Treatment Fidelity Research Articles

Hybrid Effectiveness-Implementation Studies in Infection Prevention and Infectious Diseases: A Narrative Review.

BackgroundEach year in the UK approximately 367,000 people are diagnosed with cancer of whom half will experience moderate to severe chronic pain and a third are undertreated for their pain. Most people with cancer are cared for at oncology outpatient services where there are no standardised approaches for managing pain. As a result, cancer patients are at risk of receiving inadequate care for pain. There is a need for a standardised approach to pain management within oncology outpatient services.Methods/designThe aim of this pilot trial is to establish the feasibility of conducting a multi-centre clustered-randomised trial of an integrated standardised pain assessment and management programme integrated within routine care at oncology outpatient services in the United Kingdom National Health Service (NHS).We will conduct a two-arm pilot cluster randomised trial with nested process evaluation to evaluate the feasibility and acceptability of trial processes, establish fidelity of intervention implementation, estimate variability in outcomes and feasibility of future economic evaluation. Twelve outpatient services (clusters) from at least two NHS tertiary oncology referral centres (sites), in the North of England will be randomised (1:1) to deliver a pain management programme plus usual care or usual care alone and will recruit a total sample of 180 participants. Adults attending a participating outpatient service who self-report a score of ≥ 3 on the 0–10 Numerical Rating Scale (NRS) for worst pain in the past 72 h in any part of their body, and will be available for 1-week follow-up will be eligible. Participant self-reported questionnaires will be collected at baseline, 1-week, 1-month, and 2-months with medical record review at 1-month and 2-months. Progression to a future trial will be based on pre-defined criteria associated with eligibility and consent rates, follow-up and intervention delivery and acceptability.DiscussionLittle research has described optimal ways to implement a standardised pain assessment and management programme into oncology outpatient services. The strengths of the pilot trial are its sample size, number of clusters, and planned evaluation of trial processes and intervention fidelity to provide robust trial evidence to fully inform a future definitive phase III multi-centre cluster randomised trial within the UK NHS.Trial registrationThe CAPTURE pilot trial is registered on the ISRCTN registry (86,926,298).

BackgroundDementia caregiver intervention research often lacks focus on mechanisms of benefit. This study addresses this gap through a process evaluation of the Residential Care Transition Module (RCTM), a telehealth intervention designed to assist family caregivers of persons with dementia post-institutionalization, consisting of six sessions with flexible ad hoc support over a 12-month period. This process evaluation describes the RCTM’s content and delivery, examines treatment fidelity, identifies implementation factors that influenced the primary outcomes (caregiver subjective stress and depressive symptoms), and clarifies mechanisms of intervention benefit.MethodsThe RCTM enrolled 240 primary caregivers randomly assigned to the intervention or attention control group (n = 120 each). Process/implementation data were collected through study logs documenting session duration, modality, and content, and treatment review checklists completed at four, eight, and 12 months, capturing caregiver ratings of intervention content, utility, and acceptability. Additionally, 30 purposively selected caregivers completed semi-structured interviews probing their perceptions of the intervention. This process evaluation employed a parallel convergent mixed-methods design, integrating quantitative data from longitudinal surveys with qualitative thematic analysis of interviews.ResultsMost caregivers (107; 89%) completed all six intervention sessions; of these, the majority (80; 75%) completed the intervention in four months. Caregivers found the intervention beneficial across multiple domains, expressing strong support for its utility and acceptability. Interviews revealed nine intervention components that facilitated treatment enactment and highlighted mechanisms of benefit. Longitudinal models showed participation in ad hoc intervention sessions was associated with greater benefit over the 12-month period, with higher frequency and longer duration of ad hoc sessions significantly associated with larger reductions in depressive symptoms and care-related stress, respectively.ConclusionsThe RCTM was delivered with high fidelity, demonstrating strong caregiver participation and positive feedback. Qualitative and quantitative data highlight the RCTM’s value in providing emotional support and informational counseling to help caregivers build mastery for managing residential care-related issues. In particular, results demonstrated the potential importance of flexible ad hoc sessions in complementing the core intervention. These insights can inform future adaptation/implementation of the RCTM to support dementia caregivers within residential long-term care settings.Trial RegistrationClinicalTrials.gov: NCT02915939; 09-26-2016Supplementary informationThe online version contains supplementary material available at 10.1186/s12913-025-13547-2.

