831.
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of the four grant programs. The committee sought to understand broadly what actions were taken by the grantees and their partners; what impacts to clients, patients, the community, and public were observed; and what structural or environmental changes might have resulted from the grant funding. The committee reviewed information provided by SAMHSA as reported by grantees through the mandatory reporting tools, required progress reports, and contracted qualitative, anonymous interviews conducted for the committee by NORC. Although some grantees provided progress reports, the material provided by SAMHSA was redacted, anonymous, and often aggregated across the respective grantees of each of the four programs.

Ensuring Cost-effectiveness

The committee was concerned with its ability to make recommendations to Congress concerning the appropriate allocation of resources to “ensure cost-effectiveness” in the federal government’s response to the opioid epidemic. This was due in part to the challenges in evaluating effectiveness, as laid out above, and in part due to the lack of cost data on any of the four programs. The committee suggested in its second report that a strategy to answering the third interpretation of the charge would consist of an analysis of “how, in the future, Congress can specify required evaluation methods and processes to assess program effectiveness and cost-benefit analysis, and how SAMHSA can improve program evaluation capacity and efforts in similar programs,” which “would result in more robust evaluation assessment and information for decision makers responsible for guarding the public’s health and related expenditure decisions” (NASEM, 2021).

FINDINGS

The following paragraphs summarize some of the grantee activity accomplishments described for each of the four programs. Throughout the report, the committee notes relevant literature about the effectiveness of interventions similar to those grantees implemented. However, because the committee often did not have enough information about grantee contexts, it could not directly compare grantee efforts to this literature or directly extrapolate inferences about grantee effectiveness. Nevertheless, it notes some instances in which grantee plans were rooted in interventions that have potential to be effective.

BCOR grantees primarily provided two main types of direct services: recovery support services and wraparound to individuals with SUDs, and training to individuals seeking to work as peer recovery coaches. Such recovery and wraparound services have been demonstrated to support

Suggested Citation:"Summary." National Academies of Sciences, Engineering, and Medicine. 2023. Review of Four CARA Programs and Preparing for Future Evaluations. Washington, DC: The National Academies Press. doi: 10.17226/26831.
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recovery (Eddie et al., 2019; McLellan et al., 1999; Scott and Dennis, 2009; Stewart et al., 2021), as has peer recovery coaching (Eddie et al., 2019; White et al., 2007). Their work extended far beyond these direct services, however. They developed partnerships across a wide variety of sectors, invested in internal capacity building efforts such as technology systems improvement and physical infrastructure development, and facilitated workforce development. In an effort to spread knowledge about SUD and reduce stigma, they engaged with the broader community through public events, advocacy efforts and speakers bureaus, public events, resources distribution, and other programming.

Grantees in the PPW-PLT program provided outpatient treatment services to pregnant and postpartum women; several grantees intended to expand the availability of these services to rural areas where they were not previously available. Several grantees used CARA funds to enhance their services by engaging peer support workers or by training staff in evidence-based practices and particularly trauma-informed care relevant to the PPW patient population (Henry et al., 2021; Sperlich et al., 2017). Like BCOR grantees, they connected with a wide variety of partners to train other service providers, to advocate for policy changes, and to facilitate treatment and ancillary services for services like housing that impact recovery for this population (Frazer et al., 2019; Petzold et al., 2022).

OD Treatment Access grantees created and disseminated training materials, toolkits, and presentations about overdose reversal. In addition to distributing naloxone, they engaged in a broader range of overdose prevention activities as well, including efforts to expand access to medications for opioid use disorder (MOUDs) and distribution of fentanyl test strips, both of which are evidence-based (Fairley et al., 2021; Karamouzian et al., 2018; Krieger et al., 2018, NASEM, 2019; Peiper et al., 2019). They undertook steps to support these efforts by increasing staffing, developing their informational technology systems, encouraging co-prescribing in their communities, formulating assessments and approaches to direct interventions to high-risk settings, and strengthening community partnerships with relevant stakeholders.

The FR-CARA grantees also used funds to perform naloxone distribution and training, which have been shown to be effective and cost-effective in reducing overdose events (CDC, 2018b; Chao and Loshak, 2019; Chimbar and Moleta, 2018; Coffin and Sullivan, 2013; McClellan et al., 2018; Naumann et al., 2019; NIDA, 2017; Townsend et al., 2020). They took steps to tailor their trainings to a variety of audiences, create and distribute toolkits, and evaluate their efforts. They also focused efforts on partnership formation and collaboration in an effort to extend the reach and potential sustainability of their programming.

