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Opioid addiction is a chronic disease treatable in primary care settings with buprenorphine, but this treatment remains underutilized. We describe a collaborative care model for managing opioid addiction with buprenorphine.
This is a cohort study of patients treated for opioid addiction utilizing collaborative care between nurse care managers and generalist physicians in an urban academic primary care practice over 5 years. We examine patient characteristics, 12-month treatment success (i.e., retention or taper after 6 months), and predictors of successful outcomes.
From 2003 to 2008, 408 patients with opioid addiction were treated with buprenorphine. Twenty-six patients were excluded from analysis as they left treatment due to preexisting legal or medical conditions or a need for transfer to another buprenorphine program. At 12 months 51% of patients (196/382) underwent successful treatment. Of patients remaining in treatment at 3-, 6-, 9- and 12 months, 93% were no longer using illicit opioids or cocaine based on urine drug tests. On admission, patients who were older, employed, and used illicit buprenorphine had significantly higher odds of treatment success; those of African American or Hispanic race had significantly lower odds of treatment success. These outcomes were achieved with a model that facilitated physician involvement.
Collaborative care with nurse care managers in an urban primary care practice is an alternative and successful method of service delivery for the majority of patients with opioid addiction while effectively utilizing the time of physicians prescribing buprenorphine.
Opioid addiction is a chronic, relapsing brain disease that affects millions of Americans and produces tremendous burden on the healthcare system.1, 2 Recent epidemiological studies have revealed alarming increases in opioid addiction and overdoses, particularly with regard to prescription opioids.3 Less than 25% of individuals addicted to opioids receive addiction treatment.3 For over 45 years, research has confirmed that opioid agonist therapy (i.e., methadone) is a highly effective treatment for opioid addiction provided outside of primary care.4–6 In 2002, U.S. physicians gained the opportunity to treat opioid-addicted patients with buprenorphine in primary care settings, commonly referred to as office-based opioid treatment (OBOT).7 OBOT has been shown to be effective in primary care settings,8–15 however remains underutilized in traditional care models.16 One consistently cited barrier preventing OBOT expansion is lack of adequate clinical support given the additional needs for patient monitoring.16–18 While collaborative care improves management of other chronic diseases (e.g. hypertension19, diabetes20) experience with this model for the treatment of opioid addiction in primary care has not been described.21
In September 2003, an OBOT program utilizing a collaborative care model began at Boston Medical Center (BMC) – an urban, academic medical setting. This model accommodated both the large public demand for OBOT and faculty physicians with part-time clinical practices. We describe BMC’s OBOT program and report on patient and program outcomes.
The collaborative care office-based opioid treatment (OBOT) program included a full-time nurse program director, nurse care managers (NCMs), a program coordinator and generalist physicians with part-time clinical practices.
The nurse program director (0.40 full time equivalent (FTE)) supervised the NCMs and program coordinator, and integrated care with OBOT physicians. The program coordinator (1 FTE), a former medical assistant, was trained to collect standardized intake information on individuals requesting OBOT. The NCMs, registered nurses who completed a one day buprenorphine training, performed patient care roles, followed treatment protocols and maintained a standard of clinical practice that satisfied federal regulations for buprenorphine treatment. Their clinical responsibilities included assessing for appropriateness for OBOT, educating patients, obtaining informed consent, developing treatment plans, overseeing medication management, referring to other addiction treatment, monitoring for treatment adherence and communicating with prescribing physicians, addiction counselors, and pharmacists. Collaboration with pharmacists reduced the OBOT physician burden by allowing buprenorphine prescriptions with multiple refills while allowing for cancelation of the refills if the patient was non-adherent. The OBOT program currently includes NCMs (2.2 FTE) for 22 clinical half day sessions per week. The OBOT physicians, all generalists with part-time clinical practices, reviewed and supplemented the NCM assessments including laboratory results, performed physical examinations, prescribed buprenorphine and followed patients at least every 6 months or more frequently if needed. The OBOT program includes 9 generalist physicians, all waivered to prescribed buprenorphine by completing the required 8 hours of buprenorphine training, three are certified by the American Board of Addiction Medicine. The physicians had an average of three primary care half day sessions each week, ranging from one to six.
