Rapid Assessment Procedure Informed Clinical Ethnography (RAPICE) in Pragmatic Clinical Trials of Mental Health Services Implementation: Methods and Applied Case Study.
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SUBMITTER: Palinkas LA
PROVIDER: S-EPMC7427407 | biostudies-literature | 2019 Mar
REPOSITORIES: biostudies-literature
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Rapid Assessment Procedure Informed Clinical Ethnography (RAPICE) in Pragmatic Clinical Trials of Mental Health Services Implementation: Methods and Applied Case Study.
Palinkas Lawrence A LA Zatzick Douglas D
Administration and policy in mental health 20190301 2
Pragmatic clinical trials of mental health services are increasingly being developed to establish comparative effectiveness, influence sustainable implementation, and address real world policy decisions. However, use of time and resource intensive qualitative methods in pragmatic trials may be inconsistent with the aims of efficiency and cost minimization. This paper introduces a qualitative method known as Rapid Assessment Procedure-Informed Clinical Ethnography (RAPICE) that combines the techn ...[more]
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Project description:BackgroundThere is wide recognition that pragmatic randomised trials are the best vehicle for economic evaluation. This is because trials provide the best chance of ensuring internal validity, not least through the rigorous prospective collection of patient-specific data. Furthermore the marginal cost of collecting economic data alongside clinical data is typically modest. UK Clinical Research Collaboration (UKCRC) does not require a standard operating procedure (SOP) for economic evaluation as a prerequisite for trial unit registration. We judge that such a SOP facilitates the integration of health economics into trials.MethodsA collaboration between health economists and trialists at Bangor University led to the development of a SOP for economic evaluation alongside pragmatic trials, in addition to the twenty SOPs required by UKCRC for registration, which include randomisation, data management and statistical analysis.ResultsOur recent telephone survey suggests that no other UKCRC-registered trials unit currently has an economic SOP.ConclusionWe argue that UKCRC should require, from all Trials Units undertaking economic evaluation and seeking registration or re-registration, a SOP for economic evaluation as one of their portfolio of supporting SOPs.
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Project description:AimsPragmatic randomized clinical trials (pRCTs) collect data that have the potential to improve medical care significantly. However, these trials may be undermined by the requirement to obtain written informed consent, which can decrease accrual and increase selection bias. Recent data suggest that the majority of the US public endorses written consent for low-risk pRCTs. The present study was designed to assess whether this view is specific to the US.MethodsThe study took the form of a cross-sectional, probability-based survey, with a 2 × 2 factorial design, assessing support for written informed consent vs. verbal consent or general notification for two low-risk pRCTs in hypertension, one comparing two drugs with similar risk/benefit profiles and the other comparing the same drug being taken in the morning or at night. The primary outcome measures were respondents' personal preference and hypothetical recommendation to a research ethics committee regarding the use of written informed consent vs. the alternatives.ResultsA total of 2008 adults sampled from a probability-based online panel responded to the web-based survey conducted in May 2016 (response rate: 61%). Overall, 77% of respondents endorsed written consent. In both scenarios, the alternative of general notification received significantly more support (28.7-37.1%) than the alternative of verbal consent (12.7-14.0%) (P = 0.001). Forty per cent of respondents preferred and/or recommended general notification rather than written consent.ConclusionsThe results suggested that, rather than attempting to waive written consent, current pRCTs should focus on developing ways to implement written consent that provide sufficient information without undermining recruitment or increasing selection bias. The finding that around 40% of respondents endorsed general notification over written consent raises the possibility that, with educational efforts, the majority of Spaniards might accept general notification for low-risk pRCTs.
