Dataset Information

Process evaluation protocol for the I-WOTCH study: an opioid tapering support programme for people with chronic non-malignant pain.

ABSTRACT:

Introduction

The Improving the Wellbeing of people with Opioid Treated CHronic Pain (I-WOTCH) randomised controlled trial uses a multicomponent self-management intervention to help people taper their opioid use. This approach is not widely used and its efficacy is unknown. A process evaluation alongside the trial will help to assess how the intervention was delivered, looking at the dose of intervention received and the fidelity of the delivery. We will explore how the intervention may have brought about change through the experiences of the participants receiving and the staff delivering the intervention and whether there were contextual factors involved.

Methods and analysis

A mixed methods process evaluation will assess how the processes of the I-WOTCH intervention fared and whether these affected the outcomes. We will collect quantitative data, for example, group attendance analysed with statistical methods. Qualitative data, for example, from interviews and feedback forms will be analysed using framework analysis. We will use a 'following a thread' and a mixed methods matrix for the final integrated analysis.

Ethics and dissemination

The I-WOTCH trial and process evaluation were granted full ethics approval by Yorkshire and The Humber-South Yorkshire Research Ethics Committee on 13 September 2016 (16/YH/0325). All data were collected in accordance with data protection guidelines. Participants provided written informed consent for the main trial, and all interviewees provided additional written informed consent. The results of the process evaluation will be published and presented at conferences.

Trial registration number

ISRCTN49470934; Pre-results.

SUBMITTER: Nichols VP

PROVIDER: S-EPMC6797361 | biostudies-literature | 2019 Oct

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Process evaluation protocol for the I-WOTCH study: an opioid tapering support programme for people with chronic non-malignant pain.

Nichols Vivien P VP Abraham Charles C Eldabe Sam S Sandhu Harbinder K HK Underwood Martin M Seers Kate K

BMJ open 20191010 10

<h4>Introduction</h4>The Improving the Wellbeing of people with Opioid Treated CHronic Pain (I-WOTCH) randomised controlled trial uses a multicomponent self-management intervention to help people taper their opioid use. This approach is not widely used and its efficacy is unknown. A process evaluation alongside the trial will help to assess how the intervention was delivered, looking at the dose of intervention received and the fidelity of the delivery. We will explore how the intervention may h ...[more]

PMID: 31601587

Similar Datasets

Project description:IntroductionChronic non-malignant pain has a major impact on the well-being, mood and productivity of those affected. Opioids are increasingly prescribed to manage this type of pain, but with a risk of other disabling symptoms, when their effectiveness has been questioned. This trial is designed to implement and evaluate a patient-centred intervention targeting withdrawal of strong opioids in people with chronic pain.Methods and analysisA pragmatic, multicentre, randomised controlled trial will assess the clinical and cost-effectiveness of a group-based multicomponent intervention combined with individualised clinical facilitator led support for the management of chronic non-malignant pain against the control intervention (self-help booklet and relaxation compact disc). An embedded process evaluation will examine fidelity of delivery and investigate experiences of the intervention. The two primary outcomes are activities of daily living (measured by Patient-Reported Outcomes Measurement Information System Pain Interference Short Form (8A)) and opioid use. The secondary outcomes are pain severity, quality of life, sleep quality, self-efficacy, adverse events and National Health Service (NHS) healthcare resource use. Participants are followed up at 4, 8 and 12 months, with a primary endpoint of 12 months. Between-group differences will indicate effectiveness; we are looking for a difference of 3.5 points on our pain interference outcome (scale 40 to 77). We will undertake an NHS perspective cost-effectiveness analysis using quality adjusted life years.Ethics and disseminationFull approval was given by Yorkshire & The Humber - South Yorkshire Research Ethics Committee on 13 September, 2016 (16/YH/0325). Appropriate local approvals were sought for each area in which recruitment was undertaken. The current protocol version is 1.6 date 19 December 2018. Publication of results in peer- reviewed journals will inform the scientific and clinical community. We will disseminate results to patient participants and study facilitators in a study newsletter as well as a lay summary of results on the study website.Trial registration numberISRCTN49470934; Pre-results.

