A randomized trial of collaborative support for opioid taper after trauma hospitalization

doi:10.21203/rs.3.rs-2476223/v1

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Research Article

A randomized trial of collaborative support for opioid taper after trauma hospitalization

https://doi.org/10.21203/rs.3.rs-2476223/v1

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published 23 Jun, 2024

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The COTAT (Collaborative Opioid Taper After Trauma) Study was a randomized trial of an opioid taper support program using a physician assistant (PA) to provide pain and opioid treatment guidance to primary care providers assuming care for adult patients with moderate to severe trauma discharged from a Level I trauma center on opioid therapy. Patients were recruited, assessed, and randomized individually by a surgery research recruitment team one to two days prior to discharge to home. Participants randomized to the opioid taper support program were contacted by phone within a few days of discharge by the PA interventionist to confirm enrollment and their primary care provider (PCP). The intervention consisted of PA support to the PCP as needed concerning pain and opioid care at weeks 1, 2, 4, 8, 12, 16, and 20 after discharge or until the PCP office indicated they no longer needed support or the patient had tapered off opioids. The PA was supervised by a pain physician-psychiatrist, a family physician, and a trauma surgeon. Patients randomized to usual care received standard hospital discharge instructions and written information on managing opioid medications after discharge. Trial results were analyzed using repeated measures analysis. 37 participants were randomized to the intervention and 36 were randomized to usual care. The primary outcomes of the trial were pain, enjoyment, general activity (PEG score) and mean daily opioid dose at 3 and 6 months after hospital discharge. Treatment was unblinded but assessment was blinded. No significant differences in PEG or opioid outcomes were noted at either time point. Physical function at 3 and 6 months and pain interference at 6 months were significantly better in the usual care group. No significant harms of the intervention were noted. COVID limited recruitment of high-risk opioid tolerant subjects, and limited contact between the PA interventionist and the participants and the PCPs. Our opioid taper support program failed to improve opioid and pain outcomes, since both control and intervention groups tapered opioids and improved PEG scores after discharge. Future trials of post-trauma opioid taper support with populations at higher risk of persistent opioid use are needed.

This trial is registered at clinicaltrials.gov under NCT04275258 11/02/2020. This trial was funded by a grant from the Centers for Disease Control and Prevention to the University of Washington Harborview Injury Prevention & Research Center (R49 CE003087, PI: Monica S. Vavilala, MD). The funder had no role in the analysis or interpretation of the data.

collaborative care

care management

post-trauma care

long-term opioid use

chronic pain

The U.S. remains in the midst of an unprecedented opioid crisis. Nearly one million people have died since 1999 from a drug overdose. In 2020, 91,799 drug overdose deaths occurred in the United States. Opioids were involved in three-fourths of these drug overdose deaths and 82% of these opioid overdose deaths included synthetic opioids.¹ However, 30–50% of patients who develop OUD or die from opioid overdose begin opioid use with prescribed opioids.[6; 20]

Opioid pain relievers are essential for treatment of pain after trauma, with over half of hospitalized trauma patients experiencing moderate to severe pain, and most patients still reporting pain at hospital discharge.⁴ Persistent pain after trauma is common and associated with poor quality of life, psychological distress, reduced return to work, and the development of chronic pain.^5–7 Most trauma patients are discharged on opioids.⁸ Patients discharged after major trauma are at high risk for opioid misuse and OUD, with two-thirds having at least one risk factor for unintentional opioid overdose and almost half showing signs of misuse.⁹

Few opioid tapering guidelines exist for patients discharged after injury. Opioid tapering requires collaboration among the trauma center care team, the patient, and the primary care provider (PCP). This collaboration is especially difficult for patients living in rural areas remote from the trauma center, resulting in unequal risks for OUD and opioid overdose.¹³ We therefore conducted a pilot randomized clinical trial of an individualized opioid taper support program to support the PCPs of patients discharged from Level I inpatient trauma care after moderate to severe trauma and at high risk for prolonged opioid use because of the severity of their injury, their acute care exposure to opioids, and their discharge to outlying counties in Washington State. Our hypothesis was that: a 20-week collaborative pain care and opioid taper program will: a) improve pain outcomes (pain severity, general activity interference, enjoyment of life interference) and b) facilitate return to off or pre-injury opioid dose, c) improve secondary outcomes such as general patient-reported health status, and problem use of alcohol, cannabis, and illicit drugs.

