Abstract
Introduction/background:
Video directly observed therapy (video-DOT) through a mobile health platform may improve buprenorphine adherence and decrease diversion. This pilot study tested the acceptability and feasibility of using this technology among patients receiving buprenorphine in an office-based setting.
Methods:
Participants were instructed to record videos of themselves taking buprenorphine. Data were collected from weekly in-person visits over a four-week period; assessments included self-report of medication adherence, substance use, satisfaction with treatment and use of the application, as well as urine drug testing. Open-ended questions at the final visit solicited feedback on patients’ experiences using the mobile health application.
Results:
The sample consisted of 14 patients; a majority were male (86%) and White (79%). All participants except one (93%) were able to use the application successfully to upload videos. Among those who successfully used the application, the percentage of daily videos uploaded per participant ranged from 18 to 96%; on average, daily videos were submitted by participants 72% of the time. Most participants (10/14; 71%) reported being “very satisfied” with the application; of the remaining 4 participants, 2 were “satisfied” and 2 were “neutral.” Participants reported liking the accountability and structure the application provided and its ease of use. Negative feedback included minor discomfort at viewing one’s self during recording and the time required.
Conclusions:
Based on these results, use of a mobile health application for video-DOT of buprenorphine appears feasible and acceptable for patients who are treated in an office-based setting. Further research is needed to test whether use of such an application can improve treatment delivery and health outcomes.
Keywords: adherence, mobile health, opioid use disorder, buprenorphine
1. Introduction
Despite efforts to combat the opioid crisis, the rate of opioid-related drug overdoses in the United States has increased by 5-fold over the past decade (Hedegaard et al., 2018). Buprenorphine is an efficacious and accessible treatment for persons with opioid use disorder, blocking opioid cravings, reducing illicit opioid use and allowing individuals to interrupt the cycle of maladaptive behavior associated with addiction(Mattick et al., 2014). Rather than having daily dispensing of medication observed in a federally licensed opioid treatment program, such as a methadone clinic or an intensive outpatient program, providers may prescribe buprenorphine in an office-based setting allowing greater flexibility for patients.
Successful treatment with buprenorphine requires adherence to medications. One study utilizing computerized medication bottle caps to monitor buprenorphine administration in an office-based setting demonstrated 71% adherence (Fiellin et al., 2006), leaving room for improvement. Retention in treatment is a major challenge for buprenorphine treated patients, with up to one half dropping out of treatment within one year (Alford et al., 2011; Weinstein et al., 2017). Supervised treatment, or directly observed therapy (DOT), has long been mandated for methadone treatment in federally licensed opioid treatment programs in the U.S. Research suggests higher rates of retention among methadone treated patients compared to buprenorphine (Hser et al., 2016), which could in part relate to its DOT method of delivery. However, most models for office-based treatment with buprenorphine currently do not include DOT. A recent pilot study for real-time observation of buprenorphine ingestion via video conferencing between patient and trained recovery coaches showed a similar adherence to computerized medication bottle caps at 72% adherence (Schuman-Olivier et al., 2018). While many patients like the autonomy and flexibility of buprenorphine, there are also patients who express desire for greater accountability and structure to their treatment (Yarborough et al., 2016).
Video-based directly observed therapy (video-DOT) is a method of monitoring medication adherence via an asynchronous video platform modeled after in-person DOT. With asynchronous video-DOT, patients can be observed in their own environment without the inconvenience and time commitment of attending a clinic for in-person observation, and providers can review the video at any time further decreasing provider burden. Video-DOT has been successfully utilized for the treatment of tuberculosis (Garfein et al., 2015; Story et al., 2016; Holzman et al., 2018) and was implemented post-disaster relief to provide medical monitoring for patients affected by Hurricane Katrina (Olano-Soler et al., 2017).
While video-DOT has been found to be acceptable in other treatment settings, it is unknown whether patients would be receptive for its use with buprenorphine. The aims of this study were to assess the acceptability and feasibility of using a customized, innovative mobile health platform to provide asynchronous, video-DOT and enhanced monitoring among patients treated for opioid use disorder with buprenorphine.
