Background Emergency department (ED) patients are among the many groups at risk for prescription drug overdose. There is limited research on how best to communicate with ED patients about options for pain management and the risks of opioids. The aim of this study is to pilot test a web-based, patient-centred educational programme that encourages the patient to have an informed discussion about pain medication options with their ED provider.
Methods This multisite, randomised trial will evaluate an m-health programme designed to aid the patient in making an informed decision about their pain treatment. Patients reporting to the ED with an injury-related or pain- related chief complaint who agree to participate are randomised to receive the intervention programme, My Healthy Choices, or an attention-matched control. My Healthy Choices pairs tailored education with a patient decision aid to describe what opioid and non-opioid pain medications are, assess the patient's risk factors for opioid-related adverse effects, and produce a tailored report that patients are encouraged to share with their doctor. Data are collected through surveys at three time points during the ED encounter (baseline, immediately after the intervention and just before discharge), and at a 6-week follow-up survey. The primary outcomes are whether the patient prefers an opioid pain reliever (OPR) and whether the patient takes an OPR.
Discussion We hope this programme will facilitate patient-provider communication, as well as reduce the number of prescriptions written for OPRs and thus the number of patients exposed to prescription opioids and the associated risks of addiction and overdose.
Trial registration number NCT03012087; Pre-results.
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Prescription drug overdose is a growing problem, largely fuelled by opioid pain relievers (OPRs).
In 2008, OPRs were involved in 14 800 (74%) of the 20 044 prescription drug overdose deaths in the USA.1 High levels of opioid dependence, addiction and abuse have been observed among long-term medical users of opioids,2–4 which has been associated with increased risk of overdose and death.5 ,6
Among the many groups at risk are emergency department (ED) patients. A survey of ED patients discharged with an OPR found that 42% of patients had misused opioids within 30 days of discharge from the ED, mostly due to self-escalating beyond the prescribed dose.7 Another study found that opioid-naïve patients discharged from the ED with a prescription for an OPR were more likely to go on to recurrent use within 1 year of their ED visit than patients discharged without an opioid prescription.8 ED patients with acute musculoskeletal injury have a particular risk as they are at high probability of being prescribed OPRs. A study of more than 13 000 ED patients found that 65% of those with a non-fracture musculoskeletal diagnosis were discharged with an OPR.9
The American College of Emergency Physicians has called for better patient education to address the opioid epidemic;10 however, there is limited research on how best to communicate with ED patients about options for pain management and the risks of opioids. A single intervention trial found that correct recall of instructions for taking analgesics increased from 40% to 71% after the introduction of written discharge instructions.11 Additionally, a descriptive study found that without an intervention, none of the 20 patients discharged from an ED with OPRs stored or disposed of them safely.12
The evolution of m-health is particularly promising as a medium to deliver educational programmes to patients in the ED setting.13 Computer algorithms can seamlessly tailor education and provide immediate feedback, supplementing or enhancing the patient-provider dialogue. Patient decision aids (PDAs) are taking advantage of such computer technology and providing evidence-based tools that help patients better engage in health decision-making when there is uncertainty.14 PDAs inform patients of their options, guide them in weighing risks and benefits of each option, and prepare patients for an informed discussion with their clinicians about the options.
We could find no studies of m-health programmes providing tailored education to ED patients about their pain medication options or the safe use, storage and disposal of prescription opioids. The aim of this study is to develop and pilot test the My Healthy Choices programme. The programme pairs tailored education with a PDA to describe what opioid and non-opioid pain medications are, assess the patient's risk factors for opioid-related adverse effects, and produce a tailored report that patients are encouraged to share with their doctor. Follow-up text messages and access to a web portal are the additional programme components, which provide education on safe use, storage and disposal for those who receive a prescription pain reliever.
Study design and setting
My Healthy Choices is being tested via a randomised trial in the EDs at The Johns Hopkins Hospital and West Virginia University. Study participants will be assessed at study enrolment (T0), before and after seeing the ED clinician (T1 and T2, respectively), and at 6 weeks postdischarge (T3) (see figure 1).
Screening, enrolment and randomisation
Patients reporting to the ED with an injury-related or pain-related chief complaint are invited to participate. Participants will be approached and screened by a trained recruiter to determine if they meet eligibility criteria. Inclusion criteria are: (1) ED visit for an injury-related or pain-related chief complaint; (2) 18 years of age or older; (3) speak English; (4) has a smartphone or email address that is used on a regular basis; and (5) triage pain score between 7 and 10. Patients are excluded if they have any allergy to pain medications; have used a prescription pain medication for more than 2 days in the past month; or, report renal problems or a history of dialysis. Patients for whom clinical or study staff identify as lacking capacity to grant informed consent are excluded.
