A Facility-Wide Plan to Increase Access to Medication for Opioid Use Disorder in Primary Care and General Mental Health Settings

Abstract

Background

The opioid epidemic in the United States has generated a pressing need to enhance access to medications for opioid use disorder (MOUD). This program description illustrates a quality-improvement effort to extend MOUD to primary care and general mental health clinics within the US Department of Veterans Affairs (VA) Connecticut Healthcare system (VACHS), and to examine barriers and facilitators to implementation of MOUD in target clinics.

Observations

As part of the national VA Stepped Care for Opioid Use Disorder Train the Trainer (SCOUTT) initiative to improve MOUD access, a VACHS team identified and resolved barriers to MOUD in target clinics. Key interventions were to obtain leadership support, increase waivered prescribers, and develop processes and tools to enhance prescribing. New initiatives included quarterly educational sessions, templated progress notes, and instant messaging for addiction specialist electronic consultations. MOUD receipt and prescriber characteristics were evaluated before and 1 year after implementation. There was a 4% increase in eligible patients receiving MOUD, from 552 (44%) to 582 (48%) (P = .04). The number of waivered prescribers increased from 67 to 131, and the number of buprenorphine prescribers increased from 35 to 52 over a 6-month span, and the percentage of health care practitioners capable of prescribing within the electronic health record increased from 75% to 89% (P = .01).

Conclusions

An interdisciplinary team approach to identifying and overcoming barriers to MOUD target clinics expands access. Key interventions include interdisciplinary leadership engagement, proactive education and incentivization of target prescribers, removal of procedural barriers, and development of tools to facilitate and support prescribing. These concrete interventions can help inform other institutions interested in expanding MOUD access.

In the United States, opioid use disorder (OUD) is a major public health challenge. In 2018 drug overdose deaths were 4 times higher than they were in 1999.¹ This increase highlights a critical need to expand treatment access. Medication for opioid use disorder (MOUD), including methadone, naltrexone, and buprenorphine, improves outcomes for patients retained in care.² Compared with the general population, veterans, particularly those with co-occurring posttraumatic stress disorder (PTSD) or depression, are more likely to receive higher dosages of opioid medications and experience opioid-related adverse outcomes (eg, overdose, OUD).^3,4 As a risk reduction strategy, patients receiving potentially dangerous full-dose agonist opioid medication who are unable to taper to safer dosages may be eligible to transition to buprenorphine.⁵

Buprenorphine and naltrexone can be prescribed in office-based settings or in addiction, primary care, mental health, and pain clinics. Office-based opioid treatment with buprenorphine (OBOT-B) expands access to patients who are not reached by addiction treatment programs.^6,7 This is particularly true in rural settings, where addiction care services are typically scarce.⁸ OBOT-B prevents relapse and maintains opioid-free days and may increase patient engagement by reducing stigma and providing treatment within an existing clinical care team.⁹ For many patients, OBOT-B results in good retention with just medical monitoring and minimal or no ancillary addiction counseling.^10,11

Successful implementation of OBOT-B has occurred through a variety of care models in selected community health care settings.^8,12,13 Historically in the Veterans Health Administration (VHA), MOUD has been prescribed in substance use disorder clinics by mental health practitioners. Currently, more than 44% of veterans with OUD are on MOUD.¹⁴

The VHA has invested significant resources to improve access to MOUD. In 2018, the Stepped Care for Opioid Use Disorder Train the Trainer (SCOUTT) initiative launched, with the aim to improve access within primary care, mental health, and pain clinics.¹⁵ SCOUTT emphasizes stepped-care treatment, with patients engaging in the step of care most appropriate to their needs. Step 0 is self-directed care/self-management, including mutual support groups; step-1 environments include office-based primary care, mental health, and pain clinics; and step-2 environments are specialty care settings. Through a series of remote webinars, an inperson national 2-day conference, and external facilitation, SCOUTT engaged 18 teams representing each Veterans Integrated Service Network (VISN) across the country to assist in implementing MOUD within 2 step-1 clinics. These teams have developed several models of providing step-1 care, including an interdisciplinary team-based primary care delivery model as well as a pharmacist care manager model.^{16, 17}