2. Methods
2.1. Study Design
Based on information derived from prior qualitative work (Godersky et al., 2019), we conducted a pilot study of the use of a mobile health platform to support patients treated for opioid use disorder with buprenorphine. The smartphone application allows patients to record themselves taking buprenorphine then uploads the videos to a secure, cloud-based server for subsequent review by research and clinical team members. Patients currently treated with buprenorphine in an office-based setting were asked to use the mobile application for a one-month study period. They met with research staff on a weekly basis for assessments including medication adherence and substance use. Urine drug testing was conducted at every study assessment. Participants were compensated $20 for the first 4 visits and $40 for the final visit, for up to $120 for completing all research procedures. The University of Washington Institutional Review Board approved all study procedures.
2.2. Study Sample
Participants were recruited from the Adult Medicine Clinic at Harborview Medical Center, located in Seattle, WA, between November 2017 and February 2018. Research staff worked closely with nurses and physicians to identify patients who were interested in participating. Patients were eligible if they were between 18 and 65 years of age, English speaking, currently receiving buprenorphine treatment in clinic and willing to use a mobile phone application. Buprenorphine treatment was confirmed by study staff via the electronic medical record. Participants were excluded for acute or chronic cognitive impairment resulting in inability to provide informed consent based on researcher assessment.
2.3. Study Intervention
Participants were instructed to download the mobile application on their personal device or were provided a smartphone for use during the study period if they did not have a personal phone. Phones reported lost or stolen during the study could be replaced. Supplemental Figure S1 depicts participant-facing application interface. Research staff oriented participants on how to use the application and provided basic instruction regarding functionality. In addition to allowing participants to record themselves taking their medication, the application also provides users with clinic contact information, and sends a daily notification when videos are not uploaded. The application included daily assessments of medication side effects and opioid cravings and also included links to relevant resources including: buprenorphine information, overdose prevention, syringe service programs, 12-step meetings, community mental health crisis hotline, and a link to the electronic medical record patient portal, which allows patients to contact their primary care teams. Patients were instructed to upload videos to confirm daily dosing from the initial ingestion until the medication was fully dissolved. If they took medication more than once daily (e.g. twice daily) they were encouraged to submit videos for all doses, but were requested to upload at least one video per day. Study staff reviewed all submitted videos for acceptable quality (e.g., patient and medication were visible, patient demonstrated initial medication ingestion and video was uninterrupted) to confirm medication administration.
2.3. Data Collection and Measures
Data were collected from questionnaires administered at in-person study visits as well as from the mobile smartphone application. Baseline and weekly study visits were completed over a one-month period for a total of five visits. Demographic information including age, race/ethnicity, housing, employment and relationship status were collected at the baseline visit, as well as information about current and past treatment for opioid use disorder. At subsequent visits participants’ data were collected on buprenorphine adherence and recent substance use using a 7-day timeline follow-back method (McLellan et al., 1992). At weekly visits patients were also asked if they had any problems using the application, and the research coordinator attempted to resolve any difficulties. At the final visit participants were also asked open-ended questions to elicit feedback on perceptions of using the application (e.g., “What did you like best/least about [the application]?”), barriers to use (e.g., “Were there any effects on your privacy?) and suggested changes (e.g., “Is there anything you would recommend changing?”).
Data on video completion (e.g., video successfully uploaded and was of acceptable quality) was abstracted by research staff from an online provider interface that provides data from the mobile application. Urine drug testing (UDT) was completed at all visits to confirm self-reported illicit drug use and presence of buprenorphine using Alere® iCup DX 14 Panel Drug Test Cup (Alere Toxicology) for 14 substances (marijuana, cocaine, opiates, oxycodone, methadone, buprenorphine, methamphetamine, amphetamine, benzodiazepines, barbiturates, nortriptyline, MDMA, propoxyphene and phencyclidine).