Study Design, Participants and Setting

This randomized controlled trial (RCT) was conducted at Harborview Medical Center in Seattle, Washington. Harborview Medical Center is the only Level I trauma center in the 5-state Northwest region of the US, covering 25% of the land mass of the US. This RCT included unblinded intervention administration but blinded outcome assessment. The study was approved by the UW institutional review board. All participants provided written informed consent. Study enrollment occurred from June 2020 and February 2022. Figure 1 shows participant flow through the study.

Study inclusion criteria were: age ≥ 18 years, admitted to Harborview Medical Center after trauma (Injury Severity Score ≥ 4), speaks and reads English or Spanish, insurer in All Payer Claims Database (Medicare, Medicaid, other public WA insurance, WA commercial payors), planned to be discharged on opioids to Washington State counties outside King County. Study exclusion criteria included: admission Glasgow Coma Score < 15, unable to read English or Spanish, currently active cancer, enrollment in palliative care or hospice, plan for discharge to skilled nursing facility or assisted living, implanted device for pain control, Opioid Use Disorder (OUD) diagnosis in the electronic health record (including evidence of OUD treatment with buprenorphine, methadone, or naltrexone), use of illicit drugs in past month, psychotic symptoms, and psychiatric hospitalization or suicide attempt in past year.

Procedures

Study participants’ electronic medical records were screened for eligibility during their hospital admission at Harborview Medical Center following moderate to severe trauma. Patients were recruited and consent obtained while inpatients by a surgery research recruitment team. Patients who provided consent were asked to complete a set of baseline questionnaires prior to randomization. Participants completed baseline questionnaires in the hospital prior to randomization. Follow-up assessments were conducted over the phone. Participants received $20 for completing the baseline assessment, $40 for the 12-week follow-up, and $50 for the 24-week follow-up.

Intervention

Opioid Taper Support Program

The taper support intervention was primarily aimed at supporting the PCP, but began with an introductory phone call from the physician assistant (PA) interventionist to the patient within a few days of hospital discharge. This introductory call was used to confirm patient enrollment, clarify their PCP and follow-up plans, review discharge instructions and the pain management plan, and solicit any patient post-discharge concerns, focused on pain and opioid management. The PA was supervised by a pain physician-psychiatrist, a family physician, and a trauma surgeon.

If the patient identified a PCP with whom they planned to follow-up, the PA called the PCP’s office to describe the study, determine if the patient had a follow-up appointment, and review the discharge instructions. If the PCP was unavailable, the PA asked to speak with other clinical staff (e.g., registered nurse or medical assistant). If clinical staff were unavailable, the PA spoke with clerical staff, describing the study and its purpose of providing collaborative support for pain and opioid taper following a trauma hospitalization. The PA offered support as needed at weeks 1, 2, 4, 8, 12, 16, and 20 after discharge or until the PCP office indicated they no longer needed support or the patient had tapered off opioids or were no longer following up with their PCP. If no PCP was identified by the patient, the PA made an effort to identify a PCP for the patient.

Support offered by the interventionist to the PCP included:

1) Faxing the patient’s discharge summary, discharge instructions, and a detailed study instruction sheet to the PCP within a few days of the patient’s discharge

2) Contacting the hospital trauma team if questions about trauma recovery arose

3) Advising on the opioid taper plan if it was not proceeding as planned, including any concerns about prescription opioid use, misuse, or abuse or illicit opioid use

4) Problem solving if the PCP had any concerns about their patient’s pain management

5) Arranging a case presentation to a multidisciplinary telemedicine pain specialist panel about the patient if the PCP desired additional advice

Usual care

Patients randomized to usual care received standard hospital discharge instructions and a written information on managing opioid medications after discharge. No other alterations or restrictions in usual follow-up care were imposed.

