Practical Monitoring of Treatment Fidelity: Examples From a Team-Based Intervention for People With Early Psychosis.
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ABSTRACT:
SUBMITTER: Essock SM
PROVIDER: S-EPMC4490109 | biostudies-literature | 2015 Jul
REPOSITORIES: biostudies-literature
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Practical Monitoring of Treatment Fidelity: Examples From a Team-Based Intervention for People With Early Psychosis.
Essock Susan M SM Nossel Ilana R IR McNamara Karen K Bennett Melanie E ME Buchanan Robert W RW Kreyenbuhl Julie A JA Mendon Sapna J SJ Goldman Howard H HH Dixon Lisa B LB
Psychiatric services (Washington, D.C.) 20150102 7
Mental health programs can address many components of fidelity with routinely available data. Information from client interviews can be used to corroborate these administrative data. This column describes a practical approach to measuring fidelity that used both data sources. The approach was used in the Recovery After an Initial Schizophrenia Episode (RAISE) Connection Program, a team-based intervention designed to implement evidence-based practices for people experiencing early psychosis sugge ...[more]
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Project description:BackgroundMobile health (mHealth) technologies have been used extensively in psychosis research. In contrast, their integration into real-world clinical care has been limited despite the broad availability of smartphone-based apps targeting mental health care. Most apps developed for treatment of individuals with psychosis have focused primarily on encouraging self-management skills of patients via practicing cognitive behavioral techniques learned during face-to-face clinical sessions (eg, challenging dysfunctional thoughts and relaxation exercises), reminders to engage in health-promoting activities (eg, exercising, sleeping, and socializing), or symptom monitoring. In contrast, few apps have sought to enhance the clinical encounter itself to improve shared decision-making (SDM) and therapeutic relationships with clinicians, which have been linked to positive clinical outcomes.ObjectiveThis qualitative study sought clinicians' input to develop First Episode Digital Monitoring (FREEDoM), an app-based mHealth intervention. FREEDoM was designed to improve the quality, quantity, and timeliness of clinical and functional data available to clinicians treating patients experiencing first-episode psychosis (FEP) to enhance their therapeutic relationship and increase SDM.MethodsFollowing the app's initial development, semistructured qualitative interviews were conducted with 11 FEP treatment providers at 3 coordinated specialty care clinics to elicit input on the app's design, the data report for clinicians, and planned usage procedures. We then generated a summary template and conducted matrix analysis to systematically categorize suggested adaptations to the evidence-based intervention using dimensions of the Framework for Reporting Adaptations and Modifications-Enhanced (FRAME) and documented the rationale for adopting or rejecting suggestions.ResultsThe clinicians provided 31 suggestions (18 adopted and 13 rejected). Suggestions to add or refine the content were most common (eg, adding questions in the app). Adaptations to context were most often related to plans for implementing the intervention, how the reported data were displayed to clinicians, and with whom the reports were shared. Reasons for suggestions primarily included factors related to health narratives and priorities of the patients (eg, focus on the functional impact of symptoms vs their severity), providers' clinical judgment (eg, need for clinically relevant information), and organizations' mission and culture. Reasons for rejecting suggestions included requests for data and procedures beyond the intervention's scope, concerns regarding dilution of the intervention's core components, and concerns about increasing patient burden while using the app.ConclusionsFREEDoM focuses on a novel target for the deployment of mHealth technologies in the treatment of FEP patients-the enhancement of SDM and improvement of therapeutic relationships. This study illustrates the use of the FRAME, along with methods and tools for rapid qualitative analysis, to systematically track adaptations to the app as part of its development process. Such adaptations may contribute to enhanced acceptance of the intervention by clinicians and a higher likelihood of integration into clinical care.Trial registrationClinicalTrials.gov NCT04248517; https://tinyurl.com/tjuyxvv6.
