Dataset Information

A process evaluation of the Mind Your Back trial examining psychologically informed physical treatments for chronic low back pain.

ABSTRACT:

Background

In chronic conditions, such as back pain, the use of interventions that address physical, social and psychological aspects within a biopsychosocial framework are encouraged, however, applying this holistic multimodal approach in physical therapy practice (i.e., chiropractic and physiotherapy) is challenging. To explore the problem of delivering a biopsychosocially informed package of care in physical therapy practice a recent randomised control trial (RCT) called 'Mind Your Back' was conducted to evaluate the effectiveness of a combined physical and internet-delivered psychological intervention (psychologically informed physical treatments) compared to standard treatment for improving disability and self-efficacy in people with chronic LBP. The results of the trial indicated no difference between the two intervention groups. Although high-quality RCTs are considered gold standard for effectiveness of interventions, qualitative research methods embedded within a process evaluation framework are also used to reveal other issues and important information that help to explain clinical trial results, and to further the field of digital health interventions research. Therefore, within a process evaluation framework, the aim is to explore participants experiences of the interventions received throughout the Mind Your Back trial which led to a null result.

Methods

In-line with recommendations for a process evaluation this study used in-depth interviews and qualitative thematic analysis with participants of both arms of the trial 5-6 months after study completion. Semi-structured telephone interviews were conducted with twenty-five participants to explore their experiences of taking part in the Mind Your Back trial. Interviews were conducted in November 2017, transcribed verbatim and data analysed thematically.

Results

Two main themes were identified: (1) Personalised support and therapeutic alliance are important, and (2) MoodGYM lacked relevant, personalised and tailored support.

Conclusion

It is important to deliver tailored digital health supports that is personalised and fosters a therapeutic alliance.

SUBMITTER: Petrozzi MJ

PROVIDER: S-EPMC8369773 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundLow back pain (LBP) is a public health concern because it is highly prevalent and the leading cause of disability worldwide. Psychologically informed physical therapy (PIPT) is a secondary prevention approach that first aims to identify individuals at high risk for transitioning to chronicity and then provides tailored treatment to reduce that risk. Training models that are feasible to implement with acceptable training quality are needed to improve scalability for widespread implementation of PIPT. This manuscript describes the PIPT training program that was developed for training physical therapists providing PIPT in the TARGET trial.MethodsThe PIPT training program was developed, tested, and modified using an iterative process. Content development consisted of stakeholder engagement, beta testing, modification of training, and confirmation of final course objectives. Methods of delivery consisted of a website that included brief online educational modules followed by a live 8-h workshop that included video-based mock case scenarios and case-based role playing. Attitudes, beliefs, and confidence in implementing PIPT principles were assessed before and immediately after training to measure training quality and impact.ResultsEarly stakeholder engagement and beta testing indicated the need for increased emphasis on experiential learning opportunities and patient-centered communication training. Booster training varied extensively across TARGET sites with involvement of 'clinician champions' providing brief follow-up sessions identified as best practice. Favorable post-training changes in physical therapist attitudes and beliefs toward biopsychosocial treatment orientation and increased confidence in implementing PIPT principles were observed.ConclusionsPIPT training for provider participation in the TARGET trial was feasible to deliver. Course content was acceptable to physical therapists and resulted in improved beliefs and confidence in applying PIPT skills during clinical practice. Ongoing consultation and site-based continuing education were methods by which specific TARGET sites maintained or augmented PIPT skill training; however, implementing ongoing training was challenging in general. Due to the pragmatic nature of the TARGET trial, it was not possible to directly measure the effect of PIPT training on treatment fidelity, which was a limitation of our approach.Trial registrationClinicalTrials.gov, NCT02647658 . Registered on 6 January 2016.

Project description:IntroductionExercise therapy is the most recommended treatment for chronic low back pain (LBP). Effect sizes for exercises are usually small to moderate and could be due to the heterogeneity of people presenting with LBP. Thus, if patients could be better matched to exercise based on individual factors, then the effects of treatment could be greater. A recently published study provided evidence of better outcomes when patients are matched to the appropriate exercise type. The study demonstrated that a 15-item questionnaire, the Lumbar Spine Instability Questionnaire (LSIQ), could identify patients who responded best to one of the two exercise approaches for LBP (motor control and graded activity). The primary aim of the current study isill be to evaluate whether preidentified baseline characteristics, including the LSIQ, can modify the response to two of the most common exercise therapies for non-specific LBP. Secondary aims include an economic evaluations with a cost-effectiveness analysis.Methods and analysisParticipants (n=414) will be recruited by primary care professionals and randomised (1:1) to receive motor control exercises or graded activity. Participants will undergo 12 sessions of exercise therapy over an 8-week period. The primary outcome will be physical function at 2 months using the Oswestry Disability Index. Secondary outcomes will be pain intensity, function and quality of life measured at 2, 6 and 12 months. Potential effect modifiers will be the LSIQ, self-efficacy, coping strategies, kinesiophobia and measures of nociceptive pain and central sensitisation. We will construct linear mixed models with terms for participants (fixed), treatment group, predictor (potential effect modifier), treatment group×predictor (potential effect modifier), physiotherapists, treatment group×physiotherapists and baseline score for the dependent variable.Ethics and disseminationThis study received ethics approval from the Hamilton Integrate Research Ethics Board. Results will be submitted for publication in peer-reviewed journals.Trial registration numberNCT04283409.