Introduction Male involvement is crucial in optimizing maternal reproductive health outcomes, offering the potential to bolster reproductive health outcomes for mothers. The Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework can describe the implementation of interventions focused on promoting male involvement in maternal reproductive health. This study aims to (1) examine the implementation of male involvement interventions that influence maternal reproductive health outcomes and (2) report the implementation outcomes as conceptualized in the RE-AIM framework. Methods This protocol followed the preferred reporting items for systematic review and meta-analysis. We searched PubMed, CINAHL, PsycINFO, and Web of Science utilizing a systematic review with narrative synthesis methodology to identify studies describing interventions that promote male involvement in maternal reproductive health outcomes in Africa from 2000 to 2024 Furthermore, we evaluated the public health impact of male involvement interventions from selected studies using the RE-AIM framework. Two reviewers independently screened articles, selected eligible studies, and extracted data. The quality of included studies was assessed using the NIH Assessment Tool for Observational Cohort and Cross-Sectional Studies. Results This review included six studies that met the inclusion criteria. Overall, the studies reported increased maternal reproductive health indicators (e.g., antenatal care uptake, antiretroviral medication adherence, and postnatal care uptake) after implementing the male involvement-focused interventions. The most commonly reported RE-AIM dimensions were Reach (83.4%) and Efficacy/Effectiveness (70%). Adoption (40.5%), Implementation (38.9%), and Maintenance (13.3%) were less often reported. All studies reported on measures of primary outcomes, intervention duration and frequency, sample size, and participants’ characteristics. However, few reported on implementation fidelity, quality of life, methods used to identify staff, staff inclusion/exclusion criteria, implementation cost, and maintenance indicators. Conclusions The review underscores the potential of male-involvement interventions in advancing maternal reproductive health outcomes. However, the limited reporting of external validity indicators such as intervention fidelity, intervention cost, and maintenance indicators limits such interventions’ scalability and long-term sustainability. This calls for more focus on reporting external validity indicators to inform the scalability and transferability of such interventions in real-world settings. Systematic Review Registration https://www.crd.york.ac.uk/PROSPERO/view/CRD420251031192 , PROSPERO CRD420251031192.

Abstract Background and Aims The multi-component PIDO-P intervention (pharmacist intervention and dose optimization of phosphate-binding medication) was designed to improve hyperphosphatemia by increasing medication adherence in hemodialysis patients with a high pill burden of phosphate-binding medication (PBM). Although this intervention reduced PBM pill burden and improved PBM adherence, phosphate levels remained high. We wanted to investigate if this finding was caused by a low implementation fidelity (IF) of the intervention. IF assesses the degree to which an intervention is performed as intended, and is an important mediator of the relationship between the intervention and the intended outcome. This mixed methods study, using qualitative and quantitative data sources, aimed to evaluate IF of the PIDO-P intervention. Method The study was performed in the Franciscus Gasthuis and Vlietland, a large teaching hospital in Rotterdam, the Netherlands, with a hemodialysis facility for 250 patients. The PIDO-P intervention consisted of three pharmacist consultations in three months, in patients with ≥6 sevelamer tablet equivalents and phosphate levels >1.50 mmol/L. During these consultations barriers to adherence to PBM were addressed (using the Quick Barrier Scan) and PBM dose was reduced. The implementation fidelity of the PIDO-P intervention was studied according to Carroll's framework, evaluating adherence to the intervention (coverage, content, frequency, and duration) and moderating factors (intervention complexity, facilitation strategies, quality of delivery, and participant responsiveness). Six key intervention components were identified in advance. Feasibility in clinical practice was also investigated. Qualitative data (semi-structured interviews with patients, pharmacists, and prescribers) were thematically analyzed according to Braun with Atlas.ti, quantitative data were analyzed using descriptive statistics in SPSS. Results The adherence to the intervention was high. Coverage was high, with the selection procedure performed as planned, a high percentage of invited patients participating, and 4% drop-out. Regarding the content of the intervention were 5 of 6 key components delivered to a high degree. PBM dose reduction was performed in 71 of 73 patients, PBM pill burden was reduced from 8.8 ± 3.1 (mean ± SD) to 5.8 ± 2.7 sevelamer tablet equivalents. After the third consultation PBM dose was still reduced in 60 of 72 patients. IF was high for frequency and duration: the 3 consultations were carried out in 72 of 75 patients. The pharmacists considered the intervention not complex with easy-to-use intervention materials. Pharmacists and prescribers perceived the facilitation strategies as helpful. The quality of delivery and participant responsiveness were generally good; 88.1% of the patients thought the intervention improved their understanding. Prescribers considered recurrent attention to PBM, discussing patient preferences, and adequate collaboration and communication with other healthcare professionals as essential parts of the intervention. Regarding feasibility in clinical practice, pharmacists and prescribers thought the intervention should focus on patients with higher phosphate levels. Pharmacists believed that the patient screening and selection process should be improved. Patients would prefer more recurrent consultations with a single pharmacist. Conclusion The IF of the PIDO-P intervention was high. Therefore, the lack of an effect of the PIDO-P intervention on phosphate levels cannot be explained by a low IF of the intervention. However, after dose reduction, the PBM dose might have been too low to improve phosphate levels in patients with high dietary phosphate content. Furthermore, no extra pharmacist-patient consultations were conducted between three and twelve months of follow-up. Over time, this might have led to less attentive use of PBM in patients, reducing PBM effectiveness. Further research is needed to improve the intervention, focusing on patients with higher phosphate levels and higher PBM pill burden, and including recurrent consultations with a single pharmacist.