US Department of Veterans Affairs (VA) Connecticut Health Care System (VACHS), which delivers care to approximately 58,000 veterans, was chosen to be a phase 1 SCOUTT site. Though all patients in VACHS have access to specialty care step-2 clinics, including methadone and buprenorphine programs, there remained many patients not yet on MOUD who could benefit from it. Baseline data (fiscal year [FY] 2018 4th quarter), obtained through electronic health record (EHR) database dashboards indicated that 710 (56%) patients with an OUD diagnosis were not receiving MOUD. International Classification of Disease, 10th Revision codes are the foundation for VA population management dashboards, and based their data on codes for opioid abuse and opioid dependence. These tools are limited by the accuracy of coding in EHRs. Additionally, 366 patients receiving long-term opioid prescriptions were identified as moderate, high, or very high risk for overdose or death based on an algorithm that considered prescribed medications, sociodemographics, and comorbid conditions, as characterized in the VA EHR (Stratification Tool for Opioid Risk Mitigation [STORM] report).¹⁸

This article describes the VACHS quality-improvement effort to extend OBOT-B into step-1 primary care and general mental health clinics. Our objectives are to (1) outline the process for initiating SCOUTT within VACHS; (2) examine barriers to implementation and the SCOUTT team response; (3) review VACHS patient and prescriber data at baseline and 1 year after implementation; and (4) explore future implementation strategies.

SCOUTT TEAM

A VACHS interdisciplinary team was formed and attended the national SCOUTT kick-off conference in 2018.¹⁵ Similar to other SCOUTT teams, the team consisted of VISN leadership (in primary care, mental health, and addiction care), pharmacists, and a team of health care practitioners (HCPs) from step-2 clinics (including 2 addiction psychiatrists, and an advanced practice registered nurse, a registered nurse specializing in addiction care), and a team of HCPs from prospective step-1 clinics (including a clinical psychologist and 2 primary care physicians). An external facilitator was provided from outside the VISN who met remotely with the team to assist in facilitation. Our team met monthly, with the goal to identify local barriers and facilitators to OBOT-B and implement interventions to enhance prescribing in step-1 primary care and general mental health clinics.

Implementation Steps

The team identified multiple barriers to dissemination of OBOT-B in target clinics (Table). The 3 main barriers were limited leadership engagement in promoting OBOT-B in target clinics, inadequate number of HCPs with active X-waivered prescribing status in the targeted clinics, and the need for standardized processes and tools to facilitate prescribing and follow-up.

TABLE.

Barriers and Resolutions to implementation of OBOT-B in VACHS Clinics

Barriers	Approaches
Limited leadership engagement in promoting OBOT-B	Incorporated quarterly progress reports into regional primary care leadership call 90-minute leadership summit with primary care, mental health care, SUD care, nursing, and pharmacy leadership 1-day in-person SUD regional leadership meeting
Clinicians without X-waivers	Quarterly emails to target clinic clinicians Training courses included: 8 h online (learning.pcssnow.org); 4 h webinar and 4-h online self-study X-licensure status linked to incentives for primary care; X-waiver/opioid safety components qualified for $3000 incentive for 2019 Quarterly case-based education sessions during existing clinician education time
Procedural barrier for waivered prescribers	SOP onboarding for new waivered prescribers SOP generated and accepted by stakeholders
SOP to ensure adherence with evidence-based practice within target clinics	Created and solicited stakeholders support for SOP for waivered prescribers in clinics to prescribe buprenorphine Templated buprenorphine induction and maintenance progress notes; active links to urine toxicology and pharmacy order sets, home induction guides, informed consent, prescription drug monitoring website, and naloxone prescription
Unstructured support for clinicians in step-1 clinics	SUD e-consult for potential OBOT-B problems Instant messaging group for addiction care team
Understaffed clinics unable to accommodate buprenorphine prescribing	Telebuprenorphine clinics at outpatient clinics

Abbreviations: OBOT-B, office-based opioid treatment with buprenorphine; SOP, standard operating procedure; SUD, substance use disorder; VACHS, Veterans Affairs Connecticut Healthcare System.

To address leadership engagement, the SCOUTT team held quarterly presentations of SCOUTT goals and progress on target clinic leadership calls (usually 15 minutes) and arranged a 90-minute multidisciplinary leadership summit with key leadership representation from primary care, general mental health, specialty addiction care, nursing, and pharmacy. To enhance X-waivered prescribers in target clinics, the SCOUTT team sent quarterly emails with brief education points on MOUD and links to waiver trainings. At the time of implementation, in order to prescribe buprenorphine and meet qualifications to treat OUD, prescribers were required to complete specialized training as necessitated by the Drug Addiction Treatment Act of 2000. X-waivered status can now be obtained without requiring training

The SCOUTT team advocated for X-waivered status to be incentivized by performance pay for primary care practitioners and held quarterly case-based education sessions during preexisting allotted time. The on-boarding process for new waivered prescribers to navigate from waiver training to active prescribing within the EHR was standardized via development of a standard operating procedure (SOP).

