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.

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 < 0.01). Survey completion was 5% and 4% greater among participants offered reimbursement at three- and six-month time-points, respectively. CONCLUSION: Results suggest that providing Service members with reimbursement for research participation is associated with modest increases in retention rates in clinical trials. Findings provide useful insight for researchers, funding agencies, and policy-makers in considering retention strategies to maximize the value and impact of military research.

Implementing collaborative primary care for depression and posttraumatic stress disorder: design and sample for a randomized trial in the U.S. military health system.

BACKGROUND: War-related trauma, posttraumatic stress disorder (PTSD), depression and suicide are common in US military members. Often, those affected do not seek treatment due to stigma and barriers to care. When care is sought, it often fails to meet quality standards. A randomized trial is assessing whether collaborative primary care improves quality and outcomes of PTSD and depression care in the US military health system. OBJECTIVE: The aim of this study is to describe the design and sample for a randomized effectiveness trial of collaborative care for PTSD and depression in military members attending primary care. METHODS: The STEPS-UP Trial (STepped Enhancement of PTSD Services Using Primary Care) is a 6 installation (18 clinic) randomized effectiveness trial in the US military health system. Study rationale, design, enrollment and sample characteristics are summarized. FINDINGS: Military members attending primary care with suspected PTSD, depression or both were referred to care management and recruited for the trial (2592), and 1041 gave permission to contact for research participation. Of those, 666 (64%) met eligibility criteria, completed baseline assessments, and were randomized to 12 months of usual collaborative primary care versus STEPS-UP collaborative care. Implementation was locally managed for usual collaborative care and centrally managed for STEPS-UP. Research reassessments occurred at 3-, 6-, and 12-months. Baseline characteristics were similar across the two intervention groups. CONCLUSIONS: STEPS-UP will be the first large scale randomized effectiveness trial completed in the US military health system, assessing how an implementation model affects collaborative care impact on mental health outcomes. It promises lessons for health system change.

Compensation and treatment: disability benefits and outcomes of U.S. veterans receiving residential PTSD treatment.

The U.S. Department of Veterans Affairs (VA) provides specialized intensive posttraumatic stress disorder (PTSD) programs to treat trauma-related symptoms in addition to providing service-connected disability to compensate veterans for injury sustained while serving in the military. Given the percentage of veterans who are receiving treatment for PTSD, in addition to seeking compensation for PTSD, a debate has emerged about the impact of compensation on symptom recovery. This study examined the associations among status of compensation, treatment expectations, military cohort, length of stay, and outcomes for 776 veterans who were enrolled in 5 VA residential PTSD programs between the years of 2005 and 2010. Mixed model longitudinal analyses, with age, gender, and baseline symptoms nested within treatment site in the model, found that treatment expectations were modestly predictive of treatment outcomes. Veterans seeking increased compensation reported marginally lower treatment expectations (d = .008), and did not experience poorer outcomes compared to veterans not seeking increased compensation with the effect of baseline symptoms partialled out. Veterans from the era of the Iraq and Afghanistan conflicts reported lower treatment expectations (d = .020) and slightly higher symptoms at intake (d = .021), but had outcomes at discharge equivalent to veterans from other eras with baseline symptoms partialled out. These findings help further inform the debate concerning disability benefits and symptom changes across time.