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A national study of a telephone support service for patients receiving office-based buprenorphine medication-assisted treatment: Study feasibility and sample description
Opioid-dependent (OD) patients seeking treatment have multiple treatment options including abstinence-based and medication replacement therapies. A recent and growing addition to medication replacement therapy is buprenorphine medication-assisted treatment (B-MAT), which may be provided by certified physicians practicing in private offices. Research on OD treatment is often performed on samples of patients recruited from specialty treatment facilities, which may not generalize to B-MAT patients. Thus, B-MAT as a treatment approach has been understudied. The present research describes (a) new methods developed to facilitate sample recruitment and survey data collection from a national B-MAT patient sample and (b) a telephonic support program designed for new B-MAT patients. Results indicate that by using appropriate tools, it is feasible to conduct a clinical study of B-MAT patients, recruited at the point of service, and that telephonic patient support was an acceptable treatment adjunct.
The Drug Addiction Treatment Act of 2000 (DATA 2000) allows physicians with specific qualifications to prescribe and dispense a limited array of narcotics for the treatment of opioid dependence (OD) within private practice office settings. In response, more than 15,000 practitioners have become certified to provide buprenorphine medication-assisted treatment (B-MAT) in their offices. By contrast, most substance abuse treatment (SAT) research has been conducted within or through affiliations with publicly funded programs (e.g., Department of Veterans Affairs health care system and specialty SAT programs;
). Consistent with DATA 2000, SAT is increasingly becoming a recognized part of and integrated into behavioral and general health care. SAT is being routinely offered within venues that traditionally have not treated addiction, such as family practice, internal medicine, and psychiatric offices (
). Medications such as Suboxone and Subutex (buprenorphine) and their associated treatment models are becoming more widely available through these nontraditional and disparate service venues. In response, the number of patients treated for addiction, and more specifically for OD, in these office-based settings has increased in recent years (
It is unclear how this population of OD patients being treated in nontraditional settings differs, and in what ways, compared with patients who were treated in more traditional specialty care settings. Further, it is unclear whether results from existing studies are generalizable to the population of patients treated in office-based settings, revealing a possible knowledge gap for addiction treatment providers and researchers.
This gap in knowledge presents an opportunity to examine and document clinical process and treatment outcomes associated with the office-based approach to opioid replacement therapy to better understand patient characteristics (e.g., demographics, biopsychosocial functioning, and treatment history), treatment response, service demands, and provider practice patterns (
). However, access to and identification of these patients for enrollment in SAT studies are challenges for the field and will likely require innovative approaches for participant recruitment, enrollment, data collection, and study retention. This article describes and examines the effectiveness of methods for conducting a follow-up random controlled trial focused on OD patients being treated in office-based settings.
1.1 Treatment options for OD patients
Traditionally, treatment for OD has included either abstinence-based or medication-assisted treatment (MAT) using either agonist or antagonist medications (
). Agonist MAT involves pharmacological substitution of the opioid of abuse with controlled dosing of a long-acting opioid, which reduces cravings and the likelihood of relapse (
). Thus, it has long been a goal of providers and third-party payors to develop interventions that facilitate adherence and retention in treatment, particularly for chronic diseases (
found that this general finding applied to OD patients receiving methadone-medication assisted treatment (M-MAT). who demonstrated improved treatment retention and outcomes when exposed to enhanced counseling services compared to standard or minimum monitoring and care.
1.2 Telephonic treatment adjuncts
Recently, several studies have demonstrated the effectiveness of telephonic monitoring on improving clinical outcomes among substance abuse patients (
used telephone monitoring and guidance as part of a continuing care intervention following intensive outpatient treatment for cocaine and/or alcohol dependence. The telephonic intervention was generally as effective as in-person treatments. Telephonic monitoring and messaging to support recovery from chemical dependence following hospital discharge (
examined the utility of monitoring to reengage relapsed clients with formal treatment. Clients receiving quarterly Recovery Management Checkups experienced better outcomes compared to those who received only placebo interviews. Although these specific initiatives indicate that the SAT field has begun to use remote monitoring and messaging in creative and productive ways, such approaches are not widely or routinely used. More specifically, they have not been evaluated in populations within MAT for OD.
