Recruitment and retention for chronic pain clinical trials: a narrative review

Kennedy, Nan; Nelson, Sarah J.; Jerome, Rebecca N; Edwards, Terri; Stroud, Mary; Wilkins, Consuelo H.; Harris, Paul A.

doi:10.1097/pr9.0000000000001007

Cited by 7 publications

(7 citation statements)

References 119 publications

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“…Although participant attrition for the MR trial was commiserated with published rates [18][19][20]23,24,43], there are still lessons to be learned and opportunities to mitigate cited reasons for attrition in future efforts. First, it is recommended to separate the study process during the onboarding phase from the actual intervention and the data collection as these are specific areas of focus, which will benefit from proactive approaches throughout the study implementation process.…”

Section: Principal Resultsmentioning

confidence: 99%

Mobile and Web-Based Partnered Intervention to Improve Remote Access to Pain and Posttraumatic Stress Disorder Symptom Management: Recruitment and Attrition in a Randomized Controlled Trial (Preprint)

Haun,

Venkatachalam,

Fowler

et al. 2023

Preprint

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BACKGROUND Increasing access to nonpharmacological interventions to manage pain and posttraumatic stress disorder (PTSD) is essential for veterans. Complementary and integrative health (CIH) interventions can help individuals manage symptom burden with enhanced accessibility via remotely delivered health care. Mission Reconnect (MR) is a partnered, self-directed intervention that remotely teaches CIH skills. OBJECTIVE The purpose of this paper is to describe the recruitment, onboarding phase, and attrition of a fully remote randomized controlled trial (RCT) assessing the efficacy of a self-directed mobile and web-based intervention for veterans with comorbid chronic pain and PTSD and their partners. METHODS A total of 364 veteran-partner dyads were recruited to participate in a mixed methods multisite waitlist control RCT. Qualitative attrition interviews were conducted with 10 veterans with chronic pain and PTSD, and their self-elected partners (eg, spouse) who consented but did not begin the program. RESULTS At the point of completing onboarding and being randomized to the 2 treatment arms, of the 364 recruited dyads, 97 (26.6%) failed to complete onboarding activities. Reported reasons for failure to complete onboarding include loss of self-elected partner buy-in (n=8, 8%), difficulties with using remote data collection methods and interventions (n=30, 31%), and adverse health experiences unrelated to study activities (n=23, 24%). Enrolled veterans presented at baseline with significant PTSD symptom burden and moderate-to-severe pain severity, and represented a geographically and demographically diverse population. Attrition interviews (n=10) indicated that misunderstanding MR including the intent of the intervention or mistaking the surveys as the actual intervention was a reason for not completing the MR registration process. Another barrier to MR registration was that interviewees described the mailed study information and registration packets as too confusing and excessive. Competing personal circumstances including health concerns that required attention interfered with MR registration. Common reasons for attrition following successful MR registration included partner withdrawal, adverse health issues, and technological challenges relating to the MR and electronic data collection platform (Qualtrics). Participant recommendations for reducing attrition included switching to digital forms to reduce participant burden and increasing human interaction throughout the registration and baseline data collection processes. CONCLUSIONS Challenges, solutions, and lessons learned for study recruitment and intervention delivery inform best practices of delivering remote self-directed CIH interventions when addressing the unique needs of this medically complex population. Successful recruitment and enrollment of veterans with chronic pain and PTSD, and their partners, to remote CIH programs and research studies requires future examination of demographic and symptom-associated access barriers. Accommodating the unique needs of this medically complex population is essential for improving the effectiveness of CIH programs. Disseminating lessons learned and improving access to remotely delivered research studies and CIH programs is paramount in the post–COVID-19 climate. CLINICALTRIAL ClinicalTrials.gov NCT03593772; https://clinicaltrials.gov/ct2/show/NCT03593772

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Section: Principal Resultsmentioning

confidence: 99%

Mobile and Web-Based Partnered Intervention to Improve Remote Access to Pain and Posttraumatic Stress Disorder Symptom Management: Recruitment and Attrition in a Randomized Controlled Trial (Preprint)

Haun,

Venkatachalam,

Fowler

et al. 2023

Preprint

View full text Add to dashboard Cite

show abstract

“…Attrition rates for veterans with PTSD range from 12% to 72% across various RCTs and real-world clinical therapies [18][19][20] and are strongly correlated with comorbidities [21,22]. Similar variability in attrition rates (5%-62%) has been observed in chronic pain intervention studies, even with self-administered and noninvasive interventions [23,24]. High attrition rates can impact the generalizability of findings and threaten the ability to implement interventions in a systems-wide manner [24,25].…”

Section: Remote Interventions and Attritionmentioning

confidence: 90%

“…The similar attrition rates reveal either parallel or overlapping factors that make it difficult for veterans to participate in remote interventions for symptom management. Although participant attrition for the MR trial was commiserated with published rates [ 18 - 20 , 23 , 24 , 43 ], there are still lessons to be learned and opportunities to mitigate cited reasons for attrition in future efforts. First, it is recommended to separate the study process during the onboarding phase from the actual intervention and the data collection as these are specific areas of focus, which will benefit from proactive approaches throughout the study implementation process.…”

Section: Discussionmentioning

confidence: 99%

Mobile and Web-Based Partnered Intervention to Improve Remote Access to Pain and Posttraumatic Stress Disorder Symptom Management: Recruitment and Attrition in a Randomized Controlled Trial

Haun,

Venkatachalam,

Fowler

et al. 2023

J Med Internet Res

View full text Add to dashboard Cite

Background Increasing access to nonpharmacological interventions to manage pain and posttraumatic stress disorder (PTSD) is essential for veterans. Complementary and integrative health (CIH) interventions can help individuals manage symptom burden with enhanced accessibility via remotely delivered health care. Mission Reconnect (MR) is a partnered, self-directed intervention that remotely teaches CIH skills. Objective The purpose of this paper is to describe the recruitment, onboarding phase, and attrition of a fully remote randomized controlled trial (RCT) assessing the efficacy of a self-directed mobile and web-based intervention for veterans with comorbid chronic pain and PTSD and their partners. Methods A total of 364 veteran-partner dyads were recruited to participate in a mixed methods multisite waitlist control RCT. Qualitative attrition interviews were conducted with 10 veterans with chronic pain and PTSD, and their self-elected partners (eg, spouse) who consented but did not begin the program. Results At the point of completing onboarding and being randomized to the 2 treatment arms, of the 364 recruited dyads, 97 (26.6%) failed to complete onboarding activities. Reported reasons for failure to complete onboarding include loss of self-elected partner buy-in (n=8, 8%), difficulties with using remote data collection methods and interventions (n=30, 31%), and adverse health experiences unrelated to study activities (n=23, 24%). Enrolled veterans presented at baseline with significant PTSD symptom burden and moderate-to-severe pain severity, and represented a geographically and demographically diverse population. Attrition interviews (n=10) indicated that misunderstanding MR including the intent of the intervention or mistaking the surveys as the actual intervention was a reason for not completing the MR registration process. Another barrier to MR registration was that interviewees described the mailed study information and registration packets as too confusing and excessive. Competing personal circumstances including health concerns that required attention interfered with MR registration. Common reasons for attrition following successful MR registration included partner withdrawal, adverse health issues, and technological challenges relating to the MR and electronic data collection platform (Qualtrics). Participant recommendations for reducing attrition included switching to digital forms to reduce participant burden and increasing human interaction throughout the registration and baseline data collection processes. Conclusions Challenges, solutions, and lessons learned for study recruitment and intervention delivery inform best practices of delivering remote self-directed CIH interventions when addressing the unique needs of this medically complex population. Successful recruitment and enrollment of veterans with chronic pain and PTSD, and their partners, to remote CIH programs and research studies requires future examination of demographic and symptom-associated access barriers. Accommodating the unique needs of this medically complex population is essential for improving the effectiveness of CIH programs. Disseminating lessons learned and improving access to remotely delivered research studies and CIH programs is paramount in the post–COVID-19 climate. Trial Registration ClinicalTrials.gov NCT03593772; https://clinicaltrials.gov/ct2/show/NCT03593772

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“…While our review focused on adult cancer patients, previously published reviews focused on people with heart disease, depression, diabetes and hypertension. [40][41][42][43] The preoperative period for cancer patients is known to carry higher levels of stress and anxiety, 44 combined with additional treatments (i.e. neoadjuvant therapy), exams (i.e.…”

Section: Discussionmentioning

confidence: 99%

A review of patient recruitment in randomised controlled trials of preoperative exercise

Steffens,

Solomon,

Young

et al. 2023

Clinical Trials

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Background Randomised controlled trials (RCTs) are considered the gold standard design to determine the effectiveness of an intervention, as the only method of decreasing section bias and minimising random error. However, participant recruitment to randomised controlled trials is a major challenge, with many trials failing to recruit the targeted sample size accordingly to the planned protocol. Thus, the aim of this review is to detail the recruitment challenges of preoperative exercise clinical trials. Methods A comprehensive search was performed on MEDLINE, Embase, The Cochrane Library, CINAHL, AMED and PsycINFO from inception to July 2021. Randomised controlled trials investigating the effectiveness of preoperative exercise on postoperative complication and/or length of hospital stay in adult cancer patients were included. Main outcomes included recruitment rate, retention rate, number of days needed to screen and recruit one patient and trial recruitment duration. Descriptive statistics were used to summarise outcomes of interest. Results A total of 27 trials were identified, including 3656 patients screened (N = 21) and 1414 randomised (median recruitment rate (interquartile range) = 53.6% (25.2%–67.6%), N = 21). The sample size of the included trials ranged from 19 to 270 (median = 48.0; interquartile range = 40.0–85.0) and the duration of trial recruitment ranged from 3 to 50 months (median = 19.0 months; interquartile range = 10.5–34.0). Overall, a median of 3.6 days was needed to screen one patient, whereas 13.7 days were needed to randomise one participant. Over the trials duration, the median dropout rate was 7.9%. Variations in recruitment outcomes were observed across trials of different cancer types but were not statistically significant. Conclusion The recruitment of participants to preoperative exercise randomised controlled trials is challenging, but patient retention appears to be less of a problem. Future trials investigating the effectiveness of a preoperative exercise programme following cancer surgery should consider the time taken to recruit patients. Strategies associated with improved recruitment should be investigated in future studies.

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Recruitment and retention for chronic pain clinical trials: a narrative review

Abstract: Greater awareness of design issues and recruitment and retention strategies can increase pain study success. The Recruitment Innovation Center developed generalizable methods for improving recruitment.

Cited by 7 publications

References 119 publications

Mobile and Web-Based Partnered Intervention to Improve Remote Access to Pain and Posttraumatic Stress Disorder Symptom Management: Recruitment and Attrition in a Randomized Controlled Trial (Preprint)

Mobile and Web-Based Partnered Intervention to Improve Remote Access to Pain and Posttraumatic Stress Disorder Symptom Management: Recruitment and Attrition in a Randomized Controlled Trial (Preprint)

Mobile and Web-Based Partnered Intervention to Improve Remote Access to Pain and Posttraumatic Stress Disorder Symptom Management: Recruitment and Attrition in a Randomized Controlled Trial

A review of patient recruitment in randomised controlled trials of preoperative exercise

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