| S-EPMC9675009 | biostudies-literature
Project description:BACKGROUND:Technology-based lifestyle behavioral interventions (i.e., telehealth, mHealth, eHealth, and/or digital health) are becoming an alternative standard of care and possess several advantages over traditional clinical settings such as convenience, cost, and the ability to tailor plans and feedback to a participant's individual needs. These technology-based interventions also present unique challenges to intervention fidelity due to extra elements involved in executing the intervention. Intervention fidelity monitoring is essential to ensure internal and external validity, yet the development and utilization of fidelity protocols is under-reported in the literature. The purpose of this paper is to describe the intervention fidelity protocol for the 24-START study, a behavior change intervention delivered through telephone and internet. This paper also discusses the results of a pilot audit conducted to determine the feasibility of monitoring adherence to the fidelity protocol. METHODS:The 24-START fidelity protocol was developed in accordance with the five fidelity areas outlined by the NIH Behavior Change Consortium (NIH BCC) including: design of study, provider training, delivery of treatment, receipt of treatment, and enactment of treatment. The fidelity strategies provided by the NIH BCC in each area were tailored to fit the specific design of the 24-START study. Twenty-six total fidelity strategies were developed in accordance with the five areas and a corresponding fidelity monitoring plan was created. Because these strategies are only beneficial if implemented, the fidelity monitoring plan was developed to ensure the fidelity strategies are consistently implemented over the course of the intervention. RESULTS:A pilot audit of nine participant files was conducted to test the feasibility of the fidelity protocol developed. Out of the nine participant files reviewed, 89% of scheduled phone calls between a telehealth coach and participant were successfully completed. Of the completed calls, telehealth coaches delivered the intervention as intended 85.3% of the time, and 74% of planned secondary contacts made through the internet were delivered successfully. Additionally, between treatment group dosing was found to be equal. Several weak areas in the fidelity protocol were identified for improvement. The results were satisfactory and the audit was deemed feasible for ongoing use. CONCLUSIONS:The NIH BCC provides a valuable framework for telehealth interventions to develop fidelity protocols ultimately contributing to improved internal and external validity, better translation of results, increased transparency, and increased opportunities for replication within the field. The 24-START pilot audit found the fidelity protocol efficacious and feasible while also identifying areas of weakness in need of revision. The refined protocol will continue to be utilized throughout the data collection phase. Future telehealth interventions should develop and disclose fidelity protocols to improve the overall quality and standard of telehealth interventions.
| S-EPMC5583039 | biostudies-literature
Project description:The objective of the study was to investigate the development of clinical outcomes of young people with early psychosis in a specialized inpatient treatment and assess the feasibility of such an intervention in an inpatient setting. The study was a prospective cohort study of patients with early psychosis treated at the specialized inpatient treatment "Fühinterventions-und Therapiezentrum, FRITZ" (early intervention and therapy center) in Berlin, Germany. The primary outcomes were attitudes towards psychiatric medication and patient satisfaction with treatment after 6 weeks. Secondary outcomes were clinical symptoms, functioning, remission, recovery, all-cause treatment discontinuation, and rehospitalisation at 6 and 12 months after inpatient treatment. We recruited 95 inpatients with early psychosis. Attitudes towards psychiatric medication (Δ6weeks = 3.00, d6weeks = 0.55; Δ6mo = 2.15, d6mo = 0.35; Δ12mo = 3.03, d12mo = 0.52) and patient satisfaction (Δ6weeks = 0.21, d6weeks = 0.40; Δ6mo = 0.32, d6mo = 0.43; Δ12mo = 0.13, d12mo = 0.17) changed with medium effect sizes at six weeks up to a 6- and 12-month follow-up. Clinical outcomes changed significantly with medium-to-large-effect sizes over 12 months CGIΔ12mo = 1.64, d12mo = -1.12; PANSS totalΔ12mo = 20.10, d12mo = -0.76; GAFΔ12mo = 19.58, d12mo = 1.25). The all-cause treatment discontinuation rate was 13.69% (n = 13) at a 6-month and 35.79% (n = 34) at a 12-month follow-up. The rehospitalization rate was 30.53% (n = 29) at a 6-month and 43.16% (n = 41) at a 12-month follow-up. Patients with specialized inpatient treatment for early psychosis showed improvements in attitude towards psychiatric medication, patient satisfaction, symptoms, and functioning for up to 12 months.Trial registration: DRKS00024351, 2021/02/11 retrospectively registered.
