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

ABSTRACT: 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.

SUBMITTER: Winhusen T

PROVIDER: S-EPMC7954981 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundWorkplace Health Promotion Programs (WHPP) have been shown to be an efficient way of improving workers' health. These programs can be incorporated in the worker's daily schedule and improve their productivity at work. Improving employees' health also benefits the employers by increasing their return on investment and lowering healthcare costs. The Activate Your Health program, created by Capsana in 2015, is a WHPP targeting multiple lifestyle habits for a three-year period. This WHPP includes tailored web-based interventions and the support of different health professionals throughout the years. We hypothesize that this approach will yield long-term lifestyle changes. The objective of the current paper is to describe the Activate Your Health program's design.Methods/designEleven companies are taking part in this WHPP and had to choose among five different options of this program and all their employees were encouraged to participate. Each option differs by the number and type of interventions included. The limited option, which is considered the control group, only consists in completing a questionnaire regarding their health status, lifestyle habits and behaviors. On the other end, the extensive option receives a combination of multiple interventions: online menus, health challenges, support in creating a healthy work environment, coaching by health professionals (nurse, nutritionist, and kinesiologist), health screening and flexibility assessment, online resources, social health platform, and activity tracking. The remaining options are in between these options and vary by the amount of intervention. Baseline data are already gathered; two other data collection periods will take place after one and 2 years into the program. The primary outcomes of the current program are physical activity and fitness measures, nutritional data, smoking habits, stress and intention to change.DiscussionThe Activate Your Health program will allow us to compare which combinations of interventions are the most effective. It is expected that the extensive option will be the most advantageous to improve lifestyle habits. The results will indicate the strength and weakness of each intervention and how it could be improved.Trial registrationClinicaltrails.gov, registration number: NCT02933385 (updated on the 26th of March 2019, initially registered on the 5th of October 2016).

Project description:ImportanceElectronic patient-reported outcomes (ePROs) may have the potential to improve cancer care delivery by enhancing patient quality of life, reducing acute care visits, and extending overall survival. However, the optimal cadence of ePRO assessments is unknown.ObjectiveTo determine patient response preferences and the clinical value associated with a daily cadence for ePROs for patients receiving antineoplastic treatment.Design, setting, and participantsThis quality improvement study of adult patients undergoing antineoplastic treatment assessed a remote monitoring program using ePROs that was developed to manage cancer therapy-related symptoms. ePRO data submitted between October 16, 2018 to February 29, 2020, from a single regional site within the Memorial Sloan Kettering Cancer Center network were included. Data were analyzed from April 2020 to January 2022.ExposureWhile undergoing active treatment, patients received a daily ePRO assessment that, based on patient responses, generated yellow (moderate) or red (severe) symptom alerts that were sent to clinicians.Main outcomes and measuresThe main outcomes assessed included patient response rate, symptom alert frequency, and an analysis of the clinical value of daily ePROs.ResultsA total of 217 patients (median [range] age, 66 [31-92] years; 103 [47.5%] women and 114 [52.5%] men) initiating antineoplastic therapy at high risk for symptoms were monitored for a median (range) of 91 (2-369) days. Most patients had thoracic (59 patients [27.2%]), head and neck (48 patients [22.1%]), or gastrointestinal (43 patients [19.8%]) malignant neoplasms. Of 14 603 unique symptom assessments completed, 7349 (50.3%) generated red or yellow symptom alerts. Symptoms commonly generating alerts included pain (665 assessments [23.0%]) and functional status (465 assessments [16.1%]). Most assessments (8438 assessments [57.8%]) were completed at home during regular clinic hours (ie, 9 am-5 pm), with higher response rates on weekdays (58.4%; 95% CI, 57.5%-59.5%) than on weekend days (51.3%; 95% CI, 49.5%-53.1%). Importantly, 284 of 630 unique red alerts (45.1%) surfaced without a prior yellow alert for the same symptom within the prior 7 days; symptom severity fluctuated over the course of a week, and symptom assessments generating a red alert were followed by an acute care visit within 7 days 8.7% of the time compared with 2.9% for assessments without a red alert.Conclusions and relevanceThese findings suggest that daily ePRO assessments were associated with increased insight into symptom management in patients undergoing antineoplastic treatment and symptom alerts were associated with risk of acute care.

Project description:BACKGROUND:Chronic non-cancer pain is a common problem that is often accompanied by psychiatric comorbidity and disability. The effectiveness of a multi-disciplinary pain management program was tested in a 3 month before and after trial. METHODS:Providers in an academic general medicine clinic referred patients with chronic non-cancer pain for participation in a program that combined the skills of internists, clinical pharmacists, and a psychiatrist. Patients were either receiving opioids or being considered for opioid therapy. The intervention consisted of structured clinical assessments, monthly follow-up, pain contracts, medication titration, and psychiatric consultation. Pain, mood, and function were assessed at baseline and 3 months using the Brief Pain Inventory (BPI), the Center for Epidemiological Studies-Depression Scale scale (CESD) and the Pain Disability Index (PDI). Patients were monitored for substance misuse. RESULTS:Eighty-five patients were enrolled. Mean age was 51 years, 60% were male, 78% were Caucasian, and 93% were receiving opioids. Baseline average pain was 6.5 on an 11 point scale. The average CESD score was 24.0, and the mean PDI score was 47.0. Sixty-three patients (73%) completed 3 month follow-up. Fifteen withdrew from the program after identification of substance misuse. Among those completing 3 month follow-up, the average pain score improved to 5.5 (p = 0.003). The mean PDI score improved to 39.3 (p < 0.001). Mean CESD score was reduced to 18.0 (p < 0.001), and the proportion of depressed patients fell from 79% to 54% (p = 0.003). Substance misuse was identified in 27 patients (32%). CONCLUSIONS:A primary care disease management program improved pain, depression, and disability scores over three months in a cohort of opioid-treated patients with chronic non-cancer pain. Substance misuse and depression were common, and many patients who had substance misuse identified left the program when they were no longer prescribed opioids. Effective care of patients with chronic pain should include rigorous assessment and treatment of these comorbid disorders and intensive efforts to insure follow up.

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

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