Measures

Descriptive measures

At the time of study enrollment, the following information was collected from the electronic medical record: age, sex, language preference, ZIP code, Injury Severity Score, Glasgow Coma Score, injury locations, trauma care interventions (hospital and ICU days, procedures, intubation, pain infusions), inpatient pain management strategies (, total opioid days, IV opioid days, oral opioid days) admission alcohol and drug screens. The following pain, opioid and substance use information was collected: a) pre-admission chronic pain, b) lifetime opioid exposure, opioid exposure in pre-trauma month, c) lifetime cannabis, past year non-medical drug use.

Primary outcomes

Pain: Total Pain, Enjoyment of life, and General activities (PEG) score. The PEG is a three item self-reported assessment of average pain intensity (P), interference with enjoyment of life (E), and interference with general activity (G). Construct validity of the PEG is good for various pain-specific measures and comparable to that of the legacy Brief Pain Inventory (BPI). The PEG has been demonstrated to be sensitive to change and be able to differentiate between patients with and without pain improvement at 6 months.[12]

Opioids: Mean daily prescribed opioid dose in oral morphine equivalent dose (MED) milligrams (continuous outcome), and percent at or below self-reported baseline pre-trauma opioid dose (categorical outcome). These measures were collected through the electronic medical record (EMR), using EMR access to Washington State Prescription Drug Monitoring Program (PDMP) data for 12 and 24 week of drug abuse.

Secondary outcomes

PROMIS-29 Health Profile (29 items)[8] The PROMIS-29 v2.0 profile assesses pain intensity using a single 0–10 numeric rating item and seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) using four items per domain. It has been used to monitor health outcomes after trauma.[7] For PROMIS instruments, a score of 50 is the average for the United States general population with a standard deviation of 10. A higher PROMIS T-score represents more of the concept being measured. For negatively-worded concepts like Anxiety, a T-score of 60 is one SD worse than average. By comparison, an Anxiety T-score of 40 is one SD better than average. However, for positively-worded concepts like Physical Function-Mobility, a T-score of 60 is one SD better than average while a T-score of 40 is one SD worse than average.

DAST-10: Drug Abuse Screening Test (10 items)[19] is a self-reported screening tool that assesses patient drug use (including both nonmedical use of drugs and excessive use of prescription drugs) over the 12-month period leading up to the time of the screening, yielding a quantitative index. The DAST-10 total score can range from 0 to 10.

Alcohol Use Disorders Identification Test Screen (3 items)[9] The 3-item AUDIT-C measures alcohol consumption [frequency, quantity, and binge-drinking (defined as ≥ 6 drinks on any one occasion)] during the past six months. It has been used to assess problem drinking in patients with chronic pain.[3] The AUDIT-C is scored on a scale of 0–12 (scores of 0 reflect no alcohol use). In men, a score of 4 or more is considered positive; in women, a score of 3 or more is considered positive. Generally, the higher the AUDIT-C score, the more likely it is that the patient's drinking is affecting his/her health and safety.

Monitoring the Future cannabis questions (4 items)[16] Monitoring the Future is a NIDA-sponsored survey asking participants to report their drug use behaviors across three time periods: lifetime, past year, and past month. Four items assess recent cannabis use. It has been used to monitor cannabis in patients with chronic pain treated with opioids.[4]

HUNT3 study patient experience with PCP items (5 items)[18] is a self-report survey concerning satisfaction with PCP care adapted from the Hunt Norwegian Pain Study.[14] We report here only on the satisfaction with pain care item.

Randomization Procedures

Study participants were randomized 1:1 according to computer generated sequence to receive either the opioid taper support intervention or usual care according to a computer-generated randomization list in sealed envelopes. Randomization was initially stratified according to whether the patient was taking regular opioids during the month prior to injury, but this stratification was discontinued due to low overall recruitment related to COVID, making it impossible to oversample individuals taking opioids prior to injury.

For this study, the proposed sample size of 100 would have provided 80% power to detect a 23 percent decrease in the proportion of patients on opioids at 6 months, from 30–7%, in a z-test with pooled variance and an alpha level of 0.05. For pain outcomes, assuming a final study population of 80 subjects with independent PCPs, we would have 80% power to detect a difference in PEG score of 1.3 points between the treatment and control arm, with a standard deviation of 2.1 and alpha level 0.05. Due to recruitment restrictions associated with the COVID-19 epidemic, the trial was stopped after 73 subjects were randomized.

