Summary of Changes to OMB Pkg_11-21-2019

Instrument Changes

Strategic Prevention Framework for Prescription Drugs (SPF-Rx) Cross-Site Evaluation

OMB Number: 0930-0377

Expiration Date: 8/31/2020

This document summarizes questions removed and modified from the original SPF-Rx OMB package (0930-0377, exp. 8/31/2020). The changes are summarized below and the specific questions/rationales for revision are provided in the pages that follow. Efforts were made to streamline reporting and to reduce burden. Note that the items removed from the Grantee- and Community-Level Outcomes module are critically important to this cross-site evaluation. They were removed because equivalent modules exist in SAMHSA’s Performance Accountability and Reporting System (SPARS). By having SPF-Rx grantees collect these data in SPARS, prevention-related opioid overdose outcomes reporting will be unified and the duplicative instruments eliminated.

• ATTACHMENT 1: Annual Implementation Instrument (All)

Questions Removed: 33, 45-48, 74-77, 98-101, 105, 118.4, 118.5, 121-124

Questions Modified: 1, 9, 10, 12, 18, 20, 23, 24, 25, 28.1, 32, 44, 53, 65, 73, 128.16

• ATTACHMENT 2: Grantee-Level Outcomes module

Questions Removed: 1.1, 1.2, 1.3, 3

• ATTACHMENT 3: Community-Level Outcomes module

Questions Removed: 1.1, 1.2, 1.3, 3

• ATTACHMENT 4: Grantee Interview Protocol

Questions Removed: 5, 6

Questions Modified: 1, 7, 9

• REMOVED INSTRUMENT: Substitute Data Request form

Questions Removed: all

Attachment 1

Annual Implementation Instrument (AII) - Deleted Questions

QUESTION

RATIONALE

33. How many of your key stakeholders, partners, and partner organizations supported or partnered with you on this prevention intervention-service type during the past year? Indicate the number of organizations and number or individuals who partnered with you on this prevention intervention-service type from each sector.^E

33.1. Sectora	33.2. Number of organizations	33.3. Number of individuals

^a Sectors will be prepopulated in this table on the basis of response to Question 18.

Repetitive of Question 18.

45. Of the total number of participants who were reached or affected by this community-based process intervention-service type during the past year (reported in Question 44), estimate how many were male and how many were female. The number of females, males, and unknown should add up to the total of participants reported in Question 44. This response should be written as a whole number (e.g., 4) and not as a percentage.^E

45.1. Females:

45.2. Males:

45.3. Transgender:

45.4. Other: _____________________________ (Specify: _________________________)

45.5. Gender unknown:

Demographic information not needed for indirect services. Unlikely to be accurate.

46. Of the total number of participants were reached or affected by this community-based process intervention-service type during the past year (reported in Question 44), indicate how many were in each of the age groups listed below. The number of children, youth, young adults, adults, and unknown should add up to the total of participants reported in Question 44. This response should be written as a whole number (e.g., 4) and not as a percentage.^E

46.1. Children age 0 to 11: _____________

46.2. Youth age 12 to 17:

46.3. Young adults age 18 to 25:

46.4. Adults age 26 and older:

46.5. Age unknown:

Demographic information not needed for indirect services. Unlikely to be accurate.

47. Of the total number of participants reached or affected by this community-based process intervention-service type during the past year (reported in Question 44), indicate how many were in each of the racial groups listed below. You will have an opportunity to report ethnicity in the next question. Ethnicity is counted separately from race. For example, if you reached or affected African Americans of Hispanic ethnicity, they would be counted in both the ethnicity (Hispanic) category and the race category under African American. The number of American Indian/Alaskan Native, Asian, Black, Pacific Islander, White, multiracial, other, and unknown should add up to the total of participants reported in Question 44. This response should be written as a whole number (e.g., 4) and not as a percentage.^E

47.1. American Indian or Alaska Native: _____________

47.2. Black or African American: _____________

47.3. White: _____________

47.4. Asian: _____________

47.5. Native Hawaiian or Other Pacific Islander: ______________

47.6. Multiracial: ___________

47.7. Other: _____________

47.8. Race unknown: ___________

Demographic information not needed for indirect services. Unlikely to be accurate.

48. Of the total number of participants reached or affected by this community-based process intervention-service type during the past year (reported in Question 44), indicate how many were Hispanic/Latino and how many were non-Hispanic/Latino. The number of Non-Hispanic/Latino, Hispanic/Latino, and unknown should add up to the total of participants reported in Question 44. This response should be written as a whole number (e.g., 4) and not as a percentage.^E

48.1. Hispanic, Latino/a, or of Spanish origin: ____________

48.2. Non-Hispanic, non-Latino/a, and not of Spanish origin: ____________

48.3. Hispanic ethnicity unknown: ____________

Demographic information not needed for indirect services. Unlikely to be accurate.

74. Of the total number of participants provided this problem identification and referral services during the past year (reported in Question 73), indicate how many were male and how many were female. The number of females, males, and unknown should add up to the total of participants reported in Question 73. This response should be written as a whole number (e.g., 4) and not as a percentage.^E

74.1. Females: _____________

74.2. Males: ______________

74.3. Transgender: _____________________

74.4 Other: ___________________ (Specify: _____________________)

74.5 Gender unknown: _______________

Demographic information not needed. Focusing on location of the referral and type of services the individuals were referred to.

75. Of the total number of participants provided this problem identification and referral services during the past year (reported in Question 73), indicate how many were in each of the age groups listed below. The number children, youth, young adults, adults, and unknown should add up to the total of new participants reported in Question 73. This response should be written as a whole number (e.g., 4) and not as a percentage.^E

75.1 Children age 0 to 11: _____________

75.2 Youth age 12 to 17: _____________

75.3. Young adults age 18 to 25: _____________

75.4. Adults age 26 and older: _____________

75.5. Age unknown: ______________

Demographic information not needed. Focusing on location of the referral and type of services the individuals were referred to.

