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

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.

Text messaging intervention to support patients with chronic pain during prescription opioid tapering: protocol for a double-blind randomised controlled trial.

INTRODUCTION: Increases 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 ANALYSIS: A 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 DISSEMINATION: The 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 NUMBER: ACTRN12622001423707.

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

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 co-designed psycho-educational video and SMS text messaging intervention to support patients with chronic pain during prescription opioid tapering. Methods: A pilot randomised controlled trial was conducted. In addition to their usual care, participants in the intervention group received a psycho-educational video and 28 days of text messages (two SMS/day). The control group received usual care. 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 in each group). Text message delivery was 99.2% successful. Most participants rated the messages as useful, supportive, encouraging, and engaging, 78.5% would recommend the intervention to others, and 64% desired a longer intervention period. Tapering self-efficacy (Cohen's d = 0.74) and pain self-efficacy (d = 0.41) were higher and pain intensity (d = 0.65) and affective interference (d = 0.45) lower in the intervention group at week 4. Conclusions: It is feasible, acceptable, and potentially efficacious to support patients with chronic pain during prescription opioid tapering with a psycho-educational video and SMS text messaging intervention. A definitive trial has been initiated to test a 12-week intervention.

A Digital Video and Text Messaging Intervention to Support People With Chronic Pain During Opioid Tapering: Content Development Using Co-design.

BACKGROUND: People 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. OBJECTIVE: We aimed to evaluate and improve the content of an mHealth intervention before pilot-testing, based on consumer and clinician feedback. METHODS: Participants 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. RESULTS: Consumers 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. CONCLUSIONS: This 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.

Evaluating acceptability and feasibility of a mobile health intervention to improve self-efficacy in prescription opioid tapering in patients with chronic pain: protocol for a pilot randomised, single-blind, controlled trial.

INTRODUCTION: Opioid 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 ANALYSIS: The 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 DISSEMINATION: The 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 NUMBER: ACTRN12621000795897.