1.3 Current study challenges and objectives
The target population for this study was OD patients who are new to B-MAT, sampled from the general patient population in the United States. In addition to the usual challenges inherent in recruiting chronically ill patients entering a new episode of treatment, it was expected that this population might be resistant to study participation because of patient stigma and denial, as well as the physical, cognitive, and emotional burden of opioid withdrawal. There are few documented methods or techniques for recruiting large numbers of OD patients from office-based treatment settings, particularly in suburban and rural areas. The present trial required a large, nationwide participant sample (n > 2,000) to be enrolled in a short period (<4 months). Concern about achieving these goals using existing health care research techniques (e.g., face-to-face recruitment and interviews, small number of study sites) motivated the research team to borrow from other disciplines and develop new tools and techniques when necessary.
To guide development of the methods necessary to successfully conduct this study, three principles were established to address major implementation barriers while not compromising scientific integrity. First, because B-MAT is less regulated and is provided in a large number of office settings allowing providers more latitude in treatment approaches, the amount of variability in B-MAT practice patterns and physician skill level is unclear. Therefore, patients were to be randomized within physician, and numerous and geographically diverse practices would be used as patient recruitment sites. Second, to reduce time and cost of the trial, all enrollments were to be completed at a central location, the Principal Investigator's offices, making it the only study site for institutional review board (IRB) oversight. Third, all data were to be collected remotely but managed centrally. Participant study enrollment and informed consent would be performed using Internet tools, and all survey data would be captured telephonically. Use of the Internet within health care research raises information security concerns. Technology, including secure links, SSL, and other software solutions, were determined to adequately resolve such issues (
This article describes a large, national study examining the impact of a telephonic support program designed for B-MAT patients. First, the procedures are described with a focus on new methodologies, which address specific barriers to researching this population. Second, an intervention, called HereToHelp (HTH), is described, as it may be the first telephonically based patient support program designed specifically for B-MAT patients. Finally, the study sample, because it was drawn from a largely understudied population, is described using baseline clinical indicators and demographic characteristics.
2. Methods
2.1 Activation of study participant recruitment sites
Recruitment of a national sample of new B-MAT patients required collaboration with multiple certified physicians from as many offices and locations as possible. At project startup, the Substance Abuse and Mental Health Services Administration (SAMHSA) listed 15,540 physicians who were certified under DATA 2000 to prescribe buprenorphine for the treatment of OD. To increase the yield of patients per physician, those who treated fewer than five B-MAT patients per month were not recruited as study sites. Physicians were initially sent (via e-mail and regular mail) a recruitment flyer that described the study goals and physician and patient participation requirements. All targeted physicians were contacted and evaluated on specific criteria, including (a) active certification (buprenorphine waiver); (b) willingness to invite patients into the study; (c) case load of at least five B-MAT patients per month; (d) willingness to sign a contract with the contract research organization; and (e) ability to complete a brief site training session.
Interested physicians were asked to contact the Principal Investigator's offices with questions or to receive an information kit. Physicians who agreed to participate in the study were sent a contract. Once contracted, physicians were sent a binder that contained all materials necessary for the site training and were prompted to choose either group or independent training. Those who chose group training were then scheduled for one of several available training sessions. During the group training sessions, the facilitator gave an overview of the materials in the site binder, which included the following five sections:
1.
Purpose of the study along with the hypotheses, design, and outcomes measures
2.
Eligibility criteria and compensation plans for both patients and physicians
3.
PowerPoint training session materials:
i.
Introduction to the contract research organization and sponsor,
ii.
Study purpose,
iii.
HTH intervention program description,
iv.
Study design and patient inclusion/exclusion criteria,
v.
Informed consent procedures (Web and paper based), and
vi.
The physician self-test.
4.
Suboxone/Subutex product insert sheet
5.
A copy of their contract.
The facilitator discussed each section of the binder, with emphasis on the PowerPoint slides. Patient understanding of the study was of prime importance, as enrollment could be completed by patients independently (i.e., while not in the physician's presence) at their home computer. The session ended with a question-and-answer period.
