Form PDO Instrument PDO Instrument PDO Instrument

Attachment 6

OMB Number: XXXX-XXXX

Expiration Date: XX/XX/XXXX

DRAFT

Substance Abuse and Mental Health Services Administration (SAMHSA)

Center for Substance Abuse Prevention (CSAP) Online Reporting Tool (CORT)

Grants to Prevent Prescription Drug/Opioid Overdose-Related Deaths (PDO)

Center for Substance Abuse Prevention (CSAP)

Online Reporting Tool (CORT)

Grants to Prevent Prescription Drug/Opioid Overdose-Related Deaths (PDO)

1. Annual Targets Report (ATR)

[To be entered in the “Work Plan” section of SPARS for the appropriate federal fiscal year.]

Note: Definition of Terms can be found in Appendix A.

1. Grant Information

[Section to be pre-populated in SPARS.]

1. Organization name: ___________________________

2. Grant number: _______________________________

3. Federal fiscal year: __________

2. Performance Measures

For each performance indicator, enter a numeric value. If your grant program is not planning to implement a specific activity or service identified during the federal fiscal year for which you are reporting, enter “0” for the corresponding performance indicator.

For reporting purposes, “naloxone” refers to naloxone or other FDA-approved opioid overdose-reversing medication or device.

Naloxone purchases and distribution

1. Percent of total award budgeted for naloxone product purchases: _____%

2. Amount budgeted for purchase of naloxone products by type:

1. Injectable: $____

2. Autoinjector: $____

3. Intranasal spray: $____

3. Estimated number of naloxone kits to be distributed to high need communities:¹ ___

4. Estimated number of naloxone kits to be distributed to…

1. Professional first responders: ____

2. Other key community sector members: ____

3. Nontraditional community sector members: ____

4. Other community members: ____

Education/training

5. Estimated number of trainings to be conducted on opioid overdose death prevention strategies: ___

6. Estimated number of individuals to be trained on opioid overdose death prevention strategies by participant type:

1. Professional first responders: ____

2. Other key community sector members: ____

3. Nontraditional community sector members: ____

4. Other community members: ____

7. Estimated number of individuals to be trained on use of naloxone by participant type:²

1. Professional first responders: ____

2. Other key community sector members: ____

3. Nontraditional community sector members: ____

4. Other community members: ____

8. Estimated number of medical professionals to be trained on risks of overprescribing: ___

2. Quarterly Performance Report (QPR)

[To be entered in the “Performance Reports” section of SPARS for the appropriate reporting period.]

1. Grant Information

[Section to be pre-populated in SPARS.]

1. Organization name: ___________________________

2. Grant number: _______________________________

3. Federal fiscal year/quarter: __________

2. Performance Measures

For each performance indicator, enter a numeric value. If your grant program did not implement a specific activity or service identified during the reporting period, enter “0” for the corresponding performance indicator. If your grant implemented an “other (please specify)” option, enter a numeric value and provide a brief description of what your program implemented.

For reporting purposes, “naloxone” refers to naloxone or other FDA-approved opioid overdose-reversing medication or device.

Naloxone purchase and distribution

1. Percent of total grant funds spent on naloxone product purchases: ____%

2. Amount of award funds spent on naloxone product purchases by type:

1. Injectable: $ ____

2. Autoinjector: $____

3. Intranasal spray: $____

3. Total number of naloxone kits distributed to high need communities using PDO grant-funded resources:³ ____

1. Number of PDO grant-purchased naloxone kits distributed: ___

2. Number of non-PDO grant-purchased naloxone kits distributed: ___

4. Number of naloxone kits distributed to …

1. Professional first responders: ____

2. Other key community sector members: ____

3. Nontraditional community sector members: ____

4. Other community members: ____

Education/training

5. Total number of trainings conducted on opioid overdose death prevention strategies: ____

6. Number of individuals trained on use of naloxone by participant type:⁴

1. Professional first responders: ____

2. Other key community sector members: ____

3. Nontraditional community sector members: ____

4. Other community members: ____

7. Number of medical professionals trained on risks of overprescribing: ___

Opioid overdose/naloxone administration

8. Total number of known or suspected opioid overdose events: ______

9. Number of naloxone administration events by participant type:

1. Professional first responders: ____

2. Other key community sector members: ____

3. Nontraditional community sector members: ____

4. Other community members: ____

10. Number of naloxone doses administered: _____

11. Number of naloxone administration events by location:

1. At a private residence: ___

2. In a public outdoor location (e.g., street, park), car, camp, or shelter: ___

3. At an indoor public place/business (including hotel/motel): ___

4. Unknown: ___

5. Other (Please specify: _____): ___

12. Number of events where naloxone was administered by first responders by outcome:

1. Opioid overdose reversal: ______

2. Death: ______

3. Not an opioid overdose: ______

4. Unknown: ______

[If Unknown = 0, then skip to II.B.14]

