Dataset Information

A digital health intervention to support patients with chronic pain during prescription opioid tapering: a pilot randomised controlled trial.

ABSTRACT:

Introduction

Recent changes in opioid prescribing guidelines have led to an increasing number of patients with chronic pain being recommended to taper. However, opioid tapering can be challenging, and many patients require support.

Objectives

We evaluated the feasibility, acceptability, and potential efficacy of a codesigned digital health intervention to support patients with chronic pain during voluntary prescription opioid tapering.

Methods

In a pilot randomised controlled trial, participants received a psychoeducational video and 28 days of text messages (2 SMS/day) in addition to their usual care (intervention) or usual care alone (control). The feasibility, acceptability, and potential efficacy of the intervention were evaluated. The primary outcome was opioid tapering self-efficacy. Secondary outcomes were pain intensity and interference, anxiety and depression symptom severity, pain catastrophising, and pain self-efficacy.

Results

Of 28 randomised participants, 26 completed the study (13 per group). Text message delivery was high (99.2%), but fidelity of video delivery was low (57.1%). Most participants rated the messages as useful, supportive, encouraging, and engaging; 78.5% would recommend the intervention to others; and 64.2% desired a longer intervention period. Tapering self-efficacy (Cohen d = 0.74) and pain self-efficacy (d = 0.41) were higher, and pain intensity (d = 0.65) and affective interference (d = 0.45) were lower in the intervention group at week 4.

Conclusion

First evidence supports the feasibility, acceptability, and potentially efficacy of a psychoeducational video and SMS text messaging intervention to support patients with chronic pain during voluntary prescription opioid tapering. Definitive trials with longer intervention duration are warranted.

SUBMITTER: Gholamrezaei A

PROVIDER: S-EPMC10863948 | biostudies-literature | 2024 Apr

REPOSITORIES: biostudies-literature

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Publications

A digital health intervention to support patients with chronic pain during prescription opioid tapering: a pilot randomised controlled trial.

Gholamrezaei Ali A Magee Michael R MR McNeilage Amy G AG Dwyer Leah L Sim Alison A Ferreira Manuela L ML Darnall Beth D BD Brake Timothy T Aggarwal Arun A Craigie Meredith M Hollington Irina I Glare Paul P Ashton-James Claire E CE

Pain reports 20240212 2

<h4>Introduction</h4>Recent changes in opioid prescribing guidelines have led to an increasing number of patients with chronic pain being recommended to taper. However, opioid tapering can be challenging, and many patients require support.<h4>Objectives</h4>We evaluated the feasibility, acceptability, and potential efficacy of a codesigned digital health intervention to support patients with chronic pain during voluntary prescription opioid tapering.<h4>Methods</h4>In a pilot randomised controll ...[more]

PMID: 38352024

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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: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:BackgroundPeople living with chronic pain report that tapering prescribed opioids is challenging and more support is needed. In our formative research, consumers indicated that mobile health (mHealth) technology could be an acceptable form of support for opioid tapering and may improve tapering self-efficacy.ObjectiveWe aimed to evaluate and improve the content of an mHealth intervention before pilot-testing, based on consumer and clinician feedback.MethodsParticipants were 12 consumers and 12 clinicians who evaluated an initial draft of a video script and 90 SMS text messages. Consumers and clinicians rated the appropriateness and likely usefulness (consumers) or likely effectiveness (clinicians) of a video script and a random selection of 15 SMS text messages using a 5-point Likert-type scale (1=totally disagree; 5=totally agree). Each draft SMS text message was reviewed by 2 consumers and 2 clinicians. Texts were deemed acceptable for inclusion in the pilot intervention only if the summed participant ratings of text appropriateness and usefulness or effectiveness were ≥8. Participants were also invited to provide open-text feedback on the draft script and SMS text messages.ResultsConsumers generally agreed that the draft video script and text content were likely to be appropriate (video: mean 4.4, SD 0.52; text: mean 4.3, SD 0.79) and useful (video: mean 4.3, SD 0.65; text: mean 4.2, SD 0.84). Similarly, clinicians generally agreed that the draft video script and text content were likely to be appropriate (video: mean 4.5, SD 0.67; text: mean 4.4, SD 0.81) and effective (video: mean 4.0, SD 0.43; text: mean 4.3, SD 0.76). Overall, 77% (69/90) of the draft texts met the threshold rating for acceptability for inclusion in the pilot test of mHealth intervention by consumers, and 82% (74/90) met the threshold for acceptability by clinicians. Consumers' and clinicians' ratings were used to rank order the texts. The top 56 draft texts (all meeting the threshold levels of acceptability) were selected for inclusion in the pilot intervention. When consumer or clinician feedback was provided, the texts meeting the criteria for inclusion in the pilot were further revised and improved. Feedback on the video script was also used to further improve the acceptability of the video script before pilot-testing the intervention.ConclusionsThis study describes the process by which a 28-day mHealth intervention to support patients with chronic pain to taper opioid medications was evaluated and improved before pilot-testing. The mHealth intervention consisted of a 10-minute psychoeducational video about pain and opioid tapering and 56 unique SMS text messages providing information and reassurance (texts delivered twice per day for 28 days). Having established that the content of the mHealth intervention is acceptable to both consumer and clinician groups, the mHealth intervention will be piloted in future research.

Project description:IntroductionOpioid medications are no longer recommended as long-term therapy for chronic non-cancer pain, and many patients are advised to reduce or discontinue opioid medications. Many patients report difficulties in tapering opioid medications, necessitating supporting interventions. This protocol describes a pilot randomised controlled trial (RCT) to investigate the acceptability, feasibility and potential efficacy of a mobile health intervention to improve the opioid tapering self-efficacy of patients with chronic non-cancer pain.Methods and analysisThe trial will be a single-blind (clinician, data collector and statistician-blinded) pilot RCT with two parallel arms. Forty adult patients with chronic non-cancer pain who are voluntarily reducing their prescribed opioid medications under medical guidance will be recruited from two tertiary pain clinics (Start date 25 August 2021). Participants will be randomly assigned to an intervention or control group. Both groups will receive usual care, including multidisciplinary pain management. In addition to usual care, the intervention group will receive a short informational and testimonial video about opioid tapering and will receive two specifically text messages per day for 28 days. The intervention is codesigned with patients and clinicians to provide evidence-based informational, motivational and emotional support to patients with chronic pain to taper opioid medications. Feasibility of the intervention and a future definitive RCT will be evaluated by measuring patient acceptability, delivery of the intervention, rates and reasons of exclusions and drop-outs, completion rates and missing data in the study questionnaires, and obtaining estimates for sample size determination. Potential efficacy will be evaluated by comparing changes in opioid tapering self-efficacy between the two groups.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 numberACTRN12621000795897.

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

A digital health intervention to support patients with chronic pain during prescription opioid tapering: a pilot randomised controlled trial.

Introduction

Objectives

Methods

Results

Conclusion

Publications

A digital health intervention to support patients with chronic pain during prescription opioid tapering: a pilot randomised controlled trial.

Similar Datasets

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