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Project description:BACKGROUND:Significant debate surrounds the issue of whether written consent is necessary for pragmatic randomized, controlled trials (RCTs) with low risk. OBJECTIVE:To assess the U.S. public's views on alternatives to written consent for low-risk pragmatic RCTs. DESIGN:National experimental survey (2 × 2 factorial design) examining support for written consent versus general notification or verbal consent in 2 research scenarios. SETTING:Web-based survey conducted in December 2014. PARTICIPANTS:2130 U.S. adults sampled from a nationally representative, probability-based online panel (response rate, 64.0%). MEASUREMENTS:Respondent's recommendation to an ethics review board and personal preference as a potential participant on how to obtain consent or notification in the 2 research scenarios. RESULTS:Most respondents in each of the 4 groups (range, 60.3% to 71.5%) recommended written informed consent, and personal preferences were generally in accord with that advice. Most (78.9%) believed that the pragmatic RCTs did not pose additional risks, but 62.5% of these respondents would still recommend written consent. In contrast, a substantial minority in all groups (28.5% to 39.7%) recommended the alternative option (general notification or verbal consent) over written consent. LIMITATION:Framing effects could have affected respondents' attitudes, and nonrespondents may have differed in levels of trust toward research or health care institutions. CONCLUSION:Most of the public favored written informed consent over the most widely advocated alternatives for low-risk pragmatic RCTs; however, a substantial minority favored general notification or verbal consent. PRIMARY FUNDING SOURCE:Time-sharing Experiments for the Social Sciences and Intramural Research Program of the National Institutes of Health Clinical Center.
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Project description:BackgroundThe requirement to obtain written informed consent may undermine the potential of pragmatic randomized clinical trials (pRCTs) to improve evidence-based care. This requirement could compromise trials statistical power or even force it to close them down prematurely. However, recent data from the U.S. and Spain suggest that a majority of the public endorses written consent for low-risk pRCTs. The present manuscript assesses whether this view is shared by patients.MethodsThis was a cross-sectional, probability-based survey, with a 2 × 2 factorial design, assessing support for written informed consent versus verbal consent or general notification for two low-risk pRCTs in hypertension, one comparing 2 drugs with similar risk/benefit profiles and the other comparing the same drug being taken in the morning or at night. This web-based survey was conducted in May 2016. Two-thousand and eight adults who were representative of the Spanish population participated in the survey (response rate: 61%). Of these 2008 respondents, 338 indicated that they had been diagnosed with hypertension and were being treated with prescription medicines for this condition at the time of responding to the survey. The primary outcome measures were respondents' personal preference and recommendation to a research ethics committee regarding the use of written informed consent versus verbal consent or general notification.ResultsOverall, 74% of the 338 patient respondents endorsed written consent. In both scenarios, general notification received significantly more support (30.6%-44.7%) than verbal consent (13.3%-17.6%). 43% of respondents preferred and/or recommended general notification rather than written consent.ConclusionsAs in the survey of the general public, more patients endorsed written consent than the alternative option. However, two factors suggest that a different approach to written consent should be investigated for low-risk pRCTs: a) a substantial minority of respondents supported general notification, b) data from the US have shown that most patients who prefer written consent are willing to forego it if obtaining written consent makes the trial too difficult to be conducted; and c) 2016 CIOMS guidelines endorse waivers of consent when the trial fulfills specific conditions. Surveys in other EU countries are needed to assess what patients believe towards pRCTs. If similar results to that reported in this study are found, it is foreseeable that with educational efforts, general notification could be an acceptable and widespread approach to the conduct of low-risk pRCTs.
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Project description:BackgroundBeing subjected to or witnessing coercive measures in mental health services can have a negative impact on service users, carers and professionals, as they most often are experienced as dehumanising and traumatic. Coercion should be avoided, but when it does happen, it is important to understand how the experience can be processed so that its consequences are managed.MethodA systematic review and meta-ethnography was used to synthesise findings from qualitative studies that examined service users', staff's and relatives' experiences of recovery from being exposed to coercive measures in mental health care settings. We identified, extracted and synthesised, across 23 studies, the processes and factors that were interpreted as significant to process the experience.ResultsRecovery from coercion is dependent on a complex set of conditions that support a sense of dignity and respect, a feeling of safety and empowerment. Being in a facilitating environment, receiving appropriate information and having consistent reciprocal communication with staff are the means through which these conditions can be achieved. People employ strategies to achieve recovery, both during and after coercion, to minimise its impact and process the experience.ConclusionsThe findings point to the importance of mental health care settings offering recovery-oriented environments and mental health professionals employing recovery-oriented practices, that would empower service users to develop strategies for managing their mental distress as well as their experiences in mental health care in a way that minimises traumatisation and fosters recovery.
