Opioid dose and pain effects of an online pain self-management program to augment usual care in adults with chronic pain: a multisite randomized clinical trial.

ABSTRACT: Readily accessible nonpharmacological interventions that can assist in opioid dose reduction while managing pain is a priority for adults receiving long-term opioid therapy (LOT). Few large-scale evaluations of online pain self-management programs exist that capture effects on reducing morphine equivalent dose (MED) simultaneously with pain outcomes. An open-label, intent-to-treat, randomized clinical trial recruited adults (n = 402) with mixed chronic pain conditions from primary care and pain clinics of 2 U.S. academic healthcare systems. All participants received LOT-prescriber-provided treatment of MED ≥ 20 mg while receiving either E-health (a 4-month subscription to the online Goalistics Chronic Pain Management Program), or treatment as usual (TAU). Among 402 participants (279 women [69.4%]; mean [SD] age, 56.7 [11.0] years), 200 were randomized to E-health and 202 to TAU. Of 196 E-heath participants, 105 (53.6%) achieved a ≥15% reduction in daily MED compared with 85 (42.3%) of 201 TAU participants (odds ratio, 1.6 [95% CI, 1.1-2.3]; P = 0.02); number-needed-to-treat was 8.9 (95% CI, 4.8, 66.0). Of 166 E-health participants, 24 (14.5%) achieved a ≥2 point decrease in pain intensity vs 13 (6.8%) of 192 TAU participants (odds ratio, 2.4 [95% CI, 1.2-4.9]; P = 0.02). Benefits were also observed in pain knowledge, pain self-efficacy, and pain coping. The findings suggest that for adults on LOT for chronic pain, use of E-health, compared with TAU, significantly increased participants' likelihood of clinically meaningful decreases in MED and pain. This low-burden online intervention could assist adults on LOT in reducing daily opioid use while self-managing pain symptom burdens.

Design considerations for a remote randomized multi-site clinical trial evaluating an e-health self-management program for chronic pain patients receiving opioid therapy.

Based on the adverse consequences and inadequate evidence of effectiveness for long-term opioid therapy (LOT), the CDC developed recommendations to decrease the use of LOT and morphine equivalent dose (MED) for patients receiving LOT. However, the majority of these patients report that opioid medication is significantly beneficial for pain management and are hesitant to reduce/decrease its use. Compounding the problem is poor access to non-pharmacologic therapies for many patients due to insurance reimbursement structures and limited pain-service availability. EMPOWER is an intent-to-treat, two-arm, open-label, randomized controlled trial evaluating a web-based self-management chronic pain program (E-Health) that has been found to reduce self-reported MED, while also decreasing pain, in two randomized controlled trials. Approximately 400 chronic pain patients receiving LOT at a daily average prescribed MED ≥ 20 mg at one of two U.S. healthcare systems, located in North Carolina and Ohio, will be randomized in a 1:1 ratio to treatment as usual (TAU) or TAU plus E-Health (E-Health+). TAU consists of LOT from a prescribing clinician. E-Health+ participants are provided with a 4-month E-Health subscription (active treatment phase). All participants will complete web-based self-report measures at baseline, the end of the active treatment phase, and 6-months post-active treatment. Opioid prescription information will be collected from the participants' electronic health record (EHR) from baseline through 6 months post-active treatment. This paper describes design considerations for this unique trial which is conducted completely remotely, with no in-person visits, and utilizes the EHR for participant identification and primary outcome collection.

Clinical evaluation of e-Quit worRx: a mobile app to enhance smoking cessation shared decision making in primary care.

BACKGROUND: Smoking is the leading preventable cause of morbidity and mortality in the United States. Primary care providers (PCPs) have a unique opportunity to engage patients to quit smoking, but to be effective, clinicians must be able to personalize evidence-based interventions that are useful and appealing to patients in a time efficient manner. We pilot tested a novel iPad application (app), called e-Quit worRx™, designed to enhance patient-centered shared-decision making (SDM) about smoking cessation, with the primary goal of determining feasibility in primary care offices. METHODS: A total of 73 patients from three offices within a local diverse primary care network were enrolled in a pragmatic single crossover-controlled trial. The decision aid app was incorporated into current smokers' waiting time for their PCP in the exam room, and their PCP reviewed their personal responses and selections to finalize treatment choices. Mixed methods were used in the evaluation and the primary outcomes were app feasibility in primary care and enhanced SDM. RESULTS: Our app was determined to be feasible for use in primary care for both patients and PCPs. It significantly increased time spent discussing smoking cessation with their PCP and the likelihood that a decision was made at the time of the visit. While not significant, mean differences were observed in other study measures including SDM, decisional conflict, quality of patient-provider communication, and stage of change progression at 12 weeks post-trial. CONCLUSIONS: We created a usable and acceptable iPad app-based decision aid for use in primary care offices. The design process presented several challenges including integration into a clinical setting. Despite these challenges, we successfully ran a pragmatic pilot trial in three primary care offices using a technology novel to many of the users.

Challenges in the Development of e-Quit worRx: An iPad App for Smoking Cessation Counseling and Shared Decision Making in Primary Care.

