Browsing by Author "Moons, Philip"

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    Facilitators of and barriers to reducing thirty-day readmissions and improving patient-reported outcomes after surgical aortic valve replacement: a process evaluation of the AVRre trial
    (2020-03-27) Danielsen, Stein O; Moons, Philip; Leegaard, Marit; Solheim, Svein; Tønnessen, Theis; Lie, Irene
    Abstract Background The Aortic Valve Replacement Readmission (AVRre) randomized control trial tested whether a telephone intervention would reduce hospital readmissions following surgical aortic valve replacement (SAVR). The telephone support provided 30 days of continuous phone-support (hotline) and two scheduled phone-calls from the hospital after discharge. The intervention had no effect on reducing 30-day all-cause readmission rate (30-DACR) but did reduce participants’ anxiety compared to a control group receiving usual care. Depression and participant-reported health state were unaffected by the intervention. To better understand these outcomes, we conducted a process evaluation of the AVRre trial to gain insight into the (1) the dose and fidelity of the intervention, (2) mechanism of impacts, and (3) contextual factors that may have influenced the outcomes. Methods The process evaluation was informed by the Medical Research Council framework, a widely used set of guidelines for evaluating complex interventions. A mix of quantitative (questionnaire and journal records) and qualitative data (field notes, memos, registration forms, questionnaire) was prospectively collected, and retrospective interviews were conducted. We performed descriptive analyses of the quantitative data. Content analyses, assisted by NVivo, were performed to evaluate qualitative data. Results The nurses who were serving the 24/7 hotline intervention desired to receive more preparation before intervention implementation. SAVR patient participants were highly satisfied with the telephone intervention (58%), felt safe (86%), and trusted having the option of calling in for support (91%). The support for the telephone hotline staff was perceived as a facilitator of the intervention implementation. Content analyses revealed themes: “gap in the care continuum,” “need for individualized care,” and “need for easy access to health information” after SAVR. Differences in local hospital discharge management practices influenced the 30-DACR incidence. Conclusions The prospective follow-up of the hotline service during the trial facilitated implementation of the intervention, contributing to high participant satisfaction and likely reduced their anxiety after SAVR. Perceived less-than-optimal preparations for the hotline could be a barrier to AVRre trial implementation. Integrating user experiences into a mixed-methods evaluation of clinical trials is important for broadening understanding of trial outcomes, the mechanism of impact, and contextual factors that influence clinical trials. Trial registration ClinicalTrials.gov, NCT02522663. Registered on 11 August 2015.
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    Factors affecting adolescents’ participation in randomized controlled trials evaluating the effectiveness of healthcare interventions: the case of the STEPSTONES project
    (2020-08-03) Saarijärvi, Markus; Wallin, Lars; Moons, Philip; Gyllensten, Hanna; Bratt, Ewa-Lena
    Abstract Background Recruitment of adolescents to intervention studies is a known challenge. For randomized controlled trials (RCT) to be generalizable, reach must be assessed, which means ascertaining how many of the intended population actually participated in the trial. The aim of this study was to evaluate the reach and representativeness of an RCT evaluating the effectiveness of a complex intervention for adolescents with chronic conditions. Methods A mixed methods sequential explanatory design was employed. Firstly, quantitative cross-sectional data from the RCT, patient registries and medical records were collected and analysed regarding baseline differences between participants and non-participants in the trial. Secondly, qualitative data on their reasons for participating or not were collected and analysed with content analysis to explain the quantitative findings. Results Participants showed larger differences in effect sizes and a significantly more complex chronic condition than non-participants. No other statistically significant differences were reported, and effect sizes were negligible. Reasons for declining or accepting participation were categorized into three main categories: altruistic reasons, personal reasons and external reasons and factors. Conclusions Integration of quantitative and qualitative findings showed that participation in the RCT was affected by disease complexity, the perceived need to give back to healthcare and research and the adolescents’ willingness to engage in their illness. To empower adolescents with chronic conditions and motivate them to participate in research, future intervention studies should consider developing tailored recruitment strategies and communications with sub-groups that are harder to reach.