76. Of the total number of participants provided this problem identification and referral services during the past year (reported in Question 73, indicate how many were in each of the racial groups listed below. You will have an opportunity to report ethnicity in the next question. Ethnicity is counted separately from race. For example, if you provided services to African Americans of Hispanic ethnicity, they would be counted in both the ethnicity (Hispanic) category and the race category under African American. The number of American Indian/Alaskan Native, Asian, Black, Pacific Islander, White, multiracial, other, and unknown should add up to the total of participants reported in Question 73. This response should be written as a whole number (e.g., 4) and not as a percentage.^E

76.1. American Indian or Alaska Native: _____________

76.2. Black or African American: _____________

76.3. White: _____________

76.4. Asian: _____________

76.5. Native Hawaiian or Other Pacific Islander: ______________

76.6. Multiracial: ___________

76.7. Other: _____________

76.8. Race unknown: ___________

Demographic information not needed. Focusing on location of the referral and type of services the individuals were referred to.

77. Of the total number of participants provided this problem identification and referral services during the past year (reported in Question 73), indicate how many were Hispanic, Latino/a, or of Spanish original and how many were not. The number of Non-Hispanic/Latino, Hispanic/Latino, and unknown should add up to the total of participants reported in Question 73. This response should be written as a whole number (e.g., 4) and not as a percentage.^E

77.1. Hispanic, Latino/a, or of Spanish origin: ____________

77.2. Non-Hispanic, non-Latino/a, and not of Spanish origin: ____________

77.3. Hispanic ethnicity unknown: ____________

Demographic information not needed. Focusing on location of the referral and type of services the individuals were referred to.

98. Of the total number of participants reached by your environmental strategy during the past year (reported in Question 97), indicate how many were male and how many were female. The number of females, males, and unknown should add up to the total of participants reported in Question 97. This response should be written as a whole number (e.g., 4) and not as a percentage.E

98.1. Females: _____________

98.2. Males: ______________

98.3. Transgender: __________________

98.4 Other: __________________ (Specify: _______________________)

98.5. Gender unknown: _______________

Demographic information not needed for indirect services. Unlikely to be accurate.

99. Of the total number of participants reached by your environmental strategy during the past year (reported in Question 97), indicate how many were in each of the age groups listed below. The number children, youth, young adults, adults, and unknown should add up to the total of new participants reported in Question 97. This response should be written as a whole number (e.g., 4) and not as a percentage.^E

99.1 Children age 0 to11: _____________

99.2 Youth age 12 to 17: _____________

99.3. Young adults age 18 to 25: _____________

99.4. Adults age 26 and older: _____________

99.5. Age unknown: ______________

Demographic information not needed for indirect services. Unlikely to be accurate.

100. Of the total number of participants reached by your environmental strategy during the past year (reported in Question 97), indicate how many were in each of the racial groups listed below. You will have an opportunity to report ethnicity in the next question. Ethnicity is counted separately from race. For example, if you reached African Americans of Hispanic ethnicity, they would be counted in both the ethnicity (Hispanic) category and the race category under African American. The number of American Indian/Alaskan Native, Asian, Black, Pacific Islander, White, multiracial, other, and unknown should add up to the total of participants reported in Question 97. This response should be written as a whole number (e.g., 4) and not as a percentage.^E

100.1. American Indian or Alaska Native: _____________

100.2. Black or African American: _____________

100.3. White: _____________

100.4. Asian: _____________

100.5. Native Hawaiian or Other Pacific Islander: ______________

100.6. Multiracial: ___________

100.7. Other: _____________

100.8. Race unknown: ___________

Demographic information not needed for indirect services. Unlikely to be accurate.

101. Of the total number of participants reached by your environmental strategy during the past year (reported in Question 97), indicate how many were Hispanic/Latino and how many were non-Hispanic/Latino. The number of Non-Hispanic/Latino, Hispanic/Latino, and unknown should add up to the total of participants reported in Question 97. This response should be written as a whole number (e.g., 4) and not as a percentage.E

101.1. Hispanic, Latino/a, or of Spanish origin: ____________

101.2. Non-Hispanic, non-Latino/a, and not of Spanish origin: ____________

101.3. Hispanic ethnicity unknown: ____________

Demographic information not needed for indirect services. Unlikely to be accurate.

105. For this intervention-service type activity, did you engage in a social marketing or social norms campaign during the past year? Social marketing is using the principles of commercial marketing to develop, implement, and evaluate programs designed to influence the behavior of a target audience. Rather than dictating the way that information is to be conveyed, social marketing involves listening to the needs and desires of the target audience and building the program from there. Social norms campaigns use a variety of methods to correct negative misperceptions (usually overestimations of use) and to identify, model, and promote the healthy, protective behaviors that are the actual norm in a given population. (Select one response.)E

• Yes

• No

Information not germane to evaluation.

118.4. What is the total number of unique page views that the Web sites had during the past year? This response should be written as a whole number (e.g., 4)^.E

• Specify number of unique page views _____

• Do not know

Information not germane to evaluation.

118.5. What was the average amount of time spent on the Web sites during the past year? This response should be written in the hours:minutes:seconds format (e.g., 00:14:30 means that the average amount of time spent on the Web site was 14 minutes and 30 seconds).^E

• Specify time spent (hours:minutes:seconds) ___:___:___

• Do not know

Information not germane to evaluation.

121. Of the total number of participants reached by this information dissemination service type activities during the past year (reported in Question 120), indicate how many were male and how many were female. The number of females, males, and unknown should add up to the total of participants reported in Question 120. This response should be written as a whole number (e.g., 4) and not as a percentage.^E

121.1. Females: _____________

121.2. Males: ______________

121.3. Transgender: ____________________

121.4. Other: __________________ (Specify: _______________________)

121.5. Gender unknown: _______________

Demographic information not needed for indirect services. Unlikely to be accurate.

122. Of the total number of participants reached by this information dissemination service type activities during the past year (reported in Question 120), indicate how many were in each of the age groups listed below. The number children, youth, young adults, adults, and unknown should add up to the total of new participants reported in Question 120. This response should be written as a whole number (e.g., 4) and not as a percentage.E

122.1. Children age 0 to 11: _____________

122.2. Youth age 12 to 17: _____________

122.3 Young adults age 18 to 25: _____________

122.4 Adults age 26 and older: _____________

122.5. Age unknown: ______________

Demographic information not needed for indirect services. Unlikely to be accurate.

