Aim: To evaluate healthcare professionals' performance and treatment fidelity in the Cardiac Care Bridge (CCB) nurse-coordinated transitional care intervention in older cardiac patients to understand and interpret the study results. Design: A mixed-methods process evaluation based on the Medical Research Council Process Evaluation framework. Methods: Quantitative data on intervention key elements were collected from 153 logbooks of all intervention patients. Qualitative data were collected using semi-structured interviews with 19 CCB professionals (cardiac nurses, community nurses and primary care physical therapists), from June 2017 until October 2018. Qualitative data-analysis is based on thematic analysis and integrated with quantitative key element outcomes. The analysis was blinded to trial outcomes. Fidelity was defined as the level of intervention adherence. Results: The overall intervention fidelity was 67%, ranging from severely low fidelity in the consultation of in-hospital geriatric teams (17%) to maximum fidelity in the comprehensive geriatric assessment (100%). Main themes of influence in the intervention performance that emerged from the interviews are interdisciplinary collaboration, organizational preconditions, confidence in the programme, time management and patient characteristics. In addition to practical issues, the patient's frailty status and limited motivation were barriers to the intervention. Conclusion: Although involved healthcare professionals expressed their confidence in the intervention, the fidelity rate was suboptimal. This could have influenced the non-significant effect of the CCB intervention on the primary composite outcome of readmission and mortality 6 months after randomization. Feasibility of intervention key elements should be reconsidered in relation to experienced barriers and the population. Impact: In addition to insight in effectiveness, insight in intervention fidelity and performance is necessary to understand the mechanism of impact. This study demonstrates that the suboptimal fidelity was subject to a complex interplay of organizational, professionals' and patients' issues. The results support intervention redesign and inform future development of transitional care interventions in older cardiac patients.
Alliance has been shown to predict treatment outcome in family-involved treatment for youth problems in several studies.However, meta-analytic research on alliance in family-involved treatment is scarce, and to date, no meta-analytic study on the alliance–outcome association in this field has paid attention to moderating variables. We included 28 studies reporting on the alliance–outcome association in 21 independent study samples of families receiving family-involved treatment for youth problems (N= 2126 families,Mage youth ranging from 10.6 to 16.1). We performed three multilevel meta-analyses of theassociations between three types of alliance processes and treatment outcome, and of several moderator variables. The quality of the alliance was significantly associated with treatment outcome (r= .183,p< .001). Correlations were significantly stronger when alliance scores of different measurement moments were averaged or added, when families were help-seekingrather than receiving mandated care and when studies included younger children. The correlation between alliance improvement and treatment outcome just failed to reached significance (r= .281,p= .067), and no significant correlation was found between split alliances and treatment outcome (r= .106,p= .343). However, the number of included studies reporting onalliance change scores or split alliances was small. Our findings demonstrate that alliance plays a small but significant role in the effectiveness of family-involved treatment. Future research should focus on investigating the more complex systemic aspects of alliance to gain fuller understanding of the dynamic role of alliance in working with families
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Background:Tobacco consumption is a leading cause of death and disease, killing >8 million people each year. Smoking cessation significantly reduces the risk of developing smoking-related diseases. Although combined treatment for addiction is promising, evidence of its effectiveness is still emerging. Currently, there is no published research comparing the effectiveness of blended smoking cessation treatments (BSCTs) with face-to-face (F2F) treatments, where web-based components replace 50% of the F2F components in blended treatment.Objective:The primary objective of this 2-arm noninferiority randomized controlled trial was to determine whether a BSCT is noninferior to an F2F treatment with identical ingredients in achieving abstinence rates.Methods:This study included 344 individuals who smoke (at least 1 cigarette per day) attending an outpatient smoking cessation clinic in the Netherlands. The participants received either a blended 50% F2F and 50% web-based BSCT or only F2F treatment with similar content and intensity. The primary outcome measure was cotinine-validated abstinence rates from all smoking products at 3 and 15 months after treatment initiation. Additional measures included carbon monoxide–validated point prevalence abstinence; self-reported point prevalence abstinence; and self-reported continuous abstinence rates at 3, 6, 9, and 15 months after treatment initiation.Results:None of the 13 outcomes showed statistically confirmed noninferiority of the BSCT, whereas 4 outcomes showed significantly (P<.001) inferior abstinence rates of the BSCT: cotinine-validated point prevalence abstinence rate at 3 months (difference 12.7, 95% CI 6.2-19.4), self-reported point prevalence abstinence rate at 6 months (difference 19.3, 95% CI 11.5-27.0) and at 15 months (difference 11.7, 95% CI 5.8-17.9), and self-reported continuous abstinence rate at 6 months (difference 13.8, 95% CI 6.8-20.8). The remaining 9 outcomes, including the cotinine-validated point prevalence abstinence rate at 15 months, were inconclusive.Conclusions:In this high-intensity outpatient smoking cessation trial, the blended mode was predominantly less effective than the traditional F2F mode. The results contradict the widely assumed potential benefits of blended treatment and suggest that further research is needed to identify the critical factors in the design of blended interventions.Trial Registration:Netherlands Trial Register 27150; https://onderzoekmetmensen.nl/nl/trial/27150