Abstract
Background:
HIV clinicians report low confidence and satisfaction prescribing chronic opioid therapy (COT). We hypothesized that the Targeting Effective Analgesia in Clinics for HIV (TEACH) intervention [a system-level improvement to increase guideline concordant care for COT] would improve satisfaction, confidence, and trust among PWH and their clinicians.
Methods:
We conducted a two-arm, unblinded cluster randomized controlled trial (RCT) to assess the TEACH intervention. Clinicians were randomized in a 1:1 ratio to receive either the TEACH intervention (an IT-enabled nurse care manager, opioid education, academic detailing, and access to addiction specialists) or usual care. Outcomes were the following: clinician satisfaction (primary); confidence prescribing COT; patient satisfaction with COT; and trust in clinician. Intention-to-treat analyses were conducted using linear and logistic regression models.
Results:
Clinicians (n=41) were randomized and their 114 patients assessed. At 12 months, the adjusted mean difference in satisfaction with COT was 1.11 points for intervention vs control clinicians (Scale 1–10; 95% confidence interval [CI]: −0.04–2.26, p=0.06). The adjusted mean confidence with prescribing COT was 1.01 points higher among intervention clinicians (Scale 1–10; 95% CI: 0.05–1.96, p=0.04). There were no significant differences in patient satisfaction with COT (adjusted odds ratio (AOR) 1.17, 95% CI: 0.50–2.76, p=0.72) or trust in provider (AOR 1.63, 95% CI: 0.65–4.09, p=0.30).
Conclusions:
TEACH did not significantly affect prescriber satisfaction, patient satisfaction with pain management or patient trust; however, it did improve prescriber confidence. TEACH is a promising strategy to improve provider prescribing of COT for PWH without adverse patient satisfaction or trust in provider.
Keywords: chronic opioid therapy, HIV, opioids, pain management
1. Introduction
In 2020, an estimated 93,000 drug overdose deaths occurred in the United States, and in prior years opioids were responsible for 70% of overdose related deaths (Scholl et al., 2018, Wilson et al., 2020, Ahmad et al.). The rise in opioid use and misuse, along with increasing synthetic opioids infiltrating illicit drug supplies, has contributed to overdose deaths and the declaration of the opioid crisis as a public health emergency (O’Donnell et al., 2020, Gladden et al., 2016). The 2019 national drug control strategy includes recommendations to 1) reduce demand and over-prescription, 2) decrease supply of illicit drugs and 3) provide evidence-based treatment and recovery services for those living with addiction. The national drug control strategy highlights need to curb overprescribing, while people with HIV (PWH) suffer from more chronic pain and receive more chronic opioid therapy (COT) than the general population (Merlin et al., 2012, Jiao et al., 2016, Vijayaraghavan et al., 2013). In that context, HIV clinicians generally lack confidence and comfort managing patients on COT (Matthias et al., 2010) and also have concerns about potential negative consequences to the patient-provider relationship and retention in HIV care (Starrels et al., 2016).
Published guidelines for managing chronic pain with opioid therapy are meant to guide monitoring of patients to identify potential abuse, misuse or diversion such that poor downstream outcomes (e.g., overdose or death) are avoided (Dowell et al., 2016, Bruce et al., 2017, Bohnert et al., 2018). The TEACH study found that a collaborative care, Informatics Technology (IT)-enhanced, nurse care manager intervention was able to improve elements of guideline concordant care using COT (e.g., collecting urine drug tests without increasing aberrant behaviors such as early refills) (Samet et al., 2020, Lira et al., 2019). We hypothesized that the intervention would improve clinician knowledge and comfort with opioid management through didactics and academic detailing (peer-to-peer education). These improvements in patient satisfaction and trust in their clinician might be mediated by better knowledge around COT as well as increased time spent assessing and developing pain management care plan through the nurse care manager. The full impact of a TEACH-style program on clinician and patient satisfaction, confidence and trust around opioid therapy is unknown. The current analysis tested whether there was any difference between the TEACH intervention and usual care on clinician and patient satisfaction, clinician confidence, and patient trust. We hypothesized that the TEACH intervention would improve clinician and patient satisfaction, clinician confidence, and patient trust, compared to usual care
2. Methods
2.1. Study objective and design
The TEACH intervention was a cluster-randomized clinical trial with a nested observational cohort of patients to assess whether a collaborative care intervention improves HIV clinicians’ adherence to COT guidelines and patient level outcomes (e.g., providing urine drug tests, early refills) compared to usual care (Samet et al., 2020). Randomization occurred at the clinician level with patients included through a waiver of informed consent. In the current analysis we assess the impact of the TEACH collaborative care intervention on clinician satisfaction (primary outcome) along with secondary outcomes of clinician confidence in COT prescribing, patient satisfaction with COT, and patient trust in clinician. The TEACH study protocol has been described in detail previously (Lira et al., 2019, Samet et al., 2020).
