Implementation and maintenance of an enhanced pulmonary rehabilitation program in a single centre: An implementation study.

BACKGROUND: Pulmonary rehabilitation (PR) has major benefits for patients with chronic obstructive pulmonary disease (COPD). An enhanced PR program was developed with a self-management education intervention. The objective of our study was to evaluate the implementation of the enhanced PR program into a single centre. METHODS: Pre-post implementation study consisted of two evaluation periods: immediately after implementation and 18 months later. Guided by the RE-AIM framework, outcomes included: Reach, Effectiveness, Adoption, Implementation and Maintenance. RESULTS: Reach: 70-75% of referred patients agreed to a PR program (n = 26). Effectiveness: Clinically important improvements occurred in some patients in functional exercise capacity (64% of the patients achieved clinical important difference in 6-min walk test in the first evaluation period and 44% in the second evaluation period), knowledge, functional status, and self-efficacy in both evaluation periods. Adoption: All healthcare professionals (HCPs) involved in PR (n = 8) participated. Implementation: Fidelity for the group education sessions ranged from 76 to 95% (first evaluation) and from 82 to 88% (second evaluation). Maintenance: The program was sustained over 18 months with minor changes. Patients and HCPs were highly satisfied with the program. CONCLUSIONS: The enhanced PR program was accepted by patients and HCPs and was implemented and maintained at a single expert center with good implementation fidelity.

Effect of Bronchodilation, Exercise Training, and Behavior Modification on Symptoms and Physical Activity in Chronic Obstructive Pulmonary Disease.

RATIONALE: Bronchodilation and exercise training (ExT) improve exercise tolerance in patients with chronic obstructive pulmonary disease (COPD); however, behavior modification is required to impact daily physical activity (PA). OBJECTIVES: To assess whether tiotropium/olodaterol, with or without ExT, would improve exercise endurance time (EET) and PA compared with placebo in patients participating in a self-management behavior-modification (SMBM) program. METHODS: This was a 12-week, randomized, partially double-blind, placebo-controlled, parallel-group trial in patients with COPD (PHYSACTO; NCT02085161). All patients were enrolled into SMBM and randomized 1:1:1:1 to once-daily placebo, tiotropium 5 µg, tiotropium/olodaterol 5/5 µg, or tiotropium/olodaterol 5/5 µg plus 8 weeks ExT. EET, measured by endurance shuttle walk test after 8 weeks, was the primary endpoint. Additional endpoints assessed downstream effects on PA (measured via accelerometry), and activity-related dyspnea and difficulty (using validated patient-reported questionnaires). MEASUREMENTS AND MAIN RESULTS: SMBM plus tiotropium/olodaterol, with or without ExT, significantly improved EET at Week 8 versus SMBM plus placebo (treatment ratio vs. placebo: with ExT, 1.46; 95% confidence interval, 1.20-1.78; P = 0.0002; without ExT, 1.29; 95% confidence interval, 1.06-1.57; P = 0.0109). No significant increases in steps per day from baseline were observed over SMBM plus placebo at Week 12 (increase of 1,098) when other therapies were added. Adding tiotropium/olodaterol, with or without ExT, to SMBM reduced activity-related dyspnea versus placebo, whereas adding tiotropium/olodaterol plus ExT reduced activity-related difficulty. CONCLUSIONS: Tiotropium/olodaterol, with or without ExT, improved EET in patients with COPD taking part in an SMBM program. Combination bronchodilation, with or without ExT, did not provide additional increases in objective PA compared with SMBM alone but did reduce PA-related dyspnea and difficulty. Clinical trial registered with www.clinicaltrials.gov (NCT02085161).

Characteristics of effective self-management interventions in patients with COPD: individual patient data meta-analysis.

It is unknown whether heterogeneity in effects of self-management interventions in patients with chronic obstructive pulmonary disease (COPD) can be explained by differences in programme characteristics. This study aimed to identify which characteristics of COPD self-management interventions are most effective.Systematic search in electronic databases identified randomised trials on self-management interventions conducted between 1985 and 2013. Individual patient data were requested for meta-analysis by generalised mixed effects models.14 randomised trials were included (67% of eligible), representing 3282 patients (75% of eligible). Univariable analyses showed favourable effects on some outcomes for more planned contacts and longer duration of interventions, interventions with peer contact, without log keeping, without problem solving, and without support allocation. After adjusting for other programme characteristics in multivariable analyses, only the effects of duration on all-cause hospitalisation remained. Each month increase in intervention duration reduced risk of all-cause hospitalisation (time to event hazard ratios 0.98, 95% CI 0.97-0.99; risk ratio (RR) after 6 months follow-up 0.96, 95% CI 0.92-0.99; RR after 12 months follow-up 0.98, 95% CI 0.96-1.00).Our results showed that longer duration of self-management interventions conferred a reduction in all-cause hospitalisations in COPD patients. Other characteristics are not consistently associated with differential effects of self-management interventions across clinically relevant outcomes.

