Design, methods, and recruitment outcomes of the Veterans' Pain Care Organizational Improvement Comparative Effectiveness (VOICE) study

Krebs, Erin E.; Becker, William C.; Nelson, David B.; DeRonne, Beth; Nugent, Sean; Jensen, Agnes; Amundson, Erin; Manuel, Jennifer K.; Borsari, Brian; Kats, Allyson M; Seal, Karen H.

doi:10.1016/j.cct.2022.107001

Cited by 3 publications

(2 citation statements)

References 58 publications

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“…For pain outcomes, assuming a final study population of 80 subjects with independent PCPs, we would have 80% power to detect a difference in PEG score of 1.3 points between the treatment and control arm, with a standard deviation of 2.1 and alpha level 0.05. These treatment effects are similar to those used to power other pain and opioid trials [20,21]. Due to recruitment restrictions associated with the COVID-19 epidemic, the trial was stopped after 73 subjects were randomized.…”

Section: Randomization Proceduresmentioning

confidence: 81%

A randomized trial of collaborative support for opioid taper after trauma hospitalization

Sullivan,

Katers,

Wang

et al. 2024

Subst Abuse Treat Prev Policy

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The COTAT (Collaborative Opioid Taper After Trauma) Study was a randomized trial of an opioid taper support program using a physician assistant (PA) to provide pain and opioid treatment guidance to primary care providers assuming care for adult patients with moderate to severe trauma discharged from a Level I trauma center on opioid therapy. Patients were recruited, assessed, and randomized individually by a surgery research recruitment team one to two days prior to discharge to home. Participants randomized to the opioid taper support program were contacted by phone within a few days of discharge by the PA interventionist to confirm enrollment and their primary care provider (PCP). The intervention consisted of PA support as needed to the PCP concerning pain and opioid care at weeks 1, 2, 4, 8, 12, 16, and 20 after discharge or until the PCP office indicated they no longer needed support or the patient had tapered off opioids. The PA was supervised by a pain physician-psychiatrist, a family physician, and a trauma surgeon. Patients randomized to usual care received standard hospital discharge instructions and written information on managing opioid medications after discharge. Trial results were analyzed using repeated measures analysis. 37 participants were randomized to the intervention and 36 were randomized to usual care. The primary outcomes of the trial were pain, enjoyment, general activity (PEG score) and mean daily opioid dose at 3 and 6 months after hospital discharge. Treatment was unblinded but assessment was blinded. No significant differences in PEG or opioid outcomes were noted at either time point. Physical function at 3 and 6 months and pain interference at 6 months were significantly better in the usual care group. No significant harms of the intervention were noted. COVID-19 (corona virus 2019) limited recruitment of high-risk opioid tolerant subjects, and limited contact between the PA interventionist and the participants and the PCPs. Our opioid taper support program failed to improve opioid and pain outcomes, since both control and intervention groups tapered opioids and improved PEG scores after discharge. Future trials of post-trauma opioid taper support with populations at higher risk of persistent opioid use are needed. This trial is registered at clinicaltrials.gov under NCT04275258 19/02/2020. This trial was funded by a grant from the Centers for Disease Control and Prevention to the University of Washington Harborview Injury Prevention & Research Center (R49 CE003087, PI: Monica S. Vavilala, MD). The funder had no role in the analysis or interpretation of the data.

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Section: Randomization Proceduresmentioning

confidence: 81%

A randomized trial of collaborative support for opioid taper after trauma hospitalization

Sullivan,

Katers,

Wang

et al. 2024

Subst Abuse Treat Prev Policy

View full text Add to dashboard Cite

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“…Other studies were able to pivot successfully from in‐person to remote visits. One example from our team was the Veterans’ Pain Care Organizational Improvement Comparative Effectiveness (VOICE) study (2). Our VOICE site at the Durham Department of Veterans Affairs (VA) Health Care System had been using telehealth for some enrollment and clinical visits prior to the COVID‐19 pandemic.…”

Section: Immediate Impactsmentioning

confidence: 99%

Reflections on the COVID‐19 Pandemic: Impacts on Clinical Rheumatology Research

Huffman

Grimm

Allen

2023

Arthritis Care & Research

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The COVID-19 pandemic and associated shutdowns significantly affected clinical research, with interruptions and changes in research processes, personnel responsibilities, and participant engagement, resulting in both immediate and long-term impacts for investigators and study teams. In this editorial, we describe our study team's experiences, lessons learned, and ways in which the pandemic has changed our approach to clinical rheumatology research. Immediate impactsResearch processes. On March 18, 2020, the University of North Carolina at Chapel Hill Office of the Vice Chancellor for Research issued guidance to suspend "non-critical" in-person research but encouraged teams to continue research remotely to the fullest extent possible. Like other study teams worldwide, we were faced with the challenge of quickly evaluating each study to determine what could be continued, then developing plans for modifying activities to meet university COVID-19 policies for research. Table 1 shows our projects that were active in 2020 and the changes to research processes during the COVID-19 pandemic.Although our university worked quickly to provide infrastructure and services to remote staff so they could continue essential daily research tasks, the first six months required creativity, flexibility, and patience. For example, in the early months, research staff used their personal cellphones with call masking to make recruitment and assessment calls. We found that it was more difficult to reach participants from a blocked number than it had been calling from our university landlines. This made study recruitment and enrollment far more challenging. Additionally, if participants wanted to speak to research staff, they had to leave a message on our university voicemail and wait for our return call, which sometimes led to delays in communication. Furthermore, mailings to and from participants were delayed as a result of reduced university post office hours and services, US Postal Service interruptions, and remote work.

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Methods for pragmatic randomized clinical trials of pain therapies: IMMPACT statement

Hohenschurz-Schmidt,

Cherkin,

Rice

et al. 2024

Pain

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Pragmatic, randomized, controlled trials hold the potential to directly inform clinical decision making and health policy regarding the treatment of people experiencing pain. Pragmatic trials are designed to replicate or are embedded within routine clinical care and are increasingly valued to bridge the gap between trial research and clinical practice, especially in multidimensional conditions, such as pain and in nonpharmacological intervention research. To maximize the potential of pragmatic trials in pain research, the careful consideration of each methodological decision is required. Trials aligned with routine practice pose several challenges, such as determining and enrolling appropriate study participants, deciding on the appropriate level of flexibility in treatment delivery, integrating information on concomitant treatments and adherence, and choosing comparator conditions and outcome measures. Ensuring data quality in real-world clinical settings is another challenging goal. Furthermore, current trials in the field would benefit from analysis methods that allow for a differentiated understanding of effects across patient subgroups and improved reporting of methods and context, which is required to assess the generalizability of findings. At the same time, a range of novel methodological approaches provide opportunities for enhanced efficiency and relevance of pragmatic trials to stakeholders and clinical decision making. In this study, best-practice considerations for these and other concerns in pragmatic trials of pain treatments are offered and a number of promising solutions discussed. The basis of these recommendations was an Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) meeting organized by the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks.

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Design, methods, and recruitment outcomes of the Veterans' Pain Care Organizational Improvement Comparative Effectiveness (VOICE) study

Cited by 3 publications

References 58 publications

A randomized trial of collaborative support for opioid taper after trauma hospitalization

A randomized trial of collaborative support for opioid taper after trauma hospitalization

Reflections on the COVID‐19 Pandemic: Impacts on Clinical Rheumatology Research

Methods for pragmatic randomized clinical trials of pain therapies: IMMPACT statement

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