The SCOUTT team also assisted in the development of standardized processes and tools for prescribing in target clinics, including implementation of a standard operating procedure regarding prescribing (both initiation of buprenorphine, and maintenance) in target clinics. This procedure specifies that target clinic HCPs prescribe for patients requiring less intensive management, and who are appropriate for office-based treatment based on specific criteria (eAppendix, available at doi:10.12788/fp.0186).

Templated progress notes were created for buprenorphine initiation and buprenorphine maintenance with links to recommended laboratory tests and urine toxicology test ordering, home induction guides, prescription drug monitoring database, naloxone prescribing, and pharmacy order sets. Communication with specialty HCPs was facilitated by development of e-consultation within the EHR and instant messaging options within the local intranet. In the SCOUTT team model, the prescriber independently completed assessment/follow-up without nursing or clinical pharmacy support.

Analysis

We examined changes in MOUD receipt and prescriber characteristics at baseline (FY 2018 4th quarter) and 1 year after implementation (FY 2019 4th quarter). Patient data were extracted from the VHA Corporate Data Warehouse (CDW), which contains data from all VHA EHRs. The VA STORM, is a CDW tool that automatically flags patients prescribed opioids who are at risk for overdose and suicide. Prescriber data were obtained from the Buprenorphine/X-Waivered Provider Report, a VA Academic Detailing Service database that provides details on HCP type, X-waivered status, and prescribing by location. χ² analyses were conducted on before and after measures when total values were available.

RESULTS

There was a 4% increase in patients with an OUD diagnosis receiving MOUD, from 552 (44%) to 582 (48%) (P = .04), over this time. The number of waivered prescribers increased from 67 to 131, the number of prescribers of buprenorphine in a 6-month span increased from 35 to 52, and the percentage of HCPs capable of prescribing within the EHR increased from 75% to 89% (P =.01).

Initially, addiction HCPs prescribed to about 68% of patients on buprenorphine, with target clinic HCPs prescribing to 24% (with the remaining coming from other specialty HCPs). On follow-up, addiction professionals prescribed to 63%, with target clinic clincians prescribing to 32%.

Interpretation

SCOUTT team interventions succeeded in increasing the number of patients receiving MOUD, a substantial increase in waivered HCPs, an increase in the number of waivered HCPs prescribing MOUD, and an increase in the proportion of patients receiving MOUD in step-1 target clinics. It is important to note that within the quality-improvement framework and goals of our SCOUTT team that the data were not collected as part of a research study but to assess impact of our interventions. Within this framework, it is not possible to directly attribute the increase in eligible patients receiving MOUD solely to SCOUTT team interventions, as other factors may have contributed, including improved awareness of HCPs.

SUMMARY AND FUTURE DIRECTIONS

Since implementation of SCOUTT in August 2018, VACHS has identified several barriers to buprenorphine prescribing in step-1 clinics and implemented strategies to overcome them. Describing our approach will hope-fully inform other large health care systems (VA or non-VA) on changes required in order to scale up implementation of OBOT-B. The VACHS SCOUTT team was successful at enhancing a ready workforce in step-1 clinics, though noted a delay in changing prescribing practice and culture.

We recommend utilizing academic detailing to work with clinics and individual HCPs to identify and overcome barriers to prescribing. Also, we recommend implementation of a nursing or clinical pharmacy collaborative care model in target step-1 clinics (rather than the HCP-driven model). A collaborative care model reflects the patient aligned care team (PACT) principle of team-based efficient care, and PACT nurses or clinical pharmacists should be able to provide the minimal quarterly follow-up of clinically stable patients on MOUD within the step-1 clinics. Templated notes for assessment, initiation, and followup of patients on MOUD are now available from the SCOUTT national program and should be broadly implemented to facilitate adoption of the collaborative model in target clinics. In order to accomplish a full collaborative model, the VHA would need to enhance appropriate staffing to support this model, broaden access to telehealth, and expand incentives to teams/clinicians who prescribe in these settings.

eAppendix. Standard Operating Procedure for Treatment in Step-1 Clinics

Treatment of Opioid Use Disorder Using Buprenorphine: For Primary Care, Specialty, and Mental Health Clinicians in an Office-Based Setting, Excluding Specialty Addiction Care^a

1. SCOPE/EFFECT: The following service lines may be affected by this policy: Primary Care, General Mental Health, Specialty Care, Pharmacy Service Line, excluding Specialty Addiction care. This is a new policy.