Background: African American (AA)/Black and Latinx communities have limited access to evidence-based fall prevention programs such as Tai Chi Prime (TCP). Community-led interventions that incorporate peer support are cost-effective and sustainable. Using the Treatment Fidelity Framework (TFF) and a mixed-methods research approach, we evaluated the training and support given to trainees during the TCP leader training pathway process and their subsequent fidelity in delivering six culturally tailored community courses. Methods: Trainees completed feedback forms after each TCP leader training pathway course. Using a fidelity checklist, a TCP master trainer rated six community TCP classes led by race- and language-concordant leaders. Trainees were invited to participate in virtual one-on-one semi-structured interviews to share their perspectives on the appropriateness and relevance of the TCP leader training pathway and their experience leading community TCP classes. Quantitative data was analyzed using descriptive statistics on Microsoft Excel. Three study team members coded qualitative data using directed content analysis approach. Results: Twenty-five candidates enrolled in the TCP leader training. Forty-eight percent identified as AA/Black while 52% identified as Latinx. Eleven trainees (six AA/Black and five Latinx) completed the entire TCP leader training pathway to become certified TCP leaders. Trainees rated the training process as highly satisfactory and appropriate. Leaders from both communities received high fidelity scores for community course delivery. Conclusions: Findings contribute to the existing literature, particularly regarding how to effectively disseminate and evaluate a culturally tailored TCP leader training and certification process for culturally diverse communities while maintaining fidelity to the curriculum.

Newborn units in resource-constrained low-middle-income countries (LMICs) often have high neonatal mortality rates. Programmes to improve care quality often accept understaffing that directly affects care in these settings as a norm, and the effects of improving staff numbers are not studied. To address a major evidence gap, we examined the effects on quality of care of improving nurse staffing in four intermediate-level Kenyan newborn units. We introduced three additional nurses to each of four newborn units. We measured nursing care provision using direct bedside observations with a validated structured checklist before and 6 months after intervention. Our primary outcome, changes in nurse-delivered care, was examined using descriptive analysis and multilevel modelling to adjust for confounding. We also examined the pattern of nursing care delivery and intervention fidelity. We observed a total of 1872 hours of care, over 156 nursing shifts for 290 and 300 babies before and after our intervention, respectively, across our four neonatal units. Our intervention increased the nursing hours per patient per shift observed from 34 to 43 min associated with a 4.7% increase in our primary outcome, nurse-delivered care and an 8.4% increase in delivery of 10 tasks nurses prioritise (adjusted B-coefficient 0.047 (95% CI 0.028 to 0.066) and B-coefficient 0.084 (95% CI 0.053 to 0.115), respectively). Intervention strength was reduced by changes in existing nurses' deployment and an increase in workload. In very high workload settings in LMICs where nurses can only deliver a fraction of nursing care, staffing increases improve care delivery more obviously for high-priority tasks. These findings provide much needed evidence that increasing neonatal nurse staffing in under-resourced newborn units improves care quality.