Project description:IMPORTANCE:Treatment of chronic low back pain (LBP) in older adults is limited by the adverse effects of analgesics. Effective nonpharmacologic treatment options are needed. OBJECTIVE:To determine the effectiveness of a mind-body program at increasing function and reducing pain in older adults with chronic LBP. DESIGN, SETTING, AND PARTICIPANTS:This single-blind, randomized clinical trial compared a mind-body program (n = 140) with a health education program (n = 142). Community-dwelling older adults residing within the Pittsburgh metropolitan area were recruited from February 14, 2011, to June 30, 2014, with 6-month follow-up completed by April 9, 2015. Eligible participants were 65 years or older with functional limitations owing to their chronic LBP (?11 points on the Roland and Morris Disability Questionnaire) and chronic pain (duration ?3 months) of moderate intensity. Data were analyzed from March 1 to July 1, 2015. INTERVENTIONS:The intervention and control groups received an 8-week group program followed by 6 monthly sessions. The intervention was modeled on the Mindfulness-Based Stress Reduction program; the control program, on the "10 Keys" to Healthy Aging. MAIN OUTCOMES AND MEASURES:Follow-up occurred at program completion and 6 months later. The score on the Roland and Morris Disability Questionnaire was the primary outcome and measured functional limitations owing to LBP. Pain (current, mean, and most severe in the past week) was measured with the Numeric Pain Rating Scale. Secondary outcomes included quality of life, pain self-efficacy, and mindfulness. Intent-to-treat analyses were conducted. RESULTS:Of 1160 persons who underwent screening, 282 participants enrolled in the trial (95 men [33.7%] and 187 women [66.3%]; mean [SD] age,74.5 [6.6] years). The baseline mean (SD) Roland and Morris Disability Questionnaire scores for the intervention and control groups were 15.6 (3.0) and 15.4 (3.0), respectively. Compared with the control group, intervention participants improved an additional -1.1 (mean, 12.1 vs 13.1) points at 8 weeks and -0.04 (mean, 12.2 vs 12.6) points at 6 months (effect sizes, -0.23 and -0.08, respectively) on the Roland and Morris Disability Questionnaire. By 6 months, the intervention participants improved on the Numeric Pain Rating Scale current and most severe pain measures an additional -1.8 points (95% CI, -3.1 to -0.05 points; effect size, -0.33) and -1.0 points (95% CI, -2.1 to 0.2 points; effect size, -0.19), respectively. The changes in Numeric Pain Rating Scale mean pain measure after the intervention were not significant (-0.1 [95% CI, -1.1 to 1.0] at 8 weeks and -1.1 [95% CI, -2.2 to -0.01] at 6 months; effect size, -0.01 and -0.22, respectively). CONCLUSIONS AND RELEVANCE:A mind-body program for chronic LBP improved short-term function and long-term current and most severe pain. The functional improvement was not sustained, suggesting that future development of the intervention could focus on durability. TRIAL REGISTRATION:clinicaltrials.gov Identifier: NCT01405716.

Project description:ImportanceDespite epidemic rates of addiction and death from prescription opioids in the United States, suggesting the importance of providing alternatives to opioids in the treatment of pain, little is known regarding how payers' coverage policies may facilitate or impede access to such treatments.ObjectiveTo examine coverage policies for 5 nonpharmacologic approaches commonly used to treat acute or chronic low back pain among commercial and Medicare Advantage insurance plans, plus an additional 6 treatments among Medicaid plans.Design, setting, and participantsCross-sectional study of 15 commercial, 15 Medicaid, and 15 Medicare Advantage health plans for the 2017 calendar year in 16 states representing more than half of the US population. Interviews were conducted with 43 senior medical and pharmacy health plan executives from representative plans.Main outcomes and measuresMedical necessity and coverage status for the treatments examined, as well as the use of utilization management tools and cost-sharing magnitude and structure.ResultsCommercial and Medicare insurers consistently regarded physical and occupational therapy as medically necessary, but policies varied for other therapies examined. Payers most commonly covered physical therapy (98% [44 of 45 plans]), occupational therapy (96% [43 of 45 plans]), and chiropractic care (89% [40 of 45 plans]), while transcutaneous electrical nerve stimulation (67% [10 of 15 plans]) and steroid injections (60% [9 of 15 plans]) were the most commonly covered among the therapies examined for Medicaid plans only. Despite evidence in the literature to support use of acupuncture and psychological interventions, these therapies were either not covered by plans examined (67% of all plans [30 of 45] did not cover acupuncture) or lacked information about coverage (80% of Medicaid plans [12 of 15] lacked information about coverage of psychological interventions). Utilization management tools, such as prior authorization, were common, but criteria varied greatly with respect to which conditions and what quantity and duration of services were covered. Interviewees represented 6 Medicaid managed care organizations, 2 Medicare Advantage or Part D plans, 9 commercial plans, and 3 trade organizations (eg, Blue Cross Blue Shield Association). Interviews with plan executives indicated a low level of integration between the coverage decision-making processes for pharmacologic and nonpharmacologic therapies for chronic pain.Conclusions and relevanceWide variation in coverage of nonpharmacologic treatments for low back pain may be driven by the absence of best practices, the administrative complexities of developing and revising coverage policies, and payers' economic incentives. Such variation suggests an important opportunity to improve the accessibility of services, reduce opioid use, and ultimately improve the quality of care for individuals with chronic, noncancer pain while alleviating the burden of opioid addiction and overdose.