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Project description:IntroductionEngagement and retention in health care is vital to sustained health among people living with HIV (PLWH), yet clinical environments can deter health-seeking behavior, particularly for survivors of interpersonal violence. PLWH face disproportionate rates of interpersonal violence; clinical interactions can provoke a re-experiencing of the sequalae of trauma from violence, called re-traumatization. Trauma-informed care (TIC) is a strengths-based approach to case that minimizes potential triggers of re-traumatization and promotes patient empowerment, increasing acceptability of care. Yet, Ryan White HIV/AIDS clinics, at which over 50% of PLWH received care, have struggled to IMPLEMENT TIC. In this analysis, we sought to (1) identify unique sub-groups of HIV clinics based on clinical attributes (i.e., resources, leadership, culture, climate, access to knowledge about trauma-informed care) and (2) assess relationships between sub-group membership and degree of implementation of TIC and trauma-responsive services offered.MethodsA total of 317 participants from 47 Ryan White Federally-funded HIV/AIDS clinics completed a quantitative survey between December 2019 and April 2020. Questions included assessment of inner setting constructs from the Consolidated Framework for Implementation Research (CFIR), perceived level of TIC implementation, and trauma-responsive services offered by each respondent's clinic. We employed latent class analysis to identify four sub-groups of clinics with unique inner setting profiles: Weak Inner Setting (n = 124, 39.1%), Siloed and Resource Scarce (n = 80, 25.2%), Low Communication (n = 49, 15.5%), and Robust Inner Robust (n = 64, 20.2%). We used multilevel regressions to predict degree of TIC implementation and provision of trauma-responsive services.ResultsResults demonstrate that clinics can be distinctly classified by inner setting characteristics. Further, inner setting robustness is associated with a higher degree of TIC implementation, wherein classes with resources (Robust Inner Setting, Low Communication) are associated with significantly higher odds reporting early stages of implementation or active implementation compared to Weak class membership. Resourced class membership is also associated with availability of twice as many trauma-responsive services compared to Weak class membership.DiscussionAssessment of CFIR inner setting constructs may reveal modifiable implementation setting attributes key to implementing TIC and trauma-responsive services in clinical settings. Introduction.
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Project description:AimPracticing physicians inevitably become involved in pragmatic clinical trials (PCTs), including comparative effectiveness research. We sought to identify physicians' perspectives related to PCTs.MethodsIn-depth semistructured interviews with 20 physicians in the USA.ResultsAlthough physicians are generally willing to participate in PCTs, their support is predicated on several factors including expected benefits, minimization of time and workflow burdens and physician engagement. Physicians communicated a desire to respect patients' rights and interests while maintaining a high level of care.ConclusionFuture work is needed to systematically assess the impact of PCTs on clinicians in meeting their ethical obligations to patients and the burdens clinicians are willing to accept in exchange for potential benefits.
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Project description:The principle of pragmatism in clinical trials has been broadly recognised as a way to close the gap between research and practice. In this contribution, we argue that the conduct of pragmatic clinical trials in Europe may be hampered by poor implementation of current European Union's Clinical Trial Regulation No. 536/2014.
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Project description:Study a quality improvement approach for implementing evidence-based employment services at specialty mental health clinics.Semistructured interviews with clinicians and administrators before, during, and after implementation. Qualitative field notes, structured baseline and follow-up interviews with patients, semistructured interviews with patients after implementation, and administrative data.Site-level controlled trial at four implementation and four control sites. Hybrid implementation-effectiveness study with mixed methods intervention evaluation design.Site visits, in-person and telephone interviews, patient surveys, patient self-assessment. A total of 801 patients completed baseline surveys and 53 clinicians and other clinical key stakeholders completed longitudinal qualitative interviews.At baseline, sites varied in the availability, utilization, and quality of supported employment. Each site needed quality improvement for this service, though for differing reasons, with some needing development of the service itself and others needing increased service capacity. Improvements in knowledge, attitudes, beliefs, and referral behaviors were evident in mid- and postimplementation interviews, though some barriers persisted. Half of patients expressed an interest in working at baseline. Patients at implementation sites were 2.3 times more likely to receive employment services during the study year. Those who had a service visit were more likely to be employed at follow-up than those who did not.Studies of implementation and effectiveness require mixed methods to both enhance implementation in real time and provide context for interpretation of complex results. In this study, a quality improvement approach resulted in superior patient-level outcomes and improved clinician knowledge, attitudes, and behaviors, in the context of substantial variation among sites.
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