The effect of an integrated palliative care intervention on quality of life and acute healthcare use in patients with COPD: Results of the COMPASSION cluster randomized controlled trial.

BACKGROUND: COPD causes high morbidity and mortality, emphasizing the need for palliative care. AIM: To assess the effectiveness of palliative care in patients with COPD. DESIGN: Cluster randomized controlled trial (COMPASSION study; Netherlands Trial Register (NTR): NL7644, 07-04-2019). Healthcare providers within the intervention group were trained to implement palliative care components into routine COPD care. Patients completed questionnaires at baseline, after 3 and 6 months; medical records were assessed after 12 months. The primary outcome was quality of life (FACIT-Pal). Secondary outcomes were anxiety, depression, spiritual well-being, satisfaction with care, acute healthcare use, documentation of life-sustaining treatment preferences and place of death. Generalized linear mixed modelling was used for analyses. SETTING: Eight hospital regions in the Netherlands. PARTICIPANTS: Patients hospitalized for an acute exacerbation of COPD and positive ProPal-COPD score. RESULTS: Of 222 patients included, 106 responded to the questionnaire at 6 months. Thirty-six of 98 intervention patients (36.7%) received the intervention. Intention-to-treat-analysis showed no effect on the primary outcome (adjusted difference: 1.09; 95% confidence interval: -5.44 to 7.60). In the intervention group, fewer intensive care admissions for COPD took place (adjusted odds ratio: 0.21; 95% confidence interval: 0.03-0.81) and strong indications were found for fewer hospitalizations (adjusted incidence rate ratio: 0.69; 95% confidence interval: 0.46-1.03). CONCLUSIONS: We found no evidence that palliative care improves quality of life in patients with COPD. However, it can potentially reduce acute healthcare use. The consequences of the COVID-19 pandemic led to suboptimal implementation and insufficient power, and may have affected some of our findings.

Implementation of effective blended periconception lifestyle care in a tertiary hospital in the Netherlands: a cross-sectional study on determinants and patient satisfaction.

OBJECTIVE: To identify implementation determinants of blended periconception lifestyle care, and to evaluate patient satisfaction. DESIGN: Cross-sectional study. SETTING: The outpatient clinic of the department of Obstetrics and Gynaecology of the Erasmus MC. PARTICIPANTS: Implementation part: counsellors providing blended periconception lifestyle care. Patient satisfaction part: women who received blended periconception lifestyle care. METHODS: Blended periconception lifestyle care, including face-to-face counselling and 26 weeks of lifestyle coaching via the online platform 'Smarter Pregnancy', was implemented between June-December 2018. The Measurement Instrument for Determinants of Innovations questionnaire was used as input for the consolidated framework for implementation research to assess determinants of implementation. To evaluate patient satisfaction, patients receiving lifestyle care filled out an evaluation questionnaire, including questions on the needs for lifestyle counselling, information provision during counselling, and motivation and lifestyle change after counselling. PRIMARY AND SECONDARY OUTCOME MEASURES: Identification of implementation determinants and the level of patient satisfaction. RESULTS: Facilitators were reported in the implementation domains 'characteristics of the intervention' and 'characteristics of the individuals'. Barriers were in the implementation domains 'inner setting' and 'implementation process'. Regarding patient satisfaction on nutrition counselling, 31% of the respondents wanted information prior to the counselling session, 22% received new information after consultation, 51% got motivated to change and 40% changed their nutritional behaviour. CONCLUSIONS: A considerable number of patients improved lifestyle after counselling, although, a relatively small number wanted lifestyle counselling prior to consultation.This study underlines the importance of implementation science and the information it provides for improving the implementation process.

Selective prevention of cardiovascular disease using integrated lifestyle intervention in primary care: protocol of the Healthy Heart stepped-wedge trial.

INTRODUCTION: Lifestyle interventions are shown to be effective in improving cardiovascular disease (CVD) risk factors. It has been suggested that general practitioners can play an essential role in CVD prevention. However, studies into lifestyle interventions for primary care patients at high cardiovascular risk are scarce and structural implementation of lifestyle interventions can be challenging. Therefore, this study aims to (1) evaluate (cost-)effectiveness of implementation of an integrated group-based lifestyle programme in primary care practices; (2) identify effective intervention elements and (3) identify implementation determinants of an integrated group-based lifestyle intervention for patients with high cardiovascular risk. METHODS AND ANALYSIS: The Healthy Heart study is a non-randomised cluster stepped-wedge trial. Primary care practices will first offer standard care during a control period of 2-6 months, after which practices will switch (step) to the intervention, offering participants a choice between a group-based lifestyle programme or standard care. Participants enrolled during the control period (standard care) will be compared with participants enrolled during the intervention period (combined standard care and group-based lifestyle intervention). We aim to include 1600 primary care patients with high cardiovascular risk from 55 primary care practices in the area of The Hague, the Netherlands. A mixed-methods process evaluation will be used to simultaneously assess effectiveness and implementation outcomes. The primary outcome measure will be achievement of individual lifestyle goals after 6 months. Secondary outcomes include lifestyle change of five lifestyle components (smoking, alcohol consumption, diet, weight and physical activity) and improvement of quality of life and self-efficacy. Outcomes are assessed using validated questionnaires at baseline and 3, 6, 12 and 24 months of follow-up. Routine care data will be used to compare blood pressure and cholesterol levels. Cost-effectiveness of the lifestyle intervention will be evaluated. Implementation outcomes will be assessed using the RE-AIM model, to assesses five dimensions of implementation at different levels of organisation: reach, efficacy, adoption, implementation and maintenance. Determinants of adoption and implementation will be assessed using focus groups consisting of professionals and patients. ETHICS AND DISSEMINATION: This study is approved by the Ethics Committee of the Leiden University Medical Center (P17.079). Results will be shared with the primary care group, healthcare providers and patients, and will be disseminated through journal publications and conference presentations. TRIAL REGISTRATION NUMBER: NL60795.058.17. Status: pre-results.