2.4. Statistical Analysis
We conducted descriptive statistics of participants’ usage of the video-DOT application. We calculated the mean/median number of daily videos completed during the study, as well as self-reported days of medication adherence. Correlation co-efficients (Pearson’s) between videos and self-reported adherence were calculated, as well as videos and time in treatment. The number/percentage of weekly urine drug tests positive for buprenorphine and other substances was calculated. Quantitative analyses were performed using RStudio (v1.1.456)(RStudio Team, 2016). Responses from open-ended questions were reviewed by two authors (MG and KB) to arrive at consensus of main themes. Results from open-ended questions at the final study visit were tabulated by theme.
3. Results
3.1. Participant Characteristics
The sample was comprised of 14 participants of which the mean age was 44.7 (±12.2) years; the majority were male (85.7%) and self-identified as White (78.6%) (Table 1). Just under a third experienced housing insecurity in the past 90 days (28.6%). Most had received buprenorphine treatment in the clinic for less than 90 days (57.1%). A majority of participants received a dose of 16 milligrams (57.1%) and used the tablet formulation of buprenorphine (64.3%). Six participants (42.9%) had prior buprenorphine treatment, and eight (57.1%) had previously been in a methadone program. Phones were provided for 13/14 (92.9%) participants; 1/13 (7.7%) reported lost/stolen phones at the final visit; zero phones were damaged during the study. All participants completed the study, and 68/70 (96.4%) of weekly study follow-up visits were completed.
Table 1:
Characteristics of video-DOT participants for buprenorphine in office-based setting (n=14)
| Race (n (%)) | |
| White, not Latino | 11 (78.6) |
| Black, not Latino | 1 (7.1) |
| Latino | 1 (7.1) |
| Other | 1 (7.1) |
| Age | |
| Mean (SD) | 44.7 (12.2) |
| Range | 28–61 |
| Median (IQR) | 46.5 (32, 54.5) |
| Sex (n (%)) | |
| Male | 12 (85.7) |
| Female | 2 (14.3) |
| On the street/in a shelter in past 90 days (n (%)) | 4 (28.6) |
| Days in treatment | |
| Range | 7–672 |
| Mean (SD) | 199.1 (243.7) |
| Median (IQR) | 77.5 (17.0, 412.2) |
| Patients with <90 days in treatment (n (%)) | 8 (57.1) |
| Dosing schedule (n (%)) | |
| Once daily | 5 (35.7) |
| Twice daily | 8 (57.1) |
| Three times daily | 1 (7.1) |
| Total mg daily dose (n (%)) | |
| 8 mg | 1 (7.1) |
| 12 mg | 1 (7.1) |
| 16 mg | 8 (57.1) |
| 20 mg | 2 (14.3) |
| 24 mg | 2 (14.3) |
| Medication type (n (%)) | |
| Film | 5 (35.7) |
| Tablet | 9 (64.3) |
| Previous medication treatment for opioid use disorder (n (%)) | |
| Buprenorphine | 6 (42.9) |
| Methadone | 8 (57.1) |
3.2. Video Submissions and Medication Adherence
Figure 1 shows the number of daily videos submitted per week (Weeks 1–4) for each participant. Nearly all participants (13/14; 92.8%) were able to use the application successfully to upload videos of buprenorphine ingestion for review: only one participant was unable or unwilling to use the technology and did not upload any videos. Another participant was incarcerated during part of the study period and was unable to complete videos while in custody. No clear pattern of reduction in video submissions was seen with positive opioid urine drug tests. Table 2 provides a descriptive summary of the number and percentage of daily videos that were submitted during the 28-day study period, as well as days of self-reported adherence, which was assessed at weekly study visits. The percentage of days with a submitted video ranged from 0–96.4%. The median percentage of submitted videos was 73.2% (IQR: 50.0, 85.7); the mean percentage of submitted videos was 63.3% (SD±30.4%) among all participants and 71.7% (SD±22.7%) among those who were able to use the platform (i.e. excluding incarcerated participant and the participant who was unable to upload videos). In general, the number/percentage of days with self-reported adherence to medication exceeded that of days submitting videos confirming adherence. However, the correlation between self-reported adherence and video-confirmation of adherence was strong (Figure 2). There was a modest but statistically significant correlation between time on buprenorphine treatment and success of video-DOT (Figure 3).