123. Of the total number of participants reached by this information dissemination service type activities during the past year (reported in Question 120), indicate how many were in each of the racial groups listed below. You will have an opportunity to report ethnicity in the next question. Ethnicity is counted separately from race. For example, if you reached African Americans of Hispanic ethnicity, they would be counted in both the ethnicity (Hispanic) category and the race category under African American. The number of American Indian/Alaskan Native, Asian, Black, Pacific Islander, White, multiracial, other, and unknown should add up to the total of participants reported in Question 120. This response should be written as a whole number (e.g., 4) and not as a percentage.E

123.1. American Indian or Alaska Native: _____________

123.2. Black or African American: _____________

123.3. White: _____________

123.4. Asian: _____________

123.5. Native Hawaiian or Other Pacific Islander: ______________

123.6. Multiracial: ___________

123.7. Other: _____________

123.8. Race unknown: ___________

Demographic information not needed for indirect services. Unlikely to be accurate.

124. Of the total number of participants reached by this information dissemination service type activities during the past year (reported in Question 120), indicate how many were Hispanic/Latino and how many were non-Hispanic/Latino. The number of Non-Hispanic/Latino, Hispanic/Latino, and unknown should add up to the total of participants reported in Question 120. This response should be written as a whole number (e.g., 4) and not as a percentage.^E

124.1. Hispanic, Latino/a, or of Spanish origin: ____________

124.2. Non-Hispanic, non-Latino/a, and not of Spanish origin: ____________

124.3. Hispanic ethnicity unknown: ____________

Demographic information not needed for indirect services. Unlikely to be accurate.

AII - Modified Questions

*Additions in red font, removed text in strikethrough.

QUESTION

RATIONALE

1. What type of organization would you say you are? You should identify your organization in terms of as the entity that will be carrying out the activities of the SPF‑Rx program. (Select the one response that best describes your organization.) ^{B, F}

• We are a community coalition. (If selected, you will skip Question 2.)

• Local public health/mental health government agency responsible for substance abuse prevention

• Local health/mental health care service provider or facility (e.g., local hospital, community mental health center)

• Youth-focused local grassroots or community-based service or advocacy organization (e.g., local chapter of Students Against Destructive Decisions [SADD], local youth councils)

• Non-youth-focused, local grassroots or community-based service or advocacy organization (e.g., substance abuse prevention organizations, YMCAs)

• Faith-based organization

• School or school district

• Law enforcement organization

• College or university

• Tribal entity or organization

• Other government agency, not listed above

• Other nonprofit organization, not listed above

• Other (Describe.)

Clarification/accuracy language update.

9. Indicate the population(s) you will be focusing on for your SPF Rx prevention activities. In the first column, we would like to know if you have very specific groups of people at whom your you are focusing on for your prevention interventions. For example, if you are delivering a prevention intervention to all middle schools in an area, then you would select only “middle school students”; you would not have to select all the possible race/ethnicity categories that might be enrolled in the schools. If, however, you are delivering a prevention intervention specifically designed to target high-school-age Latinos, then you would select Hispanic and high school students. (Note: If you are targeting the whole community or jurisdiction, then choose that answer option [9.1], and do not check all the subpopulations.)

Clarification language to capture population of focus.

10. Indicate the intervening variable(s) you will be targeting for SPF‑Rx prevention. (Select all that apply.)^{E (autofill once completed initially)}

• Have not yet selected an intervening variable to target

• Laws related to prescription drugs

• Level of enforcement

• Social access to prescription drugs (e.g., through friends or family members)

• Physician/prescriber registration with prescription drug monitoring program

• Physician/prescriber use of prescription drug monitoring program (increased queries)

• Rate of opioid prescribing

• Rate of high dose (>90 MME/day) opioid prescribing

• Rate of multiple prescriber episodes for opioid pain medications (or other indicators of possible “doctor shopping”)

• Norms—perceived parent or peer attitudes or both (towards prescription drug misuse)

• Norms—perceived peer or friend misuse of prescription drugs

• Perceived risk of harm of prescription drug misuse

• Perceived risk of getting caught misusing prescription drugs (e.g., by parents or law enforcement)

• Family communication around prescription drug misuse

• Resistance or life skills or both

• Availability of prosocial activities

• Other intervening variable (Describe.)

• Other intervening variable (Describe.)

• Other intervening variable (Describe.)

Clarifying the response.

12. How would you rate the current capacity of your organization in the following areas for SPF‑Rx prevention efforts? (Note: At baseline, the questions should be answered with regard to your organization’s capacity at the time the SPF‑Rx grant was awarded.) ^E

How much would you agree or disagree that your organization currently has enough capacity in each of the following areas to effectively implement your SPF‑Rx prevention efforts?	Strongly disagree	Disagree	Agree	Strongly agree
12.1. Capability and experience using the 5 SPF steps				
12.2. Experience with the target population populations of focus for prescription drug misuse prevention				
12.3. Experience working with health care providers and pharmacists for prescription drug misuse prevention				
12.4. Experience with relevant interventions for prevention of prescription drug misuse				
12.5. Experience collaborating with other organizations on interventions to prevent prescription drug misuse				
12.6. Capability to use prescription drug monitoring program (PDMP) data for prevention planning and surveillance				
12.7. Capability to use PDMP data for prevention evaluation				
12.8. Capability to combine PDMP with other data sources (e.g., overdose data) for prevention planning				
12.9. Staff with the right skills to effectively implement SPF‑Rx prevention efforts				
12.10. Enough staff to effectively implement SPF‑Rx prevention efforts				
12.11. Enough fiscal/financial resources to effectively implement SPF‑Rx prevention efforts				
12.12. Capability to sustain the prevention efforts over time				

Updated terminology to be culturally sensitive to tribal grantees.

18. Provide more information on the key stakeholders, partners, and partner organizations that participate in your organization’s SPF‑Rx activities. This may include a combination of individuals and organizations. “Active” refers to stakeholders/partners who demonstrated support or participation in your activities and interventions during the past year.

Language clarification.

20. During the past Federal fiscal year, approximately how often did you receive updated PDMP data/reports for your SPF‑Rx target communities (or the closest available substate area)? (Select one)^E

• Did not receive any PDMP data/reports in the past fiscal year

• Once

• Semi-annually (twice per year)

• Quarterly

• Every other month

• Monthly

• Other (Specify.)

Clarification.

