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This document provides details on an upcoming clinical decision support services solicitation from the Department of Veterans Affairs. The solicitation will be for subject matter expertise, policy guidance, and strategic recommendations regarding clinical decision support standards implementation for VA IT systems. It will be issued as a request for proposal on August 11, 2018, with responses due 28 calendar days later. The small business set-aside solicitation will have a NAICS code of 541611 and size standard of $16.5 million. Any responsible small business may submit an offer. The multiple award, firm-fixed-price, indefinite delivery/indefinite quantity contract will have a 10-year ordering period and 15-year effective period. All questions must be directed to the points of contact by email only.

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Mental Health: Opioids and Chronic Noncancer Pain Opioid Therapy Risk

Report (OTRR)/Stratification Tool for Opioid Risk Mitigation (STORM)

Query Documentation Template Documentation Tem-plate: Conceptual Structure

Contract: VA118-16-D-1008, Task Order (TO): VA-118-16-F-1008-0007, CLIN0009BA

Department of Veterans Affairs (VA)

Knowledge Based Systems (KBS) Office of Informatics and Information Governance (OIIG)

Clinical Decision Support (CDS)

Publication date 06/06/2018

Version: 1.0

Mental Health: Opioids and Chronic Noncancer Pain Opioid Thera-py Risk Report (OTRR)/Stratification Tool for Opioid Risk Mitigation (STORM) Query Documentation Template: Documentation Template:

Conceptual Structure by Knowledge Based Systems (KBS), Office of Informatics and Information Governance (OIIG), and Clinical Decision Support (CDS)

Publication date 06/06/2018 Copyright © 2018 B3 Group, Inc.

Copyright © 2018 Cognitive Medical Systems, Inc.

B3 Group, Inc.

NOTICE OF GOVERNMENT COPYRIGHT LICENSE AND UNLIMITED RIGHTS LICENSE

Licensed under the Apache License, Version 2.0 (the "License"); you may not use this file except in compliance with the License.

You may obtain a copy of the License at http://www.apache.org/licenses/LICENSE-2.0

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Contribution by contractors to the US Veterans Health Administration during this period are contractually contributed under the Apache License, Version 2.0 and US Government sponsorship is acknowledged under Contract VA118-16-D-1008-0007.

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Table of Contents Preface ............................................................................................................................. vi Artifact Applicability ........................................................................................................ viii Models ............................................................................................................................. ix

1. External Data Definitions

2. Expression Definitions

3. Opioid Therapy Risk Report (OTTR) Query

4. Stratification Tool for Opioid Risk Mitigation (STORM) Query

5. Tabular List

6. Behavior Symbols A. References iv

List of Tables

1. Revision History ............................................................................................................ vi

2. Clinical White Paper Contributors ..................................................................................... vi

3. Artifact Identifier .......................................................................................................... vii

4. Applicability Foci, Description and Codes ........................................................................ viii

5. Model References ........................................................................................................... ix

5.1. Terminology Versions

5.2. Terminology References

6.1. Group Organizational Behavior

6.2. Group Selection Behavior

6.3. Required Behavior

6.4. Precheck Behavior

6.5. Cardinality Behavior

6.6. Item Flags

6.7. Read Only Behavior

v

Preface Table 1. Revision History

Date Life Cycle Event June 6, 2018 Published June 6, 2018 Reviewed March 1, 2018 Pre-published August 10, 2017 Created

Table 2. Clinical White Paper Contributors

Name Role Affiliation

Ilene Robeck, Physician

Author Physician, Richmond VA Medical Center (VAMC), Rich-mond, VA

Jodie Trafton, Di-rector

Author Director, VA Program Evaluation and Resource Center, VA Palo Alto Health Care System, Menlo Park, CA

Friedhelm Sand-brink, Acting Di-rector of Pain Man-agement Program Office

Author Acting Director of Pain Management Program Office, De-partment of VA, Washington, DC

Elizabeth Oliva, OEND Coordinator

Author VA National Opioid Overdose Education and Naloxone Dis-tribution (OEND) Coordinator, VA Palo Alto Health Care System, Menlo Park, CA