Figure 1:
Number of Daily Videos Submitted for Each Study Week by Participant (n=14) *Participant incarcerated for two weeks
**Participant unable/unwilling to upload videos
Table 2:
Video directly observed therapy usage: percentage of days buprenorphine ingestion confirmed with videos (n=14)
| Medication Adherence | All Participants (n=14) | Completed Per Protocol (n=12)* | ||||
|---|---|---|---|---|---|---|
| Range | Median (IQR) | Mean (SD) | Range | Median (IQR) | Mean (SD) | |
| # of Days with a video submission | 0–27 | 20.5 (14.0 – 24.0) | 17.7 (8.5) | 5–27 | 22.5 (17.8–24.0) | 20.1 (6.4) |
| % of Days with a video submission | 0–96.4% | 73.2% (50.0, 85.7) | 63.3% (30.4%) | 17.9–96.4% | 80.4% (63.4–85.7%) | 71.7% (22.7%) |
| # of Days with self-reported dosing | 4–28 | 27 (21.3, 28) | 22.6 (8.0) | 15–28 | 27 (25–28) | 25.4 (4.1) |
| % of Days with self-reported dosing | 14.3–100% | 96.4% (75.9,100) | 80.9% (28.6) | 53.6–100% | 96.4% (89.3–100%) | 90.8 (14.5%) |
Excludes one participant who was incarcerated for two weeks and one participant unable/unwilling to upload videos
Figure 2:
Correlation of Self-Report Adherence and Video Adherence
Figure 3:
Correlation of Time on Buprenorphine Treatment and Video-DOT Adherence (n=14)
3.3. Urine Drug Testing Results
Buprenorphine was present in all UDTs except for the sample provided immediately after release of the participant who was incarcerated (buprenorphine was not continued while in custody). The results for illicit drugs and prescribed buprenorphine are as follows: at baseline, 42.9% of participants had a UDT positive result for opioids (combined measure for opiates, oxycodone and methadone). The following weeks results for opioids were 28.6% at week 2, 38.5% at week 3, 46.2% at week 4 and 35.7% positive at the final visit. Methamphetamine results were 28.6% positive at baseline and 15.4% at week 2, 30.8% at weeks 3 and 4 and 35.7% positive at the final visit. Cocaine results were 21.4% positive at baseline and 35.7% at week 2, 30.8% at weeks 3 and 4 and 14.3% positive at the final visit.
3.4. Patient Experience
At the final visit, participants were asked about their satisfaction using the application. Most (10/14; 71.4%) reported being “very satisfied” with the experience. Of the remaining participants, two (14.3%) were “satisfied” and two (14.3%) were “neutral”, including the participant who was unable to use the application; no participants reported that they were “dissatisfied” nor “very dissatisfied” using the application.
A summary of responses to open ended questions soliciting positive and negative aspects of using the application at the final visit is provided in Table 3. For positive aspects of using the application, participants reported increased accountability for and structure to medication taking (n=10; 71.4%), the application was simple to use (n=8; 57.1%), helpful (n=4; 28.6%) and assisted with reflection on progress in treatment (n=3; 21.4%). One participant reported that using the application helped open a dialog to discuss recovery with family and friends; one reported enjoying learning to use new technology, and one reported a benefit with the flexibility to use the application as it fit into personal schedule.