Early COPD Exacerbation Treatment with Combination of ICS and LABA for Patients Presenting with Mild-to-Moderate Worsening of Dyspnea.

This is a proof of concept study that aims to establish feasibility and safety of a new strategy that includes an action plan for early treatment of acute exacerbations of COPD (AECOPD) with doubling dose of a combination of a long-acting beta2 agonist and an inhaled corticosteroid, and to explore its potential for avoiding the requirement of prednisone and its safety. Thirty-seven COPD outpatients with previous exacerbations were enrolled and followed-up for 12 months. The written action plan included a standing prescription to be used in the event of an AECOPD: Antibiotic, for 5 days (for purulent exacerbations) and doubling a combination of Salmeterol and Fluticasone Propionate for 10 days. The primary outcome was "treatment success" defined as "no need of prednisone within 30 days of the onset." Twenty-seven patients experienced an AECOPD and doubled their combination dose. Among the 27 patients, there were 21 patients (78%) who did not require prednisone, and none of those had cardiovascular events, pneumonia, ER and hospital admissions. We have assessed that an early treatment of AECOPD with doubling the dose of a combination of Salmeterol and Fluticasone Propionate appears to be safe, well-tolerated and adhered to, and results in no requirement of systemic corticosteroid in a large proportion of patients presenting with mild-to-moderate worsening of dyspnea. This trial has the potential to change the approach of treatment of AECOPD and reduce the use of oral corticosteroids.

Effects of written action plan adherence on COPD exacerbation recovery.

BACKGROUND: The effects of written action plans on recovery from exacerbations of chronic obstructive pulmonary disease (COPD) have not been well studied. The aims of this study were to assess the effects of adherence to a written action plan on exacerbation recovery time and unscheduled healthcare utilisation and to explore factors associated with action plan adherence. METHODS: This was a 1-year prospective cohort study embedded in a randomised controlled trial. Exacerbation data were recorded for 252 patients with COPD who received a written action plan for prompt treatment of exacerbations with the instructions to initiate standing prescriptions for both antibiotics and prednisone within 3 days of exacerbation onset. Following the instructions was defined as adherence to the action plan. RESULTS: From the 288 exacerbations reported by 143 patients, start dates of antibiotics or prednisone were provided in 217 exacerbations reported by 119 patients (53.8% male, mean age 65.4 years, post-bronchodilator forced expiratory volume in 1 s (FEV(1)) 43.9% predicted). In 40.1% of exacerbations, patients adhered to their written action plan. Adherence reduced exacerbation recovery time with statistical (p=0.0001) and clinical (-5.8 days) significance, but did not affect unscheduled healthcare utilisation (OR 0.94, 95% CI 0.49 to 1.83). Factors associated with an increased likelihood of adherence were influenza vaccination, cardiac comorbidity, younger age and lower FEV(1) as percentage predicted. CONCLUSIONS: This study shows that adherence to a written action plan is associated with a reduction in exacerbation recovery time by prompt treatment. Knowing the factors that are associated with proper and prompt utilisation of an action plan permits healthcare professionals to better focus their self-management support on appropriate patients.

Multicentre comparison of self-management in patients with COPD.

In patients with COPD, self-management plays an important role in disease management. Recently, self-management programmes have expanded patient education practices to include a variety of disease management techniques. We hypothesised that COPD patients have insufficient and/or different self-management needs according to institution. We compared information needs of patients between specialised clinics in Canada (SCC) and Japan and a hospital outpatient clinic in Japan (HCJ), all employing different self-management interventions. This cross-sectional study evaluated patients' information needs for disease management using the Lung Information Needs Questionnaire (LINQ). Furthermore, we assessed pulmonary function tests, modified Medical Research Council (mMRC) dyspnoea scale and frequencies of hospitalisations and emergency visits. The total number of patients was 183. Those attending SCC were younger (p=0.047), with lower forced expiratory volume in 1 s % predicted (p<0.0001), and scored higher on the mMRC dyspnoea scale. Total LINQ scores showed differences between institutions (p<0.0001). There was no difference for the smoking domain; however, SCC recorded significantly lower information needs for all other domains (p<0.02). No significant difference in emergency visits was seen between institutions, but HCJ recorded the highest rate of emergency visits, while SCC had significantly higher rates of hospitalisation (p=0.004). Differences were seen for frequency and duration of education between institutions. These results highlight the differences in information needs by institution and the importance of assessing individual needs. We believe, despite representing only one aspect of self-management, our findings reflect real-world circumstances, adding to the argument that self-management education should be structured, but flexible, to meet the changing needs of COPD patients.