The TEACH study was approved by the institutional review boards at Boston University Medical Campus and Emory University as well as the Grady [Health System] Research Oversight Committee.
2.2. Provider and Patient Participant Recruitment and Assessment
HIV physicians and advanced practice providers were recruited from September 2015 through December 2016 from two safety-net, hospital-based, HIV clinics in Boston and Atlanta. Clinicians and their patients were identified by electronic medical record queries. Clinician inclusion criteria included the following: 1) being a physician or advanced practice provider at the medical centers’ HIV clinic; and 2) being the main clinician for one or more PWH receiving COT. COT was defined as having received ≥3 opioid prescriptions ≥21 days apart within a 6-month period in the prior year. Clinician exclusion criteria included the following: 1) being a study investigator; and 2) planning to leave the clinic within 9 months from enrollment.
Clinicians completed baseline and 12-month follow-up assessments, which included questions on demographics, training and practice characteristics, practices for assessing and treating pain and substance use, and practices for managing use of prescribed opioids. The primary outcome, clinician satisfaction, was assessed through the question, “How satisfied are you in managing chronic opioid therapy in your HIV-infected patients who are on chronic opioid therapy for pain?” with a Likert scale including scores ranging from “1 – not at all”, to “10 – extremely”. The secondary outcome, clinician confidence, was similarly assessed through the question, “How confident are you in managing chronic opioid therapy in your HIV-infected patients who are on chronic opioid therapy for pain?” with scores ranging from 1 to 10. Clinicians were compensated with a $100 gift card upon completion of each assessment. The paper assessment forms were double-entered into REDCap© [30] by research staff, and any data entry discrepancies were resolved by checking against paper forms.
2.3. Patient Cohort - Participant Recruitment and Assessment
Patients on COT (N=114), of the providers enrolled in the RCT, were recruited into a nested cohort from July 2015 through December 2016 to provide patient reported outcomes and comprise the patient participant study sample for these analyses. Participants were formally screened for additional eligibility criteria: 1) provision of contact information of 2 individuals to assist with follow-up; 2) possession of a telephone; and 3) ability to speak English. Exclusion criteria included plans to move from the area within 12 months and inability to consent or understand interviews. Research staff obtained written informed consent. Participants completed 60 to 90-minute surveys administered by a research associate at both baseline and 12-month follow-up (Samet et al., 2020). The detailed assessment included questions on patient satisfaction with pain management and provider trust. The secondary outcome, trust in clinician, was assessed through the Trust in Physician Scale (Anderson and Dedrick, 1990, Thom et al., 1999), for which the word “physician” was modified to “provider”, since some patients received their COT from physician assistants and nurse practitioners. The eleven questions were scored 1 to 5 and summed, with higher scores representing greater trust. The secondary outcome, patient satisfaction, was assessed through a single question adapted from the REACH study by Kushel et al., “How satisfied are you with … the way this clinic helps you manage your pain?”, with a Likert scale including scores ranging from “1 – not satisfied at all”, to “10 – extremely satisfied”.
2.4. Randomization
Clinicians were randomized to either the control group or the year-long TEACH intervention. Randomization was stratified by site (Atlanta, Boston) and patient volume (1–2, 3–6, 7–11, and 12+ eligible patients). To ensure balance with respect to the number of providers in each group, the permuted blocks strategy was used with blocks of 2. Due to the nature of the intervention, blinding regarding receipt of the TEACH intervention did not occur for providers, participants or study team members who worked with the providers.
2.4.1. Control condition.
Clinicians in the control group received an informational brochure summarizing guidelines for COT and web resources (http://mytopcare.org) with electronic tools.