Physicians who chose to complete the independent training session were given directions for reviewing the binder, including the PowerPoint slides, and documents that reinforce key points discussed during the group training. Prior to initiating recruitment, all physicians who elected to complete the independent training were required to complete a five-item self-test that assessed study protocol knowledge. Completed self-tests were faxed to the study coordinator. The physician was contacted, briefed on any incorrectly answered questions, and retested. To participate in the study, sites were required to answer all questions correctly before initiating recruitment. A study coordinator telephoned each physician who correctly answered the entire quiz to offer further guidance. Finally, Frequently Asked Questions (FAQ) document was created from the initial training sessions and sent to all participating sites.
Physician remuneration for site activation was $400 for time spent reviewing study materials, attending the training, and reviewing and signing the contract. Remuneration for each successfully enrolled patient participant was $100. Both physician and patient remunerations for this study were well within industry standards for reimbursement (
). To decrease study setup time, physicians were not asked to collect or store any data or records for the study. Thus, IRB review, approval, and oversight of each site were not required. In general, the physician's role was to provide information and to give appropriate candidates the opportunity to enroll in the study. During the site training and follow-up calls, study coordinators instructed providers to ensure that patients understood the study and their role in it. A few physicians (n = 4) requested and received laptop computers for use in their office for patients who wanted to enroll using the Web-based system but had no computer or Web access of their own.
2.2 Participant recruitment and enrollment
Patients were eligible for inclusion if they (a) started B-MAT within a 14-day window around the date of enrollment (3 days prior and 10 days after); (b) were naive to B-MAT for at least 6 months; (c) had never been in a B-MAT compliance program; (d) had no signs of organic brain disorder; and (e) were not pregnant. Participants were enrolled during a 4-month period and were contacted by interviewers at scheduled intervals during the 12-month follow-up period. Essex IRB approved the study.
Physicians were given study fliers to inform potentially eligible patients of the study. Each patient who preliminarily agreed to enroll received a Study Participant Recruitment Packet from the physician. It included a brief description of the study, the participant remuneration schedule, and the Web address for the Participant Enrollment Recruitment and Randomization System. The enrollment system allowed candidates to get information and enroll in the study at any time and at their own pace.
The enrollment system was designed to parallel a paper informed consent form and presented information on multiple Web pages so patients were not continually scrolling down one, long page. The enrollment system was pilot-tested on research team staff members and several independent contractors. Once finalized, the enrollment system provided a series of screens spawned within commonly used Web browsers using a secure Internet link. Patients navigated between pages and fields using orthodox Internet tools (i.e., browsers, mouse, arrow buttons, and standard computer keyboards) and entered information into well-identified fields.
The first screen of the enrollment system included a welcome message to confirm that the participant had arrived at the correct Web site. It also presented a participant identification (ID) response field. ID numbers were provided by the treating physician and were contained in each candidate's Study Participant Recruitment Packet. Once an activated ID number was entered into the ID response field, the system verified the validity of the number, created a new record in the enrollment database, and continued to the next set of screens—informed consent. The last informed consent screen presented fields for the candidate to provide or deny consent to participate in the study. Those who denied consent were thanked and advised that their involvement was complete and their ID was deactivated. For those who consented, the informed consent question was repeated in a newly spawned window. Responses to the two consent questions were considered valid “e-click-signatures” for obtaining informed consent. The e-click-signature, accepted in other industries (e.g., finance), received IRB approval to establish informed consent for this study. After providing consent, the next screens presented fields that prompted each participant to provide contact information. Finally, before ending the session, the enrollment system prompted participants to schedule a 1-hour appointment during the next business day to complete a baseline survey. The survey scheduling screen presented an array of available 1-hour interview times during the following business day with instructions to choose one using a radio button. Choosing their preferred baseline survey appointment time concluded the enrollment and consent process. The enrollment system then presented a thank you screen and terminated the session. All responses were time and date stamped and stored in the enrollment database.
Once informed consent was obtained, the system automatically randomized each new participant. Given that differences in physician skill and experience in treating OD could affect outcomes (
), the system was designed to perform block design randomization within physician. For each physician, a block of 10 random numbers was generated and assigned to participants in chronological order of their enrollment. Participants within each provider-specific block were randomly assigned to either the experimental or control condition. Seven out of every block of 10 random numbers were assigned to the intervention group, leaving 30% for standard care.