The treatment model included 3 stages: 1) NCM and physician assessment (appropriateness for OBOT and intake evaluations); 2) NCM supervised induction and stabilization (buprenorphine dose adjustments during days 1–7); and 3) maintenance (buprenorphine treatment with monitoring for illicit drug use and weekly counseling) or discharge (voluntary or involuntary).
The program coordinator conducted a scripted screen, by phone or in person, documenting substance use, addiction treatment history, medical and psychiatric history, medications, addiction treatment goals, and availability of social support. The nurse program director reviewed the screen and triaged the patient to either NCM and physician intake appointments or to other treatment options. Patients were triaged to other treatment options (e.g., detoxification program) if they had active co-occurring substance use disorders. The NCM intake included documenting opioid dependence diagnosis based on a checklist of the DSM IV22 criteria, assessing ability to adhere with treatment plan, mental health stability, polysubstance use, absence of painful conditions requiring chronic opioid analgesics, and absence of medical contraindications (e.g., pregnancy). All patients transferring from methadone maintenance were required to taper their methadone to 30 mg per day.23 Individuals were excluded if they were unwilling to stop all illicit drug use or were not interested in buprenorphine maintenance lasting at least 6 months. Patients were educated about the scientific basis of buprenorphine maintenance. All patients signed an informed consent and treatment agreement which included a weekly counseling requirement with a release for communication. Initial laboratory tests included: viral hepatitis and syphilis serologies, liver function tests, pregnancy tests and a urine drug test for opiates, cocaine, benzodiazepines, barbiturates and amphetamines. Because many of these patients were new to primary health care, lab tests for a broader primary care evaluation were also ordered including a complete blood count, and electrolytes. Starting in February 2007 all patients were also tested for oxycodone, methadone and buprenorphine. Patients were required to test negative for all non-prescribed substances other than opioids before starting buprenorphine.
The OBOT physician intake included reviewing and supplementing the NCM assessment and treatment plan, performing a physical examination and evaluating any medical issues (e.g., need for hepatitis vaccinations). Patients with active psychiatric diagnoses were co-managed with a psychiatrist, with releases to facilitate communication.
The physician prescribed buprenorphine following an induction protocol based on federal guidelines.23 Induction and stabilization occurred during the first 7 days. Induction occurred on-site (i.e., in the office) with direct observation by the NCM for signs of opioid withdrawal prior to the first dose of buprenorphine and signs of precipitated withdrawal after the first dose. Physicians were not present during buprenorphine induction but were available by pager for consultation. Dose adjustments were made based on OBOT program protocols. The combination tablet buprenorphine/naloxone was used for all inductions. During dose stabilization (days 2–7), dosing occurred off-site (i.e., at home) with patients having at least daily phone contact with the NCM to assess for withdrawal and side effects. Phone support continued until a stable maintenance dose was achieved, usually 8–16 mg. All patients were re-assessed in-person by the NCM on day 8 or sooner if needed.
Ongoing monitoring occurred at follow-up appointments at least weekly for the first 4–6 weeks followed by visits every 2–4 weeks if adherent (i.e., 4 consecutive urine drug tests with results negative for illicit drugs and positive for buprenorphine and attending at least 3 of 4 counseling sessions per month). Patients who maintained sobriety and treatment adherence for 3 months had their NCM visit frequency decreased to monthly followed by every 3 months. Patients seen less than monthly had up to 6 random “call-backs” per year for unscheduled urine drug testing and pill counts. Patients were always subject to requests to return to the clinic within 72 hours for urine drug tests, observed dosing, pill counts or treatment plan revisions. Urine drug tests occurred at every NCM visit and OBOT physician visits, at least every 6 months. All patients with abnormal urine drug tests were called in the following week to meet with the NCM. If a patient continued to use illicit drugs (e.g., opiates, cocaine, benzodiazepines) or remained non-adherent with scheduled appointments or monitoring requests (i.e., urine drug tests, pill counts), the NCM intensified treatment including: increased visits to 2 or more times per week for pill counts, observed urine drug tests and adjusted buprenorphine dose, reengagement of social supports, and intensified counseling.