2.4.2. Intervention.
The 12-month TEACH intervention consisted of 3 main components: 1) a nurse care manager with an IT-enabled electronic registry to manage patients; 2) opioid education and academic detailing [peer-to-peer education] for clinicians; and 3) facilitated access to addiction specialists. Details on the intervention are previously published (Samet et al., 2020, Lira et al., 2019).
3. Analysis
Descriptive statistics were calculated for patient-specific and clinician-specific variables at baseline and the 12-month follow-up with the primary analysis occurring at 12-month follow-up. Demographic characteristics were assessed to ascertain whether randomization was balanced across the 2 arms (Tables 1 & 2).
Table 1.
Baseline Clinician Characteristics in the TEACH Study, by Study Arm and Overall
| Intervention n = 21 | Control n = 20 | Overall n = 41 | |
|---|---|---|---|
|
| |||
| Mean Age (years ± SD) | 45.0 (11.5) | 46.1 (11.7) | 45.5 (11.5) |
|
| |||
| Female, No. (%) | 12 (57.1) | 14 (70.0) | 26 (63.4) |
|
| |||
| Race, No. (%) | |||
| White | 12 (57.1) | 14 (70.0) | 26 (63.4) |
| African American | 2 (9.5) | 2 (10.0) | 4 (9.8) |
| Asian | 4 (19.0) | 3 (15.0) | 7 (17.1) |
| More than one race | 3 (14.3) | 0 (0.0) | 3 (7.3) |
| Other race | 0 (0.0) | 1 (5.0) | 1 (2.4) |
|
| |||
| Hispanic, No. (%) | 2 (9.5) | 2 (10.0) | 4 (9.8) |
|
| |||
| Professional Title, No. (%) | |||
| MD | 17 (81.0) | 15 (75.0) | 32 (78.0) |
| Advanced Practice Provider | 4 (19.0) | 5 (25.0) | 9 (22.0) |
|
| |||
| Boston Site, No. (%) | 6 (28.6) | 5 (25.0) | 11 (26.8) |
|
| |||
| Buprenorphine Waivered, No. (%) | |||
| Yes | 2 (9.5) | 3 (15.0) | 5 (12.2) |
| No | 15 (71.4) | 12 (60.0) | 27 (65.9) |
| Not a physician* | 4 (19.0) | 5 (25.0) | 9 (22.0) |
|
| |||
| Number of patients on COT (mean ± SD) | 4.10 (4.12) | 5.00 (6.69) | 4.54 (5.47) |
|
| |||
| Patients on COT, No. (%) | |||
| 1–2 | 9 (42.9) | 9 (45.0) | 18 (43.9) |
| 3–6 | 9 (42.9) | 8 (40.0) | 17 (41.5) |
| 7–11 | 1 (4.8) | 0 (0.0) | 1 (2.4) |
| 12+ | 2 (9.5) | 3 (15.0) | 5 (12.2) |
At the time of study only physicians could obtain waiver to prescribe buprenorphine
Table 2:
Baseline Patient Characteristics in the TEACH Study, by Study Arm and Overall
| Intervention n = 58 | Control n = 56 | Overall n = 114 | |
|---|---|---|---|
|
| |||
| Mean Age (years ± SD) | 54.1 (8.0) | 52.5 (8.5) | 53.3 (8.2) |
|
| |||
| Female, No. (%) | 20 (34.5) | 18 (32.1) | 38 (33.3) |
|
| |||
| Race, No. (%) | |||
|
| |||
| White | 15 (25.9) | 11 (19.6) | 26 (22.8) |
| Black | 40 (69.0) | 43 (76.8) | 83 (72.8) |
| Other | 3 (5.2) | 2 (3.6) | 5 (4.4) |
|
| |||
| Hispanic, No. (%) | 3 (5.2) | 2 (3.6) | 5 (4.4) |
|
| |||
| Sexual Orientation, No. (%) | |||
| Straight/Heterosexual | 38 (65.5) | 37 (66.1) | 75 (65.8) |
| Gay/Lesbian/Queer/Homosexual | 14 (24.1) | 16 (28.6) | 30 (26.3) |
| Bisexual | 5 (8.6) | 3 (5.4) | 8 (7.0) |
| Other | 1 (1.7) | 0 (0.0) | 1 (0.9) |
|
| |||
| High School Graduate, No. (%) | 37 (63.8) | 39 (69.6) | 76 (66.7) |
|
| |||
| Housing,* No. (%) | |||
| Own or rent home/apartment | 47 (81.0) | 49 (87.5) | 96 (84.2) |
| Staying at home of family member(s) | 6 (10.3) | 3 (5.4) | 9 (7.9) |
| In a rooming, boarding, halfway house | 1 (1.7) | 4 (7.1) | 5 (4.4) |
| Other | 4 (6.9) | 0 (0.0) | 4 (3.5) |
|
| |||
| Jail or prison (past 12 mo.), No. (%) | 4 (6.9) | 6 (10.7) | 10 (8.8) |
|
| |||
| HIV transmission route, No. (%) | |||
| MSM/IDU | 3 (5.2) | 3 (5.4) | 6 (5.3) |
| MSM only | 16 (27.6) | 13 (23.2) | 29 (25.4) |
| IDU only | 6 (10.3) | 5 (8.9) | 11 (9.6) |
| Presumed heterosexual + blood/blood products | 5 (8.6) | 6 (10.7) | 11 (9.6) |
| Presumed heterosexual only | 28 (48.3) | 29 (51.8) | 57 (50.0) |