There have only been 3 efficacy trials reporting head-to-head comparisons of pharmacotherapy and trauma-focused psychotherapy for posttraumatic stress disorder (PTSD), and none were conducted in primary care. In addition, few trials have examined treatment sequences for patients not responding to an initial treatment. To test the hypothesis that (1) brief trauma-focused psychotherapy (written exposure therapy [WET]) is more effective than a choice of 3 selective serotonin reuptake inhibitors (SSRIs; ie, sertraline, fluoxetine, or paroxetine) and (2) WET augmentation is more effective than switching to the serotonin-norepinephrine reuptake inhibitor (SNRI) venlafaxine for those not responding to an SSRI. This was a pragmatic comparative effectiveness trial conducted from April 2021 to June 2024 that randomized primary care patients to 1 of 3 treatment sequences: (1) SSRI followed by WET augmentation, (2) SSRI followed by switch to SNRI, or (3) WET followed by SSRI. Effectiveness in this pragmatic trial depends on treatment engagement and treatment fidelity. The study included patients meeting clinical criteria for PTSD from primary care clinics of 7 federally qualified health centers and 8 Department of Veterans Affairs medical centers. SSRI followed by WET augmentation, SSRI followed by switch to SNRI, or WET followed by SSRI. PTSD symptom severity, as measured by the DSM-5 PTSD Checklist (PCL-5). A total of 700 patients (mean [SD] age, 45.1 [15.4] years; 368 men [62.1%]). The mean (SD) baseline PCL-5 score was 52.8 (11.1), indicating considerable symptom severity. At 4 months, 144 of 278 patients (51.8%) randomized to an SSRI were adherent and reported a 14.0-point PCL-5 decrease, whereas 11 of 352 patients (31.5%) randomized to WET completed all sessions and reported a 12.1-point decrease. There was no significant between-group difference (adjusted mean difference [MD], 1.79; 95% CI, -0.76 to 4.34; P = .17). For the 122 of 295 patients (41.4%) randomized to an SSRI who did not respond to treatment, those randomized to switch to the SNRI reported a 9.2-point PCL-5 decrease compared with a 2.3-point decrease for those randomized to WET augmentation, which was a statistically significant between-group difference (adjusted MD, 10.19; 95% CI, 4.97-15.41; P < .001). Study results showed that treatment of PTSD in primary care with either SSRIs or WET was feasible and effective. For patients not responding to an SSRI, switching to an SNRI may be more effective than WET augmentation. ClinicalTrials.gov Identifier: NCT04597190.

Pediatric randomized controlled trials (RCTs) inform decisions concerning the choice of interventions in children and adolescents. To enable the implementation of effective interventions, RCT reports need to provide adequate details on the elements, infrastructure, and delivery of these interventions. Using the 12-item Template for the Intervention Description and Replication (TIDieR) framework, an international team developed guidance for comprehensive reporting of trial interventions in pediatric RCT protocols and reports. We (1) identified initial pediatric considerations (PCs) and examples of good reporting using 50 recent pediatric RCT reports, (2) held an expert panel meeting, (3) conducted a Family Caregiver Workshop to discuss and get input on PCs, (4) compiled PCs and examples of good reporting, and (5) achieved consensus on final PCs and examples. Thirteen PCs reached consensus; they address how trial intervention materials were appropriate for the age and developmental stage of trial participants, which adjustments to enhance palatability of medications and acceptability of interventions were implemented, and how pediatric-specific dosing was determined. Consensus was also reached on accompanying good reporting exemplars. Presenting a minimum set of considerations pertinent to pediatric trial interventions, the TIDieR-Child & Adolescent Health (TIDieR-C) checklist can help trial authors and evidence end users comprehensively report and appraise tested interventions. It can be used with the pediatric-specific extensions of the Standard Protocol Items for Randomized Trials (SPIRIT) and Consolidated Standards of Reporting Trials (CONSORT): SPIRIT-Children & Adolescents and CONSORT-Children & Adolescents. Uptake of this guidance may lead to improved understanding, replicability, and implementation fidelity of effective trial interventions.

