Mixing methods in randomized controlled trials (RCTs): Validation, contextualization, triangulation, and control

Spillane, James P.; Pareja, Amber Stitziel; Dorner, Lisa M.; Barnes, Carol A.; May, Henry; Huff, Jason; Camburn, Eric M.

doi:10.1007/s11092-009-9089-8

Cited by 40 publications

(41 citation statements)

References 47 publications

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“…Hybrid effectiveness-implementation studies vary in the degree to which they emphasize the test of intervention effectiveness (Hybrid Type I), the test of implementation strategy effectiveness (Hybrid Type III), or both (Hybrid Type II) 36 . A Hybrid Type I study, such as this one, provides a randomized test of a clinical intervention (i.e., rigorous effectiveness trial) while gathering descriptive information to guide future implementation efforts 36,37 . Hybrid Type I trials are appropriate when the clinical intervention appears likely to be effective using the new setting, population, or delivery method (in our case, IPT is a front-line treatment for MDD in many other populations and evidence from our pilot RCT suggests that it is likely to be effective among prisoners 22 ) and when the clinical intervention provides minimal risk to study participants.…”

Section: Methodsmentioning

confidence: 99%

Study protocol: Hybrid Type I cost-effectiveness and implementation study of interpersonal psychotherapy (IPT) for men and women prisoners with major depression

Johnson

Miller

Stout

et al. 2016

Contemporary Clinical Trials

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Purpose This article describes the protocol for a Hybrid Type I cost-effectiveness and implementation study of interpersonal psychotherapy (IPT) for men and women prisoners with major depressive disorder (MDD). The goal is to promote uptake of evidence-based treatments in criminal justice settings by conducting a randomized effectiveness study that collects implementation data, including a full cost-effectiveness analysis. Background More than 2.3 million people are incarcerated in the United States on any given day. MDD is the most common severe mental illness among incarcerated individuals. Despite the prevalence and consequences of MDD among incarcerated populations, this study will be the first fully-powered randomized trial of any treatment for MDD in an incarcerated population. Design Given the politically charged nature of the justice system, advantageous health outcomes are often not enough to get an intervention implemented in prisons. To increase the policy impact of this trial, we sought advice from prison providers and administrators about outcomes that would be persuasive to policy-makers and defensible to the public. In this trial, effectiveness questions will be answered using a randomized clinical trial design comparing IPT plus prison treatment as usual (TAU) to TAU alone, with outcomes including depressive symptoms (primary), suicidality, and in prison functioning (enrollment and completion of correctional programs; disciplinary and incident reports; aggression/victimization; social support). Implementation outcomes will include cost-effectiveness; feasibility and acceptability of IPT to clients, providers, and administrators; prison provider intervention fidelity, attitudes, and competencies; and barriers and facilitators of implementation assessed through surveys, interviews, and process notes.

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Section: Methodsmentioning

confidence: 99%

Study protocol: Hybrid Type I cost-effectiveness and implementation study of interpersonal psychotherapy (IPT) for men and women prisoners with major depression

Johnson

Miller

Stout

et al. 2016

Contemporary Clinical Trials

View full text Add to dashboard Cite

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“…An exclusively quantitative or qualitative approach cannot appropriately assess the feasibility of a large multi-country community-based clinical trial. A mixed methods design has advantages for validation, contextualization, and triangulation [44]. …”

Section: Discussionmentioning

confidence: 99%

The feasibility of community level interventions for pre-eclampsia in South Asia and Sub-Saharan Africa: a mixed-methods design

et al. 2016

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BackgroundGlobally, pre-eclampsia and eclampsia are major contributors to maternal and perinatal mortality; of which the vast majority of deaths occur in less developed countries. In addition, a disproportionate number of morbidities and mortalities occur due to delayed access to health services. The Community Level Interventions for Pre-eclampsia (CLIP) Trial aims to task-shift to community health workers the identification and emergency management of pre-eclampsia and eclampsia to improve access and timely care. Literature revealed paucity of published feasibility assessments prior to initiating large-scale community-based interventions. Arguably, well-conducted feasibility studies can provide valuable information about the potential success of clinical trials prior to implementation. Failure to fully understand the study context risks the effective implementation of the intervention and limits the likelihood of post-trial scale-up. Therefore, it was imperative to conduct community-level feasibility assessments for a trial of this magnitude.MethodsA mixed methods design guided by normalization process theory was used for this study in Nigeria, Mozambique, Pakistan, and India to explore enabling and impeding factors for the CLIP Trial implementation. Qualitative data were collected through participant observation, document review, focus group discussion and in-depth interviews with diverse groups of community members, key informants at community level, healthcare providers, and policy makers. Quantitative data were collected through health facility assessments, self-administered community health worker surveys, and household demographic and health surveillance.ResultsRefer to CLIP Trial feasibility publications in the current and/or forthcoming supplement.ConclusionsFeasibility assessments for community level interventions, particularly those involving task-shifting across diverse regions, require an appropriate theoretical framework and careful selection of research methods. The use of qualitative and quantitative methods increased the data richness to better understand the community contexts.Trial registrationNCT01911494Electronic supplementary materialThe online version of this article (doi:10.1186/s12978-016-0133-0) contains supplementary material, which is available to authorized users.