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    Healthcare system inputs and patient-reported outcomes: a study in adults with congenital heart defect from 15 countries
    (2020-06-03) Van Bulck, Liesbet; Goossens, Eva; Luyckx, Koen; Apers, Silke; Oechslin, Erwin; Thomet, Corina; Budts, Werner; Enomoto, Junko; Sluman, Maayke A; Lu, Chun-Wei; Jackson, Jamie L; Khairy, Paul; Cook, Stephen C; Chidambarathanu, Shanthi; Alday, Luis; Eriksen, Katrine; Dellborg, Mikael; Berghammer, Malin; Johansson, Bengt; Mackie, Andrew S; Menahem, Samuel; Caruana, Maryanne; Veldtman, Gruschen; Soufi, Alexandra; Fernandes, Susan M; White, Kamila; Callus, Edward; Kutty, Shelby; Moons, Philip
    Background The relationship between healthcare system inputs (e.g., human resources and infrastructure) and mortality has been extensively studied. However, the association between healthcare system inputs and patient-reported outcomes remains unclear. Hence, we explored the predictive value of human resources and infrastructures of the countries’ healthcare system on patient-reported outcomes in adults with congenital heart disease. Methods This cross-sectional study included 3588 patients with congenital heart disease (median age = 31y; IQR = 16.0; 52% women; 26% simple, 49% moderate, and 25% complex defects) from 15 countries. The following patient-reported outcomes were measured: perceived physical and mental health, psychological distress, health behaviors, and quality of life. The assessed inputs of the healthcare system were: (i) human resources (i.e., density of physicians and nurses, both per 1000 people) and (ii) infrastructure (i.e., density of hospital beds per 10,000 people). Univariable, multivariable, and sensitivity analyses using general linear mixed models were conducted, adjusting for patient-specific variables and unmeasured country differences. Results Sensitivity analyses showed that higher density of physicians was significantly associated with better self-reported physical and mental health, less psychological distress, and better quality of life. A greater number of nurses was significantly associated with better self-reported physical health, less psychological distress, and less risky health behavior. No associations between a higher density of hospital beds and patient-reported outcomes were observed. Conclusions This explorative study suggests that density of human resources for health, measured on country level, are associated with patient-reported outcomes in adults with congenital heart disease. More research needs to be conducted before firm conclusions about the relationships observed can be drawn. Trial registration ClinicalTrials.gov: NCT02150603. Registered 30 May 2014,
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    Phenotypes of adults with congenital heart disease around the globe: a cluster analysis
    (2021-02-10) Callus, Edward; Pagliuca, Silvana; Boveri, Sara; Ambrogi, Federico; Luyckx, Koen; Kovacs, Adrienne H; Apers, Silke; Budts, Werner; Enomoto, Junko; Sluman, Maayke A; Wang, Jou-Kou; Jackson, Jamie L; Khairy, Paul; Cook, Stephen C; Chidambarathanu, Shanthi; Alday, Luis; Eriksen, Katrine; Dellborg, Mikael; Berghammer, Malin; Johansson, Bengt; Mackie, Andrew S; Menahem, Samuel; Caruana, Maryanne; Veldtman, Gruschen; Soufi, Alexandra; Fernandes, Susan M; White, Kamila; Kutty, Shelby; Moons, Philip
    Objective To derive cluster analysis-based groupings for adults with congenital heart disease (ACHD) when it comes to perceived health, psychological functioning, health behaviours and quality of life (QoL). Methods This study was part of a larger worldwide multicentre study called APPROACH-IS; a cross sectional study which recruited 4028 patients (2013–2015) from 15 participating countries. A hierarchical cluster analysis was performed using Ward's method in order to group patients with similar psychological characteristics, which were defined by taking into consideration the scores of the following tests: Sense Of Coherence, Health Behavior Scale (physical exercise score), Hospital Anxiety Depression Scale, Illness Perception Questionnaire, Satisfaction with Life Scale and the Visual Analogue Scale scores of the EQ-5D perceived health scale and a linear analogue scale (0–100) measuring QoL. Results 3768 patients with complete data were divided into 3 clusters. The first and second clusters represented 89.6% of patients in the analysis who reported a good health perception, QoL, psychological functioning and the greatest amount of exercise. Patients in the third cluster reported substantially lower scores in all PROs. This cluster was characterised by a significantly higher proportion of females, a higher average age the lowest education level, more complex forms of congenital heart disease and more medical comorbidities. Conclusions This study suggests that certain demographic and clinical characteristics may be linked to less favourable health perception, quality of life, psychological functioning, and health behaviours in ACHD. This information may be used to improve psychosocial screening and the timely provision of psychosocial care.