Evaluation of an Enhanced Pulmonary Rehabilitation Program: A Randomized Controlled Trial.

Rationale: Pulmonary rehabilitation (PR) is the most effective strategy to improve health outcomes in people with chronic obstructive pulmonary disease (COPD), although it has had limited success in promoting sustained physical activity. PR with a strong focus on disease self-management may better facilitate long-term behavior change. Objectives: To compare a newly developed enhanced PR (EPR) program with a traditional PR program on outcome achievement. Methods: In this randomized parallel-group controlled trial, PR classes were block-randomized to EPR or traditional PR and were delivered over 16 sessions each. The EPR program incorporated new and updated "Living Well with COPD" education modules, which had a stronger focus on chronic disease self-management. Fidelity of the intervention for content and delivery was assessed. Physical activity, self-efficacy, exercise tolerance, and health-related quality of life (HRQoL) were collected before, after, and 6 months after PR. Healthcare visits were collected 2 years before PR and 1 year after. Mortality was recorded 1 year after PR. Results: Of the 207 patients with COPD enrolled, 108 received EPR and 99 received traditional PR. Physical activity (steps) and self-efficacy improved from before to after PR in both programs, with no differences between groups. These effects were not sustained at 6 months. Exercise tolerance and HRQoL improved from before to after PR with no between-group differences and were maintained at 6 months. Visits to primary care providers and respiratory specialists decreased in the EPR program relative to the traditional PR program. EPR was delivered as intended, and there was no meaningful cross-contamination between the two programs. Conclusions: Enhancing PR to have a greater emphasis on chronic disease self-management did not result in a superior improvement of physical activity and health outcomes compared with traditional PR except for reduced resource usage from primary and specialist physician visits in the EPR program.Clinical trial registered with ClinicalTrials.gov (NCT02917915).

Mechanisms associated with increased physical activity in patients undergoing self-management behaviour modification in the randomised PHYSACTO trial.

INTRODUCTION: In this analysis of the PHYSACTO® study, we assessed the efficacy of a self-management behaviour modification (SMBM) programme to improve physical activity (PA) levels, and the extent to which effects were mediated by readiness to change, motivation and confidence. METHODS: PHYSACTO® was a randomised, partially double-blind, parallel-group, 12-week trial to evaluate the effects of treatment on exercise capacity and PA. COPD patients received placebo, tiotropium 5 µg or tiotropium/olodaterol 5/5 µg, with or without exercise training, all with an SMBM intervention (the Living Well with COPD programme). Changes were assessed in readiness to change (stage of change visual analogue scale [VAS]), motivation (Treatment Self-Regulation Questionnaire [TSRQ]) and confidence (Perceived Competence Scale [PCS]) to engage in PA. RESULTS: PA was increased in all patients with complete PA data at Week 12 (n=262; +6038 steps·week-1, p<0.001). Significant increases were observed in patients' readiness to change (VAS 0.7 [0.6-0.8]), autonomous regulation (TRSQ 0.2 [0.1-0.3]) and confidence (PCS 0.5 [0.3-0.6]) (all p<0.01). Of note, 23% of the total effect of SMBM on steps·week-1 was found to be mediated by increases in readiness to change, 5% by TSRQ autonomous regulation and 12% by PCS. CONCLUSION: Our study demonstrated that an SMBM programme delivered to COPD patients increased PA, mediated by an improvement of three key hypothesised mechanisms of change: readiness to change, autonomous motivation and confidence. For the first time, this study shows that an SMBM programme can be successful in altering the mechanisms of change targeted by the intervention.

A self-management education program including an action plan for acute COPD exacerbations.