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“…Previous randomized training studies have not examined the organizational context. Our use of mixed-methods research strategies in the context of a randomized controlled trial [72] will allow us to examine a broad range of potential influences on the outcomes that we are assessing. This approach will extend our understanding of interactions between these factors and training outcomes.…”

Section: Discussionmentioning

confidence: 99%

“…In the second stage, codes will be derived deductively by identifying categories at the beginning of the research ( e.g ., elements of the CFIR), and inductively by identifying those that emerge gradually from the data. In subsequent phases, survey data on contextual factors will be examined in conjunction with fidelity scores for the purposes of validation, hypothesis generation, and expansion [71,72] to understand ways in which contextual factors influence fidelity to CPT.…”

Section: Methodsmentioning

confidence: 99%

A randomized controlled dismantling trial of post-workshop consultation strategies to increase effectiveness and fidelity to an evidence-based psychotherapy for Posttraumatic stress disorder

et al. 2013

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BackgroundPosttraumatic Stress Disorder (PTSD) is a serious mental health condition with substantial costs to individuals and society. Among military veterans, the lifetime prevalence of PTSD has been estimated to be as high as 20%. Numerous research studies have demonstrated that short-term cognitive-behavioral psychotherapies, such as Cognitive Processing Therapy (CPT), lead to substantial and sustained improvements in PTSD symptoms. Despite known benefits, only a minority of clinicians provide these therapies. Transferring this research knowledge into clinical settings remains one of the largest hurdles to improving the health of veterans with PTSD. Attending a workshop alone is insufficient to promote adequate knowledge transfer and sustained skill; however, relatively little research has been conducted to identify effective post-training support strategies.MethodsThe current study investigates whether clinicians receiving post-workshop support (six-month duration) will deliver CPT with greater fidelity (i.e., psychotherapy adherence and competence) and have improved patient outcomes compared with clinicians receiving no formal post-workshop support. The study conditions are: technology-enhanced group tele-consultation; standard group tele-consultation; and fidelity assessment with no consultation. The primary outcome is independent assessment (via audio-recordings) of the clinicians’ adherence and competence in delivering CPT. The secondary outcome is observed changes in patient symptoms during and following treatment as a function of clinician fidelity. Post-consultation interviews with clinicians will help identify facilitators and barriers to psychotherapy skill acquisition. The study results will inform how best to implement and transfer evidence-based psychotherapy (e.g., CPT) to clinical settings to attain comparable outcomes to those observed in research settings.DiscussionFindings will deepen our understanding of how much and what type of support is needed following a workshop to help clinicians become proficient in delivering a new protocol. Several influences on clinician learning and patient outcomes will be discussed. An evidence-based model of clinical consultation will be developed, with the ultimate goal of informing policy and influencing best practice in clinical consultation.Trial registrationClinicalTrials.gov: NCT01861769

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Mixing methods in randomized controlled trials (RCTs): Validation, contextualization, triangulation, and control

Cited by 40 publications

References 47 publications

Study protocol: Hybrid Type I cost-effectiveness and implementation study of interpersonal psychotherapy (IPT) for men and women prisoners with major depression

Study protocol: Hybrid Type I cost-effectiveness and implementation study of interpersonal psychotherapy (IPT) for men and women prisoners with major depression

The feasibility of community level interventions for pre-eclampsia in South Asia and Sub-Saharan Africa: a mixed-methods design

A randomized controlled dismantling trial of post-workshop consultation strategies to increase effectiveness and fidelity to an evidence-based psychotherapy for Posttraumatic stress disorder

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