23. In During this reporting period, how have you worked to develop or enhance data infrastructure needed for data-driven needs assessment, planning, monitoring, and evaluation? (Select all that apply.)^E

• Not applicable; no work was done to enhance data infrastructure during this reporting period

• Developed or enhanced procedures for accessing prescription drug monitoring program (PDMP) data/reports

• Developed or enhanced procedures for accessing hospital data

• Developed or enhanced procedures for accessing data from other agencies (e.g., vital statistics, Census)

• Developed or implemented a community-level survey data collection effort

• Developed or implemented a community-led qualitative data collection effort (e.g., interviews, focus groups)

• Created or enhanced a local database to house community surveillance data

• Developed procedures for participation in a state/tribal/jurisdiction database

• Enhanced skills or expertise of local stakeholders to use PDMP data…

How did you enhance skills or expertise of local stakeholders to use PDMP data? (Check all that apply)

• For development of local strategies and interventions (e.g., with medical and pharmacy communities)

• For surveillance and performance monitoring

• Other (Describe.) ________________________________________________

• Developed procedures for utilizing PDMP data provided by the state/tribal entity/jurisdiction

• Developed or enhanced standardized prescription drug/opioid misuse surveillance reports

• Other (Describe.) ___________________________________________________________

Clarification.

24. During the past Federal fiscal year, how have you worked to ensure that prescription drug misuse prevention intervention activities and outcomes continue after SPF‑Rx funding has ended? (Select all that apply.)^E

• Not applicable; no work was done in the past year to ensure that prescription drug misuse prevention intervention activities and outcomes continue after SPF‑Rx funding has ended.

• Leveraged, redirected, or realigned other funding sources or in-kind resources (e.g., used the success of the SPF‑Rx efforts to secure other funds)

• Worked to ensure that prescription drug misuse prevention intervention activities are incorporated into the missions/goals and activities of other organizations (e.g., medical boards, local pharmacies, school districts, law enforcement agency)

• Worked to ensure that prescription drug misuse prevention staff positions are integrated folded into other organizations (e.g., health departments, school districts, community agencies)

• Worked to gain formal adoption of prescription drug misuse prevention intervention activities into other organizations’ practices (e.g., health care provider organizations, pharmacies, medical school curriculum, school district curriculum, organizational policy change)

• Worked to inform, help implement, or provide education related to new laws, policies, or regulations to guarantee the continuation of prescription drug misuse prevention intervention activities or outcomes

• Worked on developing a prescription drug misuse partnership structure that will continue to function beyond the end of the SPF‑Rx grant period

• Worked to create sustainable data infrastructure and staffing to continue to monitor PDMP and other surveillance data after SPF‑Rx grant ends

• Other (Describe.)

Clarification

25. Did you or your community partners deliver any SPF-Rx related prevention interventions during the past Federal fiscal year? Select one response.)^E

• Yes

• No (If selected, you will skip Questions 26–124.)

Clarification

28.1 To your knowledge, is this intervention a promising or an evidence-based program, policy, or practice? (A promising practice has strong quantitative and qualitative data showing positive outcomes, but it does not yet have enough research or replication to support generalizable positive public health outcomes. An evidence-based intervention has been rigorously evaluated and replicated with demonstrated effects.) Evidence Based Practices, Policies, and Programs: EBPPPs are defined as interventions that come from a Federal Registry, were reported as effective for your target substance in a published scientific journal article, were based on a documented theory of change, or were deemed effective by a panel of experts. (Select one response.)^{E (autofill after first completed)}

• Yes

• No

• Don’t know

Removal of promising practice reference and updating of the evidence-based practice, policy, and programs definition to align with other SAMHSA – CSAP instruments.

32. For Questions 32.1–32.5, indicate the locations and population of focus being served by this prevention intervention-service type. If you are implementing in separate settings (e.g., schools, workplaces), list each setting separately. (Note: If you are implementing a media campaign that reaches the whole county, you may enter “county-wide” for location (Question 32.1).)

Use one line to describe each location served by the intervention-service type. Other than estimated target population population of focus (Question 32.5), you need to complete only those categories that are appropriate for this prevention intervention-service type and community served.^{E (autofill after first completed)}

	32.1. Location (e.g., school name, business, community center)	32.2. City/town	32.3. County/ parish	32.4. Target population Population of focus description (Describe; 500-character limit)	32.5. What is the estimated target population population of focus number intended to reach within the area described? a
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.

^a The target population population of focus of the intervention strategy is likely smaller than the total population in the community. For example, if 10,000 individuals live in the area (total population), but only 3,000 of those are in the target 12- to 20-year-old age group for this prevention intervention strategy, your estimated target population is 3,000. If your target population for this prevention intervention strategy is more specific (e.g., Hispanic high school students or non-college youth age 18 to 20), your target population population of focus number would be even smaller (e.g., 200). Report your target population population of focus size as accurately as possible.

Updated terminology to be culturally sensitive to tribal grantees.

44. Estimate the total number of individuals in your target population population of focus who were reached (defined as served by the program) or affected by this community-based process intervention-service type during the past Federal fiscal year. Approximately how many individuals were affected by the results of this intervention-service type? (Note: Because this is a population-based intervention, you are asked to estimate the number of people reached. In most cases, this number should not exceed the sum of the target population populations of focus you reported in item 32.7 for this service type. For direct service interventions, such as prevention education, you will be asked to report the number directly served.)^E

(Prepopulate: Sum of reported target population population of focus in item 32.7 for this service type: ___________________)

Enter the estimated number of individuals in the target population population of focus reached or affected by this intervention-service type. (If none, enter “0”—you will automatically proceed to the end of this sub-form.) _____________________

Updated terminology to be culturally sensitive to tribal grantees.

53. Of the total number of participants served by this prevention education intervention during the past year (reported in Question 52), indicate how many were male and how many were female. The number of females, males, transgender, other, and unknown should add up to the total of participants reported in Question 52. This response should be written as a whole number (e.g., 4) and not as a percentage.^E

53.1. Females: _____________

53.2. Males: ______________

53.3. Transgender: ______________

53.4. Other: _____________________________ (Specify: _____________________)

53.5. Gender unknown: ______________

Updating directions to accurately reflect responses available.