Although most interested patients accessed the Web-based enrollment system on their own, some physicians preferred to enroll their patients using traditional written informed consent. The paper-based informed consent form was often completed in the doctor's office and faxed, using encryption software, to the Principal Investigator's offices where the participant's information was entered into the enrollment system.
Is the Addiction Severity Index a reliable and valid assessment instrument among clients with severe and persistent mental illness and substance abuse disorders?.
) was the core baseline and follow-up survey. The ASI assesses problem severity in seven functional areas commonly affected by drug and alcohol abuse: medical, psychiatric, family/social, employment, alcohol, drug, and legal. In addition to the ASI, the follow-up surveys included the Treatment Services Review to assess utilization of health care, social, legal, and other public and private services. Both instruments are widely used in addictions research and have been validated in a number of studies in various populations (
). The ASI was modified by eliminating items that are less relevant and adding questions that assessed adherence to B-MAT and readiness to change chemical dependence-related behaviors. The remaining item set contained all questions necessary to derive ASI subscale scores including the composite scores (summary scores that range from 0 to 1, with higher scores indicating greater problem severity). These composite scores reflect patient functioning over the previous 28 days. The baseline and follow-up surveys were scripted into a telephonic survey and automated in a Computer Assisted Telephone Interview (CATI) system. On average, the baseline took 45–55 minutes to complete, whereas the follow-up surveys took 30–45 minutes to complete.
Survey measures were collected at baseline and at 1, 2, 3, and 6 months postbaseline. The 6-month follow-up survey was the end point for the study. The 3-month survey was the half-way point to provide insight into early treatment outcomes process. Months 1 and 2 surveys were used to measure factors that affect early treatment adherence to medication and for sample maintenance purposes. The length that a patient stays on MAT varies widely due to many factors, including individual patient needs. Length of treatment is contingent upon the specific goals that are agreed upon by both the patient and the physician. Therefore, MAT can be either a short-term (e.g., <12 months) or a lifetime process (
). After the first draft of this article, a 12-month measurement point was added to the study but is not described here.
2.4 Participant contact and interview procedures
Participants received $25 for enrolling, $25 for each of the first three surveys, $50 for each of the last two surveys, and a $25 bonus for completing all five surveys. Those who consented to participate were contacted at the agreed-upon time by a trained interviewer who completed the baseline survey telephonically. Participants who did not complete the baseline survey at the appointment time were placed in a salvage queue and called two more times that day. If the participant was still not available, he or she was queued for interview calls starting the next business day. Salvage participants were called three times per day for up to 10 days. After the first day of baseline calls, participants were prioritized in the salvage queue based on the first known date of service or the first fill date for their Suboxone or Subutex prescription. Once contacted, the interviewer initiated and completed the baseline survey and recorded answers to each question in the CATI system. Participants randomized to the intervention group were given the option of declining to participate in the intervention. At the end of the baseline survey, all participants were asked to confirm the address where the remuneration was to be sent and to schedule the second survey approximately 1 month later.
Follow-up surveys used a similar CATI system and contact pattern as the baseline with one exception. The participant was called 3 days prior to the scheduled follow-up appointment and left a reminder message. The reminder included the telephone number where the interviewer could be reached so that the participant could call to complete the follow-up survey. If the participant answered the reminder call, he or she was offered the opportunity to complete the survey at that time. Otherwise, the follow-up interview call was placed at the scheduled appointment time. If the participant was not available to complete the survey at the scheduled time, two more attempts were made that day. If the survey was not completed during the target day, then the salvage procedure was implemented and the participant was called three times per day for the next 10 days. Cases that did not complete a follow-up survey during the 14-day follow-up measurement window were deemed “lost to follow-up,” were assigned missing data for that point, and were automatically scheduled for the next follow-up measurement point. At the end of each follow-up survey (except the 6-month survey), the participant was asked to choose a preferred time on or within 3 days of the target day to complete the next follow-up survey.
2.5 Intervention
The study intervention was a confidential, outbound, telephonic support program called HTH, which was administered by the manufacturer of Suboxone and Subutex (Reckitt Benckiser Pharmaceuticals Inc., Richmond, VA). The HTH intervention was designed to provide new patients encouragement and help them resolve problems inherent to early B-MAT. Each participant assigned to HTH was contacted by a “care coach.” Care coaches contacted participants two to three times per month during the first 3 months of treatment for a total of eight calls.
