Hybrid effectiveness-implementation trial of guided relaxation and acupuncture for chronic sickle cell disease pain (GRACE): A protocol

Doorenbos, Ardith Z.; Schlaeger, Judith M.; deMartelly, Victoria; Burke, Larisa A.; Boyd, Andrew D.; Knisely, Mitchell R.; Leigh, Jonathan; Li, Hongjin; Mandernach, Molly W.; Molokie, Robert E.; Patil, Crystal L.; Steffen, Alana; Shah, Nirmish; Ezenwa, Miriam O.

doi:10.1016/j.conctc.2023.101076

Cited by 6 publications

(2 citation statements)

References 59 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Given the feasibility of daily diary assessments in this trial, future trials could adopt an adaptive design where SCED outcomes are assessed "in real time" and crossover from GL to MPM or vice versa if the patient is not reporting improvements after a certain period of time. This is aligned with Sequential Multiple Assessment Randomized Trial (SMART) designs that are emerging in the adult pain treatment field (eg, low back pain 24 and sickle cell disease 9 ) and hold promise as a new path forward for devising mechanistic RCTs. In addition to enhancing effectiveness and the proportion of patients who improve with treatment, we continue to struggle with treatment access.…”

Section: Discussionmentioning

confidence: 99%

A randomized controlled trial of graded exposure treatment (GET living) for adolescents with chronic pain

Simons,

Harrison,

Boothroyd

et al. 2023

Pain

View full text Add to dashboard Cite

Graded exposure treatment (GET) is a theory-driven pain treatment that aims to improve functioning by exposing patients to activities previously feared and avoided. Combining key elements of GET with acceptance-based exposure, GET Living (GL) was developed for adolescents with chronic pain (GL). Based on robust treatment effects observed in our single-case experimental design pilot trial of GL (NCT01974791), we conducted a 2-arm randomized clinical trial comparing GL with multidisciplinary pain management (MPM) comprised of cognitive behavioral therapy and physical therapy for pain management (NCT03699007). A cohort of 68 youth with chronic musculoskeletal pain (M age 14.2 years; 81% female) were randomized to GL or MPM. Owing to COVID-19 restrictions, 54% of participants received zoom video delivered care. Assessments were collected at baseline, discharge, as well as at 3-month and 6-month follow-up. Primary outcomes were self-reported pain-related fear and avoidance. Secondary outcomes were child functional disability and parent protective responses to child pain. As hypothesized, GL improved in primary and secondary outcomes at 3-month follow-up. Contrary to our superiority hypothesis, there was no significant difference between GL and MPM. Patients reported both GL and MPM (in person and video) as credible and were highly satisfied with the treatment experience. Next steps will involve examining the single-case experimental design data embedded in this trial to facilitate an understanding of individual differences in treatment responses (eg, when effects occurred, what processes changed during treatment within the treatment arm). The current findings support GET Living and MPM for youth with chronic pain.

show abstract

Section: Discussionmentioning

confidence: 99%

A randomized controlled trial of graded exposure treatment (GET living) for adolescents with chronic pain

Simons,

Harrison,

Boothroyd

et al. 2023

Pain

View full text Add to dashboard Cite

show abstract

“…78 Although not as elaborate as STAR*D, several ongoing pain trials use SMART designs to study clinically highly relevant issues, mainly related to tailoring of nonpharmacological pain management. 36,44,49,74,122 For example, a trial of breast cancer compares different doses of a pain-coping skills program and dose adaptations depending on an initial (non-)response. 74 However, this trial is designed to have adequate power only for the first treatment period and related analyses (ie, before rerandomization), underlining the logistical challenges of such designs.…”

Section: Adaptive and Other Designs Responsive To Accumulating Trial ...mentioning

confidence: 99%

Research objectives and general considerations for pragmatic clinical trials of pain treatments: IMMPACT statement

Hohenschurz-Schmidt¹,

Cherkin

Rice³

et al. 2023

Pain

View full text Add to dashboard Cite

Many questions regarding the clinical management of people experiencing pain and related health policy decision-making may best be answered by pragmatic controlled trials. To generate clinically relevant and widely applicable findings, such trials aim to reproduce elements of routine clinical care or are embedded within clinical workflows. In contrast with traditional efficacy trials, pragmatic trials are intended to address a broader set of external validity questions critical for stakeholders (clinicians, healthcare leaders, policymakers, insurers, and patients) in considering the adoption and use of evidence-based treatments in daily clinical care. This article summarizes methodological considerations for pragmatic trials, mainly concerning methods of fundamental importance to the internal validity of trials. The relationship between these methods and common pragmatic trials methods and goals is considered, recognizing that the resulting trial designs are highly dependent on the specific research question under investigation. The basis of this statement was an Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) systematic review of methods and a consensus meeting. The meeting was organized by the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) public–private partnership. The consensus process was informed by expert presentations, panel and consensus discussions, and a preparatory systematic review. In the context of pragmatic trials of pain treatments, we present fundamental considerations for the planning phase of pragmatic trials, including the specification of trial objectives, the selection of adequate designs, and methods to enhance internal validity while maintaining the ability to answer pragmatic research questions.

show abstract

Monitoring and responding to signals of suicidal ideation in pragmatic clinical trials: Lessons from the GRACE trial for Chronic Sickle Cell Disease Pain

Swirsky,

Boyd,

et al. 2023

Contemporary Clinical Trials Communications

View full text Add to dashboard Cite

Hybrid effectiveness-implementation trial of guided relaxation and acupuncture for chronic sickle cell disease pain (GRACE): A protocol

Cited by 6 publications

References 59 publications

A randomized controlled trial of graded exposure treatment (GET living) for adolescents with chronic pain

A randomized controlled trial of graded exposure treatment (GET living) for adolescents with chronic pain

Research objectives and general considerations for pragmatic clinical trials of pain treatments: IMMPACT statement

Monitoring and responding to signals of suicidal ideation in pragmatic clinical trials: Lessons from the GRACE trial for Chronic Sickle Cell Disease Pain

Contact Info

Product

Resources

About