BackgroundMental health problems in children and young people (CYP) are increasing with a pressing need for more effective treatments. However, the development of psychological interventions seldom explores young patients experiences of treatment, which is crucial in understanding factors influencing the uptake, impact and validity of therapy. We aimed to explore for the first time CYP experiences of how they received group metacognitive therapy for anxiety disorders and depression.MethodsA qualitative study was embedded in a larger feasibility RCT (n=95) comparing group-based MCT with treatment as usual. Seventeen CYP aged 11-17yrs who had been part of the group-MCT arm consented to participate. Interviews were semi-structured, open-ended and followed an a-priori guide. Coding and analysis adhered to guidelines for reflexive thematic analysis.ResultsThree overarching themes emerged in patient experiences: treatment fidelity, treatment delivery, and experiences of homework. Treatment fidelity had two subthemes: i) treatment receipt- which included patients understanding of MCT and performance of MCT techniques during the intervention, and ii) treatment enactment- which included performance of MCT techniques in applied settings, plus perceived benefits of treatment. Treatment delivery included two subthemes; i) format of therapy and, ii) therapist characteristics.ConclusionsThe results support the use of MCT in children and young people with mixed anxiety disorders and depression. Patients reported understanding the treatment rationale and benefiting from the intervention. They described, consistent with purported mechanisms, how treatment helped them make a shift in beliefs about thoughts and see worry as powerless and under personal control. Patients described an ability to apply specific techniques in real-life settings, despite noting major challenges with homework compliance. The results emphasised areas that might be improved and important recommendations are made for MCT delivery and practise in children and adolescents.

Background: Dissemination of evidence-based intensive health behavior and lifestyle treatments (IHBLTs) to families from low-income communities was the primary objective of the CDC Childhood Obesity Research Demonstration (CORD) 3.0 projects. The goal of RI CORD 3.0 was to adapt and test the effectiveness and context for remote implementation of an IHBLT, JOIN for ME. Methods: Children aged 6-12 years with body mass index (BMI) >85th percentile and a caregiver (N = 111) were recruited through a federally qualified health center (FQHC) or community setting and participated in an immediate or 4-month delay condition. Child and caregiver weight status, Family Nutrition and Physical Activity (FNPA), and child weight-related quality of life were assessed at baseline, 4 months, and at the end of the 10-month remotely delivered intervention. Program acceptability and intervention fidelity were assessed to inform subsequent implementation. Results: Analyses comparing active and delayed treatment groups at 4 months showed significant improvements in FNPA for the active treatment group compared with delayed group. Groups did not differ significantly on child or caregiver weight status. Ten-month treatment effects in the combined sample showed significant effects of time on child relative weight status, with children who initiated the program demonstrating decreases of 2.90% median BMI, 3.89%BMIp95, and 0.16 zBMI units. Session attendance and food security at baseline were related to greater changes in weight status. Conclusions: The adapted version of the JOIN for ME was successfully implemented and shown to be associated with significant, modest changes in child weight status.

Positive Behavioral Interventions and Supports (PBIS) is a multitiered system of support (MTSS) framework for preventing and responding to challenging behavior. Within this framework, Tier 2 is designed to meet the needs of students who fail to respond to Tier 1, universal, supports before they develop serious social, emotional, or behavioral needs that require intensive Tier 3 supports. In the present study, we sought to build upon existing knowledge of how schools are implementing Tier 2 through a nationwide survey of school professionals who serve children from early childhood through high school. Based on 172 respondents, our results include descriptive statistics of Tier 2 teaming structures, interventions implemented, student identification and intervention matching strategies, systems and intervention fidelity procedures, and methods for evaluating individual and systems outcomes. Implications for research and practice, limitations, and future directions are discussed.

Optimising hospital care to align with what matters most for people living with advanced serious illness is a global priority area for improvement. Collection and feedback of patient reported experience measures (PREMs) is one potential method to inform improvements. This study used the integrated Promoting Action on Research implementation in Health Services (i-PARIHS) framework to inform the implementation of a complex intervention that included collection and feedback of PREM data and facilitation to empower ward-based quality improvements for inpatients with advanced serious illness. A single-site pre-post quality improvement study within a large Australian hospital. The intervention titled Listen, Empower and Act to improve Palliative care ('LEAP' bundle') included three phases: 'Listen' - collecting and analysing patient (PREM) and clinician perspectives to understand current care experience and local context; 'Empower' - collating PREM feedback and facilitating local stakeholder engagement to identify and prioritise areas for improvement; and 'Act' - facilitating clinician led innovation development and implementation informed and monitored by continuing PREM collection and feedback. Intervention fidelity was summarised descriptively from field notes and meeting records. The primary effectiveness outcome was change in 'very good' experiences over time, reported from an eight-question validated PREM designed for inpatients with serious illness (consideRATE). Analysis used mixed binary logistic regression with time period as fixed effect and ward as random effect. The three participating wards completed the intervention with some adaptations, and each implemented different innovations. The proportion of 'very good' responses showed a statistically significant increase for all consideRATE questions in intervention periods 1-4 compared to period 0 (baseline). All questions except 'attention to feelings' (Q2) were significantly improved by the first measurement period, and all except 'attention to affairs' (Q6) remained significantly higher than baseline during the final measurement period. Implementation of the LEAP bundle led to improved palliative care experience within three wards in one large tertiary hospital setting. Listening to patients and empowering clinical teams to collectively reflect on data and lead change was crucial to study success and required skilled facilitation. Testing the sustainability, transferability and scalability of the intervention will be important next steps.