Statistical Analyses

Baseline demographic, injury characteristics, trauma care interventions and baseline (pre-injury) pain, and substance use variables were compared using chi-square tests for categorical variables or t-tests for continuous variables between intervention and control groups. No variables were found to be imbalanced at baseline.

All primary and secondary statistical analyses were conducted with the intent-to-treat sample. Continuous dependent variables included: baseline, 3- and 6-month assessments of the PEG scale, opioid dose, and PROMIS-29 scale scores, as well as AUDIT-C alcohol and DAST drug use scores. Dichotomous (any use vs. none) opioid use variables were also analyzed in the pre-trauma month, and at 3- and 6-month timepoints. Continuous depression (PHQ9) scores were obtained only at 3 and 6 months. Mixed effect regression models were fit containing time categories, group (I vs. C) and group by time interactions. Adjusted mean difference or relative risk (aRR) and 95% confidence interval (CI) were derived from the models. All analyses were conducted using SAS Software Version 9.4 (SAS Institute Inc., Cary, NC, USA).

Baseline characteristics of the Sample

As can be seen in Fig. 1, of 4738 potentially eligible subjects identified through medical record review, 1105 were eligible and 78 consented to the study and were randomized.

Table 1 shows the sociodemographic characteristics of the study participants, as well as baseline clinical characteristics, substance use, and pain care received during hospitalization. There were no statistically significant differences between the groups randomized to the opioid taper support intervention vs. usual care. Overall, the mean (SD) age of the study participants was 47.0 (17.4) years. The sample was 72% male. According to residence ZIP codes, 59% of the sample lived in an urban area, 27% lived in a large rural town, 11% lived in a small rural town, and 3% lived in an isolated small rural town.

During the month prior to admission, 37% reported experiencing chronic pain. During their lifetime, 76% had been prescribed opioids. During the month prior to their trauma, 10% had received opioids. The mean (SD) Injury Severity Score was 13.2 (8.2) and 85% (N = 62) of the sample had a Glasgow Coma Score of 15. On admission alcohol testing, 21% were not tested, 66% were negative, 7% were positive but below the legal limit for driving, and 7% were above the legal limit. On admission urine toxicology screen, 62% were not tested, 21% tested negative, 14% tested positive for cannabis, 6% positive for amphetamines, and 1% for cocaine. Over their lifetime, 41% of the sample reported using cannabis 40 or more times.

Mean hospital stay was 4.7 (SD = 3.6) days, with 29% spending some time in intensive care. During hospitalization 75% had orthopedic procedures and 7% had been intubated at some point.

Primary and secondary outcomes at 3 and 6 months

Table 2 shows the observed values for the primary and secondary outcome measures in each group at baseline (prior to hospital discharge) and 3 and 6 months after discharge, as well as the differences between the intervention and usual care groups in the mean change from baseline to 3 and 6 months.

At 3 months, mean total PEG scores were similar in the intervention and usual care groups with no significant differences between the groups. There were also no significant differences between the intervention and usual care groups in the change in overall PEG score or in the individual components of the PEG score (Pain severity, Enjoyment of life interference, General activity interference) between baseline and 3 months.

All participants were taking opioids when discharged from the hospital (as required by study inclusion criteria) with a mean dose of 75mg MED in the intervention group and 67mg MED in the usual care group (Table 3). By 3 months, 6 patients (17%) were on opioids in the intervention group and 3 patients (9%) in the usual care group. Mean daily opioid dose (MED) for the overall randomized groups at 3 months was 8.6 (SD = 27.9) in the intervention group and 2.1 (SD = 8.5) in the usual care group. In the intervention group, 86% were at or below their pre-trauma opioid dose, compared to 94% of the usual care group. Opioid dose at 3 months was reduced from hospital discharge (baseline) in both the intervention and usual care groups, with no significant difference between groups in dose reduction (adjusted mean difference between 3 months and baseline = -1.81 mg MED; 95% CI: -13.65, 10.03; p = 0.76) or in percent with reduction from baseline to 3 months in dose (mean, 89.6% vs 93.7%; adjusted mean difference between 3 months and baseline = 4.1%; 95% CI: -9.4%, 17.7%; p = 0.54; data not shown).