Coaching calls provided support in three key areas: education about OD and treatment; assistance resolving challenges within treatment; and encouragement to stay in treatment. Care coaches did not provide counseling, nor did they interface with the treatment providers. Care coaches had standard protocols for handling emergency situations and for helping people access community resources, including the National Alliance of Advocates for Buprenorphine Treatment counselor locator. The content and duration of telephone calls varied and were dictated by patient need. The HTH program provided more frequent calls earlier in treatment, with fewer calls as patients reached the maintenance phase of treatment.
The main purpose of the first call was to provide an overview of the program, capture patient information including addiction and treatment history, and collect contact information. In Calls 2 to 8, care coaches educated patients about the nature of addiction and what to expect during treatment. Care coaches recorded the goals, strengths, and challenges that a patient verbalized to have continuity with the patient from call to call. Educational materials were also offered online, and the coach guided patients through the HTH Web site (heretohelpprogram.com), which provided a variety of useful tools including a personalized journal calendar and self-reported B-MAT case information from patients who have previously participated in the HTH program.
Care coaches also provided assistance with appointment reminders and resource location (e.g., counseling, 12-step programs) and helped patients prepare for office visits. They facilitated resolution of challenges with patients' treatment. For example, if a participant voiced concerns about treatment, response to B-MAT, or other B-MAT-related clinical issues, the coaches helped the participants' problem-solve possible resolutions. Coaches followed up after each scheduled office visit and discussed concerns and provided feedback.
The care coaches were either registered nurses or substance abuse counselors with additional training in addiction education and telephonic patient support. This additional training (coordinated by the sponsor) lasted 2 weeks and included an overview of addiction, OD treatment, and B-MAT, as well as health care coaching and how to apply basic coaching skills to a variety of situations to increase B-MAT retention. Training was followed up with booster sessions using both individual and group training models and role-play activities to reinforce approved coaching scripts. In total, 16 care coaches were used for this study. To accommodate the various time zones and patient preferred calling times, both part-time and full-time care coaches were used.
2.6 Analyses
Analyses focused on summarizing data that illustrate the effectiveness of the methods and the uniqueness of the sample drawn from the B-MAT patient population. Summary statistics are reported on the number of physicians certified to treat OD using B-MAT, the number that met inclusion criteria, and finally the number who participated as study sites. Chi-square tests of equality of proportions were used to compare the final physician sample to population. The number of patient participants enrolled, randomized, and captured at baseline were also reported. The number of outbound telephone calls required for capturing survey data is reported for baseline as well as follow-up points. Multiple analysis of covariance (MANCOVA) was used to compare experimental and control groups on baseline ASI composite scores. Additional comparisons between patients who completed and did not complete surveys, as well as those who participated in and did not participate in the intervention, are also presented. All analyses were conducted using SPSS v18 (SPSS Inc., Chicago, IL).
3. Results
3.1 Study participation and attrition
Of the 15,450 certified B-MAT physicians in the United States at the start of the study, 7,075 had an active waiver and treated at least 1 patient during the month prior to study initiation. Of those, 3,761 treated at least 5 B-MAT patients per month during the 3 months prior to study initiation and comprised the population targeted for recruitment as sites. A total of 470 physicians signed contracts and were activated as study sites. Approximately 69% (n = 324, from 40 states) of these physicians recruited at least 1 patient into the study. Fig. 1 displays the physician sample size at each stage of recruitment, enrollment, and participation. The mean number of patients enrolled per physician was 6.75 (± 6.79). The study sample of physicians (n = 324) did not differ from the population of certified B-MAT physicians (n = 15,450) in geographic location, with the northeast and southeast regions accounting for most of the physicians in both groups (p > .05). However, the physician group for this study had a higher proportion of doctors of osteopathy compared to the population (20% vs. 10%), χ2(2, N = 13,959) = 26.5, p < .01.