|
| |||
| Mean duration of opioid prescription (yrs ± SD) | 7.2 (7.5) | 7.3 (7.6) | 7.3 (7.5) |
|
| |||
| Mean morphine milligram equivalent (MME ± SD) | 28.4 (40.8) | 36.3 (49.3) | 32.3 (45.3) |
|
| |||
| Undetectable viral load, No. (%) | 56 (96.6) | 48 (85.7) | 104 (91.2) |
|
| |||
| Ever injected drugs,a No. (%) | 14 (24.6) | 9 (18.8) | 23 (21.9) |
only asked at follow-up (n=105)
This study used an intention-to-treat analysis including all randomized participants according to their assignment. Randomization and the intervention occurred at the provider level while the unit of observation included both the providers and individual patients receiving COT, depending on the outcome of interest. In analyses of patient reported outcomes, it was necessary to account for clustering by the clinician. The primary analysis evaluating the effect of the intervention on the clinician satisfaction used linear regression models. The models included the randomization group as the main independent variable and also controlled for the randomization’s stratification factors (i.e., site and provider volume). The secondary outcome of clinician confidence was analyzed similarly. Due to their skewed distribution, the secondary outcomes trust in clinician and patient satisfaction in the way the clinic managed pain were dichotomized as ‘high’ (defined as top quartile) vs. ‘low’ (Kushel et al., 2001). The outcomes patient trust (high vs. low) and patient satisfaction (high vs. low) at 12 months were analyzed using GEE logistic regression with an exchangeable working correlation structure and results based on empirical standard errors to account for clustering by clinicians. We used multiple imputation to account for missing outcome data in the following variables: provider satisfaction (n=1), provider confidence (n = 1), patient satisfaction (n = 9), and patient trust (n = 9). We generated 25 complete datasets for the multiple imputation. Variables used for imputation of provider-level outcomes included gender, patient volume, study site, randomization group, years providing HIV care, and baseline value of the outcome. Variables used for imputation of patient-level outcomes included gender, age, depressive symptoms, hazardous drinking, drug use, race, ethnicity, BMI, CD4 cell count, HIV viral load, Charlson Comorbidity Index, randomization group, stratification variables (provider patient volume), study site, and baseline value of the outcome. For patient-level outcomes, data were imputed separately by provider and small clusters were combined in some cases due to computational issues. Analyses were conducted using SAS version 9.4 (SAS Institute, Inc.).
4. Results
4.1. Provider and Patient Characteristics
Forty-one clinicians were randomized into this trial with 21 assigned to the intervention and 20 to the control arm. The mean age was 45 years old (SD 11.5) with 26 (63%) being women, the majority (63%) white, and 4 (10%) Hispanic. Most were physicians (78%) and few physicians (5/32 [16%]) were buprenorphine waivered. The mean number of patients on COT per provider was 4.5 (SD 5.5). The patient cohort enrolled 114 total participants, 58 cared for by an intervention-provider and 56 cared for by a control-clinician (Table 2). The mean patient age was 53 years (SD 8) with 38 (33%) being women, 83 (73%) Black, and 5 (4%) Hispanic. One-third (33%) did not complete high school, 10 (8.8%) were incarcerated in prior 12 months, and 23 (22%) ever injected drugs. Participants reported back pain (22%), joint pain (15%), multiple pain sources (14%) and neuropathy (13%) as the most frequent problems being treated with COT.