Exacerbations are an important cause of morbidity and mortality in COPD. We assessed treatment initiation and health care use at exacerbation in patients receiving a self-management education program including an action plan. COPD patients were randomly assigned to usual care or to a comprehensive self-management program "Living Well with COPD" including a written action plan and case manager support, and were followed-up for 12 months. Patients in the usual care were managed by their respective practitioners. Patients in the self-management program received, as part of a written action plan, a prescription of antibiotics and prednisone for self-initiation in case of aggravation of 2 or more symptoms (dyspnea, sputum volume, sputum purulence) for at least 24 hours, and they had the support of a case-manager for reinforcement and monthly telephone follow-ups. At 12 months, 166 patients presented with at least one exacerbation. Exacerbations (606) were confirmed by aggravation of at least one symptom; 403 (67.6%) presented 2 or more. Antibiotics were used in 61.6% of exacerbations and prednisone in 47.9%. In exacerbations presenting aggravation of 2 or more symptoms, antibiotics and prednisone were used together more often in the action plan than in the usual care group (54.4% vs. 34.8%, p < 0.001). In the action plan, compared to the usual care group, 17.2% vs. 36.3% exacerbations resulted in a hospitalization (p < 0.001). Self-management with the successful use of an action plan for acute exacerbation of COPD holds promise for reducing health care use.

Behavioural interventions targeting physical activity improve psychocognitive outcomes in COPD.

This study explored the impact of a self-management behaviour modification (SMBM) programme with/without bronchodilators and with/without exercise training (ExT) to improve daily physical activity on psychological and cognitive outcomes in COPD patients as a secondary analysis of the PHYSACTO trial. A 12-week, four-group, randomised, partially double-blind, placebo-controlled, parallel-group trial of SMBM in addition to tiotropium 5 µg, tiotropium/olodaterol 5/5 µg, tiotropium/olodaterol 5/5 µg plus ExT, or placebo was conducted in 304 patients. Outcomes included anxiety (Hospital Anxiety and Depression Scale (HADS)-A), depression (HADS-D and Patient-Health Questionnaire (PHQ)-9) and cognitive function (Montreal Cognitive Assessment (MoCA)). All outcomes showed statistically and clinically significant improvements after 12 weeks independent of treatment group. However, greater improvements in HADS-A and MoCA were seen in patients who exhibited greater increases in physical activity and exercise capacity, respectively, whereas greater improvements in HADS-D and PHQ-9 were seen in patients who exhibited increases in either physical activity or exercise capacity. The results indicate that SMBM with/without bronchodilators or ExT was associated with improved psychological and cognitive functioning. Anxiety reduced with increased physical activity, cognitive function improved with increased exercise capacity, and depression reduced with increases in either physical activity or exercise capacity. Interventions that increase daily physical activity or exercise capacity may improve psychological and cognitive outcomes in COPD.

Innovating the treatment of COPD exacerbations: a phone interactive telesystem to increase COPD Action Plan adherence.

Introduction: Self-management interventions with Written Action Plans and case management support have been shown to improve outcomes in patients with chronic obstructive pulmonary disease (COPD). Novel telehealth technologies may improve self-management interventions. The objectives of this study were to determine whether the use of an interactive phone telesystem increases Action Plan adherence, improves exacerbation recovery and reduces healthcare use in a real-life practice of a COPD clinic. Methods: Initially, 40 patients were followed by a COPD telesystem for 1 year. Detailed data from patients' behaviours during exacerbations was recorded. The telesystem use was then extended to 256 patients from a real-life COPD clinic. Healthcare utilisation for the year before and after telesystem enrolment was then assessed through hospital administrative databases. Results: Thirty-three of the 40 patients completed the initial 1-year study. Eighty-one exacerbations were reported in the 1-year follow-up. Action Plan adherence was observed for 72% of the exacerbations and those who were adherent had a significantly faster exacerbation recovery time. The large-scale implementation of the telesystem resulted in a significant decrease in the proportion of patients with ≥1 respiratory-related emergency room (ER) visits (120 before vs 110 after enrolment, p<0.001) and with ≥1 COPD-related hospitalisations (75 before vs 65 after enrolment, p<0.001). Discussion: COPD Written Action Plan adherence was further enhanced with the use of telehealth technologies in a specialised clinic with experience in COPD self-management. Patients followed by the telesystem recovered faster from exacerbations and had a further decrease in COPD-related ER visits and hospitalisations. Trial registration number: NCT02275078.

Behaviour-change intervention in a multicentre, randomised, placebo-controlled COPD study: methodological considerations and implementation.