65. Of the total number of participants served or reached by this alternative drug-free activity during the past year (reported in Question 64), indicate how many were male and how many were female. The number of females, males, transgender, other, and unknown should add up to the total number of participants reported in Question 64. This response should be written as a whole number (e.g., 4) and not as a percentage.^E

65.1. Females: _____________

65.2. Males: ______________

65.3. Transgender: ____________________

65.4. Other: ___________________________ (Specify: _______________________)

65.5. Gender unknown: _______________

Updating directions to accurately reflect responses available.

73. What was the total number of individuals for whom this served by the problem identification and referral services were provided during the past year? This response should be written as a whole number (e.g., 4).E

________ individuals

(If none, enter “0”—you will automatically proceed to the end of this sub-form.)

Language clarification.

128.16. Stressful events affecting large portions of the target population population of focus (e.g., natural disasters or other unexpected traumatic community events) (Describe.) _________________

Updated terminology to be culturally sensitive to tribal grantees.

Attachment 2

Grantee-Level Outcomes – Deleted Questions

QUESTION

RATIONALE

1.1 Hospital Data for Opioid Overdoses

Grantees are required to report data on emergency department visits involving opioid overdose. If emergency department data are not available, please provide hospital admissions data. If no hospital data are available, submit a substitute data request for alternative overdose data you may have (e.g., emergency medical service data).

Report data by age group and sex. If you cannot obtain outcomes by age and sex, provide an explanation after the table. If feasible, please provide information on ethnicity and race.

State grantees do not need to report information in the Population (Denominator) field, as these data will be pulled from the CDC’s WONDER database. Tribal and nonstate jurisdiction grantees are asked to provide the total number of residents for the Population (Denominator) field.

Data Source Time Frame (Start Date and End Date)

Indicate the time frame during which data for this measure were collected. Enter the start date and end date for the time period of the data you are submitting.

Start Date: ________________________________(month/day/year)

End Date: _________________________________(month/day/year)

Types of Opioid

For which types of opioid are you submitting data now? (You are asked to provide data for all opioids excluding heroin, and then separately for heroin. Please see the guidance manual for details on how to report the data, including the specific ICD-10 codes.) If you cannot provide the data broken out as requested, choose “other,” and specify the types of opioids that are included in your data. Provide any additional relevant information about the data in the Data Comments section below. (Select One)

• Opioids excluding heroin

• Heroin

• Other (Specify types of opioids that are included:_____________________________)

Note: For the table below, provide the data you have available, and where you do not have data, leave the field blank. For example, if you do not have any data related to “sex,” you would put the total number of cases in the “unavailable” category and leave the “male” and “female” cells blank. On the other hand, if the known value of an item is 0, then enter 0 in that cell. For example, if you have hospital data, which show that there were no emergency department visits involving opioid overdose, you would enter 0 in that cell.

Hospital Data for Opioid Overdoses

Demographic Group	Population (Denominator)	Emergency Department Visits Involving Opioid Overdose	Total Emergency Department Visits (Denominator)	Hospitalizations Involving Opioid Overdose	Total Hospitalizations (Denominator)
Total
Total		Numerical	Numerical	Numerical	Numerical
By age
<18 yr	State grantees do not need to provide population data, as they will be pulled from CDC WONDER	Numerical	Numerical	Numerical	Numerical
18–24 yr		Numerical	Numerical	Numerical	Numerical
25–34 yr		Numerical	Numerical	Numerical	Numerical
35–44 yr		Numerical	Numerical	Numerical	Numerical
45–54 yr		Numerical	Numerical	Numerical	Numerical
55–64 yr		Numerical	Numerical	Numerical	Numerical
65+		Numerical	Numerical	Numerical	Numerical
Unavailable		Numerical	Numerical	Numerical	Numerical
Sex
Male		Numerical	Numerical	Numerical	Numerical
Female		Numerical	Numerical	Numerical	Numerical
Other		Numerical	Numerical	Numerical	Numerical
Unavailable		Numerical	Numerical	Numerical	Numerical
By ethnicity (if available)
Hispanic or Latino		Numerical	Numerical	Numerical	Numerical
Not Hispanic or Latino		Numerical	Numerical	Numerical	Numerical
Unavailable		Numerical	Numerical	Numerical	Numerical
Demographic Group	Population (Denominator)	Emergency Department Visits Involving Opioid Overdose	Total Emergency Department Visits (Denominator)	Hospitalizations Involving Opioid Overdose	Total Hospitalizations (Denominator)
By race (if available)
White	State grantees do not need to provide population data, as they will be pulled from CDC WONDER	Numerical	Numerical	Numerical	Numerical
Black or African American		Numerical	Numerical	Numerical	Numerical
Asian		Numerical	Numerical	Numerical	Numerical
Native Hawaiian or Other Pacific Islander		Numerical	Numerical	Numerical	Numerical
American Indian or Alaska Native		Numerical	Numerical	Numerical	Numerical
Two or more races		Numerical	Numerical	Numerical	Numerical
Unavailable		Numerical	Numerical	Numerical	Numerical

Data Source(s): List all data sources for your data. __________________________________________________________________________________

Data Comments

Please provide any additional information about the data source(s) or any other information that would be useful in understanding the overdose data you have provided.

Data	Additional Information
Population	Free text
Emergency Department Visits Involving Opioid Overdose	Free text
Hospitalizations Involving Opioid Overdose	Free text

Data can be collected in SPARS using an equivalent module that is used by other grant programs.

1.2 Other Opioid Overdose Events (for Approved Substitute Data Source)

This is where you report any alternative opioid overdose data if you do not have access to hospital data. First, you would need to submit a substitute data source request and get it approved.

Substitute Date Source

[Dropdown box that lists all the approved Substitute Data Source Requests for this grantee]

Data Source Time Frame (Start Date and End Date)

Indicate the time frame during which data for this measure were collected. Enter the start date and end date for the time period of the data you are submitting.