Sexual offenses and other problematic sexual behaviors by youths are viewed in many countries as a legal problem rather than as a public health problem that can be treated. Multisystemic Therapy for Problem Sexual Behaviors (MST-PSB) was developed to address the dearth of effective treatments for youths with criminal and non-criminal sexual behavior problems. This article begins by describing the empirical and theoretical underpinnings of the MST-PSB treatment model and the various characteristics of the model that make it well suited for the treatment of youths with problem sexual behaviors. Next, we discuss the various clinical interventions used in MST-PSB and delineate how the model is operationalized and provided to youths and their families. Research findings that demonstrate the positive clinical outcomes, mechanisms of change, and economic benefits of MST-PSB are then reviewed, followed by a summary of how MST-PSB is implemented by provider organizations using a comprehensive approach to establishing and maintaining treatment fidelity. For family therapists who treat youths with problem sexual behaviors but are not practicing within an MST-PSB program, we hope that the conceptual framework, clinical interventions, and treatment principles described in this article can contribute to the effectiveness of your work. In addition, we suggest that administrators of programs that treat youths who engage in problem sexual behaviors should consider the current evidence base as they make decisions about the adoption of interventions for this clinical population of youths. Finally, we recommend that comprehensive, empirically supported treatment models such as MST-PSB be increasingly considered by policymakers when allocating scarce financial resources to treatments for youths with problem sexual behaviors.

Abstract This paper summarizes three theoretically related experimental pilot studies conducted in developing a new intervention for students with word reading difficulties. Each independent experiment tested instructional elements influenced by perspectives on lexical quality, connectionism, and statistical learning. Intervention components that showed promise moved on to become part of a base program tested in a subsequent study. In each study, students in grades 2–4 with low word reading skills were randomly assigned to one of two intervention conditions. Researcher‐supported tutors provided small‐group instruction five days per week over ten weeks at under 25 min per session. Treatment fidelity exceeded 90% in each experimental study. Standardized and researcher‐developed measures of word and text reading were administered pretest and posttest. Although few statistical differences were observed, several educationally meaningful effect sizes were observed between groups across each study. In Study 1, effect sizes favored a condition in which decoding instruction and practice included variability in spelling–sound correspondence and larger letter units, compared to a condition in which standard spelling–sound pronunciations and sound‐by‐sound decoding were emphasized. In Study 2, effect sizes favored a condition in which a spelling activity was embedded in decoding instruction compared to identical decoding instruction without spelling. In Study 3, contrary to our expectations, embedding semantic information within a decoding and spelling program was less effective than the same instruction without semantic information. We discuss the results related to innovations to improve generalized word reading skills and our next steps that involve a randomized controlled trial and further intervention development.

A framework for monitoring intervention fidelity: The NOURISH trial.

Many patients with end-stage kidney disease begin dialysis therapy with central venous dialysis catheters, significantly increasing the risk of dialysis catheter-related bloodstream infection. Bloodstream infections are among the most severe harm events affecting patients receiving dialysis. In 2023, the dialysis catheter-related central line [catheter]-associated bloodstream infection (CLABSI) rate at an acute care medical center in southern California was thrice the national benchmark. This quality improvement project aimed to decrease this rate by adding chlorhexidine-coated dialysis catheter caps to standard care. Using the Knowledge to Action model, the medical center made a dialysis catheter-related CLABSI reduction practice change. Preimplementation and postimplementation monthly aggregate data were collected for dialysis catheter-related CLABSIs, central venous dialysis catheter days, and dialysis catheter-related infection rates. One-on-one dialysis staff simulation training and process compliance audits ensured intervention fidelity. The intervention was replacement of nonchlorhexidine dialysis catheter caps with chlorhexidine-coated dialysis catheter caps for patients with central venous dialysis catheters. An 8-week preimplementation period included 119 patients, 561 dialysis therapies, 934 central dialysis catheter days, and 2 dialysis catheter-related CLABSIs (2.14 infections per 1000 catheter days). An 8-week postimplementation period included 128 patients, 583 dialysis therapies, 897 central dialysis catheter days, and 0 dialysis catheter-related CLABSIs; no dialysis catheter-related CLABSIs occurred during postimplementation sustainability assessment (24 weeks total). Use of chlorhexidine-coated dialysis catheter caps led to clinically significant results among patients receiving dialysis with central catheters at an acute care medical center.