INTRODUCTION: Chronic obstructive pulmonary disease is generally progressive and associated with reduced physical activity. Both pharmacological therapy and exercise training can improve exercise capacity; however, these are often not sufficient to change the amount of daily physical activity a patient undertakes. Behaviour-change self-management programmes are designed to address this, including setting motivational goals and providing social support. We present and discuss the necessary methodological considerations when integrating behaviour-change interventions into a multicentre study. METHODS AND ANALYSIS: PHYSACTO is a 12-week phase IIIb study assessing the effects on exercise capacity and physical activity of once-daily tiotropium+olodaterol 5/5 µg with exercise training, tiotropium+olodaterol 5/5 µg without exercise training, tiotropium 5 µg or placebo, with all pharmacological interventions administered via the Respimat inhaler. Patients in all intervention arms receive a behaviour-change self-management programme to provide an optimal environment for translating improvements in exercise capacity into increases in daily physical activity. To maximise the likelihood of success, special attention is given in the programme to: (1) the Site Case Manager, with careful monitoring of programme delivery; (2) the patient, incorporating patient-evaluation/programme-evaluation measures to guide the Site Case Manager in the self-management intervention; and (3) quality assurance, to help identify and correct any problems or shortcomings in programme delivery and ensure the effectiveness of any corrective steps. This paper documents the comprehensive methods used to optimise and standardise the behaviour-change self-management programme used in the study to facilitate dialogue on the inclusion of this type of programme in multicentre studies. ETHICS AND DISSEMINATION: The study has been approved by the relevant Institutional Review Boards, Independent Ethics Committee and Competent Authority according to national and international regulations. The results of this study will be disseminated through relevant, peer-reviewed journals and international conference presentations. TRIAL REGISTRATION NUMBER: NCT02085161.

Do self-management interventions in COPD patients work and which patients benefit most? An individual patient data meta-analysis.

BACKGROUND: Self-management interventions are considered effective in patients with COPD, but trials have shown inconsistent results and it is unknown which patients benefit most. This study aimed to summarize the evidence on effectiveness of self-management interventions and identify subgroups of COPD patients who benefit most. METHODS: Randomized trials of self-management interventions between 1985 and 2013 were identified through a systematic literature search. Individual patient data of selected studies were requested from principal investigators and analyzed in an individual patient data meta-analysis using generalized mixed effects models. RESULTS: Fourteen trials representing 3,282 patients were included. Self-management interventions improved health-related quality of life at 12 months (standardized mean difference 0.08, 95% confidence interval [CI] 0.00-0.16) and time to first respiratory-related hospitalization (hazard ratio 0.79, 95% CI 0.66-0.94) and all-cause hospitalization (hazard ratio 0.80, 95% CI 0.69-0.90), but had no effect on mortality. Prespecified subgroup analyses showed that interventions were more effective in males (6-month COPD-related hospitalization: interaction P=0.006), patients with severe lung function (6-month all-cause hospitalization: interaction P=0.016), moderate self-efficacy (12-month COPD-related hospitalization: interaction P=0.036), and high body mass index (6-month COPD-related hospitalization: interaction P=0.028 and 6-month mortality: interaction P=0.026). In none of these subgroups, a consistent effect was shown on all relevant outcomes. CONCLUSION: Self-management interventions exert positive effects in patients with COPD on respiratory-related and all-cause hospitalizations and modest effects on 12-month health-related quality of life, supporting the implementation of self-management strategies in clinical practice. Benefits seem similar across the subgroups studied and limiting self-management interventions to specific patient subgroups cannot be recommended.

Early COPD Diagnosis in Family Medicine Practice: How to Implement Spirometry?

Introduction. COPD is often diagnosed at an advanced stage because symptoms go unrecognized. Furthermore, spirometry is often not done. Methods. Study was conducted in diverse family medicine practice settings. Patients were targeted if respiratory symptoms were present. Patients had a spirometry to confirm the presence of airflow obstruction and COPD diagnosis. An evaluation of the process was done to better understand facilitating/limiting factors to the implementation of a primary care based spirometry program. Results. 12 of 19 primary care offices participated. 196 of 246 (80%) patients targeted based on the presence of smoking and respiratory symptoms did not have COPD; 18 (7%) and 32 (13%) had COPD, respectively, GOLD I and ≥II. There was no difference in the type and number of respiratory symptoms between non-COPD and COPD patients. Most of the clinics did not have access to a trained healthcare professional to accomplish spirometry. They agreed that giving access to a trained healthcare professional was the easiest and most reliable way of doing spirometry. Conclusion. Spirometry, a simple test, is recommended in guidelines to make the diagnosis of COPD. The lack of allocated time and training of healthcare professionals makes its implementation challenging in family medicine practices.