4.2. Clinician and Patient Outcomes
Mean clinician satisfaction with managing COT was 4.24 (SD 2.10) on a scale of 1–10 in the intervention group and 3.45 (SD 1.99) in the control group at baseline with 5.20 (SD 1.88) and 4.00 (SD 2.10) respectively at follow-up (Table 3). The adjusted mean difference in satisfaction with managing COT for intervention vs. control clinicians was 1.11 points (95% CI: −0.04–2.26, p=0.06) at follow-up. Mean clinician confidence (scale of 1–10) in managing COT was 5.71 (SD 1.68) in the intervention group and 5.00 (SD 2.08) in control group at baseline compared to 6.50 (SD 1.50) and 5.40 (SD 1.73), respectively at follow-up. The adjusted mean difference in confidence in managing COT for intervention vs. control providers was 1.01 points (95% CI: 0.05–1.96, p=0.04) at follow-up.
Table 3.
Satisfaction and confidence with chronic opioid therapy (COT), and trust in clinician outcomes at 12-month follow-up
| Clinician-level Outcomes | Intervention (n=20) | Control (n=20) | Adjusted mean difference (95% CI) | p-value |
|---|---|---|---|---|
|
| ||||
| Satisfaction in managing COT (1–10) | 5.20 (1.88) | 4.00 (2.10) | 1.11 (−0.04, 2.26) | 0.059 |
| Confidence in managing COT (1–10) | 6.50 (1.50) | 5.40 (1.73) | 1.01 (0.05, 1.96) | 0.039 |
|
| ||||
| Patient-level Outcomes | Intervention (n=57) | Control (n=48) | Adjusted odds ratio (95% CI) | p-value |
|
| ||||
| Patient satisfaction with the way the clinic manages pain (75th percentile, range 1–10)*, No. (%) | 31 (54.4) | 27 (56.3) | 1.17 (0.50, 2.76) | 0.72 |
| Patient trust in provider (75th percentile, range 11–55)*, No. (%) | 21 (36.8) | 12 (25.0) | 1.63 (0.65, 4.09) | 0.30 |
odds of being in top quartile for patient satisfaction and trust
The proportions with high patient satisfaction (i.e. a score in the top quartile) with how the clinic manages pain in the intervention and control groups was 50% vs. 55%, respectively, at baseline and 54% vs. 56%, respectively, at follow-up. The proportions with high patient trust in clinicians in the intervention and controls groups was 26% vs. 39%, respectively, at baseline and 37% vs. 25%, respectively, at follow-up. There were no significant differences between intervention and control arms for high patient satisfaction with the clinic approach to pain (AOR 1.17; 95% CI: 0.5 – 2.76, p=0.72) or high patient trust in provider (AOR 1.63; 95% CI: 0.65 – 4.09, p=0.30).
5. Discussion
Chronic opioid therapy (COT) is a sensitive realm of clinical care. The TEACH intervention delivered more guideline-concordant care for PWH on COT (Samet et al., 2020). However, it is important to assess the impact of implementing this intervention on the satisfaction and trust among clinicians and patients. This analysis of the TEACH study found that provider satisfaction in providing COT for chronic pain moved in the desired direction, though the improvement was not statistically significant. Reassuringly, increased COT guideline concordance did not come at a cost to patients’ trust in their clinicians or their satisfaction with pain management. Furthermore, the intervention increased clinicians’ confidence in providing COT.
While we initially hypothesized that all domains would be positively affected by the TEACH intervention, on the national scene prescribing behaviors and the management of patients on chronic opioid therapy (COT) came under intense scrutiny from external sources, during the time of implementation. This temporal phenomenon raised concern that an intervention like TEACH might draw more attention to the issue and unintentionally, negatively, affect provider satisfaction (Strickler et al., 2020, Wiese et al., 2018)
Patient satisfaction and patient trust in their clinician are two critical pieces of healthcare delivery in the United States (Manary et al., 2013). Implementing programs that would interfere with satisfaction or trust could be counterproductive. Additionally, with HIV care an extra emphasis is placed on retention in care, so clinicians may be reluctant to engage in practices if they perceive potential to sever relationships or trust. Altering an opioid prescription raises concern about creating tension, disrupting the patient-clinician relationship and adversely impacting retention in care or maintenance of viral suppression (Starrels et al., 2016, Tsui et al., 2019) In particular, heightened monitoring around opioids may make patients suspicious or feel as though they are being policed, in turn discouraging patients from remaining in care (Starrels et al., 2016, Carroll et al., 2020). The TEACH intervention achieved heightened monitoring as evidenced by more urine drug tests, pain treatment agreements and checking of the prescription drug monitoring program (Samet et al., 2020). Importantly, while improvements in guideline concordant care for the delivery of COT occurred, we did not detect an adverse impact on patient satisfaction or trust in their clinician. This is reassuring for both clinicians and patients alike. These results can inform program administrators, clinical staff, and others who are concerned as to how implementation of this type of intervention might impact ongoing care engagement.
