Lessons Learned and Strategies for Recruitment of Diverse, Low-income Patients into an Integrative Medical Group Visit Clinical Trial

Low-income and ethnic/racial minority adults do not often participate in research or may face unique barriers when participating in research, which delays and impedes medical advances for this vulnerable population. This article describes in detail the evidenced-based methods used to enhance recruitment, participation, and retention in a clinical trial at a center serving ethnic/racial minorities and low-income individuals. The article details the partnership with a community outreach center and describes the duties and impact of a community liaison to enhance recruitment, participation, and retention in a randomized controlled trial with a 6-month follow-up. Of the 246 individuals initially recruited for screening, 80 did not meet inclusion criteria with the most common reason for disqualification being meeting criteria for substance use disorder (n = 44). One hundred sixty-six participants qualified for participation. The majority of participants identified as African American (n = 127, 77.1%) and reported an annual individual income under $10,000 (n = 121 (74.2%). Forty-five percent of the sample completed the requested number of sessions (i.e., 12). Sixty-three percent of participants completed post intervention assessments and 42% completed 6-month follow-up data collection. The participation and retention numbers in this study appear higher than typical participation and retention rates in longitudinal studies with similar populations. The methods and lessons learned may be useful for other clinical trials that recruit vulnerable populations and wish to enhance participation, engagement, and retention.

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Depression predicts chronic pain interference in racially-diverse, low-income patients

10.1101/2021.06.17.21259108 ◽

2021 ◽

Author(s):

Benjamin C Nephew ◽

Angela C Incollingo Rodriguez ◽

Veronica Melican ◽

Justin J Polcari ◽

Kathryn E Nippert ◽

...

Keyword(s):

Machine Learning ◽

Clinical Trial ◽

Chronic Pain ◽

Low Income ◽

Pain Interference ◽

Medical Group ◽

Regression Analyses ◽

Racially Diverse ◽

Group Visits ◽

Predictive Relationship

ABSTRACT Background Chronic pain is one of the most common reasons adults seek medical care in the US, with estimates of prevalence ranging from 11% to 40%. Mindfulness meditation has been associated with significant improvements in pain, depression, physical and mental health, sleep, and overall quality of life. Group medical visits are increasingly common and are effective at treating myriad illnesses including chronic pain. Integrative Medical Group Visits (IMGV) combine mindfulness techniques, evidence based integrative medicine, and medical group visits and can be used as adjuncts to medications, particularly in diverse underserved populations with limited access to non-pharmacological therapies. Objective and Design The objective of the present study was to use a blended analytical approach of machine learning and regression analyses to evaluate the potential relationship between depression and chronic pain in data from a randomized clinical trial of IMGV in socially diverse, low income patients suffering from chronic pain and depression. Methods This approach used machine learning to assess the predictive relationship between depression and pain and identify and select key mediators, which were then assessed with regression analyses. It was hypothesized that depression would predict the pain outcomes of average pain, pain severity, and pain interference. Results Our analyses identified and characterized a predictive relationship between depression and chronic pain interference. This prediction was mediated by high perceived stress, low pain self-efficacy, and poor sleep quality, potential targets for attenuating the adverse effects of depression on functional outcomes. Conclusions In the context of the associated clinical trial and similar interventions, these insights may inform future treatment optimization, targeting, and application efforts in racially diverse, low income populations, demographics often neglected in studies of chronic pain.

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In silico imaging clinical trials: cheaper, faster, better, safer, and more scalable

Trials ◽

10.1186/s13063-020-05002-w ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Aldo Badano

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Medical Devices ◽

In Silico ◽

Lessons Learned ◽

Patient Access ◽

High Quality ◽

Virtual Imaging ◽

Regulatory Evaluation

AbstractImaging clinical trials can be burdensome and often delay patient access to novel, high-quality medical devices. Tools for in silico imaging trials have significantly improved in sophistication and availability. Here, I describe some of the principal advantages of in silico imaging trials and enumerate five lessons learned during the design and execution of the first all-in silico virtual imaging clinical trial for regulatory evaluation (the VICTRE study).

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A3-4: Implementing a Pragmatic Clinical Trial: Lessons Learned about Embedded Research

Clinical Medicine & Research ◽

10.3121/cmr.2014.1250.a3-4 ◽

2014 ◽

Vol 12 (1-2) ◽

pp. 90-91

Author(s):

L. Kindler ◽

C. McMullen ◽

A. Owen-Smith ◽

S. Honda ◽

A. Firemark ◽

...

Keyword(s):

Clinical Trial ◽

Lessons Learned ◽

Pragmatic Clinical Trial

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Oversight and management of a cell therapy clinical trial network: Experience and lessons learned

Contemporary Clinical Trials ◽

10.1016/j.cct.2011.05.003 ◽

2011 ◽

Vol 32 (5) ◽

pp. 614-619 ◽

Cited By ~ 5

Author(s):

Lemuel A. Moyé ◽

Shelly L. Sayre ◽

Lynette Westbrook ◽

Beth C. Jorgenson ◽

Eileen Handberg ◽

...

Keyword(s):

Clinical Trial ◽

Cell Therapy ◽

Lessons Learned ◽

Trial Network ◽

Clinical Trial Network ◽

A Cell ◽

Therapy Clinical Trial

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Meeting the Challenges of Longitudinal Cluster-Based Trials in Schools: Lessons From the Chicago Trial of Positive Action

Evaluation & the Health Professions ◽

10.1177/0163278716673688 ◽

2016 ◽

Vol 40 (4) ◽

pp. 450-482 ◽

Cited By ~ 1

Author(s):

Kendra M. Lewis ◽

David L. DuBois ◽

Peter Ji ◽

Joseph Day ◽

Naida Silverthorn ◽

...

Keyword(s):

Public Schools ◽

Low Income ◽

Urban Areas ◽

Statistical Power ◽

Student Mobility ◽

Controlled Trial ◽

Lessons Learned ◽

Study Planning ◽

Positive Action ◽

Cluster Randomized

We describe challenges in the 6-year longitudinal cluster randomized controlled trial (CRCT) of Positive Action (PA), a social–emotional and character development (SECD) program, conducted in 14 low-income, urban Chicago Public Schools. Challenges pertained to logistics of study planning (school recruitment, retention of schools during the trial, consent rates, assessment of student outcomes, and confidentiality), study design (randomization of a small number of schools), fidelity (implementation of PA and control condition activities), and evaluation (restricted range of outcomes, measurement invariance, statistical power, student mobility, and moderators of program effects). Strategies used to address the challenges within each of these areas are discussed. Incorporation of lessons learned from this study may help to improve future evaluations of longitudinal CRCTs, especially those that involve evaluation of school-based interventions for minority populations and urban areas.

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Beyond the lessons learned from the Covid19 pandemic: Opportunities to optimize clinical trial implementation in oncology

ESMO Open ◽

10.1016/j.esmoop.2021.100237 ◽

2021 ◽

pp. 100237

Author(s):

Luis Castelo-Branco ◽

Ahmad Awada ◽

George Pentheroudakis ◽

Jose Luis Perez-Garcia ◽

Joaquin Mateo ◽

...

Keyword(s):

Clinical Trial ◽

Lessons Learned ◽

Trial Implementation

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Using Formative Research to Inform a BCC Strategy to Increase Food Security and Dietary Diversity in Low-Income Rural Communities

International Journal of Nutritional Sciences ◽

10.26420/intjnutrsci.2021.1055 ◽

2021 ◽

Vol 6 (3) ◽

Author(s):

Turk T ◽

◽

Safdar NF ◽

Hashmi S ◽

Shah N ◽

...

Keyword(s):

Literature Review ◽

Nutrition Education ◽

Low Income ◽

Rural Areas ◽

Dietary Diversity ◽

Current Knowledge ◽

Formative Research ◽

Lessons Learned ◽

Attitudes And Practices ◽

Kitchen Gardens

Background: Adequate nutrition is a public health priority, particularly in low-income rural areas where there is a high prevalence of malnutrition and stunting. Baluchistan is an arid desert and mountainous province with the worst health indicators in Pakistan. The objective of this research study was to identify current knowledge, attitudes and practices of vulnerable women with young children residing in remote areas of Baluchistan and assess their information needs to guide the development of a BCC nutrition strategy materials and activities. Methods: This study design incorporated formative research via eight focus group discussions with demand and supply-side program beneficiaries (n=124) to assess current nutrition knowledge, attitudes and beliefs toward kitchen gardens and proposed nutrition resources. Semi-structured interviews (n=16) were also conducted to provide program intelligence from key informants. A literature review supported the development of discussion agenda based on predominant behavioral theories. Data analysis was conducted with in vivo qualitative software coupled with grounded theory with qualitative findings triangulated. Results: The study identified important factors for the development of BCC resources and activities. Opportunities included effective nutrition education, improved income and livelihoods from kitchen gardens, women’s empowerment and gender equality. Challenges included traditional cultural practices, entrenched food preparation behaviour, environmental and infrastructural constraints. Conclusions: Lessons learned highlight the benefits of integrating formative research methods with a comprehensive literature review and behavioural theories for the development of BCC resources for nutrition programs in insecure and resource-constrained settings.

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Lessons learned from a multicentre clinical trial in Africa

Nature Reviews Clinical Oncology ◽

10.1038/s41571-018-0121-0 ◽

2018 ◽

Vol 16 (4) ◽

pp. 211-212 ◽

Cited By ~ 3

Author(s):

Trijn Israels ◽

◽

Elizabeth M. Molyneux

Keyword(s):

Clinical Trial ◽

Lessons Learned ◽

Multicentre Clinical Trial

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