NCMs and physicians encouraged patients to attend self help groups along with mandatory weekly addiction counseling. The majority of addiction counseling (individual and group) was offered by outside addiction services with confidentiality releases. For an 18 month period a minority of patients were seen by an “in-house” counselor. The NCM reminded patients of upcoming appointments with addiction counselors and OBOT physicians.
Patients were referred to methadone maintenance treatment if they continued to use illicit opiates as determined by 3 consecutive opiate positive urine drug tests despite increased buprenorphine dose or if they needed more structured care (e.g., daily observed dosing due to concerns about medication misuse) than could be offered in an office-based practice. Patients were involuntarily discharged if they declined transfer to methadone maintenance after continued illicit opiate use or repeated non-adherence with more than 3 OBOT appointments or monitoring requests (i.e., supplying urine sample for drug testing, bringing in remaining pills for pill counts). Patients were also discharged if they engaged in disruptive behavior. Patients could request a buprenorphine taper at any time but were encouraged to wait until they had achieved at least 6 months of abstinence and treatment adherence.
Patient characteristics documented included age, gender, race, employment, history of psychiatric illness, HIV and hepatitis status, opioid of choice, years of opioid use, history of overdose, other substance use (tobacco, alcohol, cocaine, benzodiazepines), previous addiction treatment including history of opioid agonist therapy (i.e., methadone or buprenorphine) and current use of illicit buprenorphine.
A retrospective clinical chart review was conducted for all patients admitted to the Boston Medical Center (BMC) OBOT program from September 2003 to September 2008 with 12-month outcome data continued through September 2009. All data was originally collected by OBOT clinical staff for purposes of clinical care.
Treatment status (i.e., successful, unsuccessful, methadone maintenance transfer) was determined for all patients at 12 months or at program departure, whichever came first. Successful treatment was defined as treatment retention or buprenorphine taper after treatment adherence and absence of illicit drug use for at least 6 months. Treatment retention required patients to demonstrate a consistent pattern of adherence including: physician, nursing and counseling appointments; monitoring requests (i.e., urine drug tests, pill counts), no buprenophine diversion (i.e., accurate pill counts, buprenorphine positive drug tests) and willingness to engage in intensified treatment (e.g., increased frequency of NCM visits) when illicit drug use occurred. Unsuccessful treatment included: loss to follow-up; involuntary discharge due to continued illicit drug use, treatment non-adherence or disruptive behavior; or voluntary discharge due to buprenorphine side effects. Treatment was considered neither successful nor unsuccessful if patients voluntarily transferred to methadone maintenance treatment for more structured care (e.g., observed daily dosing) or for full opioid agonist therapy due to opioid craving on maximum doses of buprenorphine. Records were reviewed for the specific date of and reason for discharge from the program.
Patients who left the program due to preexisting legal or medical conditions or transferred to another OBOT program due to relocation or consolidating their care (e.g., psychiatrist to treat both mental illness and opioid addiction) were not included in analyses as treatment discharge was not related to the buprenorphine treatment program.
Both scheduled and random “call-back” urine drug tests were conducted at least every 3 months. In each study assessment window (i.e., 3, 6, 9, and 12 months), the test that was closest, yet prior, to the time point was examined. For those patients who missed appointments within the 3-month interval, no urine sample was obtained; consequently, the number of urine samples available at each testing interval was less than the number of patients enrolled in that interval. Patients who were unable to be contacted were still considered enrolled in the program until their 30 day prescriptions ran out. Urine drug tests were mostly unsupervised but measures were taken to try to minimize falsified tests (e.g., testing urine temperature). Urine collections were supervised for patients with a recent abnormal urine test including a cold or diluted specimen and for patients with aberrant behaviors (e.g., missed appointments).