An inherent mechanism of the TEACH intervention is frequent interactions between the clinician-nurse care manager-patient triad and case conferencing. These are ideal platforms to layer more targeted education around chronic pain management and opioid prescribing to improve clinicians’ comfort and satisfaction around the process. While we do not know the mechanism for preservation of satisfaction and trust during the TEACH intervention, we hypothesize that it stems from intentional messaging and programming that centered around preserving patient safety and minimizing harms from the opioids. We also employed harm reduction approaches such as emphasizing access to naloxone for treatment of overdose and addiction services if aberrant behaviors suggested such a diagnosis.
The somewhat small magnitude of effect of TEACH on provider confidence toward prescribing and managing COT was surprising given the education and support providers received. The dampened impact on the confidence scores may be two-fold: 1) support was provided largely in the context of a team comprised of a nurse plus access to an addiction specialist, so this support system may have mitigated the ultimate impact on providers’ confidence in their own ability to manage COT; 2) the average number of patients a provider had on COT was small, so the low clinical volume may not sufficiently impact provider comfort as with most skill acquisition, volume and repetition are key. Finally, the similarly small impact on clinician satisfaction may have been in part a consequence of the overarching negative and accusatory environment that providers found themselves in during the time frame of a national crackdown on opioid prescribing.
The study has several limitations. Patients and clinicians could not be blinded to the intervention so potential exists for response bias in that those in the intervention arm may feel a need to rate domains such as satisfaction and confidence more favorably. Clinicians in the intervention and control arms worked in the same clinical spaces raising the potential for contamination bias. For instance, knowledge regarding COT prescribing could be shared among colleagues, which could have mitigated differences between intervention and control clinicians with regard to potential impact of the TEACH intervention on increasing clinicians’ confidence in prescribing. During the period of the intervention there was an increased awareness about the risks associated with inappropriate opioid prescribing by physicians which could have influenced both the intervention as well as the control group.
6. Conclusions
These data emphasize that in the context of an intervention known to improve guideline concordant opioid prescribing and monitoring by clinicians, the potential negative impact on patient satisfaction or the patient-provider relationship was averted. Our results are consistent with a large-scale patient survey where patient trust was maintained among those receiving care in clinics with ongoing opioid risk initiatives (Sherman et al., 2018). With the TEACH primary outcome demonstrating improved guideline concordant opioid monitoring and the current results showing no evidence of harm to confidence or trust among clinicians and patients, this seems to be a scalable intervention (Samet et al., 2020). Implementation and scale-up of TEACH-type interventions, which build upon a comprehensive care model fit well into existing integrated, multi-disciplinary models of HIV care delivery.
Supplementary Material
Supplemental Figure 1. CONSORT Flow Diagram of TEACH Study
Highlights:
COT monitoring for PWH (TEACH), had a neutral impact on provider satisfaction
TEACH improved provider confidence around COT compared to usual care
TEACH did not adversely affect patient satisfaction or trust
Author Disclosures
Role of Funding
This work was supported by the National Institutes of Health through (grant number R01DA037768 from the National Institute on Drug Abuse); the Emory Center for AIDS Research (grant number P30AI050409 from the National Institute of Allergy and Infectious Diseases); and the Boston/Providence Center for AIDS Research (grant number P30AI042853 from the National Institute of Allergy and Infectious Diseases).
Footnotes
Conflicts of Interest
DC serves on data and safety monitoring boards for Janssen Research and Development. The other authors have no conflicts of interest to disclose.
Clinical Trial Registration Details: The TEACH trial (NCT02564341) and observational cohort (NCT02525731) were registered on clinicaltrials.gov.
