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Comparative Effectiveness of Cognitive Behavioral Therapy for Chronic Pain and Chronic Pain Self-Management within the Context of Voluntary Patient-Centered Prescription Opioid Tapering: The EMPOWER Study Protocol.

ABSTRACT: OBJECTIVE:Evidence to date, while sparse, suggests that patients taking long-term opioids require special considerations and protections to prevent potential iatrogenic harms from opioid de-prescribing, such as increased pain or suffering. Following this study protocol, the EMPOWER study seeks to address multiple unmet needs of patients with chronic pain who desire to reduce long-term opioid therapy, and provide the clinical evidence on effective methodology. METHODS:EMPOWER applies patient-centered methods for voluntary prescription opioid reduction conducted within a comprehensive, multi-state, 3-arm randomized controlled comparative effectiveness study of three study arms (1) group cognitive behavioral therapy for chronic pain; (2) group chronic pain self-management; and (3) usual care (taper only). Specialized electronic data capture systems collect patient reported symptoms and satisfaction data weekly and monthly during the taper, with real-time clinical alerts and electronic feedback loops informing, documenting, and steering needed care actions. CONCLUSION:The EMPOWER study seeks to provide granular evidence on patient response to voluntary opioid tapering, and will provide evidence to inform clinical systems changes, clinical care, patient satisfaction, and patient outcomes for opioid reduction.

SUBMITTER: Darnall BD

PROVIDER: S-EPMC7530567 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature

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Comparative Effectiveness of Cognitive Behavioral Therapy for Chronic Pain and Chronic Pain Self-Management within the Context of Voluntary Patient-Centered Prescription Opioid Tapering: The EMPOWER Study Protocol.

Darnall Beth D BD Mackey Sean C SC Lorig Kate K Kao Ming-Chih MC Mardian Aram A Stieg Richard R Porter Joel J DeBruyne Korina K Murphy Jennifer J Perez Luzmercy L Okvat Heather H Tian Lu L Flood Pamela P McGovern Mark M Colloca Luana L King Heather H Van Dorsten Brent B Pun Ting T Cheung Matthias M

Pain medicine (Malden, Mass.) 20200801 8

<h4>Objective</h4>Evidence to date, while sparse, suggests that patients taking long-term opioids require special considerations and protections to prevent potential iatrogenic harms from opioid de-prescribing, such as increased pain or suffering. Following this study protocol, the EMPOWER study seeks to address multiple unmet needs of patients with chronic pain who desire to reduce long-term opioid therapy, and provide the clinical evidence on effective methodology.<h4>Methods</h4>EMPOWER appli ...[more]

PMID: 31876947

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Project description:BackgroundPatients with chronic pain who are tapering prescription opioids report a need for greater support for coping with symptoms of pain and withdrawal. Mobile health (mHealth) technologies (SMS text messaging- or app-based) have the potential to provide patients with educational, emotional, and motivational support for opioid tapering beyond what is offered by their health care provider. However, it is not known whether patients with chronic pain who are tapering opioids would be willing or able to engage with technology-based support.ObjectiveThis study aims to examine patients' use of mobile technologies in health care, interest in using mHealth support, preferences for the form and content of mHealth support, and potential barriers to and facilitators of engagement with mHealth support for opioid tapering.MethodsA total of 21 patients (11 women and 10 men; age range 29-83 years) with chronic noncancer pain on long-term opioid therapy who had recently initiated a voluntary opioid taper were recruited from primary and tertiary care clinics in metropolitan and regional Australia for a larger study of patients' experiences of opioid tapering. Participants had been taking prescription opioids for a mean duration of 13 (SD 9.6; range 0.25-30) years at the time of the study. Survey items characterized participants' typical mobile phone use and level of interest in mobile technology-based support for opioid tapering. Semistructured interviews further explored patients' use of mobile technologies and their interest in, preferences for, and perspectives on potential barriers to and facilitators of engagement with mHealth support for opioid tapering. Two researchers collaborated to conduct a thematic analysis of the interview data.ResultsAll participants reported owning and using a mobile phone, and most (17/21, 81%) participants reported using mobile apps. The majority of participants expressed interest in SMS text messaging-based (17/21, 81%) and app-based (15/21, 71%) support for opioid tapering. Participants expected that messages delivering both informational and socioemotional support would be helpful. Participants expected that access to technology, mobile reception, internet connectivity, vision impairment, and low self-efficacy for using apps may be barriers to user engagement. Patients expected that continuity of care from their health care provider, flexible message dosing, responsivity, and familiarity with pain self-management strategies would increase user engagement.ConclusionsThe results of this study indicate that patients with chronic noncancer pain may be willing to engage with SMS text messaging-based and app-based mHealth interventions to support opioid tapering. However, the feasibility and acceptability of these interventions may depend on how patients' preferences for functionality, content, and design are addressed.