Eleanor Lewis, Research Health Science Specialist

Author Research Health Science Specialist, VA Palo Alto Health Care System, Menlo Park, CA

Kendall Browne, Clinical Psycholo-gist

Author Clinical Psychologist, Seattle Puget Sound Health Care Sys-tem, Seattle, WA

Alicia Heapy, Men-tal Health

Author Mental Health, VA New England Healthcare System, West Haven, CT

Karen Drexler, National Mental Health Program Di-rector

Author National Mental Health Program Director, Substance Use Disorders, VA Central Office, Atlanta, GA

Andrew Saxon, Physician

Author Physician, Seattle Health Care System, Seattle, WA

Melissa Christo-pher, National Di-rector

Author National Director, Academic Detailing VA Central Office (VACO) Pharmacy Benefits Management (PBM), Mission Valley Annex Veterans Integrated Services Networks (VISN) 22, San Diego, CA

Daina Wells Author United States

Lucille Burgo, Firm Chief, Prima-ry Care

Author Firm Chief, Primary Care, VA New England Healthcare Sys-tem, West Haven, CT vi

Preface

Name Role Affiliation

Julianne Himstreet, Pharmacist

Author Pharmacist, Eugene, OR

Table 3. Artifact Identifier

Domain Artifact ID Name urn:va.gov:kbs:knart:artifact:r1 9e089171-3be9-5f50-9e04-fe8463a05f16 O29 vii

Artifact Applicability Table 4. Applicability Foci, Description and Codes

Focus Description Code Sys-tem

Code Value Set Value Set Version

TargetUser Primary Care Provider (PCP)

SNOMED

CT

453231000124104 |Primary care provider (occupa-tion)|

N/A N/A

PatientAgeGroup Adult SNOMED

CT

133936004 |Adult (person)|

N/A N/A

ClinicalVenue Outpatient SNOMED

CT

33022008 |Hospi-tal-based outpatient department (envi-ronment)|

N/A N/A viii

Models Table 5. Model References

Referenced Model Description urn:solor.io:anf-model:1.0 VA Analysis Normal Form Model ix

Chapter 1. External Data Definitions No external data expression definitions and no trigger definitions are present.

Chapter 2. Expression Definitions No expression definitions are present.

Chapter 3. Opioid Therapy Risk Report (OTTR) Query

Represented Concepts: 073a1b36-a013-4199-9d56-274cc3605908 |Opioid Therapy Risk Report (assess-ment scale) prompt:

District – VA Integrated Service Network (VISN) response: String (Single) prompt:

Parent Station response: String (Single) prompt:

Provider Group response: Boolean (Single) response range:

EnumerationConstraint (List) item: Mental Health(TSR-NoCode) item: Primary Care(TSR-NoCode) item: Last opioid prescriber(TSR-NoCode) item: Last benzodiazepine prescriber(TSR-NoCode) prompt:

Team(s) response: String (Single) prompt:

Provider(s) response: String (Single) prompt:

Opioid Group(s) response: String (Single) prompt:

Opioid Use Status response: Boolean (Multiple) response range:

EnumerationConstraint (List) item: Long-term opioid therapy (LTOT)(TSR-NoCode) item: Active opioid prescription(TSR-NoCode) item: Opioid prescription in past year(TSR-NoCode) prompt:

Opioid use category response: Boolean (Single) response range:

EnumerationConstraint (List)

Opioid Therapy Risk Report (OTTR) Query item: All opioids(TSR-NoCode) item: Exclude buprenorphine/naloxone only patients(TSR-NoCode) item: Exclude tramadol only patients(TSR-NoCode) item: Exclude tramadol and buprenorphine/naloxone only patients(TSR-NoCode) item: Buprenorphine/naloxone only patients(TSR-NoCode) item: Tramadol only patients(TSR-NoCode)

Chapter 4. Stratification Tool for Opioid Risk Mitigation (STORM) Query

Represented Concepts: 2eab2687-6f77-4218-a5a7-01af4bc04ab1 |Stratification Tool for Opioid Risk Mit-igation (assessment scale) prompt:

Station response: String (Single) prompt:

Prescriber response: String (Single) prompt:

Risk group response: String (Single) prompt:

Group type response: String (Single) prompt:

Measures not met response: String (Single) prompt:

STORM cohort response: String (Single) prompt:

Social Security number (optional) response: String (Single)

Chapter 5. Tabular List Terminology Service Request (TSR) Mappings

Table 5.1. Terminology Versions

Name Identifer Version

SNOMED CT 2.16.840.1.113883.6.96 United States Edition 20180301

Table 5.2. Terminology References

System Code Display Texta Referencesb

SNOMED CT 073a1b36-a013-4199-9d56-274c-c3605908 |Opioid Therapy Risk Report (assessment scale)

Postcoordinated Expression 1

SNOMED CT 133936004 |Adult (per-son)|

Adult 1

SNOMED CT 2eab2687-6f77-4218-a5a7-01af4bc04ab1 |Strat-ification Tool for Opioid Risk Mitigation (assess-ment scale)

Postcoordinated Expression 1

SNOMED CT 33022008 |Hospital-based outpatient department (en-vironment)|

Outpatient 1

SNOMED CT 453231000124104 |Prima-ry care provider (occupa-tion)|

Primary Care Provider (PCP) 1

SNOMED CT TSR-NoCodec Mental Health 13 aIf a code is used multiple times in the KNART, only the display text of the first instance is shown.

bCount of the number of times the given code system and code pair is used in the KNART.

cTSR-NoCode is a placeholder indicating a code was requested, but was not provided.

Chapter 6. Behavior Symbols Table 6.1. Group Organizational Behavior

Sym-bol

Name Definition

▶ Sentence Group A group of related alternative actions is a sentence group if the item referenced by the action is the same in all the actions, and each action simply constitutes a different variation on how to specify the details for that item. For example, two actions that could be in a SentenceGroup are "aspirin, 500 mg, 2 times per day" and "aspirin, 300 mg, 3 times per day". In both cases, as-pirin is the item referenced by the action, and the two actions represent two different options for how aspirin might be or-dered for the patient. Note that a SentenceGroup would almost always have an associated selection behavior of "AtMostOne", unless it's a required action, in which case, it would be "Exact-lyOne".

▷ Logical Group A group with this behavior logically groups its sub-elements, and may be shown as a visual group to the end user, but it is not required to do so.

➤ Visual Group Any group marked with this behavior should be displayed as a visual group to the end user.

Table 6.2. Group Selection Behavior

Sym-bol

Name Definition

☐ Any Any number of the items in the group may be chosen, from ze-ro to all.

◉ All All the items in the group must be selected as a single unit.

◎ AllOrNone All the items in the group are meant to be chosen as a single unit: either all must be selected by the end user, or none may be selected.

○ ExactlyOne The end user must choose one and only one of the selectable items in the group. The user may not choose none of the items in the group.

✪ AtMostOne The end user may choose zero or at most one of the items in the group.

❂ OneOrMore The end user must choose a minimum of one, and as many ad-ditional as desired.

Table 6.3. Required Behavior

Sym-bol

Name Definition

✦ Must An action with this behavior must be included in the actions processed by the end user; the end user may not choose not to include this action.

Behavior Symbols

Sym-bol

Name Definition

✧ Could An action with this behavior may be included in the set of ac-tions processed by the end user.

➢ MustUnlessDocumented An action with this behavior must be included in the set of ac-tions processed by the end user, unless the end user provides documentation as to why the action was not included.

Table 6.4. Precheck Behavior

Sym-bol

Name Definition

▲ Yes An action with this behavior is one of the most frequent actions that is, or should be, included by an end user, for the particular context in which the action occurs. The system displaying the action to the end user should consider "pre-checking" such an action as a convenience for the user.

▽ No An action with this behavior is one of the less frequent actions included by the end user, for the particular context in which the action occurs. The system displaying the actions to the end user would typically not "pre-check" such an action.

Table 6.5. Cardinality Behavior

Sym-bol

Name Definition

◆ Single An action with this behavior may only be completed once.

❖ Multiple An action with this behavior may be repeated multiple times.

Table 6.6. Item Flags

Sym-bol

Name Definition

☞ fillIn This item, in a list entry, allows the user to enter a fill in value that is not present in the set of presented choices.