Patients are invited to enrol in the study prior to seeing the treating clinician. After obtaining signed informed consent, the participant is randomly assigned by a computer-generated roster in a 1:1 ratio to receive the My Healthy Choices programme (intervention group) or a Health Risk Assessment (control group). Randomisation occurs independently at each site.
Intervention group participants complete My Healthy Choices on an Apple iPad after triage and before seeing the treating clinician. The programme content is grounded in the larger concept of patient-centredness in the delivery of healthcare and in decision theory.15 It also draws on the health communication principles and methods of tailoring,16 which are thought to make messages more impactful by making them more personalised. Development of the programme content was informed by qualitative interviews from key informants including 17 ED patients, 11 ED clinicians and 6 experts in pain management and emergency medicine. The programme content was reviewed by three collaborating clinicians who helped refine and tailor the messages to patients, and further vetted with two rounds of patients (with n=3 and n=4, respectively) to ensure that patients understood the content and could easily navigate through the computer screens.
My Healthy Choices explains what opioid and non-opioid pain medications are, assesses and explains the patient's environmental and personal risk factors related to taking opioids (figure 2), assesses patient preferences about pain medications (figure 3), and produces a tailored patient report based on the answers. The report appears immediately on the iPad, and a copy is emailed to the patient. The patient is encouraged to show the report to the treating ED clinician so they can discuss medication options for treating the patient's pain (figure 4). The time to complete this portion of the programme is about 20 min.
Following discharge from the ED, intervention group participants discharged with a prescription pain reliever receive messages about safe medication use, storage and disposal. Messages are delivered weekly for 6 weeks, sent by text or email depending on the patient's preference. The final component of the programme is an educational patient web portal that contains more information on prescription pain medications and safety. Each weekly message encourages the participant to visit the portal for more information.
In advance of launching the study, all ED clinicians at the participating institutions received an orientation to the project, including a sample of the reports that their patients may share with them. They were not asked to change anything about their prescribing practices, but rather to use the information in the report as they felt appropriate.
Participants randomised to the control group complete a health risk assessment developed by WellSource17 on an iPad. Completing the health risk assessment takes approximately the same amount of time as completing My Healthy Choices, but the content focuses on general health promotion, and the participant's overall health and wellness. A summary report based on the participants' answers is sent to their email address. There is no mention of discussing the results with the treating ED clinician because the health promotion topics are not relevant to the reason for the ED visit. There are no follow-up text or email messages for the control group participants, but participants are referred to the WellSource patient education web portal for information about a variety of health promotion topics.
Measures and outcomes
The primary outcomes of interest are whether the patient prefers an OPR and whether the patient takes an OPR. We will measure the patient's preference for an OPR by asking them to rate on a 0–10-point scale their level of comfort with taking an opioid, taking a non-opioid and taking no medication. We will measure whether the patient receives a prescription for an OPR with self-report, confirmed by documentation in the patient's medical record. Secondary outcomes include: knowledge, satisfaction, patient assessment of the decision-making process, decisional conflict, decisional regret, and, among patients discharged with a prescription, medication use, storage and disposal behaviours.
Participants complete surveys at four time points to collect measures (table 1). At enrolment (T0), participants report demographics, past experience with pain medication and baseline preference for an OPR, pain intensity, knowledge and decisional conflict (eg, how well informed, clear and supported the patient feels with regard to their medication options or choices). Following the completion of My Healthy Choices or the health risk assessment but before the participant has seen the treating clinician, participants complete a second survey which reassesses preference for an OPR (T1). Immediately after the patient sees the treating physician, the participant completes a discharge assessment (T2) which reassesses their preference for an OPR, pain intensity, knowledge and decisional conflict. Additionally, patient satisfaction with the physician encounter, discharge medications prescribed, patient assessment of the decision-making process (eg, whether it was a shared decision) and any alternative treatments recommended by the physician are measured. Participants complete a follow-up assessment (T3) 6 weeks after their ED visit, which measures current pain intensity, knowledge, decisional conflict, whether the participant received a pain medication prescription, whether the prescription was filled (and if not, why not), use of the pain medication, decisional regret about the pain treatment option, medication storage and disposal, and satisfaction with pain control.
We plan to enrol 144 patients, 72 from each ED, and we expect 114 (80%) will complete the follow-up visit. Prior data indicate that 65% of patients are prescribed an OPR.9 With the full sample across both sites, we will have adequate power (80%) to detect a 27% point effect size on being prescribed an OPR. We will be powered (at ≥80%) to detect statistical significance for knowledge questions with fair improvements (a 30%–35% absolute improvement for questions where the baseline correct response rate is 60%–40%, respectively). Based on data from previous research,18 these gains in knowledge are feasible.