Suggested Citation:"Summary." National Academies of Sciences, Engineering, and Medicine. 2023. Review of Four CARA Programs and Preparing for Future Evaluations. Washington, DC: The National Academies Press. doi: 10.17226/26831.
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CONCLUSIONS

The committee’s conclusions apply to all four programs and are based on the information provided by grantees to the National Academies, SAMHSA, and to NORC. The committee’s eight conclusions are organized around three themes: limits on inferences about program effectiveness; grantee activities; and barriers, including those that were outside of the control of grantees or SAMHSA.

Limits on Inferences About Program Effectiveness

CONCLUSION 1: The limited alignment between mandatory reporting tools, program goals, and tracked outcomes, and the lack of data suitable for a formal evaluation preclude the committee from making conclusions about whether the programs were effective.

SAMHSA’s off-the-shelf, mandatory reporting tools require grantees to track and submit a great deal of information, but not all that information aligned with the specific goals of the four CARA programs. While the committee made suggestions for improving the reporting tools as a whole in its first report, it was not until they began on the second report that the mismatch between those tools and the program goals became obvious. No amount of improvement in the existing reporting tools can overcome that they are the wrong tools for the stated purpose of understanding the reach, scope, and impact of the CARA programs. Additionally, the information that the committee did receive that related to program goals and targeted outcomes was often not suitable for a formal evaluation, due to limitations such as selection bias, missing data from some grantees, lack of outcomes data, lack of pre-post design or comparable control groups (i.e., lack of quasi-experimental or experimental design), and aggregation and redaction of grantee identities.

Given these challenges and that the programs operated in a complex milieu of health care, public health, criminal justice, law enforcement, child welfare, and employer and community programs, and often across broad geographic areas, the committee cannot attribute some reported outcomes specifically to CARA programs. Finally, other considerations such as timing of the evaluation, details of the data sharing agreements between SAMHSA and grantees, and level of SAMHSA support to grantees for evaluation purposes from the outset precluded a rigorous evaluation of program effectiveness.

Assessing Grantee Activities

CONCLUSION 2: CARA grantees and their partners engaged in a range of activities to address the worsening substance use disorder

Suggested Citation:"Summary." National Academies of Sciences, Engineering, and Medicine. 2023. Review of Four CARA Programs and Preparing for Future Evaluations. Washington, DC: The National Academies Press. doi: 10.17226/26831.
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epidemic. Based on the information provided, the committee is unable to say whether the programs as a whole were effective.

CONCLUSION 3: CARA funding supported grantees in enhancing or expanding treatment and recovery support services, as well as naloxone delivery. Grantees facilitated the education and training of community members and professionals about substance use disorder, stigma reduction, and overdose reversals.

CONCLUSION 4: Partnerships were a key feature of all four grant programs. Grantees varied in the success of partnership building and the impacts these partnerships have on reach and structural change.

Despite the limitations in the materials the committee reviewed, there was clear evidence that SAMHSA’s grantees worked diligently and used the CARA funding to stand up and expand activities intended to address the needs of individuals with SUDs and to address the worsening SUD epidemic. Grantees reported that CARA funding likely facilitated the implementation of these programs, even if the exact outcomes are not quantifiable. The committee also emphasizes that this lack of evidence about effectiveness does not amount to evidence of ineffectiveness; it also emphasizes that the data issues it identified are reflective of reporting requirements and agency expectations, not grantee underperformance.

In addition to direct treatment, recovery, and support services, grantees trained and educated relevant professionals and the public with the goals of reducing stigma and making treatment, recovery, and overdose reversal services more widely available. Grantees across all programs undertook efforts to build and sustain partnerships with a wide variety of community partners across multiple sectors; they cited both short-term and long-term benefits of these partnerships, ranging from increased referrals to their services, to an increase in community knowledge about SUDs.

But beyond just being a requirement of the grant, grantees underscored the value of those partnerships to both their short-term goals, such as providing treatment and recovery services and training others in naloxone prescribing and use, and long-term goals. Relevant long-term goals involve building grantee capacity, network-building, improving community education about SUD and overdose reversal, influencing local systems and policies, and assuring funding for work after the SAMHSA grant ended. These activities take time to come to fruition, and it is not surprising that their results are not necessarily yet apparent.

Suggested Citation:"Summary." National Academies of Sciences, Engineering, and Medicine. 2023. Review of Four CARA Programs and Preparing for Future Evaluations. Washington, DC: The National Academies Press. doi: 10.17226/26831.
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Significant Obstacles

CONCLUSION 5: Grantees identified several barriers across all four programs that inhibited their ability to achieve some of their goals, including but not limited to grant management, data collection, and staffing.