2. PURPOSE

1. To facilitate treatment of opioid use disorder (OUD) by removing barriers to care in primary care, specialty care, and general mental health settings.

2. To establish clear guidelines about who can prescribe buprenorphine for OUD in an office-based setting.

3. POLICIES

1. Buprenorphine is a proven agent for the treatment of OUD with unique pharmacologic and safety profiles that encourage treatment compliance and reduce risk of overdose.

2. Consistent with US Department of Veterans Affairs (VA) Connecticut Healthcare System (VACHS) existing buprenorphine policy, only physicians, nurse practitioners, and physician assistants who have completed Drug Enforcement Agency/Substance Abuse Mental Health Services Administration (DEA/SAMHSA) training and hold DEA X-waivers on file with VACHS shall prescribe buprenorphine for OUD in any treatment setting.

4. PROCEDURES

Veterans who meet the following criteria may be treated with buprenorphine therapy in VAHCS by any X-waivered provider.

1. Diagnosis of opioid dependence or diagnosis of OUD as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th edition criteria, and by International Classification of Disease 10th revision coding, including maintenance treatment in patients who have initiated buprenorphine in Opioid Reassessment Clinic or other specialty clinics.

2. Willingness to comply with treatment plans and goals associated with buprenorphine treatment, including interval visits and urine drug testing. Psychosocial treatments are available for providers to refer patients to.

3. Patients who exhibit significant ongoing mental health/substance use issues despite monthly follow-up should have further consultation (either virtual or face to face) with specialty addiction care.

4. Patients who have pain in addition to opioid dependence or OUD are eligible to receive buprenorphine treatment for opioid dependence or OUD.

Providers prescribing treatment for OUD in an office-based setting should adhere to the following recommendations:

1. Providers should consider treatment of OUD in an office-based setting, per VA/Department of Defense guidelines, in the following scenarios:

   • ○ Office-based setting provides the needed resources for the patient

   • ○ Patient has adequate psychosocial supports

   • ○ There are few previous failed treatment attempts with opioid maintenance

   • ○ Access issues (mobility, geographic distance) or patient preference would make formal opioid treatment program (OTP) difficult or unattainable

   • ○ Patient is not receiving treatment with full agonist opioids

   • ○ Co-occurring psychiatric disorder(s) is/are stable

   • ○ Co-occurring substance use disorders (SUDs) that pose a significant safety risk are adequately treated

   • ○ There is no central nervous system depressant (alcohol, benzodiazepine) dependence

   • ○ There has been a previous good response to buprenorphine

   • ○ There is an expectation that the patient will be reasonably compliant

2. Providers should consider higher levels of care (OTP, intensive outpatient or residential) for patients who do not meet these criteria. If serious, unstable psychiatric comorbidity, and in the case of pregnancy, providers should intensify care, via the stepped-care model, including referral to specialty addiction care when clinically indicated. Pregnant patients may be treated with buprenorphine therapy in close consultation with a specialty addiction practitioner and Obstetrics/Gynecology services.

3. Providers are responsible to stay within the prescribing limit for their waiver. Qualified providers are initially limited to treating 30 patients concurrently under the original waiver; after 1 year, an application may be filed for approval to treat up to 100 patients at a time, per DEA guidelines. Practitioners are responsible to remain in compliance with this regulation by checking buprenorphine dashboard and/or primary care almanac/opioid therapy risk tool.

4. Appropriate coverage trees will be identified in Primary Care and Mental Health to ensure no interruption of care (in the case of leave/absence of prescribing provider). After-hours access may be obtained through the psychiatric emergency department (ED).

Treatment Course in Ambulatory Care (Office-Based Setting)

1. Initiation phase: Any X-waivered practitioner may initiate induction. Consultation with addiction specialty practitioners (either virtual or face to face) will be available for use when needed.

   1. Induction should be guided by evidence-based protocols. Practitioners are required to use the templated buprenorphine induction note, to ensure that prescribing follows federal and state requirements. This will include clear documentation of rationale for use, assessment for comorbid substance use disorders, naloxone education/distribution, prescription drug monitoring program (PDMP) check, baseline toxicology testing, pregnancy testing in females, baseline liver function testing, signed informed consent, and discussion of proper administration (including timing of buprenorphine induction to avoid precipitated withdrawal).

   2. Follow-up by a designated team member, ideally, should be within 3 days of home induction, and then weekly during the first month of treatment.

   3. Medication during induction phase will be issued by pick-up at pharmacy window only. All prescriptions during the initiation phase should be written for a maximum of a 7-day supply. Each prescription should be of sufficient quantity to last only until the next scheduled appointment with the prescriber.