Table 3:
Patient Experience Using video-DOT Smart Phone Application
| n (%) | |
|---|---|
| Application likes/benefits | |
| Increased accountability for and structure to medication administration | 10 (71.4) |
| Simple to use | 8 (57.1) |
| Helpful | 4 (28.6) |
| Assisted with reflection on progress in treatment | 3 (21.4) |
| Provided an extra contact point | 1 (7.1) |
| Helped to open dialogue about recovery with family/friends | 1 (7.1) |
| Learning to use new technology | 1 (7.1) |
| Flexibility to use the application as it fit personal schedule | 1 (7.1) |
| Application dislikes/barriers to use | |
| Discomfort/awkwardness of filming medication administration | 6 (42.9) |
| Time commitment/adding steps to medication ingestion | 5 (35.7) |
| Application frustrations (charging phone, logging in for each use, agreeing to terms of use) | 4 (28.6) |
| Technical issues (videos not uploading, application closing) | 4 (28.6) |
| Finding private space to use application | 3 (21.4) |
| Difficulty remembering to use application | 2 (14.3) |
| Question regarding craving triggered desire to use | 1 (7.1) |
| Nothing to report | 2 (14.3) |
Regarding negative aspects of using the application, discomfort with filming medication ingestion was the most commonly reported drawback reported by 42.9% (n=6). Five (35.7%) participants brought up the added time commitment and steps to medication taking. Around a quarter of participants reported encountering some logistical difficulties with the application such as maintaining a charged phone and needing to login to the application each time, as well as technical issues such as the application closing mid-submission or slow submission of videos. Finding a private space where participants were comfortable taking buprenorphine while filming was a challenge reported by three (21.4%) participants. Two (14.3%) participants reported occasional difficultly remembering to use the application.
4. Discussion
This study is the first we are aware of that integrates video-DOT for buprenorphine in an office-based setting, which is a novel application of an emerging mobile health technology. Nearly all participants were able to upload videos for review, and, on average, patient-submitted videos confirmed buprenorphine ingestion nearly two-thirds of days during the study period. The application was acceptable to all participants with none expressing dissatisfaction with their experience.
A growing literature exists on new mobile health technologies promoting medication adherence for patients with challenges to optimal care for chronic medical conditions (Hamine et al., 2015), including taking HIV medications among patients with methamphetamine use (Quanbeck et al., 2014; Gustafson et al., 2016). In a prior qualitative study of providers and patients, we identified barriers to buprenorphine adherence, including factors that made it difficult to attend appointments for refills, forgetting to take medication and the temptation to refrain from using buprenorphine in order to get “high” (Godersky et al., 2019). A study of buprenorphine treated patients demonstrated that the majority (93%) reported mobile phone ownership (Tofighi et al., 2015), suggesting that untapped opportunities for mobile interventions are possible, though this may differ by clinic as most participants required a borrowed phone for the studied intervention described in this manuscript. Researchers have demonstrated text message reminders to be feasible among buprenorphine treated patients for improving appointment adherence (Tofighi et al., 2017), and technology that allows for monitoring of patients’ substance use and providing support tools has been successfully utilized for persons with methamphetamine and alcohol use disorders (Montoya et al., 2014; Gustafson et al., 2016). This technology could also be a useful adjunct for buprenorphine treatment, where non-adherence is clearly linked with illicit opioid use (Fiellin et al., 2014). While many patients prefer office-based buprenorphine treatment over methadone because of greater autonomy (Korthuis et al., 2010; Gryczynski et al., 2013), some also desire greater accountability and structure in their treatment program. The mobile application used in this study provides additional tools that could be helpful for engaging patients in their treatment, such as appointment reminders and links to online local resources.
In addition to improving patient adherence, use of video-DOT for buprenorphine could address issues of provider shortages and concerns about diversion. Currently there is a shortage of buprenorphine prescribers in many parts of the country, and providers in these regions often feel inadequately supported to implement treatment (Cunningham et al., 2007; Walley et al., 2008; Netherland et al., 2009). For patients located in such geographically remote settings, costly, hazardous or time-consuming travel for frequent in-person clinic visits creates a barrier to treatment. Even for patients who do not travel long distances, requirements for frequent appointments for monitoring can be a burden. Using video-DOT as a means for confirming medication adherence might enable providers to reduce the need for frequent face-to-face monitoring visits, which would be of benefit to both patients and providers. At the start of 2019, Medicare reimbursement codes for virtual communication were added, including for “remote evaluation of recorded video” which may allow expansion of video-DOT (Centers for Medicare & Medicaid Services, 2018).