Start Date: ________________________________(month/day/year)

End Date: _________________________________(month/day/year)

Types of Opioid

For which types of opioid are you submitting data now? (You are asked to provide data for all opioids excluding heroin, and then separately for heroin. Please see the guidance manual for details on how to report your data, including the specific ICD-10 codes.) If you cannot provide the data broken out as requested, choose “other,” and specify the types of opioids that are included in your data. Provide any additional relevant information about the data in the Data Comments section below. (Select One)

• Opioids excluding heroin

• Heroin

• Other (Specify types of opioids that are included:_____________________________)

Other Opioid Overdose Events (for Approved Substitute Data Source)

Demographic Group	Population (Denominator)	Other Opioid Overdose Events (optional)	Total Number of Events (Denominator)
Total
Total		Numerical	Numerical
By age
<18 yr	State grantees do not need to provide population data, as they will be pulled from CDC WONDER	Numerical	Numerical
18–24 yr		Numerical	Numerical
25–34 yr		Numerical	Numerical
35–44 yr		Numerical	Numerical
45–54 yr		Numerical	Numerical
55–64 yr		Numerical	Numerical
65+ yr		Numerical	Numerical
Unavailable		Numerical	Numerical
By sex
Male		Numerical	Numerical
Female		Numerical	Numerical
Other		Numerical	Numerical
Unavailable		Numerical	Numerical

Data Comments

Please provide any additional information about the data source or other information that would be useful in understanding the overdose data you have provided.

Data	Additional Information
Population	Free text
Other Opioid Overdose Events	Free text

Data can be collected in SPARS using an equivalent module that is used by other grant programs.

1.3 Opioid Overdose Deaths

In this section, grantees that are tribes or nonstate jurisdictions report data on opioid overdose deaths. State grantees do not need to report opioid overdose deaths because these data will be pulled from CDC WONDER database.

Data Source Time Frame (Start Date and End Date)

Indicate the time frame during which data for this measure were collected. Enter the start date and end date for the time period of the data you are submitting.

Start Date: ________________________________(month/day/year)

End Date: _________________________________(month/day/year)

Types of Opioid

For which types of opioid are you submitting data now? (You are asked to provide data for all opioids excluding heroin, and then separately for heroin. Please see the guidance manual for details on how to report your data, including the specific ICD-10 codes.) If you cannot provide the data broken out as requested, choose “other,” and specify the types of opioids that are included in your data. Provide any additional relevant information about the data in the Data Comments section below. (Select One)

• Opioids excluding heroin

• Heroin

• Other (Specify types of opioids that are included:_____________________________)

In the table below, provide the number of opioid deaths by age and sex. If you cannot obtain outcomes by age and sex, provide an explanation after the table.

Opioid Overdose Deaths

Demographic Group	Population (Denominator)	Opioid Overdose Deaths	Total Deaths (Denominator)
Total
Total	State grantees do not need to provide these data, as they will be pulled from CDC WONDER
By age
<18 yr	State grantees do not need to provide these data, as they will be pulled from CDC WONDER
18–24 yr
25–34 yr
35–44 yr
45–54 yr
55–64 yr
65+ yr
Unavailable
By sex
Male	State grantees do not need to provide these data, as they will be pulled from CDC WONDER
Female
Other
Unavailable

Data Source(s): List all data sources for your data. __________________________________________________________________________________

Data Comments

Please provide any additional provide information about the data source or other information that would be useful in understanding the overdose death data you have provided.

Data	Additional Information
Population	Free text
Opioid Overdose Deaths	State grantees do not need to provide this information

Data can be collected in SPARS using an equivalent module that is used by other grant programs.

3.1 Targeted Outcome Measure of Consumption/Prescription Drug Misuse

Choose the relevant consumption outcome indicator that your survey is measuring.

Prescription Drug Misuse/Abuse

Percentage of target population with any misuse of prescription drugs in the past 30 days

Percentage of target population with any misuse of prescription drugs during the past 12 months

Prescription Pain Reliever Misuse/Abuse

Percentage of target population with any misuse of prescription pain relievers in the past 30 days

Percentage of target population with any misuse of prescription pain relievers during the past 12 months

Other Targeted Prescription Drug Measure

Specify substance and measure: ______________________________________ ___________________________________________________________________________

Time Period (Select one):

• Past 30-day use

• Past 12-month use

• Other time period (Specify:____________________________________________)

Data can be collected in SPARS using an equivalent module that is used by other grant programs.

3.2 Survey Information and Results

1. Name of Survey: __________________________________________________________________

2. Survey Item/Question: Enter the source item verbatim, exactly as it appears on the survey instrument. _______________________________________________________________________________

Response Option(s): Enter the entire set of response options verbatim, exactly as they appear on the survey instrument.

_______________________________________________________________________________

If applicable, provide the associated codes for each response that was used in analyses. _______________________________________________________________________________

3. Reported Outcome Description: Provide a description of the specific outcome you will be reporting for this measure; for example, the percentage of 9^th grade students with any misuse of prescription drugs in the past 12 months.

_______________________________________________________________________________

4. Survey Population Age Range (or grades if school survey): Indicate whether the survey population was defined by age or grade level, and provide the applicable age range or grades.

• Age Range. Insert below the lower and upper bounds for the age range for the population represented by the survey. The possible values must fall between ages 1 and 99. For a community survey of adults, for example, you would enter age 18 as the lower bound and 99 as the upper bound. However, if you are reporting results for a subset of adults surveyed—e.g., ages 18 to 25—then you would enter age 18 as the lower bound and 25 as the upper bound.

Minimum_______________ Maximum_______________

• Grades. Select the grade(s) of the population represented by the survey and for which you are reporting data. For example, if the survey was administered to grades 9 and 11, and the current data being reported are for grade 9 students, then select grade 9.

Select applicable grades:

K 1 2

3 4 5

6 7 8

9 10 11

12 College

5. Other Sample Descriptors: Describe any other distinguishing characteristics of the sample, if applicable. (For example, Latino students only.)

_______________________________________________________________________________

6. Description of Sampling Design: Indicate what type of sampling was used for the survey.

• Census

• Convenience sample

• Random sample

• Stratified random sample

7. Data Collection Date: Provide the month and year in which the survey was conducted. If the data collection took multiple months, the month at the middle of the period should be reported. If it took an even number of months, report the middle month closer to the end date. If multiple years of data were combined into a single estimate due to small sample size, insert the month and year of the most recent survey date and check “multiple year pooled estimate” below. [Note: Use of multiyear estimates must be preapproved by CSAP.]

Month/Year___________________________________________

Is this a multiple year pooled estimate?

• Yes If Yes: Report the data collection years for the multiyear pooled

estimate you are reporting. For example, 2016; 2017.

_________________________________________________________________

• No

8. Value Type: Select the type of number you will report in the Calculated Value field. If you are reporting a value type other than those listed, select “Other,” and describe the value type.