A total of 2,194 B-MAT patients were recruited into the study during the 4-month recruitment period. Seventy-one percent (n = 1,558) enrolled using the Web site, with the remaining 29% (n = 636) submitting the paper informed consent form. The study sample (N = 1,426) was composed of those who enrolled, were eligible, and completed a valid baseline survey. For participants with a completed baseline, an average of 3.2 ± 2.7 calls were placed by interviewers to complete the survey. Enrollees who did not complete a valid baseline survey (n = 768) were excluded from the study and did not differ from the study sample on gender (60% male vs. 59% male, p > .05) or region of residence (p > .05). Fig. 2 displays the participant sample size at each stage of enrollment, consent, and follow-up survey completion.
Follow-up rates for each of the four measurement periods were as follows: Month 1, n = 992 (70%); Month 2, n = 887 (62%); Month 3, n = 923 (65%); and Month 6, n = 897 (63%). For participants who completed the Month 1 survey, 8.0 (± 10.9) calls were placed. Similarly, for subjects who completed the Month 2 survey, 8.4 (± 10.3) calls were placed; for Month 3, 10.8 (± 12.6) calls; and for Month 6, 13.1 (± 15.3) calls. Call attempts for survey completion did not differ by experimental condition at any measurement point (ps > .05).
At each measurement period, subjects were dichotomized into those who had completed a survey and those who did not. These groups were then compared on baseline ASI individual items, ASI composite scores, and demographics. At each measurement point, there were no gender differences between participants based on survey completion (ps > .05). By contrast, at all four follow-up measurement points, participants who completed the survey were on average 2 years older than those who did not complete the survey (ps < .01). At Months 2 and 3, participants who completed surveys did not different from those who did not complete the survey on any of the baseline ASI composite scores (p > .05). By contrast, those who completed the Month 1 survey had a lower baseline mean drug composite score compared with those who did not (0.258 vs. 0.272, p < .05). Participants who completed the Month 6 survey had a lower mean baseline legal composite score compared with those who did not complete a survey (0.091 vs. 0.113, p < .024). Approximately 44% of the sample (n = 631) completed all four follow-up surveys, whereas 87% (n = 1,243) completed at least one of follow-up.
Of the 987 subjects assigned to the experimental condition (HTH), 651 (66%) agreed to participate in HTH. Subjects randomized to the experimental group were given the option of opting out of participating in the HTH program. Demographically, subjects who declined the intervention were slightly more likely to be male (65% vs. 57%, p < .05) but did not differ on age, race, marital status, job category, or insurance type (ps > .05). Clinically, subjects who declined the intervention had lower legal (0.08 vs. 0.10), psychiatric (0.21 vs. 0.25), and family (0.26 vs. 0.31) composite scores (ps < .05) compared with those who accepted the intervention.
Using an intent-to-treat approach, 66% of HTH subjects completed at least one care coach call, with 39% completing at least four calls, and 7% completing all eight calls. Examining only those subjects who agreed to participate in the intervention, 99% completed at least one care coach call, with 59% completing at least four calls, and 11% completing all eight calls. Of the HTH group who accepted at least one call, the average number of care coach calls accepted was 4.3 (± 2.28).
3.2 Sample characteristics
Sample demographics by group are displayed in Table 1. To allow for adequate testing of the pilot program, 70% of the study sample was randomized to HTH (n = 987) and 30% assigned to the control condition (n = 439). The sample was predominantly Caucasian (88%) males (59%) with an average age of 33 (range = 18–64). There were no differences in baseline characteristics between the HTH and control groups, indicating that random assignment worked well. Health insurance status of the overall sample varied with the smallest group (13.8%) being Medicaid beneficiaries and the largest (32.8%) insured privately. Most of the sample (78.9%) had been employed during most of the past 3 years.
Table 1Demographic characteristics of participants
Baseline ASI composite scores for the HTH and control groups are presented in Table 2. Controlling for race, gender, and SES Socioeconomic Status (SES). in a MANCOVA, there were no difference between the experimental and control groups on the seven ASI composite scores, Wilks' Lambda = .994, F(7, 1,343) = 1.20, p > .05, or drugs of abuse, Wilks' Lambda = .990, F(10, 1,374) = 1.42, p > .05.
Table 3 presents individual items from the drug and alcohol items of the ASI. Considering baseline opioid abuse, participants reported using “other opiates” most frequently, averaging 14 days, followed by 4 days of heroin and 2 days for methadone abuse. Participants reported experiencing drug problems on average 16 days. Regarding lifetime drug use, 88% of the sample reported using “other opiates” at some point, with 53% reporting cocaine use and 18% reporting heroin use. Approximately 80% of the sample indicated that they were polydrug users.