Providers might be also motivated to integrate video-DOT with buprenorphine treatment to limit medication diversion. Along with expansion of treatment, reports of inappropriate use of buprenorphine (such as intravenous or intranasal administration) and diversion have emerged over the past two decades in the U.S.(Cicero and Inciardi, 2005; Gwin Mitchell et al., 2009; Cicero et al., 2014; Chilcoat et al., 2019). Although research suggests that most diverted medications are used to treat withdrawal, not induce euphoria (Monte et al., 2009; Schuman-Olivier et al., 2010), fears about being unable to control or prevent diversion may ultimately discourage providers from prescribing buprenorphine. Implementation of video-DOT may reassure providers who are particularly concerned about issues of medication diversion, and thus encourage new providers to offer this care, or current providers to prescribe to patients who are perceived as “high-risk” for diversion.
This study is limited by a small sample size and recruitment from a single site. The substantial minority of days for which participants did not upload videos precluded use of the technology to determine full medication adherence. Additional granularity of confirmation of adherence to buprenorphine through enhanced laboratory monitoring such as through buprenorphine metabolite monitoring (e.g. norbuprenorphine/Creatinine ratios) was not included. The short study duration of just four weeks did not allow us to observe whether this technology would be feasible to use for longer durations. This was a single arm study with no control group, so we are unable to make any comparisons on illicit opioid or other substance use with users of the application versus treatment as usual. Participants were using the application in the context of a research study; it is unclear if we would find similar rates of use in a real-world setting. On the other hand, participants’ use of the application was not tied to expectations from their clinical providers, and the study provided no financial incentives for using the application; participants were provided compensation at study visits regardless of whether or not they uploaded videos. Usage rates could be higher in real-world settings where use might be tied to incentives such as requiring fewer face-to-face visits. Participants in this sample had a range of time in buprenorphine treatment which may have impacted their ability to incorporate video-DOT into their medication routine. Results suggest that patients who have recently engaged in buprenorphine may have more difficulty with VDOT, yet are a population with greatest risk for non-adherence/non-retention and thus may have the most to gain. Further research is needed to understand how this technology might optimally be used (such as for patients who are recently initiating buprenorphine, who are suspected of diversion, or who have less need for face-to-face visits for monitoring, etc.).
5. Conclusion
In summary, we observed in this pilot study that use of video-DOT for buprenorphine is generally feasible and acceptable among patients who are receiving opioid use disorder treatment in an office-based setting. Planned future work should evaluate the effect of video-DOT for buprenorphine on clinical outcomes including illicit opioid use, treatment retention and medication diversion. Potential challenges related to implementing the use of video-DOT in real-world settings include burden on patients, clinics and providers, appropriateness of use for different patient groups (e.g. at start of treatment, when diversion is suspected, or adherence is questioned) and what impact patients’ acceptance and use of video-DOT will have on treatment decisions remain issues to be addressed in the future.
Supplementary Material
Acknowledgments
Funding for this research came from the National Institute on Drug Abuse (R44 DA044053). The NIDA grant is a SBIR/STTR research and business partnership; this study was complete in conjunction with emocha, a for-profit health technology company. The company reviewed results but did not influence the collection or interpretation of results. Additional funding to support Dr. Tsui received through the National Institute of Allergy and Infectious Diseases (P30AI027757).
Dr. Tsui is supported by a Small Business Innovation Research (SBIR) grant from NIH/NIDA grant (NIDA R44 DA044053) with commercial partners emocha- a health technology company. The company had no direct involvement in the study activities or interpretation/presentation of the data. Dr. Saxon receives royalties from UpToDate and served on an advisory board for Alkermes, Inc. All other authors report no conflicts.
Footnotes
Disclosures
JT and MG were responsible for the conceptualization of this study and initial writing. KB and MG complete data analysis. JK, JM, AS, KB, and JS reviewed and provided significant commentary on the manuscript. All authors have reviewed and approved the final manuscript for submission.
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