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A psychological intervention to promote acceptance and adherence to non-invasive ventilation in people with chronic obstructive pulmonary disease: study protocol of a randomised controlled trial.

ABSTRACT: BACKGROUND:People with chronic obstructive pulmonary disease (COPD) sometimes experience anxiety, depression and comorbid cognitive deficits. Rather than being merely a consequence of symptom-related physical impairments these additional problems may be part of the clinical course of the condition. The relationship between the physical and psychological aspects of the condition is illustrated by the patterns of use of non-invasive ventilation (NIV); NIV is often rejected or used inappropriately, resulting in clinical deterioration and an increase in health care costs. The study aims to analyse the effects of psychological support on the acceptance of, and adherence to, NIV. The primary outcome will be a latent variable related to indices of use of NIV equipment and adherence to treatment regime; while survival rates and psychological variables will constitute the secondary outcomes. METHODS:A two-arm randomised controlled trial will be conducted. We aim to recruit 150 COPD patients for whom NIV is indicated. The experimental group will receive a brief course of psychological support that will include counselling, relaxation and mindfulness-based exercises. In some cases, it will also include neuropsychological rehabilitation exercises. Support will be delivered via four to eight meetings at the HD Respiratory Rehabilitation Unit, at home or via telemedicine. Controls will receive standard care and watch educational videos related to the management of their disease. DISCUSSION:This investigation will gain insight about the role of a psychological intervention as part of a treatment plan during the process of adaptation to NIV in COPD patients. TRIAL REGISTRATION:ClinicalTrials.gov, ID: NCT02499653 . Registered on 14 July 2015.

SUBMITTER: Volpato E

PROVIDER: S-EPMC5294889 | biostudies-literature | 2017 Feb

REPOSITORIES: biostudies-literature

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A psychological intervention to promote acceptance and adherence to non-invasive ventilation in people with chronic obstructive pulmonary disease: study protocol of a randomised controlled trial.

Volpato Eleonora E Banfi Paolo P Pagnini Francesco F

Trials 20170206 1

<h4>Background</h4>People with chronic obstructive pulmonary disease (COPD) sometimes experience anxiety, depression and comorbid cognitive deficits. Rather than being merely a consequence of symptom-related physical impairments these additional problems may be part of the clinical course of the condition. The relationship between the physical and psychological aspects of the condition is illustrated by the patterns of use of non-invasive ventilation (NIV); NIV is often rejected or used inapprop ...[more]

PMID: 28166828

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Project description:BackgroundPatients presenting with acute hypercapnic respiratory failure due to exacerbations of chronic obstructive pulmonary disease (AECOPD) are typically managed with non-invasive ventilation (NIV). The impact of low-flow extracorporeal carbon dioxide removal (ECCO2R) on outcome in these patients has not been explored in randomised trials.MethodsOpen-label randomised trial comparing NIV (NIV arm) with ECCO2R (ECCO2R arm) in patients with AECOPD at high risk of NIV failure (pH < 7.30 after ≥ 1 h of NIV). The primary endpoint was time to cessation of NIV. Secondary outcomes included device tolerance and complications, changes in arterial blood gases, hospital survival.ResultsEighteen patients (median age 67.5, IQR (61.5-71) years; median GOLD stage 3 were enrolled (nine in each arm). Time to NIV discontinuation was shorter with ECCO2R (7:00 (6:18-8:30) vs 24:30 (18:15-49:45) h, p = 0.004). Arterial pH was higher with ECCO2R at 4 h post-randomisation (7.35 (7.31-7.37) vs 7.25 (7.21-7.26), p < 0.001). Partial pressure of arterial CO2 (PaCO2) was significantly lower with ECCO2R at 4 h (6.8 (6.2-7.15) vs 8.3 (7.74-9.3) kPa; p = 0.024). Dyspnoea and comfort both rapidly improved with commencement of ECCO2R. There were no severe or life-threatening complications in the study population. There were no episodes of major bleeding or red blood cell transfusion in either group. ICU and hospital length of stay were longer with ECCO2R, and there was no difference in 90-day mortality or functional outcomes at follow-up.InterpretationThere is evidence of benefit associated with ECCO2R with time to improvement in respiratory acidosis, in respiratory physiology and an immediate improvement in patient comfort and dyspnoea with commencement of ECCO2R. In addition, there was minimal clinically significant adverse events associated with ECCO2R use in patients with AECOPD at risk of failing or not tolerating NIV. However, the ICU and hospital lengths of stay were longer in the ECCO2R for similar outcomes. Trial registration The trial is prospectively registered on ClinicalTrials.gov: NCT02086084. Registered on 13th March 2014, https://clinicaltrials.gov/ct2/show/NCT02086084?cond=ecco2r&draw=2&rank=8.