Data analysis plan
We hypothesise that patients in the intervention group will be significantly less comfortable with being prescribed an OPR relative to the control group at T1 and T2, and they will be less likely to be prescribed an OPR as measured at T2. Additionally we hypothesise that at T2 the intervention group compared with the control group will be more knowledgeable about OPR risks and benefits, have better ratings on decisional conflict (ie, feel more informed, clearer about values, more certain about pain medication choice), will be more satisfied with their visit, will be more likely to report shared decision-making with their physician, and will be less likely to have been prescribed an OPR. At T3, we hypothesise that the intervention group relative to the control group will be more satisfied with their pain management experiences and report less pain and less decisional regret. Among those prescribed an OPR, we expect that at T3 those in the intervention group compared with those in the control group will be more likely to use it safely (as prescribed, not shared), store it safely (in a locked place) and dispose of it (or plan to dispose of it) properly.
To address these hypotheses, we will first generate descriptive measures through a series of data reduction and univariate and bivariate analyses. We will compare the two samples (Maryland and West Virginia) on sociodemographic characteristics using χ2 tests for categorical variable comparisons and t tests for continuous variable comparisons. We will examine the distribution of demographics to test whether the intervention and control groups are balanced. If the groups are not balanced, multiple variable regression techniques will be used for hypothesis testing to adjust for confounding variables. Separate outcome analyses comparing the intervention and control groups will be run for T1, T2 and T3 data, each of which will control for any outcome variable that was measured and the prior time point. In all analyses, loss to follow-up will be examined using missing data techniques. We will also describe patient satisfaction with the programme.
This study is the first to develop an m-health programme to help ED patients with an acute injury understand the risks and benefits of OPRs and non-OPRs. Results from this research will contribute to the scholarly literature on OPRs, m-health and PDAs. Findings will have real world utility for addressing the needs of injured patients seen in EDs and implications for future research with other patient populations. The sheer volume of OPRs prescribed in ED settings underscores the importance of achieving our study aims. By providing tailored education to patients and facilitating patient-provider conversations about options for pain relief, we hope to reduce the number of prescriptions written for OPRs, reducing the number of patients exposed to prescription opioids and the associated risks of addiction and overdose.
Patient-centred approaches have been underused in addressing the opioid poisoning epidemic. Major efforts are underway to control the supply of OPRs by focusing on physician prescribing practices.19–21 In most cases, patients want to be informed about treatment options.22 Thus, My Healthy Choices seeks to educate patients about the risks of OPRs based on their own circumstances so that they can make a more informed pain management decision with their physician. My Healthy Choices is designed to complement the discussion with the ED provider and encourage shared decision-making. The programme is of low burden to providers and ideally should make their time with patients more focused on the patient's priorities. Additionally, the programme is unique in that it provides a risk assessment to help inform patients and clinicians about possible risks of opioid use to oneself and others. The programme also includes a novel priority setting activity that helps guide patients towards options that are most aligned with their preferences.
This study is subject to limitations. Our application is designed to be used in the context of acute care, where there is no ongoing relationship between the patient and provider. This makes our project innovative and challenging. Because of time constraints in the ED setting, an m-health programme such as ours may be able to prepare the patient and clinician to use the clinical interaction time most efficiently in discussing options to manage pain.
This study will gather important data about potential m-health approaches to patient education that reduces the number of opioid prescriptions written in the ED setting. The results can have implications for m-health tools that can be used in other settings where patients are offered opioids such as primary care or occupational injury clinics.
Collaborators In addition to the coauthors, the My Healthy Choices Decision Aid Study Team includes: Wendy Shields, Nicholas Rizzutti, Shannon Frattaroli, James Case, Richard Rothman and Jeff Coben.
Contributors EO, the project director, drafted the initial manuscript and edited subsequent drafts. RC and AG, co-PIs for the study, conceptualised the intervention and evaluation and revised and edited the manuscript. KE and EMD developed the intervention and data collection modules. SD and UM developed the sampling criteria and recruitment strategy. All authors edited the manuscript and approve the final submitted version.
Funding This work was supported by a grant from the National Center for Injury Control and Prevention, Centers for Disease Control and Prevention (grant number 1R49CE002466).
Competing interests None declared.
Ethics approval The Institutional Review Board at the Johns Hopkins School of Public Health and the West Virginia University approved this study.
Provenance and peer review Not commissioned; internally peer reviewed.