Table 3ASI—alcohol and drug use and problems at baseline
This study was designed to evaluate the effectiveness of a telephonic support service called HTH on a national sample of OD patients new to B-MAT. The methodological challenges to implementing the study, the innovative solutions, and the intervention were a focus of this article. This article is important because the B-MAT patient population is growing and is different from other OD patient samples, making the innovative research methods described within vital to understanding this understudied patient population.
To be conducted naturalistically, this trial sampled providers and patients, randomized patients to experimental groups, and captured self-reported survey data while interfering minimally with the natural course of treatment. The design and tools used in this study addressed several challenges that would prohibit conducting the study using more orthodox methodologies. Specifically, the challenges addressed in this study included (a) the distributed locations of the patient population, (b) the logistic barriers to accessing physicians and patients, which in turn caused (c) challenges recruiting and enrolling cases, acquiring informed consent, randomizing to group, and capturing follow-up data.
As stated above, there are few if any centralized sites where large numbers of new B-MAT patients congregate, so recruiting a sample of B-MAT patients was a challenge. B-MAT practices are typically small by design and to improve patient access are distributed across geographic regions. The relatively small size of the target patient population nationally (
) further magnified recruitment challenges. The decentralized nature of B-MAT also posed logistic and sample maintenance challenges during follow-up, including ongoing data collection and delivery of the experimental intervention. The solutions that were developed and how well the solutions worked have been described and are summarized below.
The first step was to identify, recruit, train, and activate a large enough number of physicians at study sites across a geographically diverse region or nationally. The decision to identify then target several thousand physicians nationally to successfully yield several hundred sites was a very different approach than the more standard practice of engaging a small number of (e.g., 1–3) large SAT clinics. Study participant recruitment and enrollment was still a challenge, as most of the sites enrolled fewer than five participants.
To manage the sites and the anticipated small number of patient participants from each, Internet-based sample recruitment and data collection tools were employed. Such tools have proven to be time and cost efficient in survey research (
) and brought specific advantages to this study. First, because in-person recruitment, consent, and interviewing would be too resource intensive and costly, remote and automated processes were sought or developed. Because scheduling is dependent primarily upon the candidate's or participant's time constraints, a Web-based system supporting both enrollment and baseline interview scheduling was used. Nonetheless, there were concerns.
reported that access to a computer and the Internet was not yet prevalent enough that one could reasonably assume that an Internet-recruited sample would be representative of the general population. In addition, the level of computer skill required to be recruited into a study using only Internet-based tools is greater than would be expected by those least computer skilled in the population (
To address concerns about potential sample bias, the Internet-based recruitment/consent strategy was complemented with a paper-and-pencil informed consent package that paralleled the Internet tool. In both cases, study enrollment was initiated by patient invitation from the B-MAT physician at each site. The current sample predominantly enrolled using the Web-based enrollment tool (71%), but there were no differences in baseline characteristics between participants using the electronic versus paper-based approach. Finally, because the e-click-signature was approved by the IRB for capturing informed consent, neither in-person consent nor the transfer of a signed hard copy through the mail was required, both of which would have added time and expense to the enrollment process.
Data capture from this sample presented challenges as well. An automated self-report option using an Internet program or e-mail was considered. The errors associated with participants entering their responses directly via keyboard without an interviewer presented too great a risk to the validity of the study results. Therefore, all survey data were collected during telephonic interviews by trained ASI interviewers using a CATI system. The Web-based enrollment, randomization, and interview scheduling combined with the CATI survey system successfully facilitated recruitment of the target number and follow-up rate within the time parameters. For SAT research to sample large, decentralized, national populations, an increasing reliance on the solutions described here offers a promising alternative to other more typically used manual- and paper-based methods.