Project description:IMPORTANCE:Small clinical trials have shown that noninvasive ventilation (NIV) is efficacious in reducing the need for intubation and improving short-term survival among patients with severe exacerbations of chronic obstructive pulmonary disease (COPD). Little is known, however, about the effectiveness of NIV in routine clinical practice. OBJECTIVE:To compare the outcomes of patients with COPD treated with NIV to those treated with invasive mechanical ventilation (IMV). DESIGN, SETTING, AND PARTICIPANTS:This was a retrospective cohort study of 25?628 patients hospitalized for exacerbation of COPD who received mechanical ventilation on the first or second hospital day at 420 US hospitals participating in the Premier Inpatient Database. EXPOSURES:Initial ventilation strategy. MAIN OUTCOMES AND MEASURES:In-hospital mortality, hospital-acquired pneumonia, hospital length of stay and cost, and 30-day readmission. RESULTS:In the study population, a total of 17?978 (70%) were initially treated with NIV on hospital day 1 or 2. When compared with those initially treated with IMV, NIV-treated patients were older, had less comorbidity, and were less likely to have concomitant pneumonia present on admission. In a propensity-adjusted analysis, NIV was associated with lower risk of mortality than IMV (odds ratio [OR] 0.54; [95% CI, 0.48-0.61]). Treatment with NIV was associated with lower risk of hospital-acquired pneumonia (OR, 0.53 [95% CI, 0.44-0.64]), lower costs (ratio, 0.68 [95% CI, 0.67-0.69]), and a shorter length of stay (ratio, 0.81 [95% CI, 0.79-0.82]), but no difference in 30-day all-cause readmission (OR, 1.04 [95% CI, 0.94-1.15]) or COPD-specific readmission (OR, 1.05 [95% CI, 0.91-1.22]). Propensity matching attenuated these associations. The benefits of NIV were similar in a sample restricted to patients younger than 85 years and were attenuated among patients with higher levels of comorbidity and concomitant pneumonia. Using the hospital as an instrumental variable, the strength of association between NIV and mortality was modestly attenuated (OR, 0.66 [95% CI, 0.47-0.91]). In sensitivity analyses, the benefit of NIV was robust in the face of a strong hypothetical unmeasured confounder. CONCLUSIONS AND RELEVANCE:In a large retrospective cohort study, patients with COPD treated with NIV at the time of hospitalization had lower inpatient mortality, shorter length of stay, and lower costs compared with those treated with IMV.

Project description:IntroductionPatients with advanced chronic obstructive pulmonary disease (COPD) experience a great symptom burden. Breathlessness is a very frequently reported symptom that negatively affects all aspects of daily life and could lead to fear of dying. Non-invasive ventilation (NIV) could be an important palliative measure to manage breathlessness in patients with advanced COPD. We decided to conduct a scoping review to attain an overview of the existing research and to identify knowledge gaps. This scoping review aims to systematically map published studies on the use of NIV in the palliative care of COPD patients, including the perspectives and experiences of patients, families and healthcare professionals.Methods and analysisThis scoping review will employ the framework of Arksey and O'Malley. The reporting will be guided by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews checklist. A comprehensive and systematic search strategy will be developed in cooperation with an experienced librarian. Database searches will be conducted in AMED, PEDro, Embase, CINAHL, PsycInfo and MEDLINE in February 2021. Pairs of authors will independently assess studies' eligibility and extract data using a standardised data-charting form. The data will be inductively summarised and organised thematically. The results will be discussed with an advisory board consisting of nurses and physicians from respiratory and intensive care units.Ethics and disseminationApproval for the workshop with the advisory board has been attained from the Norwegian Centre for Research Data (480222), and approval will be attained from the Personal Data Protection Officers of the participating hospitals. All advisory board participants will sign an informed written consent before participation. The results could contribute to developing the body of evidence on the use of NIV in the palliative care of COPD patients and serve to identify directions for future research.