d.1. Please explain why outcomes are unknown: ____________

13. Number of events where naloxone was administered other key community sector members by outcome:

1. Opioid overdose reversal: ______

2. Death: ______

3. Not an opioid overdose: ______

4. Unknown: ______

[If Unknown = 0, then skip to II.B.15]

d.1. Please explain why outcomes are unknown: ____________

Information, referrals and linkages following naloxone administration

14. Number of referrals for naloxone-related information and resources: ____

15. Number of referrals to substance use disorder treatment services: ____

16. Number of individuals linked to treatment or recovery support services following successful overdose reversal administration: ___

3. Progress Report Overview Updates

Please share updates for grant-funded activities during the reporting period related to overall programmatic implementation and to approved goals and objectives.

1. Overall progress

Please share an update on progress completed during the reporting period related to overall programmatic implementation and to approved goals and objectives. (Suggested, but not limited to 1-2 paragraphs) [Open text field]

2. Challenges/barriers

If applicable, please share challenges faced during the reporting period related to overall programmatic implementation and to approved goals and objectives and identified strategies to overcome them. (Suggested, but not limited to 1-2 paragraphs) [Open text field]

3. Successes

If applicable, please share accomplishments achieved during the reporting period related to overall programmatic implementation and to approved goals and objectives. (Suggested, but not limited to 1-2 paragraphs) [Open text field]

4. Innovations

If applicable, please share innovations developed and/or implemented during the reporting period related to program initiatives. (Suggested, but not limited to 1-2 paragraphs) [Open text field]

4. Comments (Optional): ___________________________ [Open text field]

3. Work Plans

[To be entered in the “Work Plan” section of SPARS]

1. Disparities Impact Statement

Upload and provide a brief description of your document. Once you upload your document, you will only update this section if you revise your disparities impact statement. Due within 60 calendar days of grant award.

2. Needs Assessment

Upload and provide a brief description of your document. Once you upload your document, you will only update this section if you revise your needs assessment.

3. Strategic Plan

Depending upon your grant cohort, you may be required to submit one or more individual components of a strategic plan and/or a complete comprehensive strategic plan. If you are unsure of your requirements, consult your government project officer (GPO).

Strategic plan components

1. Naloxone distribution plan

Upload and provide a brief description of your document. Once you upload your document, you will only update this section if you revise your plan.

2. Other strategic plan component not listed above

Upload and provide a brief description of your document, if required. Once you upload your document, you will only update this section if you revise your plan.

Full strategic plan

3. Strategic plan

Upload and provide a brief description of your document, if required. Once you upload your document, you will only update this section if you revise your plan.

4. Evaluation

   1. Evaluation plan

Upload and provide a brief description of your document, if required. Once you upload your document, you will only update this section if you revise your plan.

2. Evaluation report

Upload and provide a brief description of your document, if required. Once you upload your document, you will only update this section if you revise your report.

APPENDIX A – List of Definitions

Definitions

^{Assessment: Assessment is the first step in the Strategic Prevention Framework (SPF) process and helps prevention planners understand prevention needs for the population of focus based on a careful review of data gathered from a variety of} sources^{. Specifically, assessment involves collection and analysis of available data sources to identify substance misuse consumption patterns, related consequences, and risk and protective factors impacting the population of focus. A comprehensive assessment also involves the examination of available resources to identify gaps, examines readiness to address problems identified, and prioritizes problems based on specific criteria (e.g., magnitude, trends, severity).} ​ See A Guide to SAMHSA's Strategic Prevention Framework for more details. (Also, see definition for Needs Assessment.)

Disparities impact statement: SAMHSA requires all grant recipients, or grantees, to prepare the Disparity Impact Statement (DIS) as part of a data-driven, quality improvement approach to advance equity using grant programs. The DIS helps grantees identify underserved populations at risk of experiencing behavioral health disparities. The aim is to increase inclusion of underserved populations in SAMHSA-funded grants, achieve behavioral health equity for disparity-vulnerable populations, and help systems better meet the needs of these populations.