There were no statistically significant differences between the intervention and usual care groups when comparing 3 month to baseline PROMIS-29 scale score changes except for physical function, which worsened less in the usual care group than in the intervention group. (-7.5 mean difference between groups) and pain interference. There were no differences between the intervention and usual care groups when comparing 3-month to baseline AUDIT-C and DAST-10 score changes. At 3 months, PHQ-9 depression score in the collaborative care group was 4.8 (SD = 4.3), while in the usual care group it was 7.3 (SD = 6.6), p = 0.10. Satisfaction with pain care score in the collaborative care group was 9.5 (SD = 1.0), which in the usual care group it was 9.7 (SD = 0.7), p = 0.47.

At 6 months, mean total PEG scores were similar in intervention and usual care groups with no significant differences between groups. There were also no significant differences between the intervention and usual care groups in the change in overall PEG score or in the individual components of the PEG score (Pain severity, Enjoyment of life interference, General activity interference) between baseline and 6 months.

At 6 months, 7 patients (19%) were on opioids in the intervention group and 8 patients (23%) in the usual care group. Mean daily opioid dose (MED) was reduced from hospital discharge (baseline) in both the intervention and usual care groups, with no significant difference between groups in dose reduction (adjusted mean difference between 6 months and baseline = -5.35 mg MED; 95% CI: -17.60, 6.90; p = 0.39) or in percent with reduction from baseline to 6 months in dose (mean, 93.7% vs 92.8%; adjusted mean difference between 6 months and baseline = -0.9%; 95% CI: -14.5%, 12.7%; p = 0.89; data not shown).

At 6 months, there were no statistically significant differences between the intervention and usual care groups when comparing 6 month to baseline PROMIS-29 scale scores except for small improvements in physical function and pain interference, favoring the usual care group. There were no differences between the intervention and usual care group when comparing 6-month to baseline AUDIT-C and DAST-10 score changes There were no differences between the intervention and usual care group when comparing 6-month to baseline AUDIT-C and DAST-10 score changes. At 6 months, thePHQ-9 score in the collaborative care group was 5.2 (SD = 5.7), while in the usual care group it was 6.1 (SD = 6.9) p = 0.55. Satisfaction with pain care score in the collaborative care group was 8.8 (SD = 1.8), which in the usual care group it was 9.5 (SD = 1.3), p = 0.04 (data not shown).

Figure 2 displays the PEG mean score over time, comparing intervention vs control groups at baseline, 3 and 6 months. Figure 3 displays the mean daily opioid dose (in morphine equivalent dose) over time, comparing intervention vs control groups at baseline, 3 and 6 months.

Intervention delivered

PCP offices were successfully contacted on behalf of 19 of the 37 intervention patients, and they had a total of 36 consults. Of these consults, 20 (56%) involved a medical assistant, 8 (22%) involved the PCP and 8 (22%) involved a nurse. Pain management was discussed in 68% of these consults and opioid management was discussed in 79%. The intervention was well-received by both patients and PCP offices.[2]

Our randomized trial of an opioid taper support intervention failed to improve pain or opioid outcomes compared with usual care. There were no significant differences in continuous or categorical opioid outcomes. There are multiple reasons as to why this occurred. 1) Both the intervention and control groups had low rates of opioid use and relatively low pain scores at 3 and 6 months. We aimed to recruit 50% “high-risk” patients who were opioid users at the time their trauma for our sample, but we were able to recruit only < 10%, likely due to COVID-related constraints on hospital admissions and overall subject recruitment, making it impossible to oversample individuals using opioids at the time of their trauma. Our sample was therefore mostly lower risk patients who were not opioid tolerant at the time of their injury. This meant that the control group had a low mean daily opioid dose at 3 and 6 months, so our intervention did not have much opportunity for improvement in this lower risk sample. 2) COVID limited in-person engagement with our research participants. All contact with our physician assistant was conducted over the phone, limiting development of rapport and collaboration. 3) We were unable to identify an established primary care provider (PCP) for almost half of our research participants. Our study population was largely young and male, the group least likely to have an established PCP. Since the intervention was largely focused on the PCP, the study did not have the opportunity to implement the intervention as intended for a substantial proportion of patients. 4) Of the 19 (51%) intervention subjects with confirmed and contacted PCP offices, only 22% involved direct interaction between the physician assistant and the PCP. Many PCPs were preoccupied with COVID care at the time of the study. This attenuated the strength of the intended intervention. 5) A number of our outcome measures (PEG scale, PROMIS scales) are designed to be used in outpatient care. The baseline values for our outcome analyses were collected while our participants were still hospitalized, making change scores on these measures difficult to interpret. We do provide unadjusted analyses of scores between groups at 3 and 6 months that are not affected by this problem.