Project description:BACKGROUND:People with chronic obstructive pulmonary disease (COPD) are at increased risk of depression and anxiety, which greatly reduces their quality of life and is associated with worse outcomes; but these psychological co-morbidities are under-recognised and undertreated in COPD patients. Pulmonary rehabilitation (PR) improves mood for up to 6 months but health practitioners under-refer, and patients commonly fail to attend/complete PR. Research suggests that complex non-pharmacological interventions, including both psychological and exercise components, may reduce anxiety and depression in COPD. We have developed a tailored, cognitive behavioural approach (CBA) intervention for patients with COPD and co-morbid anxiety and/or depression ('TANDEM'), which precedes and optimises the benefits of currently offered PR. We hypothesise that such a psychological intervention, delivered by supervised, trained respiratory healthcare professionals, will improve mood in patients with mild to moderate anxiety and/or depression and encourage uptake and completion of PR. METHODS:We will conduct a multi-centre, pragmatic, randomised controlled trial of the TANDEM intervention compared to usual care across the Midlands, London, the South East and Bristol, UK. We will train healthcare professionals familiar with COPD to deliver the manualised, tailored, face-to-face, one-to-one intervention weekly for 6-8?weeks. We will recruit 430 participants from primary, community and secondary care with confirmed COPD and moderate to very severe airflow limitation, who are eligible for assessment for PR, and who screen positive for symptoms of mild/moderate depression and/or anxiety using the Hospital Anxiety and Depression scale (HADS). Participants will be randomised 1.25:1 (intervention: usual care). The co-primary outcomes are the HADS anxiety and depression subscale scores at 6?months; participants will be followed up to 12?months. Secondary outcomes include uptake and completion of PR and healthcare resource use. There will be a parallel process evaluation and a health economic evaluation. DISCUSSION:The TANDEM intervention has the potential to optimise the unrealised synergy between a psychological intervention and PR. The CBA sessions will precede PR and target individuals' cognitions, behaviours and symptoms associated with anxiety and depression to decrease psychological morbidity and increase effective self-management amongst patients with COPD. TRIAL REGISTRATION:ISRCTN, ID: ISRCTN59537391. Registered on 20 March 2017. Protocol version 6.0, 22 April 2018.

Project description:BACKGROUND:High-flow nasal cannula (HFNC) oxygen therapy is being increasingly used to prevent post-extubation hypoxemic respiratory failure and reintubation. However, evidence to support the use of HFNC in chronic obstructive pulmonary disease (COPD) patients with hypercapnic respiratory failure after extubation is limited. This study was conducted to test if HFNC is non-inferior to non-invasive ventilation (NIV) in preventing post-extubation treatment failure in COPD patients previously intubated for hypercapnic respiratory failure. METHODS:COPD patients with hypercapnic respiratory failure who were already receiving invasive ventilation were randomized to HFNC or NIV at extubation at two large tertiary academic teaching hospitals. The primary endpoint was treatment failure, defined as either resumption of invasive ventilation or switching to the other study treatment modality (NIV for patients in the NFNC group or vice versa). RESULTS:Ninety-six patients were randomly assigned to the HFNC group or NIV group. After secondary exclusion, 44 patients in the HFNC group and 42 patients in the NIV group were included in the analysis. The treatment failure rate in the HFNC group was 22.7% and 28.6% in the NIV group-risk difference of -?5.8% (95% CI, -?23.8-12.4%, p?=?0.535), which was significantly lower than the non-inferior margin of 9%. Analysis of the causes of treatment failure showed that treatment intolerance in the HFNC group was significantly lower than that in the NIV group, with a risk difference of -?50.0% (95% CI, -?74.6 to -?12.9%, p?=?0.015). One hour after extubation, the mean respiratory rates of both groups were faster than their baseline levels before extubation (p?<?0.050). Twenty-four hours after extubation, the respiratory rate of the HFNC group had returned to baseline, but the NIV group was still higher than the baseline. Forty-eight hours after extubation, the respiratory rates of both groups were not significantly different from the baseline. The average number of daily airway care interventions in the NIV group was 7 (5-9.3), which was significantly higher than 6 (4-7) times in the HFNC group (p?=?0.006). The comfort score and incidence of nasal and facial skin breakdown of the HFNC group was also significantly better than that of the NIV group [7 (6-8) vs 5 (4-7), P?<?0.001] and [0 vs 9.6%, p?=?0.027], respectively. CONCLUSION:Among COPD patients with severe hypercapnic respiratory failure who received invasive ventilation, the use of HFNC after extubation did not result in increased rates of treatment failure compared with NIV. HFNC also had better tolerance and comfort than NIV. TRIAL REGISTRATION:chictr.org ( ChiCTR1800018530 ). Registered on 22 September 2018, http://www.chictr.org.cn/usercenter.aspx.

Dataset Information

A psychological intervention to promote acceptance and adherence to non-invasive ventilation in people with chronic obstructive pulmonary disease: study protocol of a randomised controlled trial.

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A psychological intervention to promote acceptance and adherence to non-invasive ventilation in people with chronic obstructive pulmonary disease: study protocol of a randomised controlled trial.

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