| S-EPMC9508217 | biostudies-literature
Project description:Obsessive-compulsive disorder (OCD), a disabling psychiatric illness, creates substantial societal burden. Evidence-based treatments, including psychopharmacology and exposure with response/ritual prevention (EX/RP), are often inaccessible. Digital health technologies, including videoconferencing, may increase access, but the best way to integrate them with current treatments remains unclear. This column describes the experiences of faculty at the Center for OCD and Related Disorders with videoconferencing-assisted treatment. Through a case series, the authors describe five ways to incorporate videoconferencing into OCD treatment: hybrid in-person/remote EX/RP; fully remote EX/RP; and videoconferencing-assisted psychopharmacology, support groups, and clinical supervision. For each strategy, the authors highlight advantages, challenges, clinical considerations, and avenues needing further research.
| S-EPMC8249317 | biostudies-literature
Project description:Abstract Careful fidelity monitoring is critical to implementing evidence-based interventions in dementia care settings to ensure that the intervention is delivered consistently and as intended. Most approaches to fidelity monitoring rely on human coding of content that has been covered during a session or of stylistic aspects of the intervention, including rapport, empathy, enthusiasm and are unrealistic to implement on a large scale in real world settings. Technological advances in automatic speech recognition and language and speech processing offers potential solutions to overcome these barriers. We compare three commercial automatic speech recognition tools on spoken content drawn from dementia care interactions to determine the accuracy of recognition and the guarantees for privacy offered by each provider. Data were obtained from recorded sessions of the Dementia Behavior Study intervention trial (NCT01892579). We find that despite their impressive performance in general applications, automatic speech recognition systems work less well for older adults and people of color. We outline a plan for automating fidelity in interaction style and content which would be integrated in an online program for training dementia care providers.
| S-EPMC7743747 | biostudies-literature
Project description:ImportanceClinical trials have not established the optimal type, sequence, and duration of interventions for people at ultrahigh risk of psychosis.ObjectiveTo determine the effectiveness of a sequential and adaptive intervention strategy for individuals at ultrahigh risk of psychosis.Design, setting, and participantsThe Staged Treatment in Early Psychosis (STEP) sequential multiple assignment randomized trial took place within the clinical program at Orygen, Melbourne, Australia. Individuals aged 12 to 25 years who were seeking treatment and met criteria for ultrahigh risk of psychosis according to the Comprehensive Assessment of At-Risk Mental States were recruited between April 2016 and January 2019. Of 1343 individuals considered, 342 were recruited.InterventionsStep 1: 6 weeks of support and problem solving (SPS); step 2: 20 weeks of cognitive-behavioral case management (CBCM) vs SPS; and step 3: 26 weeks of CBCM with fluoxetine vs CBCM with placebo with an embedded fast-fail option of ω-3 fatty acids or low-dose antipsychotic medication. Individuals who did not remit progressed through these steps; those who remitted received SPS or monitoring for up to 12 months.Main outcomes and measuresGlobal Functioning: Social and Role scales (primary outcome), Brief Psychiatric Rating Scale, Scale for the Assessment of Negative Symptoms, Montgomery-Åsberg Depression Rating Scale, quality of life, transition to psychosis, and remission and relapse rates.ResultsThe sample comprised 342 participants (198 female; mean [SD] age, 17.7 [3.1] years). Remission rates, reflecting sustained symptomatic and functional improvement, were 8.5%, 10.3%, and 11.4% at steps 1, 2, and 3, respectively. A total of 27.2% met remission criteria at any step. Relapse rates among those who remitted did not significantly differ between SPS and monitoring (step 1: 65.1% vs 58.3%; step 2: 37.7% vs 47.5%). There was no significant difference in functioning, symptoms, and transition rates between SPS and CBCM and between CBCM with fluoxetine and CBCM with placebo. Twelve-month transition rates to psychosis were 13.5% (entire sample), 3.3% (those who ever remitted), and 17.4% (those with no remission).Conclusions and relevanceIn this sequential multiple assignment randomized trial, transition rates to psychosis were moderate, and remission rates were lower than expected, partly reflecting the ambitious criteria set and challenges with real-world treatment fidelity and adherence. While all groups showed mild to moderate functional and symptomatic improvement, this was typically short of remission. While further adaptive trials that address these challenges are needed, findings confirm substantial and sustained morbidity and reveal relatively poor responsiveness to existing treatments.Trial registrationClinicalTrials.gov Identifier: NCT02751632.