As we look forward to future research in this area, we should recognize that collaboration between Level 1 trauma centers and rural primary care is underdeveloped. Communication between advanced trauma and PCPs is not listed among the World Health Organization essentials of trauma care,[15] and what little discussion of such collaboration does exist, focuses on the roles and needs of acute trauma care providers as they take rural patients, rather than consideration of the needs of PCPs and the discharged trauma patients themselves.[10]

There remains a need for improved pain care of patients who are discharged from trauma units. Trauma prompts 2.3 million hospitalizations a year. Opioid use for > 90 days after injury in the US in 2009–2012 was 15%.[1] Opioid use 3 to 4 months after trauma-related orthopedic surgery ranges from 20–35%.[17] Opioid dispensing after surgery has decreased substantially after the 2016 CDC guideline release, so these rates are likely lower in 2022.[21] Although gaps in post-trauma pain and opioid care exist, our intervention did not improve pain and opioid outcomes. The risks of prolonged opioid use after trauma are higher for patients who are opioid users at the time of their trauma. Preoperative opioid use is associated with prolonged opioid use among patients undergoing emergency general surgery.[11] We had intended to recruit 50% of our sample from patients who were opioid tolerant at the time of their injury. Due to COVID-related changes in admissions and restrictions in recruitment, we were unable to oversample this group. We thus had a lower risk group recruited into our trial than planned. This may be one reason why both our intervention and usual care groups had favorable and comparable opioid and pain outcomes.

Any program to address post-trauma opioid risks must also address post-trauma pain care. Collaborative care models have been adapted for chronic pain care, but not post-trauma pain care. Collaborative care models using care managers to improve chronic illness care have been adapted for collaborative care of chronic pain, and shown efficacy in randomized clinical trials.[5] Collaborative care for chronic pain delivered over the phone has been shown effective in a randomized trial.[13] Future trials of collaborative opioid taper support interventions will need to address: the lack of established relationships with a PCP among many patients recovering from trauma, the many other acute and chronic disease issues that these PCPs must manage on a daily basis, and the lack of capacity at Level 1 trauma centers to closely follow and monitor patients who have been discharged on opioids.

Ethics approval and consent to participate

Study protocol approved by University of Washington Institutional Review Board. Informed consent was obtained from all study participants. All study methods were carried out in accordance with relevant guidelines and regulations.

Consent for publication

Not applicable.

Availability of data and materials

The dataset supporting the conclusions of this article are available in the Harborview Injury Prevention and Research Center repository [email protected]. De-identifed data available with signed data use agreement upon request from Mark Sullivan, [email protected].

Competing interests

No relevant competing interests for any of the authors.

Funding

This trial was funded by a grant from the Centers for Disease Control and Prevention to the University of Washington Harborview Injury Prevention & Research Center (R49 CE003087, PI: Monica S. Vavilala, MD). The funder had no role in the analysis or interpretation of the data.

Authors' contributions

MS obtained funding, directed the study, authored the manuscript. LK delivered the intervention. SA helped obtain funding, supervised the interventionist, and edited the manuscript. DT supervised the interventionist and edited the manuscript. LMB helped obtain funding, assisted with direction of the study, and edited the manuscript.

Acknowledgements

The authors wish to thank: Debra Gordon for valuable assistance with study design, intervention implementation and data interpretation, Adrienne James for study coordination, Karen Segar for data management, Laura Hennessy for coordinating recruitment, Keegan Stromberg, Hikmatullah Arif, and Mahrukh Kadri for recruiting participants, and Janessa Graves for consulting on cost effectiveness.