References
- Executive Office of the President of the United States. National Drug Control Strategy. January 2019. Available at: https://www.whitehouse.gov/wp-content/uploads/2019/01/NDCS-Final.pdf. Accessed on 10 August 2020..
- AHMAD F, ROSSEN L & SUTTON P Provisional drug overdose death counts. National Center for Health Statistics. 2021. [Google Scholar]
- ANDERSON LA & DEDRICK RF 1990. Development of the Trust in Physician scale: a measure to assess interpersonal trust in patient-physician relationships. Psychol Rep, 67, 1091–100. [DOI] [PubMed] [Google Scholar]
- BOHNERT ASB, GUY GP JR. & LOSBY JL 2018. Opioid Prescribing in the United States Before and After the Centers for Disease Control and Prevention’s 2016 Opioid Guideline. Ann Intern Med, 169, 367–375. [DOI] [PMC free article] [PubMed] [Google Scholar]
- BRUCE RD, MERLIN J, LUM PJ, AHMED E, ALEXANDER C, CORBETT AH, FOLEY K, LEONARD K, TREISMAN GJ & SELWYN P 2017. 2017 HIVMA of IDSA Clinical Practice Guideline for the Management of Chronic Pain in Patients Living With HIV. Clin Infect Dis, 65, e1–e37. [DOI] [PMC free article] [PubMed] [Google Scholar]
- CARROLL JJ, LIRA MC, LUNZE K, COLASANTI JA, DEL RIO C & SAMET JH 2020. Painful Subjects: Treating Chronic Pain among People Living with HIV in the Age of Opioid Risk. Med Anthropol Q. [DOI] [PMC free article] [PubMed] [Google Scholar]
- DOWELL D, HAEGERICH TM & CHOU R 2016. CDC Guideline for Prescribing Opioids for Chronic Pain - United States, 2016. MMWR Recomm Rep, 65, 1–49. [DOI] [PubMed] [Google Scholar]
- GLADDEN RM, MARTINEZ P & SETH P 2016. Fentanyl Law Enforcement Submissions and Increases in Synthetic Opioid-Involved Overdose Deaths - 27 States, 2013–2014. MMWR Morb Mortal Wkly Rep, 65, 837–43. [DOI] [PubMed] [Google Scholar]
- JIAO JM, SO E, JEBAKUMAR J, GEORGE MC, SIMPSON DM & ROBINSON-PAPP J 2016. Chronic pain disorders in HIV primary care: clinical characteristics and association with healthcare utilization. Pain, 157, 931–937. [DOI] [PubMed] [Google Scholar]
- KUSHEL MB, VITTINGHOFF E & HAAS JS 2001. Factors associated with the health care utilization of homeless persons. JAMA, 285, 200–6. [DOI] [PubMed] [Google Scholar]
- LIRA MC, TSUI JI, LIEBSCHUTZ JM, COLASANTI J, ROOT C, CHENG DM, WALLEY AY, SULLIVAN M, SHANAHAN C, O’CONNOR K, ABRAMS C, FORMAN LS, CHAISSON C, BRIDDEN C, PODOLSKY MC, OUTLAW K, HARRIS CE, ARMSTRONG WS, DEL RIO C & SAMET JH 2019. Study protocol for the targeting effective analgesia in clinics for HIV (TEACH) study - a cluster randomized controlled trial and parallel cohort to increase guideline concordant care for long-term opioid therapy among people living with HIV. HIV Res Clin Pract, 20, 48–63. [DOI] [PMC free article] [PubMed] [Google Scholar]
- MANARY MP, BOULDING W, STAELIN R & GLICKMAN SW 2013. The patient experience and health outcomes. N Engl J Med, 368, 201–3. [DOI] [PubMed] [Google Scholar]
- MATTHIAS MS, PARPART AL, NYLAND KA, HUFFMAN MA, STUBBS DL, SARGENT C & BAIR MJ 2010. The patient-provider relationship in chronic pain care: providers’ perspectives. Pain Med, 11, 1688–97. [DOI] [PubMed] [Google Scholar]
- MERLIN JS, CEN L, PRAESTGAARD A, TURNER M, OBANDO A, ALPERT C, WOOLSTON S, CASARETT D, KOSTMAN J, GROSS R & FRANK I 2012. Pain and physical and psychological symptoms in ambulatory HIV patients in the current treatment era. J Pain Symptom Manage, 43, 638–45. [DOI] [PMC free article] [PubMed] [Google Scholar]