Project description:IntroductionIncreases in pain and interference with quality of life is a common concern among people with chronic non-cancer pain (CNCP) who are tapering opioid medications. Research indicates that access to social and psychological support for pain self-management may help people to reduce their opioid dose without increasing pain and interference. This study evaluates the efficacy of a text messaging intervention designed to provide people with CNCP with social and psychological support for pain self-management while tapering long-term opioid therapy (LTOT) under the guidance of their prescriber.Methods and analysisA double-blind randomised controlled trial will be conducted. Patients with CNCP (n=74) who are tapering LTOT will be enrolled from across Australia. Participants will continue with their usual care while tapering LTOT under the supervision of their prescribing physician. They will randomly receive either a psychoeducational video and supportive text messaging (two Short Message Service (SMS) per day) for 12 weeks or the video only. The primary outcome is the pain intensity and interference assessed by the Pain, Enjoyment of Life and General Activity scale. Secondary outcomes include mood, self-efficacy, pain cognitions, opioid dose reduction, withdrawal symptoms, and acceptability, feasibility, and safety of the intervention. Participants will complete questionnaires at baseline and then every 4 weeks for 12 weeks and will be interviewed at week 12. This trial will provide evidence for the efficacy of a text messaging intervention to support patients with CNCP who are tapering LTOT. If proven to be efficacious and safe, this low-cost intervention can be implemented at scale.Ethics and disseminationThe study protocol was reviewed and approved by the Northern Sydney Local Health District (Australia). Study results will be published in peer-reviewed journals and presented at scientific and professional meetings.Trial registration numberACTRN12622001423707.

Project description:ObjectivesTo describe the design, development and pilot of a multicomponent intervention aimed at supporting withdrawal of opioids for people with chronic non-malignant pain for future evaluation in the Improving the Wellbeing of people with Opioid Treated CHronic pain (I-WOTCH) randomised controlled trial.DesignThe I-WOTCH intervention draws on previous literature and collaboration with stakeholders (patient and public involvement). Intervention mapping and development activities of Behaviour Change Taxonomy are described.SettingThe intervention development was conducted by a multidisciplinary team with clinical, academic and service user perspectives. The team had expertise in the development and testing of complex health behaviour interventions, opioid tapering and pain management in primary and secondary care, I.T programming, and software development-to develop an opioid tapering App.ParticipantsThe I-WOTCH trial participants are adults (18 years and over) with chronic non-malignant pain using strong opioids for at least 3 months and on most days in the preceding month.OutcomesA multicomponent self-management support package to help people using opioids for chronic non-malignant pain reduce opioid use.Interventions and resultsReceiving information on the impact of long-term opioid use, and potential adverse effects were highlighted as important facilitators in making the decision to reduce opioids. Case studies of those who have successfully stopped taking opioids were also favoured as a facilitator to reduce opioid use. Barriers included the need for a 'trade-off to fill the deficit of the effect of the drug'. The final I-WOTCH intervention consists of an 8-10 week programme incorporating: education; problem-solving; motivation; group and one to one tailored planning; reflection and monitoring. A detailed facilitator manual was developed to promote consistent delivery of the intervention across the UK.ConclusionsWe describe the development of an opioid reduction intervention package suitable for testing in the I-WOTCH randomised controlled trial.Trial registration numberISRCTN49470934.

Dataset Information

Comparative Effectiveness of Cognitive Behavioral Therapy for Chronic Pain and Chronic Pain Self-Management within the Context of Voluntary Patient-Centered Prescription Opioid Tapering: The EMPOWER Study Protocol.

Publications

Comparative Effectiveness of Cognitive Behavioral Therapy for Chronic Pain and Chronic Pain Self-Management within the Context of Voluntary Patient-Centered Prescription Opioid Tapering: The EMPOWER Study Protocol.

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