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Table 1: sample demographic and clinical characteristics

Characteristic	Intervention group N=37		Usual care group N=36		Overall cohort N=73
Characteristic	n	%	n	%	n	%
Demographics
Age, Mean(SD)	45.4	17.3	48.2	17.6	47.0	17.4
Male	26	72.2	26	72.2	52	72.2
Language preference-English	36	97.3	36	100.0	72	98.6
Race White African American American Indian Pacific Islander	35 2 0 0	94.6 5.4 0.0 0.0	31 1 2 2	86.1 2.8 5.6 5.6	66 3 2 2	90.4 4.1 2.7 2.7
Hispanic	1	2.7	2	5.6	3	4.1
Residence location* Urban Large Rural Town Small Rural Town Isolated Small Rural Town	21 10 4 1	58.3 27.8 11.1 2.8	28 5 1 2	77.8 13.9 2.8 5.6	49 15 5 3	68.1 20.8 6.9 4.2
Injury descriptors
Injury Severity Score, Mean(SD)	13.0	8.5	13.5	8.0	13.2	8.2
Glasgow Coma Score 3 5 6 8 9 14 15 Unknown	0 1 0 0 1 0 33 2	0.0 2.7 0.0 0.0 2.7 0.0 89.2 5.4	1 0 1 1 0 2 29 2	2.8 0.0 2.8 2.8 0.0 5.6 80.6 5.6	1 1 1 1 1 2 62 4	1.4 1.4 1.4 1.4 1.4 2.7 84.9 5.5
Inpatient pain management strategies Total opioid days, Mean(SD) Total IV opioid days, Mean(SD) Total oral opioid days, Mean(SD)	5.1 0.4 4.7	3.2 0.7 3.0	5.7 0.6 5.1	3.6 1.6 3.1	5.4 0.5 4.9	3.3 1.2 3.0
Substance use disorder testing
Admission alcohol testing Not tested Neg Yes(1-79mg/dl) Yes(80mg/dl or higher)	6 28 2 1	16.2 75.7 5.4 2.7	9 20 3 4	25.0 55.6 8.3 11.1	15 48 5 5	20.6 65.8 6.9 6.9
Admission urine toxicology screening Not tested Neg Pos Amphetamine/Methamphetamine Cocaine Cannabis	25 6 6 2 0 4	67.6 16.2 16.2 5.4 0.0 10.8	20 9 7 2 1 6	55.6 25.0 19.4 5.6 2.8 16.7	45 15 13 4 1 10	61.6 20.6 17.8 5.5 1.4 13.7
Inpatient stay characteristics
ICU admission No Yes	29 8	78.4 21.6	23 13	63.9 36.1	52 21	71.2 28.8
Total Hospital Days, Mean (SD)	4.5	3.4	5.0	3.8	4.7	3.6
Opioid daily dose at hospital discharge, MED Mean(SD)	75.3	28.0	66.7	25.2	71.0	26.8
Pre-trauma pain, opioid, drug use
Chronic pain for the last 3 months pre-trauma	15	40.5	11	32.4	26	36.6
Lifetime Opioid exposure	28	75.7	26	76.5	54	76.1
Opioid exposure (N) during pre-trauma month (from WA PDMP)	3	8.3	4	11.1	7	9.7
Opioid dose (mean MED) during pre-trauma month (from WA PDMP)	1.8	6.3	5.3	18.3	3.5	13.7
Lifetime Cannabis (# times used) 0 1-2 3-5 10-19 20-39 40 or more	10 5 1 2 2 17	27.0 13.5 2.7 5.4 5.4 46.0	10 2 2 6 2 12	29.4 5.9 5.9 17.7 5.9 35.3	20 7 3 8 4 29	28.2 9.9 4.2 11.3 5.6 40.9
Use of any drug other than required for medical reason in 12 months prior to trauma	1	2.7	2	5.7	3	4.2

*Residence location is defined using Rural Urban Commuting Area Codes linked to the ZIP code of the patient’s residence.^34,35

Some percentages do not add up to a total of 100% due to rounding error.

