Background: Despite high numbers of VHA patients (>300,000) receiving long-term opioid therapy (LTOT), evidence of its harms is growing (e.g., inadequate pain control, side effects, overdoses). Although VA/DoD Guidelines recommend frequent, multi-component monitoring of LTOT patients, monitoring is under-utilized because it does not fit with primary care?s workflow. In addition, rates of opioid discontinuation are increasing, even though discontinuation is often harmful (e.g., more use of street heroin, worsening mental health). Further, for patients for whom both continued LTOT and tapering for discontinuation are determined to be potentially harmful, a clinical practice guideline (CPG) is not available, leaving them ?guideline-orphaned.? Significance: With increasing opioid overdose deaths and complications of LTOT due to comorbidities, policy emphases have shifted to reducing opioid prescribing, and monitoring and discontinuing opioids among LTOT patients. This project will help providers maintain high-quality patient care while responding to policy shifts. It addresses the VHA?s and HSR&D?s goal of offering patient-centered care by giving providers an integrated instrument to reduce harms due to LTOT continuation and discontinuation, which are widespread and severe among Veterans. Innovation: This project has the potential to change LTOT practices by giving primary care and other providers new, easy-to-use screening tools that will facilitate adherence to recommended guidelines on monitoring of LTOT patients, and discontinuation of LTOT when it is harmful. The integrated instrument may be incorporated into CPRS to facilitate its use in VA health care clinics. The project will also change practice by providing new, provisional guidelines for a challenging group of LTOT patients for whom CPGs do not exist. The work to be accomplished is complementary to VHA initiatives by contributing to components of best practices for balancing pain management and opioid prescribing, ?S.T.O.P. P.A.I.N,? i.e., Stepped care model; Treatment alternatives; Ongoing monitoring of usage; and Practice guidelines.
Specific Aims are to develop an integrated instrument with two screening tools, the first to indicate if LTOT is harmful to continue (yes or no;
Aim 1), and the second to indicate if tapering to discontinue opioids is harmful to initiate (yes or no;
Aim 2). Positive screens will indicate that providers should undertake additional, more comprehensive monitoring and examination to determine the harm of continued LTOT or tapering to discontinuation, respectively.
Aim 3 : Inform subsequent CPGs by determining preliminary treatment approaches for ?guideline-orphaned? LTOT patients. Methods to develop the tools will involve (1) comprehensive literature searches to yield an initial item bank for each screening tool; (2) qualitative item analyses using focus groups with patients and providers, cognitive interviewing with patients, expert review, and item revision to yield small item banks for each screening tool for field testing; and (3) field testing to yield the final bank of items for each screening tool, which will include (a) linking patients? (n=500 for each tool) telephone survey responses to their electronic health record data from the Corporate Data Warehouse, and (b) reliability testing (n=30 patients). Methods to work toward the CPG will follow the same methods used to develop the VA/DoD CPG for the Management of Substance Use Disorders, which consist of (1) conducting a systematic review, (2) obtaining input from the expert reviewers, and (3) drafting and submitting a preliminary guideline about the management of ?orphaned? LTOT patients to our operations partners on this project. Next steps/Implementation: The next step in this research program will be a multi-site project to examine the extent to which use of the screening tools and potential CPG, resulting from this proposed study, is associated with improved patient outcomes (e.g., fewer overdoses), and health care system utilization and costs (e.g., fewer emergency department visits and hospitalizations for opioid-related acute crises). Next steps also include partnering on quality improvement projects to implement the screening tools and CPG in VA primary care and pain clinics.

Public Health Relevance

Many VA patients receive long-term opioid therapy (LTOT). LTOT may be harmful, and so physicians are supposed to frequently monitor LTOT patients. However, many LTOT patients are not frequently monitored, and many are having LTOT discontinued, even though discontinuation may also be harmful. Because of potential harms of LTOT, difficulties of frequent monitoring, and potential harms of having LTOT discontinued, physicians need practical tools and guidelines to improve care. This project will improve patient care by developing integrated screening tools to indicate if LTOT is harmful to continue (yes or no), and if tapering to discontinue opioids is harmful to initiate (yes or no). When the tool indicates ?yes,? this will mean that physicians should start additional, more comprehensive monitoring and examination to determine the harms and benefits of continued LTOT or of tapering to discontinuation. This project will also identify preliminary treatment approaches for an at-risk subgroup of LTOT patients: those who screen ?yes? on both tools.

Agency
National Institute of Health (NIH)
Institute
Veterans Affairs (VA)
Type
Non-HHS Research Projects (I01)
Project #
1I01HX002833-01A2
Application #
9951608
Study Section
HSR-1 Medical Care and Clinical Management (HSR1)
Project Start
2020-09-01
Project End
2024-08-31
Budget Start
2020-09-01
Budget End
2021-08-31
Support Year
1
Fiscal Year
2020
Total Cost
Indirect Cost
Name
Veterans Admin Palo Alto Health Care Sys
Department
Type
DUNS #
046017455
City
Palo Alto
State
CA
Country
United States
Zip Code
94304