| S-EPMC10308298 | biostudies-literature
Project description:AbstractThis is a protocol for a Cochrane Review (Intervention). The objectives are as follows:To compare early intervention in psychosis (EIP) specialised teams to usual community mental health care for the treatment of people with first episode psychosis (FEP).
| S-EPMC6422233 | biostudies-literature
Project description: Not available
| S-EPMC8092671 | biostudies-literature
Project description:Attaining and demonstrating treatment fidelity is critical in the development and testing of evidence-based interventions. Treatment fidelity refers to the extent to which an intervention was implemented in clinical testing as it was conceptualized and is clearly differentiable from control or standard-of-care interventions. In clinical research, treatment fidelity is typically attained through intensive training and supervision techniques and demonstrated by measuring therapist adherence and competence to the protocol using external raters. However, in occupational and physical therapy outcomes research, treatment fidelity methods have not been used, which, in our view, is a serious gap that impedes novel treatment development and testing in these rehabilitation fields. In this article, we describe the development of methods to train and supervise therapists to attain adequate treatment fidelity in a treatment development project involving a novel occupational and physical therapy-based intervention. We also present a data-driven model for demonstrating therapist adherence and competence in the new treatment and its differentiation from standard of care. In doing so, we provide an approach that rehabilitation researchers can use to address treatment fidelity in occupational and physical therapy-based interventions. We recommend that all treatment researchers in rehabilitation disciplines use these or similar methods as a vital step in the development and testing of evidence-based rehabilitation interventions.
| S-EPMC3967862 | biostudies-literature
Project description:BackgroundPsychotic disorders are frequently associated with a public perception of dangerousness and belligerence. This situation has contributed to the social stigmatisation of people with severe mental illness and the resulting discrimination that this scenario entails. Despite efforts to demystify such disorders, the association between violent behaviour and psychosis remains unclear.AimsTo explore the incidence of the main types of violent offences in a cohort of patients presenting with first-episode psychosis (FEP).MethodParticipants were recruited from the First Episode Psychosis Intervention Program (CRUPEP) cohort between 2009 and 2016. The main clinical variables were collected, including medical-forensic records of participants registered at the Basque Institute of Forensic Medicine (BIFM), to identify any violent acts in which participants were involved, either as victims or as offenders.ResultsOverall, 79.5% (n = 182) of the participants had no record of violent crime or offence recorded in the BIFM. Annual crime rates for the 2009-2016 period show a decreasing trend in both the general population (IRR = 0.981, 95% CI 0.978-0.983, P < 0.001) and in the FEP group (IRR = 0.019, 95% CI 0.012-0.028, P < 0.001); this pattern is more pronounced in the FEP group. Victimisation accounted for the vast majority of reported incidents; nevertheless, participants who had committed violent offences were mostly involved in intrafamily violence.ConclusionsIndividuals with FEP were not involved in a higher number of crimes than the general population. The types of violent acts committed by people with FEP were heterogeneous, with extreme violence being particularly uncommon.
| S-EPMC10594161 | biostudies-literature