The average workload for the program coordinator was determined by tracking inquiries for OBOT treatment. Case load for NCMs and OBOT physicians was determined by provider schedules.
Descriptive statistics (e.g., means and proportions) were used to characterize the sample. Exploratory, hypothesis-generating tests were then performed to compare characteristics between patients with successful and unsuccessful treatments at 12 months. Chi-square or Fisher’s exact tests (for dichotomous variables) and t-tests or Wilcoxon rank sum tests (for continuous variables) were used to assess factors associated with treatment success at 12 months. Characteristics that were significantly associated in bivariate analyses, along with other characteristics deemed clinically important, were entered into a multivariable logistic regression model, with treatment success as the dependent variable. Reported P-values are two-tailed, and a P-value of less than 0.05 was considered statistically significant. All analyses were run using SAS/STAT software.24 This research was approved by the Institutional Review Board at Boston University Medical Center.
In 60 months, 408 patients with opioid dependence were admitted to the office-based opioid treatment (OBOT) program. Twenty-six patients were excluded from exploratory analysis because they left treatment due to preexisting legal issues leading to incarceration  and medical conditions unrelated to their buprenorphine treatment (chronic pain , advanced stage AIDS ), or transferred to another OBOT program due to relocation or consolidating their care , leaving 382 patients. This group, described in Table 1, was predominantly male (66%) and white (66%). The mean age was 39 years; 35% were employed at admission. Co-morbidities were common; 66% reported psychiatric illness and 50% tested positive for hepatitis C antibody. On admission, patients were using the following: 60% heroin (with or without prescription opioids); 17% prescription opioids exclusively; 13% methadone from a maintenance program; and 9% buprenorphine from another OBOT program. Past year use of tobacco [80%] and cocaine [43%] was common. Eighty-five percent reported a history of inpatient detoxification, 58% past opioid agonist maintenance treatment, 10% current use of illicit buprenorphine; 46% reported a history of opioid overdose.
Patient outcomes are described in Table 2. At 12 months, 51% (196/382) were successful (49% remained in treatment and 2% were tapered after 6 months of adherence and absence of illicit drug use) and 42% (162/382) were unsuccessful (29% lost to follow-up and 13% discharged). A minority (6%) of patients were considered neither successful nor unsuccessful as they voluntarily transferred to methadone maintenance treatment for more structured care or for full opioid agonist therapy.
Patients who achieved successful outcomes were compared to those who were unsuccessful to determine factors associated with treatment success. In bivariate analyses, treatment success at 12 months was significantly associated with the following characteristics on admission: female gender, White race, being employed, self-maintaining with illicit buprenorphine, prescription opioid abuse or methadone maintenance, and no self report of past year cocaine use.
These characteristics, along with factors that were considered clinically important to successful treatment (i.e., age, past methadone maintenance treatment, self-reported psychiatric illness, and history of opioid overdose) were entered into a multivariable logistic regression model (Table 3). The patients who were transferred to methadone maintenance treatment were excluded from the analysis of treatment success as they could be arguably perceived as successful or not, leaving 358 patients. On admission, patients who were older, employed, and who self-maintained with illicit buprenorphine had significantly higher odds of treatment success while those of African American or Hispanic race had significantly lower odds of treatment success.
At 3-, 6-, 9- and 12-month intervals, at least 93% of patients remaining in treatment had negative urine drug tests for illicit opioids and cocaine (Table 4).
On average, the program coordinator received 20 calls per week requesting OBOT. A nurse care manager saw 75 patients per week and each OBOT physician prescribed to an average of 35 patients (range 13 – 68) per month.