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.

Project description:BackgroundThe Improving the Wellbeing of people with Opioid Treated CHronic pain (I-WOTCH) randomised controlled trial found that a group-based educational intervention to support people using strong opioids for chronic non-malignant pain helped a significant proportion of people to stop or decrease opioid use with no increase in pain-related disability. We report a linked process evaluation of the group-based intervention evaluated in comparison to a usual-care control group that received a self-help booklet and relaxation CD.MethodsWe interviewed 18 intervention facilitators, and 20 intervention and 20 control participants who had chronic non-malignant pain and were recruited from general (family) practices in the UK. Quantitative data included change mechanism questions on the trial questionnaires which explored motivation, expectations and self-efficacy. Fidelity was assessed by listening to a sample of audio-recorded group sessions and nurse consultations. Quantitative and qualitative data were integrated using 'follow a thread' and a mixed-methods matrix.FindingsFour overarching themes emerged: (1) the right time to taper, (2) the backdrop of a life with chronic pain, (3) needing support and (4) the benefits of being in a group. Delivery fidelity was good, adherence (83%) and competence (79%) across a range of intervention groups. Staff delivering the intervention found three typical responses to the intervention: resistance, open to trying and feeling it was not the right time. The group experience was important to those in the intervention arm. It provided people with a forum in which to learn about the current thinking about opioid usage and its effects. It also gave them examples of how feasible or personally relevant coming off opioids might be.ConclusionThe process evaluation data showed that the I-WOTCH intervention was well delivered, well received and useful for most interviewees. Being 'the right time' to taper and having support throughout tapering, emerged as important factors within the context of living with chronic pain.Trial registration numberISRCTN49470934.

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:IntroductionOver the last two decades, the use of opioids for the treatment of chronic pain in England has steadily increased despite lack of evidence of both long-term effectiveness in pain relief and significant, well-documented physical and mental adverse events. Guidelines recommend tapering when harms outweigh benefits, but the addictive nature of opioids hinders simple dose-reduction strategies. Improving the Well-being of people with Opioid Treated CHronic pain (I-WOTCH) trial tests a multicomponent self-management intervention aimed to help patients with chronic non-malignant pain taper opioid doses. This paper outlines the methods to be used for the economic analysis of the I-WOTCH intervention compared with the best usual care.Methods and analysisEconomic evaluation alongside the I-WOTCH study, prospectively designed to identify, measure and value key healthcare resource use and outcomes arising from the treatment strategies being compared. A within-trial cost-consequences analysis and a model-based long-term cost-effectiveness analysis will be conducted from the National Health Service and Personal Social Service perspective in England. The former will quantify key parameters to populate a Markov model designed to estimate the long-term cost and quality-adjusted life years of the I-WOTCH intervention against best usual care. Regression equations will be used to estimate parameters such as transition probabilities, utilities, and costs associated with the model's states and events. Probabilistic sensitivity analysis will be used to assess the impact of parameter uncertainty onto the predicted costs and health outcomes, and the resulting value for money assessment of the I-WOTCH intervention.Ethics and disseminationFull ethics approval was granted by Yorkshire & The Humber-South Yorkshire Research Ethics Committee on 13 September 2016 (16/YH/0325). Current protocol: V.1.7, date 31 July 2019. Findings will be disseminated in peer-reviewed journals, scientific conferences, newsletters and websites.Trial registration numberInternational Standard Randomised Controlled Trial Number (49 470 934); Pre-result.

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.

Dataset Information

Process evaluation protocol for the I-WOTCH study: an opioid tapering support programme for people with chronic non-malignant pain.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

Process evaluation protocol for the I-WOTCH study: an opioid tapering support programme for people with chronic non-malignant pain.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets