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Impact of financial reimbursement on retention rates in military clinical trial research: A natural experiment within a multi-site randomized effectiveness trial with active duty service members.

ABSTRACT: Introduction:Achieving adequate retention rates in clinical trials is essential to ensuring meaningful results. Although financial reimbursement is an effective strategy to increase participant retention, current policies restrict the use of federal funds to reimburse U.S. active duty Service members for research participation. It is unknown whether permitting financial reimbursement among this population would improve trial retention rates. A recent randomized effectiveness trial received approval to provide reimbursement to Service member participants several months after recruitment began, creating a natural experiment to study the effects of financial reimbursement on retention. Materials and methods:Active duty Service members recruited from six U.S. military treatment facilities (N?=?666) were enrolled in a collaborative care study and completed assessments at baseline, three-, six-, and 12-months. Data on study assessment completion rates at three- and six-months were analyzed using the mixed-effects binary logit model to determine the probabilities of completing assessments based on reimbursement status. Results:Participants who received reimbursement were significantly more likely to complete study assessments at both time-points than participants who did not receive reimbursement (p?

SUBMITTER: Novak LA

PROVIDER: S-EPMC6477623 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature

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Impact of financial reimbursement on retention rates in military clinical trial research: A natural experiment within a multi-site randomized effectiveness trial with active duty service members.

Novak Laura A LA Belsher Bradley E BE Freed Michael C MC McCutchan Phoebe K PK Liu Xian X Evatt Daniel P DP Tanielian Terri T Bray Robert M RM Engel Charles C CC

Contemporary clinical trials communications 20190413

<h4>Introduction</h4>Achieving adequate retention rates in clinical trials is essential to ensuring meaningful results. Although financial reimbursement is an effective strategy to increase participant retention, current policies restrict the use of federal funds to reimburse U.S. active duty Service members for research participation. It is unknown whether permitting financial reimbursement among this population would improve trial retention rates. A recent randomized effectiveness trial receiv ...[more]

PMID: 31032460

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Project description:Non-battle related musculoskeletal injuries (MSKI) are one of the primary medical issues diminishing Service member medical readiness. The MSKI problem is challenging because it is difficult to assess all of the factors that increase MSKI risk and influence post-MSKI outcomes. Currently, there are no high-throughput, clinically-feasible, and comprehensive assessments to generate patient-centric data for informing pre- and post-MSKI risk assessment and mitigation strategies. The objective of the "Pre-neuromusculoskeletal injury Risk factor Evaluation and Post-neuromusculoskeletal injury Assessment for Return-to-duty/activity Enhancement (PREPARE)" study is to develop a comprehensive suite of clinical assessments to identify the patient-specific factors contributing to MSKI risks and undesired post-MSKI outcomes. This is a phased approach, multi-center prospective, observational study (ClinicalTrials.gov number: NCT05111925) to identify physical and psychosocial factors contributing to greater MSKI risk and undesired post-MSKI outcomes, and to identify and validate a minimal set of assessments to personalize risk mitigation and rehabilitation strategies. In Phase I, one cohort (n = 560) will identify the physical and psychosocial factors contributing to greater MSKI risks (single assessment), while a second cohort (n = 780) will identify the post-MSKI physical and psychosocial factors contributing to undesired post-MSKI outcomes (serial assessments at enrollment, 4 weeks post-enrollment, 12 weeks post-enrollment). All participants will complete comprehensive movement assessments captured via a semi-automated markerless motion capture system and instrumented walkway, joint range of motion assessments, psychosocial measures, and self-reported physical fitness performance and MSKI history. We will follow participants for 6 months. We will identify the minimum set of clinical assessments that provide requisite data to personalize MSKI risk mitigation and rehabilitation strategies, and in Phase II validate our optimized assessments in new cohorts. The results of this investigation will provide clinically relevant data to efficiently inform MSKI risk mitigation and rehabilitation programs, thereby helping to advance medical care and retain Service members on active duty status. PREPARE was prospectively registered on ClinicalTrials.gov (NCT05111925) on 5 NOV 2021, prior to study commencement.

Project description:OBJECTIVES:The study aimed tocompare recurring themes in the artistic expression of military service members (SMs) with post-traumatic stress disorder (PTSD), traumatic brain injury and psychological health (PH) conditions with measurable psychiatric diagnoses. Affective symptoms and struggles related to verbally expressing information can limit communication in individuals with symptoms of PTSD and deployment-related health conditions. Visual self-expression through art therapy is an alternative way for SMs with PTSD and other PH conditions to communicate their lived experiences. This study offers the first systematic examination of the associations between visual self-expression and standardised clinical self-report measures. DESIGN:Observational study of correlations between clinical symptoms of post-traumatic stress, depression and anxiety and visual themes in mask imagery. SETTING:The National Intrepid Center of Excellence at the Walter Reed National Military Medical Center, Bethesda, Maryland, USA. PARTICIPANTS:Active-duty military SMs (n=370) with a history of traumatic brain injury, post-traumatic stress symptoms and related PH conditions. INTERVENTION:The masks used for analysis were created by the SMs during art therapy sessions in week 1 of a 4-week integrative treatment programme. PRIMARY OUTCOMES:Associations between scores on the PTSD Checklist-Military, Patient Health Questionnaire-9 and Generalized Anxiety Disorder 7-item scale on visual themes in depictions of aspects of individual identity (psychological injury, military symbols, military identity and visual metaphors). RESULTS:Visual and clinical data comparisons indicate that SMs who depicted psychological injury had higher scores for post-traumatic stress and depression. The depiction of military unit identity, nature metaphors, sociocultural metaphors, and cultural and historical characters was associated with lower post-traumatic stress, depression and anxiety scores. Colour-related symbolism and fragmented military symbols were associated with higher anxiety, depression and post-traumatic stress scores. CONCLUSIONS:Emergent patterns of resilience and risk embedded in the use of images created by the participants could provide valuable information for patients, clinicians and caregivers.

Project description:To detect cerebral microhemorrhages in military service members with chronic traumatic brain injury by using susceptibility-weighted magnetic resonance (MR) imaging. The longitudinal evolution of microhemorrhages was monitored in a subset of patients by using quantitative susceptibility mapping.The study was approved by the Walter Reed National Military Medical Center institutional review board and is compliant with HIPAA guidelines. All participants underwent two-dimensional conventional gradient-recalled-echo MR imaging and three-dimensional flow-compensated multiecho gradient-recalled-echo MR imaging (processed to generate susceptibility-weighted images and quantitative susceptibility maps), and a subset of patients underwent follow-up imaging. Microhemorrhages were identified by two radiologists independently. Comparisons of microhemorrhage number, size, and magnetic susceptibility derived from quantitative susceptibility maps between baseline and follow-up imaging examinations were performed by using the paired t test.Among the 603 patients, cerebral microhemorrhages were identified in 43 patients, with six excluded for further analysis owing to artifacts. Seventy-seven percent (451 of 585) of the microhemorrhages on susceptibility-weighted images had a more conspicuous appearance than on gradient-recalled-echo images. Thirteen of the 37 patients underwent follow-up imaging examinations. In these patients, a smaller number of microhemorrhages were identified at follow-up imaging compared with baseline on quantitative susceptibility maps (mean ± standard deviation, 9.8 microhemorrhages ± 12.8 vs 13.7 microhemorrhages ± 16.6; P = .019). Quantitative susceptibility mapping-derived quantitative measures of microhemorrhages also decreased over time: -0.85 mm(3) per day ± 1.59 for total volume (P = .039) and -0.10 parts per billion per day ± 0.14 for mean magnetic susceptibility (P = .016).The number of microhemorrhages and quantitative susceptibility mapping-derived quantitative measures of microhemorrhages all decreased over time, suggesting that hemosiderin products undergo continued, subtle evolution in the chronic stage.

Dataset Information

Impact of financial reimbursement on retention rates in military clinical trial research: A natural experiment within a multi-site randomized effectiveness trial with active duty service members.

Publications

Impact of financial reimbursement on retention rates in military clinical trial research: A natural experiment within a multi-site randomized effectiveness trial with active duty service members.

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