Evaluation: Evaluation is the fifth step in the SPF process and is about enhancing prevention practice. It is the systematic collection and analysis of information about prevention activities to reduce uncertainty, improve effectiveness, and facilitate decision-making. See A Guide to SAMHSA's Strategic Prevention Framework for more details.

Evaluation plan: An evaluation plan is a written document that describes how grant-funded prevention strategies will be assessed and establishes outcome and/or impact measures tied to the original problem that the grant-funded program plans to address.

Evaluation report: An evaluation report is a written document that summarizes the purpose, methodologies, findings, and conclusions of grantee evaluations efforts and offers recommendations for program improvements. As part of the findings section, the evaluation report should examine whether prevention activities were successful in achieving the grant program’s goals and objectives as laid out in the evaluation plan. Ideally, evaluation reports should include both process and outcome evaluation.

Family members: Family members are individuals who have a relative (e.g., spouse, child, parent, sibling, grandparent, or other familial relation) that has experienced an opioid overdose.

Goal: A goal is a broad statement about the long-term expectation of what should happen because of your program (the desired result). It serves as the foundation for developing your program objectives. Goals should align with the statement of need that is described. Goals should only be one sentence. The characteristics of effective goals include:

• Goals address outcomes, not how outcomes will be achieved.

• Goals are concise.

• Goals describe the behavior or condition in the community expected to change.

• Goals describe who will be affected by the project.

• Goals lead clearly to one or more measurable results.

High need community: High need community refers to a population (e.g., defined geographic area, culture or demographic group, institutional setting) that has or is at risk of having a higher-than-average prevalence rate of prescription drug/opioid misuse, prescription drug/opioid overdoses, prescription drug/opioid overdose deaths, or adverse events related to prescription drug/opioid misuse.

Innovation/innovative strategy: An innovative prevention strategy is a method, idea, or approach that departs from the common ways of addressing a problem by applying adaptations, new processes, or new techniques to accomplish a goal.

Known or suspected opioid overdose events: For the purpose of grantee reporting, known or suspected opioid overdose events refer to situations where a first responder or other key community sector member administers one or more doses of naloxone or other FDA-approved opioid overdose-reversing medication in response to a known or suspected opioid overdose. The first responder or other key community sector member administering naloxone must have been received training or equipped with naloxone funded by the grant. The known or suspected overdose event concludes once the person experiencing the known or suspected opioid overdose leaves the location where naloxone was administered (e.g., walks away) or is transferred into the care of others assuming responsibility for medical care (e.g., transported to hospital, care transferred to emergency department attending physician). If naloxone is administered to more than one individual at the same location, grantees should consider these as separate events.

LGBTQI+: LGBTQI+ is an acronym used as an umbrella term referring to lesbian, gay, bisexual, transgender, queer, and intersex.

Linkage/linked: Linkage or linked is defined as a confirmed encounter with a support service for which an individual was provided information through verbal or written referral. See definition for “referral.”

Medical professionals: Medical professionals are defined as licensed medical service providers authorized to prescribe medication including opioids (e.g., physicians, physician assistants, nurse practitioners, dentists).

Naloxone: For the purpose of grantee reporting, naloxone refers to naloxone or any other FDA-approved opioid overdose-reversing medication or device. Naloxone is a medication approved by the Food and Drug Administration (FDA) designed to rapidly reverse opioid overdose. It is an opioid antagonist—meaning that it binds to opioid receptors and can reverse and block the effects of other opioids, such as heroin, morphine, and oxycodone. Administered when a patient is showing signs of opioid overdose, naloxone is a temporary treatment and its effects do not last long. Therefore, it is critical to obtain medical intervention as soon as possible after administering/receiving naloxone. The medication can be given by intranasal spray (into the nose), intramuscular (into the muscle), subcutaneous (under the skin), or intravenous injection.

Naloxone administration: Naloxone administration refers to an event where naloxone or any other FDA-approved opioid overdose-reversing medication is administered to a person known or suspected to be experiencing an opioid overdose.

Naloxone administration training: In addition to instruction on how to administer naloxone or any other FDA-approved opioid overdose-reversing medication or device during a known or suspected opioid overdose, naloxone administration training should include education on recognizing signs of opioid overdose and best practices for carrying and storing naloxone.

Naloxone distribution plan: A naloxone distribution plan is a component of a comprehensive strategic plan. It outlines a proposed strategy for distributing naloxone in high-need communities. The plan should also include annual goals with the proposed number naloxone kits to be distributed and to whom for each budget year of the grant.