Abstract While social prescribing research and practice originates from and has been adopted widely throughout the United Kingdom, global interest and uptake of social prescribing has increased, with well over 30 nations reporting some level of adoption and implementation. In this round table session, we examine new results from the H2020 RECETAS Consortium, dedicated to nature-based social prescribing interventions to alleviate loneliness and improve health-related quality of life. Specifically, we will showcase key elements and early results about intervention fidelity outcomes, training model adaptations, health economic evaluations, and regional health system policy integration (10 min per presentation). This will set the stage for a dynamic discussion with the audience to contemplate how research findings can best be ‘translated’ into concrete guidelines for adopting and implementing holistic and person-centred models of social prescribing to address a range of social health conditions. This session will bring multi sectoral perspectives including medicine, public health, health economics, and health policy to examine new evidence to support and advance nature-based social prescribing interventions for practice in communities worldwide. Key messages • Innovations in social prescribing offer ways to address conditions that affect physical, cognitive, and mental health through person-centered, group-supported, and nature-based strategies. • Early engagement of multisectoral stakeholders is key to ensure SP can work for diverse populations, different health conditions, and across dynamic care settings.

327 Background: Patients with LARC receive aggressive, multimodality treatment including chemotherapy, radiation, and surgery to maximize the potential for cure. However, patients often find this treatment paradigm overwhelming and difficult to navigate due to its lengthy, complex, and unpredictable nature. We developed “PATHWAYS,” an informational and supportive care intervention focused on 1) managing health, 2) building a support system, and 3) adjusting to life with cancer to enhance self-efficacy, social support, and coping as a means to improve mood and quality of life among patients initiating multimodality therapy for LARC. We sought to assess the feasibility and acceptability of PATHWAYS, and to refine the intervention based on patient feedback. Methods: We conducted a pilot randomized controlled trial (NCT05914766) among adult patients who were within four weeks of consenting for multimodality therapy for LARC. Participants were randomized 1:1 to receive PATHWAYS (an educational guide plus four weekly virtual 30-minute behavioral coaching sessions) or enhanced usual care (a curated list of online resources for patients with LARC). Participants completed questionnaires at baseline, 6 weeks, and 12 weeks, as well as in-depth interviews at 6 and 12 weeks to elicit feedback on study participation. The primary outcome was feasibility (60% of eligible patients enroll; 60% of PATHWAYS participants complete the intervention). The secondary outcome was acceptability (80% of PATHWAYS participants report satisfaction using the Client Satisfaction Questionnaire-8, CSQ-8). We assessed intervention fidelity by reviewing 20% of session recordings using a rating checklist. Results: We approached 35 eligible patients, of whom 20 (57%) enrolled (median age 55 years, 50% women, 75% non-Hispanic White, 60% married/partnered). Of the 10 patients randomized to PATHWAYS, 9 (90%) completed the intervention, all (100%) of whom reported satisfaction with the intervention as per the CSQ-8. In qualitative interviews, participants reported appreciating the supportive and tailored nature of PATHWAYS but had difficulty with navigating the educational guide’s multiple topic areas during their coaching sessions. They also reported finding the session length to be too short to adequately cover the intervention content. Review of session recordings demonstrated ≥80% protocol adherence in 7 (78%) of the 9 sessions that were evaluated. Conclusions: In this pilot RCT, we demonstrated high engagement with and acceptability of a novel informational and supportive care intervention among patients initiating multimodality therapy for LARC. Better integrating PATHWAY’s coaching strategies with the educational content and increasing session length may enhance intervention impact on patient self-efficacy for managing treatment for LARC. Clinical trial information: NCT05914766 .

The efficacy of lithium in the treatment of suicidal ideation, behavior and suicide: An updated systematic review and meta-analysis of randomized controlled trials.