This large observational study of office-based opioid treatment (OBOT) with buprenorphine in an academic medicine practice serves as a model of service delivery for facilitating access and improving outcomes in patients with opioid addiction. Collaborative care with nurse care managers resulted in feasible initiation and maintenance of buprenorphine for the majority (51%) of patients admitted which is comparable to previous studies in primary care settings involving smaller numbers of patients with 6–12 month follow-up.9–15
The collaborative care model ensured program compliance with federal laws25 (e.g., limits to the number of patients treated per OBOT physician) while maintaining access to a large number of patients. OBOT is ideal for collaborative care as much of the clinical work (e.g., assessment, medication management, monitoring) is based on established protocols.23 Having relevant clinical data (e.g., nursing assessments, documentation of treatment adherence, urine drug test results) prior to physician visits allowed efficient use of physician time to focus on patient management (e.g. dose adjustments, continued maintenance versus taper). In this particular setting, collaborative care allowed academic generalist physicians with research, administrative and part-time clinical responsibilities to treat a large number of patients, many of whom had complex psychosocial needs. As described, the nurse care manager (NCM) was central to day-today clinical care with daily open access to address the myriad needs (e.g., housing, employment, insurance) of this complicated population. This model satisfied a key principle of coordinated care by “assuring accessibility, continuity and high quality care that included effective communication with, education of, and outreach to patients.”26
Other important factors may have impacted the outcomes of this intervention. Open communication between the NCM and addiction counselors improved the patients’ ability to comply with this essential element of good addiction care. Access to methadone maintenance allowed the program to safely transfer patients who required a more structured treatment modality.
We identified several preadmission factors associated with treatment success some of which were consistent with previous studies and some not. Similar to previous reports patients who were older12 and employed11, 15 were more successful. The finding that self-maintaining on illicit buprenorphine on admission predicted success has not been previously published. These patients reported “self-treating” their opioid addiction with illicit buprenorphine rather than trying to get high. This suggests that these patients were highly motivated to obtain a dependable and insurance covered source of buprenorphine and to avoid relying on the illicit market. This finding is similar to other studies27, 28 that found patients who “self treated” with illicit methadone were more likely to have positive treatment outcomes. We did not find that cocaine use and psychiatric illness were associated with worse outcomes. This suggests that patients with these co-occurring issues should not be excluded from consideration for office-based treatment. We found that African American or Hispanic race lowered the odds of treatment success in our program. This finding requires confirmation and further study to better understand how ethnicity/race and clinic structure may impact success in office-based treatment.
Several limitations of this study should be considered. While data was collected prospectively using a medical record designed for OBOT patients, the study was retrospective examining patients from a clinical program. In addition, follow-up information was not available after patient departure from the program. However, of patients who left the program earlier than 12 months, the reasons for leaving (i.e., successful or unsuccessful treatment or methadone maintenance treatment transfer) were known. Urine drug test protocols also changed over time; testing for semi-synthetic and synthetic opioids was not standardized until 2007, so early urine results may underestimate prescription opioid abuse. However, once prescription opioid testing began, the rates of urines positive for illicit opioids did not change. This study did not have a control group but this was acceptable as its purpose was not to retest the efficacy of buprenorphine treatment but rather to evaluate the feasibility of delivering this known effective treatment using a collaborative care model. Lastly an experienced, skilled nurse care manager played an essential role in caring for patients and the ability to generalize such a model may depend on skills of such key individuals. However, the issue simply speaks to the need for the training of a nursing work force with skills in caring for patients with addiction problems. In an effort to increase nursing involvement in buprenorphine treatment, a federally supported “Guide for Nurses” has recently been developed.29
In conclusion, office-based opioid treatment (OBOT) can be effectively offered in a primary care practice utilizing a collaborative care model. In this model, heavily reliant on nurse-care managers, patient-level outcomes were comparable to other physician-centered approaches. This study of collaborative care adds to the growing body of evidence that office-based treatment of opioid addiction is feasible in primary care settings.
Preliminary results of this study were presented at the 27th annual meeting of the Society of General Internal Medicine in Chicago, Illinois in May 2004 and at the 28th annual meeting of the Association for Medical Education and Research in Substance Abuse in Washington DC in November 2004. Support for these programs and their evaluation was provided by the Massachusetts Department of Public Health: Bureau of Substance Abuse Services and HIV/AIDS Bureau. Dr. Samet receives support from NIAAA: K24-AA015674. The lead author, Daniel Alford, had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Conflict of Interest
No conflicts of interests have been identified for any of the authors.