CONCLUSION 6: The confluence of the substance use disorder epidemic and the COVID-19 pandemic posed significant challenges to all grantees, but programs continued. COVID-19 prompted some grantees to engage in novel activities in pursuit of program goals.

CONCLUSION 7: Structural and policy barriers may have limited the ability of grantees to impact the substance use disorder epidemic. The CARA grant programs were not intended to address most of these barriers.

The first of this set of conclusions pertains to general barriers to implementation that were cross-cutting across the four programs; the next two highlight individually the two biggest barriers.

Among the common barriers experienced by grantees, several related to communication and management challenges with SAMHSA, including low funding levels, short implementation time frames, delays in budget approval, lack of communication with SAMHSA government program officers, a desire for additional technical assistance, and the administrative burden of mandated reporting tools. Grantees may have benefited from additional technical assistance from SAMHSA with data collection, which also proved to be a challenge for many grantees. Staffing and funding sustainability were also frequently cited.

The implementation periods of all CARA grantees overlapped at least somewhat with the COVID-19 pandemic. The pandemic and the accompanying spikes in SUD, relapse or return to use,8 and overdoses imposed daunting challenges for most grantees. These included delays in planning and implementation, suspension of in-person activities, follow-up difficulties, difficulty communicating with burdened community partners, and increased staff turnover. Of note, some grantees across the four programs highlighted creative strategies they undertook to continue with their program activities.

Grantees across the four programs highlighted the effects of systemic and policy barriers on their ability to carry out program activities and

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8 The term “relapse” is sometimes considered to be stigmatizing. For a fuller discussion on the committee’s choice in terminology, refer to Chapter 1 of this report.

Suggested Citation:"Summary." National Academies of Sciences, Engineering, and Medicine. 2023. Review of Four CARA Programs and Preparing for Future Evaluations. Washington, DC: The National Academies Press. doi: 10.17226/26831.
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achieve program goals. They cited the lack of availability or inequitable access to, in their local environments, medical and social services that are crucial to supporting survivors of overdose and other individuals with SUD. The criminalization and stigmatization of SUDs was also frequently cited as a barrier to client engagement and treatment, hesitation from potential partners, and more. Finally, there are limited funding opportunities available to grantees in the field at large. Changing these factors requires systemic change that falls beyond the scope of work of CARA grantees. Nevertheless, some did take it upon themselves to engage in exemplary efforts around advocacy and policy change. The committee notes that for programs such as these to reach their full potential to positively impact individuals and communities, they must be accompanied by structural and systems change through policy change at local, state, and national levels.

PREPARING FOR FUTURE EVALUATIONS

Over the past 5 years, the committee has reviewed the four CARA programs and the information that SAMHSA and its grantees have supplied. The limitations of those data are outlined in this report as well as in the second report of this series; the data did not lend themselves to answering all the questions that Congress requested the committee consider.

The committee offers two recommendations, with the recognition that Congress is sometimes responding to a crisis when it passes laws to create new programs and initiatives. When doing so, there are inevitably tradeoffs between speed, quality, specificity, and cost of the response and accompanying evaluation efforts.

The committee chose to propose recommendations that could be applied to the future program development and evaluation efforts of federal programs broadly, rather than just to those conducted by SAMHSA. As such, the recommendations provided refer to “the evaluator,” “the implementing agency,” “the program,” and “the grantees” more generally. The committee does include specific illustrative examples drawn from the CARA evaluation experience, where relevant, to help explain the recommendations.

To obtain information useful for policy making through an effective evaluation requires substantial coordination, support, and data sharing among stakeholders (Congress, the implementing agency, grantees and partners, and the evaluator). The first recommendation provides advice for how Congress can coordinate with involved parties to support the evaluation, and the second for how Congress can support the implementing agency and, through it, as applicable, support grantees. Both are intended to result in evaluations that provide better data to guide policy making.

Suggested Citation:"Summary." National Academies of Sciences, Engineering, and Medicine. 2023. Review of Four CARA Programs and Preparing for Future Evaluations. Washington, DC: The National Academies Press. doi: 10.17226/26831.
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Recommendation 1: The committee recommends that Congress, when mandating evaluations, confer with the implementing agency and evaluation experts to align expectations with feasibility and resource considerations.