Naloxone dose: A naloxone dose is the measured quantity delivered in a single administration. One naloxone kit includes two doses. See also definition for naloxone kit.

Naloxone kit: One naloxone kit includes two doses of naloxone or other FDA-approved opioid-reversing medication, including all FDA-approved delivery devices (e.g., auto-injector, intranasal spray).

Needs assessment: A needs assessment uses data to define the nature and extent of substance abuse problems, identifies affected populations, identifies underlying causal factors that lead to consumption patterns, and uses findings to select appropriate strategies. (Also, see definition for Assessment.)

Nontraditional community sector members: Nontraditional community sectors members may be available to respond to an emergency but are not professional first responders or other traditional key community sector members. These individuals represent community anchor organizations and businesses such as, but not limited to, the following: faith-based or other community-based organizations, hotels, barbershops, hair salons, tattoo parlors, bars, or other places of business embedded in the culture of community.

Objectives: Objectives describe the results to be achieved and the manner in which they will be achieved. Multiple objectives are generally needed to address a single goal. Well-written objectives help set program priorities and targets for progress and accountability.

Opioid overdose death prevention strategies: Opioid overdose prevention strategies are practices intended to reduce the risk of death due to opioid overdose. Training on opioid overdose prevention strategies may include education/instruction on best practices for the use of naloxone (i.e., naloxone administration), opioid prescribing, naloxone co-prescribing or dispensing, communicating with patients, medication assisted treatment, or other prevention practices identified in the SAMHSA Overdoes Prevention and Response Toolkit.

Other community members. Other community members represent the general community and may be available to respond to an emergency. However, they are not professional first responders, and do not represent other traditional key community sectors or nontraditional community sectors. These individuals may include people who use drugs, friends or family members of people who use drugs, other individuals personally impacted by an event involving an accidental or intentional opioid overdose, and other concerned members of the community.

Other key community sector members: Other key community sector members are individuals who may be available to respond to an emergency but are not professional first responders. These individuals represent other key sectors such as, but not limited to, the following: emergency medical services agencies; agencies and organizations working with prison and jail populations; offender reentry programs; physical and behavioral health care providers including community health centers, community mental health centers, federally qualified health centers, and Certified Community Behavioral Health Clinics (CCBHCs); harm reduction agencies; organizations providing housing support including shelters; pharmacies; cultural support resources appropriate to the population of focus; family and children’s support services (including school systems); educational institutions including public and private elementary/secondary schools, colleges, universities and vocational schools; libraries; LGBTQI+ centers; other local psychosocial support providers, and other governmental organizations.

Outcomes: Outcomes reported should be based on the results of naloxone administration delivered and reported by professional first responders, other key community sector members, and nontraditional community sector members who received grant-funded naloxone training or were equipped with grant-funded naloxone. Grantees are not expected to report outcomes that occur after the person experiencing a known or suspected opioid overdose leaves the location where naloxone was administered (e.g., walks away) or is transferred into the care of others assuming responsibility for medical care (e.g., transported to hospital via ambulance, care transferred to emergency department attending physician).

1. Opioid overdose reversal: Regardless of the number of naloxone doses administered to a person known or suspected to be experiencing an opioid overdose naloxone, if the person becomes responsive and their respiration returns to normal within a few minutes of naloxone administration, the outcome is considered to be an “opioid overdose reversal.”

2. Death: If the administration of one or more doses of naloxone does not result in the return to normal respiration, and it is determined by someone with authority that the person suspected of experiencing an opioid overdose is deceased, the outcome is considered to be “death.”

3. Not an opioid overdose: If the administration of one or more doses of naloxone does not result in the return to normal respiration, and it is discovered that the person suspected of experiencing an opioid overdose is actually suffering from the effects of another health issue that mimics symptoms of opioid overdose (e.g., experiencing a heart attack, reacting to toxic levels of another substance), the outcome is considered to be “not an opioid overdose.”

4. Unknown: If a person experiencing a suspected opioid overdose is showing signs of life and remains unresponsive after receiving one or more doses of naloxone, but the naloxone administrator is unsure if the person is experiencing an opioid overdose or another health emergency when transferred to others assuming responsibility for medical care (e.g., transported to hospital, care transferred to emergency department attending physician), the outcome is considered to be “unknown.”