WA PDMP = Washington State Prescription Drug Monitoring Program

Table 2 Primary and Secondary Patient Outcomes

	Baseline- at discharge		3 months		6 months		3m-baseline	6m-baseline
	I, Mean	UC, Mean	I, Mean	UC, Mean	I, Mean	UC, Mean	I vs. UC, diff. (95% CI)	I vs. UC, diff. (95% CI)
PEG scale, past week
Pain severity	3.7	4.1	3.7	2.9	3.6	2.7	1.3(-0.2,2.9)	1.2(-0.3,2.8)
Enjoyment of life interference	3.3	3.9	3.9	3.7	3.6	3	1.2(-0.6,3.0)	1.3(-0.5,3.1)
General activity interference	3.2	3.9	4	4.2	3.9	3.2	0.8(-1.0,2.7)	1.3(-0.6,3.1)
PEG mean score	3.5	3.9	3.9	3.6	3.7	3	1.1(-0.5,2.7)	1.2(-0.4,2.8)

Post-trauma opioid use
Any Opioid use n(%)	37 (100)	36(100)	6(16)	3(9)	7(19)	8(23)	2.55(0.61,10.75)	1.12(0.29,4.37)
Group mean daily opioid dose (MED)	75.3	66.7	8.6	2.1	5.2	2	-1.8(-13.7,10.0)	-5.4(-17.6,6.9)

PROMIS- 29 scale scores
Physical Function	48.9	44.5	36.3	39.2	41.6	44.6	-7.5(-13.1,-1.8)*	-6.9(-12.5,-1.3)*
Anxiety	50.6	52.4	50.1	51.9	51.2	49.6	1.1(-3.6,5.9)	3.5(-1.2,8.1)
Depression	46.2	48.7	49.3	52.6	48.9	50.5	-0.6(-5.9,4.7)	0.7(-4.5,5.9)
Fatigue	45.8	48.4	50	49.6	49.8	47	3.9(-1.9,9.6)	5.2(-0.4,10.8)
Sleep Disturbance	49.1	51.3	51.4	52.1	50.2	48.9	2.8(-2.4,7.9)	4.2(-0.9,9.2)
Ability to participate in social roles	56.2	53.4	42.1	44.6	47	49.2	-5.0(-11.3,1.2)	-4.9(-11.0,1.2)
Pain interference	53.4	56.1	57.7	58	58.7	54.4	3.3(-2.7,9.2)	7.1(1.2,12.9)*
Pain intensity	3.8	3.8	3.7	3.1	3.7	2.6	0.7(-0.7,2.2)	0.9(-0.5,2.3)

AUDIT-C, past year	3.3	3.5	3	3.3	2.7	2.9	0.04(-0.9,0.9)	0.3(-0.6,1.2)
DAST total, past year	0.1	0.2	0	0.5	0.1	0.3	-0.4(-1.0,0.2)	-0.03(-0.7,0.6)
Satisfaction with pain care	xx	xx	9.5	9.7	8.8	9.5

*p< .05; +at hospital discharge

Table 3: Opioid Use Patterns

	Time
	Pre-trauma	Baseline (discharge)	3 months	6 months
Intervention
Using opioids, n(%)	3(8.3)	37(100)	6(16.7)	7(19.4)
Mean daily opioid dose (MED) among those using opioids, Mean(SD)	21.7(7.6)	75.3(28.0)	60.4(51.9)	42.7(33.1)
Mean daily opioid dose (MED) for intervention group overall, Mean(SD)	1.8(6.3)	75.3(28.0)	8.6(27.9)	5.2(17.4)
Usual Care
Using opioids, n(%)	4(11.1)	36(100)	3(8.8)	8(23.5)
Mean daily opioid dose (MED) among those using opioids, Mean(SD)	47.4(35.1)	66.7(25.2)	24.1(20.1)	19.5(10.8)
Mean daily opioid dose (MED) for usual care group overall, Mean(SD)	5.3(18.3)	66.7(25.2)	2.1(8.5)	2.0(6.7)

No competing interests reported.

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published 23 Jun, 2024

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A randomized trial of collaborative support for opioid taper after trauma hospitalization

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Opioid Taper Support Program

Usual care

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