To be useful, evaluations must match the realities of the programs9 they are designed to assess. This can be challenging, however, as evaluations come in many sizes and shapes and can serve a multitude of functions. The committee offers general guidance in this chapter on three broad evaluation categories: formative (which refers to the formative or early stage of a new type of program), process, and outcomes (also referred to as summative evaluation).

Formative evaluations help assess the feasibility and acceptability of a program and provide preliminary information on the program’s potential effectiveness. Formative evaluations are most often conducted in the last few years of pilot and demonstration projects. Process evaluations are used to identify the strengths and weaknesses of an ongoing program with the primary objective being to determine how the program could be improved. Process evaluations are typically used to assess programs that have been operating for several years and are in the early to mid-stages of development. Outcomes evaluations are used to systematically assess a program’s effectiveness or cost-effectiveness. Outcomes evaluations are best applied to more mature10 and fully developed programs.

In the CARA evaluation, the committee struggled with a misalignment between the type of evaluation it was requested to perform and the characteristics and goals of the CARA programs. The CARA programs were designed to fund a series of 3- to 5-year projects. Though the PPW-PLT program was the only one of the four with the official designation of being a pilot program, the other three were new programs to SAMHSA as well. Additionally, SAMHSA contracted with the National Academies to perform the review of the programs more than 1 year after Funding Opportunity Announcements were issued for the cohorts under study, mandatory reporting tools were selected and in use, and grantees had already

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9 Throughout this chapter and report, “program” is used to refer to an overarching federal grant programs (e.g., one of the four CARA programs), rather than to a project conducted by one of the grantees of those programs.

10 In response to the passage of the Government Performance and Results Act Modernization Act of 2010, the U.S. Government Accountability Office (GAO) released “Designing Evaluations,” which it referred to as a “guide to successfully completing evaluation design tasks” for federal programs and policies. Many of the committee’s recommendations in this chapter are consonant with that report, and it particularly emphasizes the importance of program maturity to choosing appropriate methodologies (GAO, 2012).

Suggested Citation:"Summary." National Academies of Sciences, Engineering, and Medicine. 2023. Review of Four CARA Programs and Preparing for Future Evaluations. Washington, DC: The National Academies Press. doi: 10.17226/26831.
×

begun work. This limited options for the National Academies to design an appropriate evaluation.

To achieve alignment of evaluation expectations with feasibility and resource considerations, Congress should confer with the implementing agency and evaluation experts. To facilitate this process, Congress should provide funding as early as possible to allow for ample time to coordinate with the implementing agency on how to best scope and plan the required assessment activities before grantees begin their implementation process.11 If brought in early, the parties can work together to help tailor data collection and evaluation methodology (e.g., research design, sampling, types of data required and most appropriate means of collecting those data, and analytic approach). It also allows time for the implementing agency and evaluator to set any necessary data sharing agreements, and to communicate those with grantees as applicable. Significant funding delays, like that which occurred between the passage of the CARA Act and the Consolidated Budget Appropriation, constrain the evaluator’s methodological flexibility and ability to conduct an appropriate assessment that is tailored to Congress’s requests.

Recommendation 2: To ensure an informative evaluation in the future, the committee recommends that Congress consider whether the implementing agency has the capacity, mission, and culture to (a) oversee the evaluation and (b) where applicable, support grantees in collecting and sharing data.

To ensure that the implementing agency and its grantees can adequately respond to Congress’s evaluation needs, the implementing agency needs sufficient internal capacity and resources, as well as a mission and culture that are supportive of the evaluation effort. Capacity includes staffing, funding, and adequate time to oversee an evaluation. These internal resources enable the implementing agency to carry out its roles of coordinating with the evaluator and of supporting grantees in their work and in their data collection. This allows the agency to create any additional systems or processes necessary to meet the specific methodological needs of the evaluator and to support the grantees in doing so as well. Additionally, the pre-existing mission and culture of the implementing

___________________

11 In its 2012 report “Defining Evaluations,” the GAO also highlighted the importance of planning and initiating evaluation processes prior to the beginning of implementation (GAO, 2012). Since its release, several studies on the U.S. Department of Health and Human Services (HHS) program evaluation have found that this does not always happen in practice. This includes an HHS Office of Inspector General (OIG) evaluation of the State Targeted Response grant (HHS-OIG, 2020) and a GAO report on HHS programs intended to increase the availability of MOUD (GAO, 2017).

Suggested Citation:"Summary." National Academies of Sciences, Engineering, and Medicine. 2023. Review of Four CARA Programs and Preparing for Future Evaluations. Washington, DC: The National Academies Press. doi: 10.17226/26831.
×

agency can impact its ability to support an evaluation.12 In particular, some federal agencies may be more practice-oriented than research-focused in their mandates.