- O’DONNELL J, GLADDEN RM, GOLDBERGER BA, MATTSON CL & KARIISA M 2020. Notes from the Field: Opioid-Involved Overdose Deaths with Fentanyl or Fentanyl Analogs Detected - 28 States and the District of Columbia, July 2016-December 2018. MMWR Morb Mortal Wkly Rep, 69, 271–273. [DOI] [PMC free article] [PubMed] [Google Scholar]
- SAMET JH, TSUI JI, CHENG DM, LIEBSCHUTZ JM, LIRA MC, WALLEY AY, COLASANTI JA, FORMAN LS, ROOT C, SHANAHAN CW, SULLIVAN MM, BRIDDEN CL, ABRAMS C, HARRIS C, OUTLAW K, ARMSTRONG WS & DEL RIO C 2020. Improving the Delivery of Chronic Opioid Therapy among People Living with HIV: A Cluster Randomized Clinical Trial. Clin Infect Dis. [DOI] [PMC free article] [PubMed] [Google Scholar]
- SCHOLL L, SETH P, KARIISA M, WILSON N & BALDWIN G 2018. Drug and Opioid-Involved Overdose Deaths - United States, 2013–2017. MMWR Morb Mortal Wkly Rep, 67, 1419–1427. [DOI] [PMC free article] [PubMed] [Google Scholar]
- SHERMAN KJ, WALKER RL, SAUNDERS K, SHORTREED SM, PARCHMAN M, HANSEN RN, THAKRAL M, LUDMAN EJ, DUBLIN S & VON KORFF M 2018. Doctor-Patient Trust Among Chronic Pain Patients on Chronic Opioid Therapy after Opioid Risk Reduction Initiatives: A Survey. J Am Board Fam Med, 31, 578–587. [DOI] [PubMed] [Google Scholar]
- STARRELS JL, PEYSER D, HAUGHTON L, FOX A, MERLIN JS, ARNSTEN JH & CUNNINGHAM CO 2016. When human immunodeficiency virus (HIV) treatment goals conflict with guideline-based opioid prescribing: A qualitative study of HIV treatment providers. Subst Abus, 37, 148–53. [DOI] [PMC free article] [PubMed] [Google Scholar]
- STRICKLER GK, KREINER PW, HALPIN JF, DOYLE E & PAULOZZI LJ 2020. Opioid prescribing behaviors - prescription behavior surveillance system, 11 States, 2010–2016. MMWR Surveill Summ, 69, 1–14. [DOI] [PMC free article] [PubMed] [Google Scholar]
- THOM D, RIBISL KM, STEWART AL & LUKE DA 1999. Further Validation and Reliability Testing of the Trust in Physician Scale. Medical Care, 37, 510–517. [DOI] [PubMed] [Google Scholar]
- TSUI JI, WALLEY AY, CHENG DM, LIRA MC, LIEBSCHUTZ JM, FORMAN LS, SULLIVAN MM, COLASANTI J, ROOT C, O’CONNOR K, SHANAHAN CW, BRIDDEN CL, DEL RIO C & SAMET JH 2019. Provider opioid prescribing practices and the belief that opioids keep people living with HIV engaged in care: a cross-sectional study. AIDS Care, 31, 1140–1144. [DOI] [PMC free article] [PubMed] [Google Scholar]
- VIJAYARAGHAVAN M, PENKO J, BANGSBERG DR, MIASKOWSKI C & KUSHEL MB 2013. Opioid analgesic misuse in a community-based cohort of HIV-infected indigent adults. JAMA Intern Med, 173, 235–7. [DOI] [PMC free article] [PubMed] [Google Scholar]
- WIESE HJC, PIERCEY RR & CLARK CD 2018. Changing prescribing behavior in the United States: Moving upstream in opioid prescription education. Clin Pharmacol Ther, 103, 982–989. [DOI] [PubMed] [Google Scholar]
- WILSON N, KARIISA M, SETH P, SMITH HT & DAVIS NL 2020. Drug and Opioid-Involved Overdose Deaths - United States, 2017–2018. MMWR Morb Mortal Wkly Rep, 69, 290–297. [DOI] [PMC free article] [PubMed] [Google Scholar]
Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
Supplemental Figure 1. CONSORT Flow Diagram of TEACH Study