• Percentage

• Mean

• Other (Describe)___________________________________________________________

9. Calculated Value: Enter your actual numeric result. For example, you may enter “10” to indicate that 10% of the target population reported misuse of prescription drugs in the past 12 months. _________________

10. Standard Error: Enter the standard error for the calculated value, computed to take account of the sampling design (e.g., simple random or two-stage cluster design). _________________

11. Standard Deviation: Enter the standard deviation for the calculated value, computed to take account of the sampling design (e.g., simple random or two-stage cluster design). ______________

12. Survey Item Valid N: Provide the total number of respondents with a valid response (i.e., not missing) to the survey item (the denominator for the data you are reporting). ________________

13. Comments (Maximum 1,500 characters): Provide any comments you feel may be helpful in understanding the data and information you have provided.

_________________________________________________________________

Data can be collected in SPARS using an equivalent module that is used by other grant programs.

Attachment 3

Community-Level Outcomes – Deleted Questions

QUESTION

RATIONALE

1.1 Hospital Data for Opioid Overdoses

Grantees are required to report opioid overdose data for subrecipient communities, including data on emergency department visits involving opioid overdose. If emergency department data are not available, please provide hospital admissions data. If no hospital data are available, submit a substitute data request for alternative overdose data you may have (e.g., emergency medical service data).

Data Source Time Frame (Start Date and End Date)

Indicate the time frame during which data for this measure were collected. Enter the start date and end date for the time period of the data you are submitting.

Start Date: ________________________________(month/day/year)

End Date: _________________________________(month/day/year)

Types of Opioid

For which types of opioid are you submitting data now? (You are asked to provide data for all opioids excluding heroin, and then separately for heroin. Please see the guidance manual for details on how to report your data, including the specific ICD-10 codes.) If you cannot provide the data broken out as requested, choose “other,” and specify the types of opioids that are included in your data. Provide any additional relevant information about the data in the Data Comments section below. (Select One)

• Opioids excluding heroin

• Heroin

• Other (Specify types of opioids that are included:_____________________________)

Data can be collected in SPARS using an equivalent module that is used by other grant programs.

Hospital Data for Opioid Overdoses

	Population (Denominator)	Emergency Department Visits Involving Opioid Overdose			Total Emergency Department Visits (Denominator)	Hospitalizations Involving Opioid Overdose		Total Hospitalizations (Denominator)
Total	Numerical		Numerical	Numerical			Numerical	Numerical

Data Source(s): List all data sources for your data. __________________________________________________________________________________

Data Comments

Please provide any additional information about the data source or any other information that would be useful in understanding the overdose data you have provided.

Data	Additional Information
Population	Free text
Emergency Department Visits Involving Opioid Overdose	Free text
Hospitalizations Involving Opioid Overdose	Free text

1.2 Other Opioid Overdose Events (for Approved Substitute Data Source)

This is where you report any alternative opioid overdose data for your subrecipient communities if you do not have access to hospital data. First, you would need to submit a substitute data request and get it approved.

Substitute Date Source

[Dropdown box that lists all the approved Substitute Data Source Requests for this grantee]

Data Source Time Frame (Start Date and End Date)

Indicate the time frame during which data for this measure were collected. Enter the start date and end date for the time period of the data you are submitting.

Start Date: ________________________________(month/day/year)

End Date: _________________________________(month/day/year)

Data can be collected in SPARS using an equivalent module that is used by other grant programs.

Types of Opioid

For which types of opioid are you submitting data now? (You are asked to provide data for all opioids excluding heroin, and then separately for heroin. Please see the guidance manual for details on how to report your data, including the specific ICD-10 codes.) If you cannot provide the data broken out as requested, choose “other,” and specify the types of opioids that are included in your data. Provide any additional relevant information about the data in the Data Comments section below. (Select One)

• Opioids excluding heroin

• Heroin

• Other (Specify types of opioids that are included:_____________________________)

Other Opioid Overdose Events (for Approved Substitute Data Source)

	Population (Denominator)	Other Opioid Overdose Events (optional)	Total Number of Events (Denominator)
Total	Numerical	Numerical	Numerical

Data Comments

Please provide any additional information about the data source or other information that would be useful in understanding the overdose data you have provided.

Data	Additional Information
Population	Free text
Other Opioid Overdose Events	Free text

1.3 Opioid Overdose Deaths

In this section, grantees report data on opioid overdose deaths for any subrecipients that are not counties. Grantees do not need to report any opioid overdose death data for counties because these data will be pulled from the CDC WONDER database. Report at the closest available substate geographic unit for each non-county subrecipient community (e.g., community or district), if available.

Data Source Time Frame (Start Date and End Date)

Indicate the time frame during which data for this measure were collected. Enter the start date and end date for the time period of the data you are submitting.

Start Date: ________________________________(month/day/year)

End Date: _________________________________(month/day/year)

Types of Opioid

For which types of opioid are you submitting data now? (You are asked to provide data for all opioids excluding heroin, and then separately for heroin. Please see the guidance manual for details on how to report your data, including the specific ICD-10 codes.) If you cannot provide the data broken out as requested, choose “other,” and specify the types of opioids that are included in your data. Provide any additional relevant information about the data in the Data Comments section below. (Select One)

• Opioids excluding heroin

• Heroin

• Other (Specify types of opioids that are included:_____________________________)

Data can be collected in SPARS using an equivalent module that is used by other grant programs.

Opioid Overdose Deaths

In the table below, provide the total population (total number of residents in the jurisdiction), the total number of opioid deaths, and the total number of deaths.

Opioid Overdose Deaths

	Population (Denominator)	Opioid Overdose Deaths	Total Deaths (Denominator)
Total	Numerical	Numerical	Numerical

Data Source(s): List all data sources for your data. __________________________________________________________________________________

Data Comments

Please provide any additional information about the data source or other information that would be useful in understanding the overdose death data you have provided.