2. Maintenance phase: Patients on stable dosages of buprenorphine and demonstrating regular adherence to medication dosages and treatment plans may continue to receive this medication from any X-waivered practitioner.

   1. Prescription fills should be on a 28-day cycle, and refills should be requested via telephone contact with a designated team member and documented via templated clinical follow up note. Ideally, face-to-face follow-up with designated team member should be on a at least quarterly basis and should include a PDMP check and urine toxicology, with quarterly follow-up considered only when patients can exhibit regular adherence to medication and treatment plan.

   2. Practitioners are required to use the buprenorphine maintenance note to ensure that federal and state requirements are met, including documentation of rationale for use, confirmation of signed informed consent, documentation of naloxone education/distribution, PDMP checks documented as per state regulation (at least every 90 days), and urine toxicology testing documented at least every 90 days (as per SUD 17 measures), with more frequent checks as clinically indicated, and urine pregnancy testing quarterly, and more often as clinically indicated. In addition, providers will assess for adherence, side effects, aberrancy, other SUDs, psychiatric comorbidity, relapse, and psychosocial stability, via use of templated note.

   3. Should the patient become unstable with respect to buprenorphine treatment, eg, through relapse to illicit pharmaceutical or street opioid use, use of other psychoactive substances (eg, alcohol, cannabis, stimulants, other illicit agents), poor attendance at scheduled appointments, failure to meet outlined treatment goals, or include a higher risk subgroup (example comorbid mental health disorders or pregnancy), practitioners are encouraged to escalate care, via the stepped-care model; options for care escalation include e-consultation with SUD specialty care, consultation with PCMHI clinicians, referral to the subspecialty SUD clinic, or to a higher level of care such as the psychiatric ED as appropriate.

   4. In the event of needed surgery, short term changes in buprenorphine treatment will be discussed and decided on a clinical case-by-case basis.

   5. Urgent access to clinical assessment can occur through the Detoxification and Addiction Stabilization Service (DASS, ext 5215, 7-East Building 1; Monday-Friday 7:30 AM-3:00 PM). The psychiatric ED may also be utilized for urgent or after-hours access.

3. Discontinuation of buprenorphine

   1. There is no recommended time limit for treatment with buprenorphine.

   2. When the decision is made to discontinue buprenorphine treatment, the daily dose should be decreased gradually over a predetermined period or at a rate decided upon by the patient and prescriber together.

   3. Buprenorphine tapering is generally accomplished over several months.

   4. Withdrawal symptoms may emerge as the buprenorphine dose is decreased. These symptoms can be managed with symptom-driven pharmacotherapy (eg, clonidine for anxiety and restlessness, ibuprofen for muscle aches, dicyclomine for abdominal cramping, etc). Patients should routinely be assessed for continued stability in maintaining a drug-free lifestyle.

   5. Reasons for escalation of care, via the stepped care model, to subspecialty addiction care, may include:

      • Diversion of buprenorphine;

      • Use of sedatives/other illicit substances that significantly increase risk of overdose or serious adverse event; and

      • Nonadherence to treatment plans and follow-up

   6. Termination should not be punitive, rather patients should be provided with additional services and higher level of care, including subspecialty addiction care referral via the stepped-care model

5. RESPONSIBILITY: Primary Care and Mental Health service line managers are responsible for ensuring staff compliance with this policy.

6. REFERENCES:

1. Fiellin DA, Pantalon MV, Chawarski MC, et al. Counseling plus buprenorphine-naloxone maintenance therapy for opioid dependence. N Engl J Med. 2006;355(4):365–374. doi:10.1056/NEJMoa055255

2. Fiellin DA, Schottenfeld RS, Cutter CJ, Moore BA, Barry DT, O’Connor PG. Primary care-based buprenorphine taper vs maintenance therapy for prescription opioid dependence: a randomized clinical trial. JAMA Intern Med. 2014;174(12):1947–1954. doi:10.1001/jamainternmed.2014.5302

3. Haddad MS, Zelenev A, Altice FL. Buprenorphine maintenance treatment retention improves nationally recommended preventive primary care screenings when integrated into urban federally qualified health centers. J Urban Health. 2015;92(1):193–213. doi:10.1007/s11524-014-9924-1

4. Substance Abuse and Mental Health Services Administration. Medications for Opioid Use Disorder. Rockville, MD: Substance Abuse and Mental Health Services Administration, 2018.

DEA Requirements https://www.deadiversion.usdoj.gov/faq/buprenorphine_faq.htm

7. RESCISSION: New

8. REVIEW DATE: 1/17/2019