Table 6.7. Read Only Behavior

Sym-bol

Name Definition

☆ true For a particular action or action group, specifies whether the elements are read only.

Appendix A. References This appendix contains the list of related resources and supporting documents used in creating this KNART.

List of References Related Resources [CCWP] Opioids and Chronic Noncancer Pain

[CSD] Mental Health: Opioids and Chronic Noncancer Pain Opioid Therapy Risk Report (OTRR)/Stratification Tool for Opioid Risk Mitigation (STORM) Query Documentation Template Conceptual Structure Document

[KVRpt] Mental Health: Opioids and Chronic Noncancer Pain Opioid Therapy Risk Report (OTRR)/Stratification Tool for Opioid Risk Mitigation (STORM) Query Documentation Template KNART Validation Report

Supporting Evidence [Oliva 2017] Oliva EM, Bowe T, Tavakoli S, et al. Development and applications of the Veterans Health Administration's Stratification Tool for Opioid Risk Mitigation (STORM) to improve opioid safety and prevent overdose and suicide. Psychol Serv.

2017;14(1):34-49. (link [https://www.ncbi.nlm.nih.gov/pubmed/?term=Development+and+applications+of +the+Veterans+Health+Administration%27s+Stratification+Tool+for+Opioid+Risk +Mitigation+(STORM)+to+improve+opioid+safety+and+prevent+overdose+and+suicide])

[Trafton 2017a] J. Trafton. Opioid risk stratification and mitigation tool: supporting targeted efforts to encourage and track use of recommended strategies for prevention of adverse events in patients with opioid prescriptions or opioid use disorders (AAPM December 2015 panel presentation for clearance2; materials provided by Jodie Trafton, December 12, 2017)

[Sanders 2017] Opioid Therapy Risk Report patient details (Office of Health Informatics - Opioid KNARTs Harmoniza-tion Project - OTRR Screenshots 20171222.docx; email communication and materials provided by William J. Sanders, December 22, 2017).

[Robeck 2017a] PBM CPPO pain PhARMD template: frequently asked questions (PBM PAIN PhARMD TEMPLATE FAQ DOCUMENT2.pptx; materials provided by Ilene R. Robeck, November 27, 2017

[Robeck 2017b] PBM PhARMD pain documentation template version 1: installation instructions, 28AUG2017 (PhARMD Pain Mgmt Note Template_Install Screenshots_28AUG2017.pptx; materials provided by Ilene R.

Robeck, November 27, 2017).

[Trafton 2017b] STORM: Patient Detail Dashboard: Stratification Tool for Opioid Risk Mitigation (STORMde-ided-screenshot.png; materials provided by Jodie Trafton, December 12, 2017).

[Rosenberg 2017] Rosenberg JM, Bilka BM, Wilson SM, Spevak C. Opioid Therapy for Chronic Pain: Overview of the 2017 US Department of Veterans Affairs and US Department of Defense Clinical Practice Guideline. Pain Med. 2017 Sep 1 (link [https://www.ncbi.nlm.nih.gov/pubmed/29025128])

[VA 2016] U.S. Department of Veterans Affairs; Veterans Health Administration. Querying State Prescription Drug Monitoring Programs (PDMP). VHA Directive 1306. VHA Publications website. https://www.va.gov/vha-https://www.ncbi.nlm.nih.gov/pubmed/?term=Development+and+applications+of+the+Veterans+Health+Administration%27s+Stratification+Tool+for+Opioid+Risk+Mitigation+(STORM)+to+improve+opioid+safety+and+prevent+overdose+and+suicide https://www.ncbi.nlm.nih.gov/pubmed/?term=Development+and+applications+of+the+Veterans+Health+Administration%27s+Stratification+Tool+for+Opioid+Risk+Mitigation+(STORM)+to+improve+opioid+safety+and+prevent+overdose+and+suicide https://www.ncbi.nlm.nih.gov/pubmed/?term=Development+and+applications+of+the+Veterans+Health+Administration%27s+Stratification+Tool+for+Opioid+Risk+Mitigation+(STORM)+to+improve+opioid+safety+and+prevent+overdose+and+suicide https://www.ncbi.nlm.nih.gov/pubmed/?term=Development+and+applications+of+the+Veterans+Health+Administration%27s+Stratification+Tool+for+Opioid+Risk+Mitigation+(STORM)+to+improve+opioid+safety+and+prevent+overdose+and+suicide https://www.ncbi.nlm.nih.gov/pubmed/29025128 https://www.ncbi.nlm.nih.gov/pubmed/29025128