Data	Additional Information
Population	Free text
Opioid Overdose Deaths	State grantees do not need to provide this information

3.1 Targeted Outcome Measure of Consumption/Prescription Drug Misuse

Prescription Pain Reliever Misuse/Abuse

Percentage of target population with any misuse of prescription pain relievers in the past 30 days

Percentage of target population with any misuse of prescription pain relievers during the past 12 months

Other Targeted Prescription Drug Outcome Measure

Specify substance and measure: ______________________________________ _________________________________________________________________

Time Period (Select one):

• Past 30-day use

• Past 12-month use

• Other time period (Specify:____________________________________________)

3.2 Survey Information and Results

1. Name of Survey: __________________________________________________________________

2. Survey Item/Question: Enter the source item verbatim, exactly as it appears on the survey instrument. __________________________________________________________________________

Response Option(s): Enter the entire set of response options verbatim, exactly as they appear on the survey instrument.

__________________________________________________________________________

If applicable, provide the associated codes for each response that was used in analyses. __________________________________________________________________________

3. Reported Outcome Description: Provide a description of the specific outcome you will be reporting for this measure; for example, the percentage of 9^th grade students with any misuse of prescription drugs in the past 12 months.

___________________________________________________________________________

4. Survey Population Age Range (or grades if school survey): Indicate whether the survey population was defined by age or grade level, and provide the applicable age range or grades.

• Age Range. Insert below the lower and upper bounds for the age range for the population represented by the survey. The possible values must fall between ages 1 and 99. For a community survey of adults, for example, you would enter age 18 as the lower bound and 99 as the upper bound. However, if you are reporting results for a subset of adults surveyed—e.g., ages 18 to 25—then you would enter age 18 as the lower bound and 25 as the upper bound.

Minimum_______________ Maximum_______________

• Grades. Select the grade(s) of the population represented by the survey and for which you are reporting data. For example, if the survey was administered to grades 9 and 11, and the current data being reported are for grade 9 students, then select grade 9.

Select applicable grades:

K 1 2

3 4 5

6 7 8

9 10 11

12 College

5. Other Sample Descriptors: Describe any other distinguishing characteristics of the sample, if applicable. (For example, Latino students only.)

__________________________________________________________________________

6. Description of Sampling Design: Indicate what type of sampling was used for the survey.

• Census

• Convenience sample

• Random sample

• Stratified random sample

7. Data Collection Date: Provide the month and year in which the survey was conducted. If the data collection took multiple months, the month at the middle of the period should be reported. If it took an even number of months, report the middle month closer to the end date. If multiple years of data were combined into a single estimate due to small sample size, insert the month and year of the most recent survey date and check “multiple year pooled estimate” below. [Note: Use of multiyear estimates must be preapproved by CSAP.]

Month/Year___________________________________________

Is this a multiple year pooled estimate?

• Yes If Yes: Report the data collection years for the multiyear pooled

estimate you are reporting. For example, 2016; 2017.

______________________________________________________________

• No

8. Value Type: Select the type of number you will report in the Calculated Value field. If you are reporting a value type other than those listed, select “Other,” and describe the value type.

• Percentage

• Mean

• Other (Describe)___________________________________________________________

9. Calculated Value: Enter your actual numeric result. For example, you may enter “10” to indicate that 10% of the target population reported misuse of prescription drugs in the past 12 months. _________________

10. Standard Error: Enter the standard error for the calculated value, computed to take account of the sampling design (e.g., simple random or two-stage cluster design). _________________

11. Standard Deviation: Enter the standard deviation for the calculated value, computed to take account of the sampling design (e.g., simple random or two-stage cluster design). ______________

12. Survey Item Valid N: Provide the total number of respondents with a valid response (i.e., not missing) to the survey item (the denominator for the data you are reporting). ________________

13. Comments (Maximum 1,500 characters): Provide any comments you feel may be helpful in understanding the data and information you have provided. ____________________________

Data can be collected in SPARS using an equivalent module that is used by other grant programs.

Attachment 4

Grantee Interview Protocol – Deleted Questions

QUESTION	RATIONALE
IF NOT BASELINE INTERVIEW, GO TO QUESTION 7. BASELINE INTERVIEW ONLY Have you been able to receive any PDMP data or PDMP reports yet to use for planning or implementing your SPF-Rx effort at the state (or tribal) level? Yes No [IF YES] How do you receive the data? a. Do you receive summary statistics from the PDMP office? Yes No b. Do you receive a deidentified data file that you can analyze? Yes No [IF NO] Please describe the challenges or barriers to accessing any PDMP data for SPF- Rx prevention work. [SKIP TO QUESTION 7]	Baseline only measure. No longer relevant.
Were you able to use PDMP data to help make decisions about selection and funding of SPF-Rx community subrecipients? Yes No [IF YES] Please describe how you used PDMP data for decision-making about selecting and funding community subrecipients. [IF NO] Please describe the challenges or barriers to using PDMP data for subrecipient selection.	Baseline only measure. No longer relevant.

Grantee Interview Protocol – Modified Questions

QUESTION	RATIONALE
[Now that you’re near the end of the grant], hHow has the SPF-Rx initiative contributed to your state’s (or tribe’s) planning and decision-making process for prevention of prescription drug misuse? This process might involve your Advisory Council, EOW, and EBPW.	Removed all references to baseline.
ALL INTERVIEWS [INTRO IF BASELINE] Since the beginning of your SPF-Rx grant, [INTRO IF FOLLOW-UP] 7. Since our last interview in (YEAR), What has changed in your capacity, understanding, or ability to use PDMP data for prevention? PROBES Have there been any significant changes in the quality of the PDMP data? [IF YES] Please summarize the changes. Have there been any changes in your access or capacity to use PDMP for your prevention efforts? For example, this could relate to using PDMP data in new ways to monitor prescribing trends, or making more use of unsolicited reports. [IF YES] In what ways has your capacity improved at the grantee level? [IF YES] How were you able to accomplish these improvements in capacity for using PDMP data?	Removed all references to baseline.
How [are you planning to/have you been] facilitating your community subrecipients’ use of PDMP data reports for prevention? PROBES Are Did you encountering any major challenges or barriers to using PDMP data reports at the subrecipient community level? Yes No [IF YES] What are were the major challenges or barriers? [IF BASELINE PROBE] Are privacy concerns a key barrier to using PDMP data reports at the community level? Yes No How are were you able to address the main challenges or barriers to using PDMP data reports at the community level? Since the start of SPF-Rx, how has capacity improved to use PDMP data at the community level?	Removed all references to baseline

Removed Instrument

Substitute Data Request Form

This form was removed from the OMB package because an equivalent module exists in SPARS. The form is attached to this document.