BACKGROUND: Smoking is the leading preventable cause of morbidity and mortality in the United States, killing more than 450,000 Americans. Primary care physicians (PCPs) have a unique opportunity to discuss smoking cessation evidence in a way that enhances patient-initiated change and quit attempts. Patients today are better equipped with technology such as mobile devices than ever before. OBJECTIVE: The aim of this study was to evaluate the challenges in developing a tablet-based, evidence-based smoking cessation app to optimize interaction for shared decision making between PCPs and their patients who smoke. METHODS: A group of interprofessional experts developed content and a graphical user interface for the decision aid and reviewed these with several focus groups to determine acceptability and usability in a small population. RESULTS: Using a storyboard methodology and subject matter experts, a mobile app, e-Quit worRx, was developed through an iterative process. This iterative process helped finalize the content and ergonomics of the app and provided valuable feedback from both patients and provider teams. Once the app was made available, other technical and programmatic challenges arose. CONCLUSIONS: Subject matter experts, although generally amenable to one another's disciplines, are often challenged with effective interactions, including language, scope, clinical understanding, technology awareness, and expectations. The successful development of this app and its evaluation in a clinical setting highlighted those challenges and reinforced the need for effective communications and team building.

Opinions on the Role of Telehealth in a Large Midwest Academic Health Center: A Case Study.

Introduction: Varying terms such as telemedicine, telehealth, and e-Health have increasingly been incorporated into medical education and clinical practice. While there is some variability in this adoption, our interest was in the opinions about the role these terms have in a large Midwestern academic health center (medical school and practice plan) in Cincinnati, Ohio.Materials and Methods: Two separate studies were conducted, one with medical students and the other with clinicians. Both studies were conducted at the University of Cincinnati. Two different questionnaires were sent to the two groups. The questionnaires were designed to solicit feedback on terminology, awareness, utilization, and perception. Several questions used a Likert scale to gauge knowledge in key areas.Results: Eighty-two medical students with an average age of 24.5 ± 2.3 years responded to the questionnaire. Most students were in their first or second year of medical school, and a majority had a Bachelor of Science degree (73.2%). A majority (84.2%) of the students indicated a knowledge of telehealth/telemedicine in clinical practice but were less likely to recommend its application. There were 155 clinician respondents, of whom the majority (95%) were primary care physicians. The majority of the respondents were more comfortable with the term telehealth rather than telemedicine. Most physicians felt that more training was needed and they expressed that management and organizational norms limited the adoption of telehealth and telemedicine.Conclusion: Two separate studies were conducted at a large Midwestern academic health center. Students and clinicians expressed awareness of the terminology and a need for more educational opportunities and training to further integrate these terms and concepts in both the educational and clinical arms of medicine.

Congruence of Patient Self-Rating of Health with Family Physician Ratings.

BACKGROUND: A single self-rated health (SRH) question is associated with health outcomes, but agreement between SRH and physician-rated patient health (PRPH) has been poorly studied. We studied patient and physician reasoning for health ratings and the role played by patient lifestyle and objective health measures in the congruence between SRH and PRPH. METHODS: Surveys of established family medicine patients and their physicians, and medical record review at 4 offices. Patients and physicians rated patient health on a 5-point scale and gave reasons for the rating and suggestions for improving health. Patients' and physicians' reasons for ratings and improvement suggestions were coded into taxonomies developed from the data. Bivariate relationships between the variables and the difference between SRH and PRPH were examined and all single predictors of the difference were entered into a multivariable regression model. RESULTS: Surveys were completed by 506 patients and 33 physicians. SRH and PRPH ratings matched exactly for 38% of the patient-physician dyads. Variables associated with SRH being lower than PRPH were higher patient body mass index (P = .01), seeing the physician previously (P = .04), older age, (P < .001), and a higher comorbidity score (P = .001). Only 25.7% of the dyad reasons for health status rating and 24.1% of needed improvements matched, and these matches were unrelated to SRH/PRPH agreement. Physicians focused on disease in their reasoning for most patients, whereas patients with excellent or very good SRH focused on feeling well. CONCLUSIONS: Patients' and physicians' beliefs about patient health frequently lack agreement, confirming the need for shared decision making with patients.

Provision of Recommended Chronic Pain Assessment and Management in Primary Care: Does Patient-Centered Medical Home (PCMH) Recognition Make a Difference?

BACKGROUND: Chronic pain (CP) care in the patient-centered medical home (PCMH) model has not been well studied. We assessed whether PCMH recognition is associated with increased provision of key practice recommendations for CP assessment and management. METHODS: Chart reviews were completed for 12 primary care practices affiliated with one health system in the Cincinnati Area Research and Improvement Group (CARInG). Recommendations were abstracted and compared based on PCMH status: 3 practices had received prior PCMH level 3 recognition, 5 were in an ongoing process of applying, and 4 had no recognition and were not applying. RESULTS: A total of 485 charts were reviewed from 65 PCPs. Eight of 10 key recommendations were documented more often in the prior and ongoing PCMH cohorts, including assessing pain severity, function, psychosocial distress, and substance abuse, and using structured instruments for these assessments. There were fewer differences between the cohorts in the management of chronic opioids, with only the ongoing PCMH cohort having higher documentation for 5 of the 7 recommendations, including performing urine drug screens and using a structured instrument to assess for misuse. CONCLUSIONS: These findings support the usefulness of the PCMH model in managing patients with CP, but patient outcomes need to be addressed in future studies.