A systematic approach to context-mapping to prepare for health interventions: development and validation of the SETTING-tool in four countries.

Effectiveness of health interventions can be substantially impaired by implementation failure. Context-driven implementation strategies are critical for successful implementation. However, there is no practical, evidence-based guidance on how to map the context in order to design context-driven strategies. Therefore, this practice paper describes the development and validation of a systematic context-mapping tool. The tool was cocreated with local end-users through a multistage approach. As proof of concept, the tool was used to map beliefs and behaviour related to chronic respiratory disease within the FRESH AIR project in Uganda, Kyrgyzstan, Vietnam and Greece. Feasibility and acceptability were evaluated using the modified Conceptual Framework for Implementation Fidelity. Effectiveness was assessed by the degree to which context-driven adjustments were made to implementation strategies of FRESH AIR health interventions. The resulting Setting-Exploration-Treasure-Trail-to-Inform-implementatioN-strateGies (SETTING-tool) consisted of six steps: (1) Coset study priorities with local stakeholders, (2) Combine a qualitative rapid assessment with a quantitative survey (a mixed-method design), (3) Use context-sensitive materials, (4) Collect data involving community researchers, (5) Analyse pragmatically and/or in-depth to ensure timely communication of findings and (6) Continuously disseminate findings to relevant stakeholders. Use of the tool proved highly feasible, acceptable and effective in each setting. To conclude, the SETTING-tool is validated to systematically map local contexts for (lung) health interventions in diverse low-resource settings. It can support policy-makers, non-governmental organisations and health workers in the design of context-driven implementation strategies. This can reduce the risk of implementation failure and the waste of resource potential. Ultimately, this could improve health outcomes.

Effectiveness and implementation of palliative care interventions for patients with chronic obstructive pulmonary disease: A systematic review.

BACKGROUND: Although guidelines recommend palliative care for patients with chronic obstructive pulmonary disease, there is little evidence for the effectiveness of palliative care interventions for this patient group specifically. AIM: To describe the characteristics of palliative care interventions for patients with COPD and their informal caregivers and review the available evidence on effectiveness and implementation outcomes. DESIGN: Systematic review and narrative synthesis (PROSPERO CRD42017079962). DATA SOURCES: Seven databases were searched for articles reporting on multi-component palliative care interventions for study populations containing ⩾30% patients with COPD. Quantitative as well as qualitative and mixed-method studies were included. Intervention characteristics, effect outcomes, implementation outcomes and barriers and facilitators for successful implementation were extracted and synthesized qualitatively. RESULTS: Thirty-one articles reporting on twenty unique interventions were included. Only four interventions (20%) were evaluated in an adequately powered controlled trial. Most interventions comprised of longitudinal palliative care, including care coordination and comprehensive needs assessments. Results on effectiveness were mixed and inconclusive. The feasibility level varied and was context-dependent. Acceptability of the interventions was high; having someone to call for support and education about breathlessness were most valued characteristics. Most frequently named barriers were uncertainty about the timing of referral due to the unpredictable disease trajectory (referrers), time availability (providers) and accessibility (patients). CONCLUSION: Little high-quality evidence is yet available on the effectiveness and implementation of palliative care interventions for patients with COPD. There is a need for well-conducted effectiveness studies and adequate process evaluations using standardized methodologies to create higher-level evidence and inform successful implementation.

Design of CIAO, a research program to support the development of an integrated approach to prevent overweight and obesity in the Netherlands.

BACKGROUND: The aim of this paper is to describe the research aims, concepts and methods of the research Consortium Integrated Approach of Overweight (CIAO). CIAO is a concerted action of five Academic Collaborative Centres, local collaborations between academic institutions, regional public health services, local authorities and other relevant sectors in the Netherlands. Prior research revealed lacunas in knowledge of and skills related to five elements of the integrated approach of overweight prevention in children (based upon the French EPODE approach), namely political support, parental education, implementation, social marketing and evaluation. CIAO aims to gain theoretical and practical insight of these elements through five sub-studies and to develop, based on these data, a framework for monitoring and evaluation. METHODS/DESIGN: For this research program, mixed methods are used in all the five sub-studies. First, problem specification through literature research and consultation of stakeholders, experts, health promotion specialists, parents and policy makers will be carried out. Based on this information, models, theoretical frameworks and practical instruments will be developed, tested and evaluated in the communities that implement the integrated approach to prevent overweight in children. Knowledge obtained from these studies and insights from experts and stakeholders will be combined to create an evaluation framework to evaluate the integrated approach at central, local and individual levels that will be applicable to daily practice. DISCUSSION: This innovative research program stimulates sub-studies to collaborate with local stakeholders and to share and integrate their knowledge, methodology and results. Therefore, the output of this program (both knowledge and practical tools) will be matched and form building blocks of a blueprint for a local evidence- and practice-based integrated approach towards prevention of overweight in children. The output will then support various communities to further optimize the implementation and subsequently the effects of this approach.