References publications/ViewPublication.asp?pub_ID=3283. Published October 19, 2016. Accessed February 8, 2018 (link [https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3283])

[VA 2014] U.S. Department of Veterans Affairs; Veterans Health Administration. Informed Consent for Long-Term Opioid Therapy for Pain. VHA Directive 1005. VHA Publications website. https://www.va.gov/vhapublica-tions/ViewPublication.asp?pub_ID=3005. Published May 6, 2014. Accessed February 8, 2018. (link [https:// www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3005])

[NLM 2016a] U.S. National Library of Medicine. BENGAY GREASELESS PAIN RELIEVING- menthol, unspecified form and methyl salicylate cream [Johnson and Johnson Consumer Inc.]. DailyMed website. https://dai-lymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=0d75b27f-496e-495d-b788-0dd3c0f5a32f. Revised April 2016 (link [https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=0d75b27f-496e-495d-b788-0dd3c0f5a32f])

[NLM 2015a] U.S. National Library of Medicine. CAPSAICIN ARTHRITIS PAIN RELIEF CREAM-capsaicin cream. [McCure Health Solutions Inc.]. DailyMed website. https://dailymed.nlm.nih.gov/dailymed/drugIn-fo.cfm?setid=7c31736c-edaa-4390-a2fb-eab2fd495f7d. Revised April 2015. (link [https://dailymed.nlm.ni-h.gov/dailymed/drugInfo.cfm?setid=7c31736c-edaa-4390-a2fb-eab2fd495f7d])

[NLM 2017a] U.S. National Library of Medicine. CELECOXIB - celecoxib capsule. [Jubilant Cadista Pharmaceuticals Inc.]. DailyMed website. https://dailymed.nlm.nih.gov/dailymed/drugIn-fo.cfm?setid=27d813ea-7798-09cb-734b-b970d7248f1f. Revised April 2017. (link [https://dailymed.nlm.ni-h.gov/dailymed/drugInfo.cfm?setid=27d813ea-7798-09cb-734b-b970d7248f1f])

[NLM 2017b] U.S. National Library of Medicine. DICLOFENAC SODIUM-diclofenac gel. [Amneal Pharma-ceuticals LLC]. DailyMed website. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f64b68a5-d6d2-4e92-87e7-90af04c1f9db. Revised January 2017 (link [https://dailymed.nlm.nih.gov/dailymed/drugIn-fo.cfm?setid=f64b68a5-d6d2-4e92-87e7-90af04c1f9db])

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[NLM 2015b] U.S. National Library of Medicine. LIDODERM-lidocaine patch. [Endo Pharmaceuticals, Inc.].

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[NLM 2018] U.S. National Library of Medicine. NAPROSYN-naproxen tablet; EC-NAPROSYN-naproxen tablet, delayed release; NAPROSYN-naproxen suspension; ANAPROX-naproxen sodium tablet; ANAPROX DS-naproxen sodium tablet. [Genentech, Inc.]. DailyMed website. https://dailymed.nlm.nih.gov/daily-med/drugInfo.cfm?setid=68848217-03c9-4377-9be6-6f567e629129. Revised January 2018. (link [https:// dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=68848217-03c9-4377-9be6-6f567e629129])

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Mental Health: Opioids and Chronic Noncancer Pain Opioid Therapy Risk Report (OTRR)/Stratification Tool for Opioid Risk Mitigation (STORM) Query Documentation Template
Table of Contents
Preface
Artifact Applicability
Models
Chapter 1. External Data Definitions
Chapter 2. Expression Definitions
Chapter 3. Opioid Therapy Risk Report (OTTR) Query
Chapter 4. Stratification Tool for Opioid Risk Mitigation (STORM) Query
Chapter 5. Tabular List
Chapter 6. Behavior Symbols
Appendix A. References
List of References

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