Although this study examined roughly 300 private practices, the HTH intervention was designed to simultaneously support thousands of often small private practices, each with small caseloads of diverse OD patients. An office-based care coach was not a realistic option. To be easily accessible to B-MAT patients across the country, the HTH program provided telephone and Internet-based access to coaches. This approach has shown some evidence of success in SAT but has not been studied with OD patient samples. Development of HTH was guided by a set of principles similar to those used to develop the tools that supported the study as both the study methodology and the HTH program addressed similar challenges. Although the efficacy of HTH will be examined in future publications, preliminary data suggest that it was a feasible and acceptable service. In the subsample (66%) who opted to participate in the intervention (a conservative research consent procedure not typically employed), nearly all (>99%) participants completed at least one call, with most (59%) completing at least half (n = 4) of the planned calls.
Another contribution of the present research is knowledge about the profile of this understudied population of OD patient treated in office-based settings. The largest and most recent, representative, and diverse national set of ASI data from the Drug Evaluation Network System (DENS;
) offer an interesting contrast. The ASI composite scores in the drug and medical areas were not significantly different. Although there was no difference in the drug composite score, examination of the items used to compute this score indicated that the current sample was more likely to use pharmaceutical opioids, whereas the DENS sample was more likely to use heroin as the drug of choice. In the other five problem areas, the two samples differed in problem severity. The B-MAT sample displayed significantly greater problem severity in the alcohol, psychiatric, and family/social areas. By contrast, the DENS sample displayed greater severity in the legal and employment areas. These findings should be understood in the context of important demographic differences—the B-MAT study sample was younger, more racially homogenous (88% Caucasian), and more likely to be married and employed than the DENS sample. These differences underline the need for research in office-based treatments, in which patients seem to have distinctly different needs than in clinical populations.
There are a few limitations of this study. Although paper- and Web-based enrollment options were available, most of the sample enrolled via the Internet. It is possible that subjects unfamiliar or uncomfortable with the basics of Internet access and computers in general were dissuaded to participate in the study. In addition the e-click-signature does not necessarily indicate a greater or lesser understanding of study demands compared to a more traditional paper-and-pencil informed consent process. Regarding physicians, investigators had access to a limited array of data with which to make comparisons between excluded and included physicians at each stage of recruitment. Furthermore, because physicians were remunerated based on patient enrollment in the study, it is possible that some physicians were more aggressive than others in encouraging participants to enroll. However, variability in the number of patients enrolled by physician indicates that other factors may have been more influential than was remuneration. Regarding the sample, subjects were predominantly Caucasian (88%), which limits generalization of results to non-White populations receiving SAT. This again points to a need for more research on OD treatment among commercially insured and B-MAT samples. Missing follow-up data were another limitation. Survey-based studies normally have missing data and use statistical methods to attenuate their influence on study results. Within this study, there was adequate power at all measurement points to conduct meaningful statistical analyses. However, the relationship between poor clinical performance and missing data is often positive and strong, which could be a potential source of bias. Furthermore, the follow-up attrition rate threatens the generalizability of findings. Another potential limitation of the study was the total reliance on patient self-reported data. Nonetheless, numerous studies have demonstrated sufficient reliability and validity of self-report data in SAT research (e.g.,
). In future studies, particularly with this and other understudied populations, objective outcome measures should be considered, including claims data for service utilization and cost, biomarkers for substance abuse behaviors, public records for legal problems, human resource data for work and school attendance and disability, and collateral data for social functioning and related problems. Finally, subjects randomized to the HTH group were given the option of declining participation in the program. Future trials should integrate study and program participation informed consent and eliminate program opt-out. In addition, greater resources should be placed on program retention, although this may limit external validity.
Overall, this study demonstrated that essential components of clinical trials, including participant enrollment, obtaining consent, randomization, and data capture, can be reasonably and effectively accomplished on a sample recruited from an office-based, B-MAT patient population using automated and Web-based tools. Results of this study are particularly encouraging to researchers interested in recruiting patients from physician offices. Streamlining the process by using electronic means also reduced physician burden. Essentially, the participating physicians' role was to describe the study and offer patients the opportunity to participate. Finally, this study also suggests that a telephonic support program for OD B-MAT patients is a feasible and acceptable and treatment adjunct.
Acknowledgments
Reckitt Benckiser Pharmaceuticals funded this research project. Reckitt Benckiser Pharmaceuticals had no role in the interpretation or analysis of study results. Jamie Severt, Jake Debus, and Sheila Song are acknowledged for manuscript editing. Kym Williams and Carol Norton are acknowledged for participant management.
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