Though not all congressionally mandated evaluations will include grantees, the committee comments on the primary roles that the implementing agency should play in supporting and guiding grantees, where applicable. Having adequate capacity, mission, and culture, as discussed above, enables the implementing agency to support grantees by (a) selecting appropriate data collection systems, (b) setting data sharing and evaluation agreements, and (c) providing resources and technical assistance to grantees. First, the selection of an appropriate data collection system should be matched to the goals of the program grant and the evaluation; the creation and approval of such tools takes time and resources. Second, establishing data sharing and evaluation agreements early is essential. If the evaluation requires any data collection and sharing across project sites or among stakeholders (e.g., implementing agency, grantees, partners, and the evaluator), then such agreements are best included as part of the funding description (e.g., SAMHSA’s Funding Opportunity Announcements). Without these agreements, the grantees and implementing agency may be unable to share much of the data they have already collected with the evaluator.13 Finally, grantees, subgrantees, and community partners might lack the experience, funding, and capacity to establish and operate effective data collection systems necessary for rigorous cross-site evaluations. To ensure that the evaluator has access to high-quality and comprehensive data, there must be appropriate funding and technical assistance for grantees to appropriately complete the needed evaluations and data collection tasks. This support must come from the implementing agency, which, in turn, needs adequate resources to be able to provide such support.

Should Congress decide to reauthorize the CARA programs and open SAMHSA funding to additional cohorts of grantees, setting them up with these recommendations in mind could enable a more useful evaluation of those cohorts and of the programs overall to inform policy.

___________________

12 In 2003, GAO highlighted the importance of “evaluation culture” to the success of evaluation strategies in five federal agencies. It defined evaluation culture as “a commitment to self-examination, data quality, analytic expertise, and collaborative partnerships” (GAO, 2003). The importance of “building a culture that values data” was also highlighted in the Office of Management and Budget’s memorandum to the heads of executive departments of agencies following the passage of the Evidence-Based Policymaking Act of 2018 (OMB, 2019).

13 The committee notes that SAMHSA has established data sharing agreements for multisite programs in the past, such as in the Guide for Applicants for Phase I and Phase II of the Women, Co-occurring Disorders and Violence Study (McHugo et al., 2005).

Suggested Citation:"Summary." National Academies of Sciences, Engineering, and Medicine. 2023. Review of Four CARA Programs and Preparing for Future Evaluations. Washington, DC: The National Academies Press. doi: 10.17226/26831.
×

CONCLUDING OBSERVATIONS

The committee has dedicated the last 5 years to responding to the congressional request to review the CARA programs. The committee has explained why it could not directly meet the full congressional expectations for this evaluation.

The reader should not take away from these three reports that the committee believes that grantee efforts were not useful; the committee has highlighted evidence that SAMHSA’s grantees have used the CARA funding to stand up and expand activities that were not previously available and that provide value to individuals with SUD, to the professionals working toward addressing the SUD epidemic, and to grantees’ communities. These efforts have already served individuals and communities and are likely to promote population health in the long run. Further, the committee hopes that the guidance it provided regarding future evaluations—either of future cohorts of the CARA programs or of other federally funded programs—will allow Congress to better understand the impact of its investments.

The committee appreciates the opportunity to work with Congress, SAMHSA, and grantees. It hopes that its reports do justice to the hard work, under very trying circumstances, of SAMHSA, CARA grantees, and individuals and populations confronting SUD.

Suggested Citation:"Summary." National Academies of Sciences, Engineering, and Medicine. 2023. Review of Four CARA Programs and Preparing for Future Evaluations. Washington, DC: The National Academies Press. doi: 10.17226/26831.
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The Comprehensive Addiction and Recovery Act (CARA; P.L. 114-198) was signed into law in 2016 to help address the challenges of overdose deaths and opioid use disorder, and to expand access to evidence-based treatment. Among these efforts was the authorization of four grant programs to be overseen by the Substance Abuse and Mental Health Services Administration (SAMHSA).

In 2018, SAMHSA requested that the National Academies establish a committee to conduct a review of the four programs, which focus primarily on opioids, but occasionally include treatment and recovery services for co-occurring substance use disorders. The review resulted in three consensus study reports over five years. This third and final report aims to (1) understand the processes of the four grant programs; actions taken by grantees and their partners; impacts to clients, patients, the community, and public; and structural or environmental changes that might have resulted from grant funding, and (2) analyze how future congressionally mandated evaluations can be structured and carried out to better support policy makers.

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