Policy: Policy is a set of organizational rules (including but not limited to laws) intended to promote healthy behavior and prevent unhealthy behavior.

Population of focus: Population of focus refers to a group of individuals that prevention efforts are intended to reach or serve.

Practice: A practice is a type of approach, technique, or strategy that is intended to promote wellbeing and reduce the onset and progression of substance misuse and its related problems.

Prevention: Prevention is the active, assertive process of creating conditions and/or personal attributes that promotes the wellbeing of people. A proactive process designed to empower individuals and systems to meet the challenges of life events and transitions by creating and reinforcing conditions that promote healthy behaviors and lifestyles. Substance misuse prevention is intended to promote wellbeing and reduce the onset and progression of substance misuse and related problems.

Prevention strategies: Prevention strategies are practices, policies, or programs intended to promote wellbeing and reduce the onset and progression of substance misuse and its related problems.

Professional first responders: Professional first responders are individuals who are expected to immediately go to the scene of an emergency when alerted and are among the first to arrive to render assistance. Professional first responders include firefighters, law enforcement officers, paramedics, emergency medical technicians, mobile crisis providers or other legally organized and recognized volunteer organizations that respond to adverse opioid-related incidents.

Program: A program is a set of predetermined, structured, and coordinated activities intended to promote wellbeing and reduce the onset and progression of substance misuse and its related problems. It can incorporate different practices; guidance for implementing a specific practice can be developed and distributed as a program.

Recovery support services: Recovery support services refers to a broad range of non-clinical services, that are culturally and linguistically designed to support individuals with mental health and/or substance use disorders seeking recovery. Recovery support services may include, but are not limited to, employment coaching, linkages to housing, recovery housing services, care navigation services, support groups, and peer support services that foster health, wellness, and resilience. Recovery support services, assisting both individuals and families, are offered in various settings and help individuals enter and navigate care systems, remove obstacles to recovery, stay engaged in the recovery process, and lead fulfilling lives in their chosen communities.

Referral: A referral is defined as the act of providing information about, or direction to, support services. A referral may be provided verbally or in writing.

SPARS: SPARS is the Substance Abuse and Mental Health Services Administration’s (SAMHSA’s) Performance Accountability and Reporting System. It is an online data entry, reporting, technical assistance request, and training system to support grantees in reporting timely and accurate data to SAMHSA.

Strategic plan: Strategic planning is the fifth step in the SPF process and increases the effectiveness of prevention efforts by ensuring prevention planners select and implement the most appropriate programs/strategies for population of focus. A strategic plan is a written document that prioritizes substance misuse problems identified in the assessment process (SPF Step 1), selects appropriate programs/practices to address each priority, combines programs/practices to ensure a comprehensive approach, and builds/shares a logic model with key stakeholders. See A Guide to SAMHSA's Strategic Prevention Framework for more details.

Training on opioid overdose death prevention strategies: See definition for opioid overdose death prevention strategies.

1 This count should include the estimated number of grant-funded naloxone kits that the grantee or grantee partner(s) plan distribute during the reporting federal fiscal year, as well as the estimated number of naloxone kits provided/purchased by another entity that the grantee plans to distribute as part of the grant during the reporting federal fiscal year.

2 If all of the trainings on opioid overdose death prevention strategies identified in item 6 included training on the use of naloxone, then the “estimated numbers of individuals to be trained on the use of naloxone” should be the same numbers as reported in item 6.

3The total number of naloxone kits distributed includes all kits distributed using PDO grant-funded resources (e.g., PDO grant-funded staff time, PDO grant-funded distribution/delivery costs), regardless of whether PDO grant funding was used to purchase the kits distributed. This should include grant-funded naloxone kits distributed by the grantee or grantee partner(s) during the reporting period, as well as naloxone kits provided/purchased by another entity that were distributed by the grantee or grantee partner(s) during the reporting period using PDO grant-funded resources.

4 If all of the trainings on opioid overdose death prevention strategies identified in item 6a included training on the use of naloxone, then the “number of first responders trained on the use of naloxone” should be the same number as reported in item 6a.

Public Burden Statement: An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control number for this project is XXXX-XXXX. Public reporting burden for this collection of information is estimated to average 25 hours per respondent per year, including the time for reviewing instructions, searching existing data sources, gathering, and maintaining the data needed, and completing and reviewing the collection of information.  Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to SAMHSA Reports Clearance Officer, 5600 Fishers Lane, Room 15E45, Rockville, Maryland, 20857.