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Effectiveness of pharmaceutical care for patients with chronic obstructive pulmonary disease (PHARMACOP): a randomized controlled trial.

ABSTRACT: Few well-designed randomized controlled trials have been conducted regarding the impact of community pharmacist interventions on pharmacotherapeutic monitoring of patients with chronic obstructive pulmonary disease (COPD). We assessed the effectiveness of a pharmaceutical care programme for patients with COPD.The pharmaceutical care for patients with COPD (PHARMACOP) trial is a single-blind 3 month randomized controlled trial, conducted in 170 community pharmacies in Belgium, enrolling patients prescribed daily COPD medication, aged ? 50 years and with a smoking history of ? 10 pack-years. A computer-generated randomization sequence allocated patients to an intervention group (n = 371), receiving protocol-defined pharmacist care, or a control group (n = 363), receiving usual pharmacist care (1:1 ratio, stratified by centre). Interventions focusing on inhalation technique and adherence to maintenance therapy were carried out at start of the trial and at 1 month follow-up. Primary outcomes were inhalation technique and medication adherence. Secondary outcomes were exacerbation rate, dyspnoea, COPD-specific and generic health status and smoking behaviour.From December 2010 to April 2011, 734 patients were enrolled. Forty-two patients (5.7%) were lost to follow-up. At the end of the trial, inhalation score [mean estimated difference (?),13.5%; 95% confidence interval (CI), 10.8-16.1; P < 0.0001] and medication adherence (?, 8.51%; 95% CI, 4.63-12.4; P < 0.0001) were significantly higher in the intervention group compared with the control group. In the intervention group, a significantly lower hospitalization rate was observed (9 vs. 35; rate ratio, 0.28; 95% CI, 0.12-0.64; P = 0.003). No other significant between-group differences were observed.Pragmatic pharmacist care programmes improve the pharmacotherapeutic regimen in patients with COPD and could reduce hospitalization rates.

SUBMITTER: Tommelein E

PROVIDER: S-EPMC4004396 | biostudies-literature | 2014 May

REPOSITORIES: biostudies-literature

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Effectiveness of pharmaceutical care for patients with chronic obstructive pulmonary disease (PHARMACOP): a randomized controlled trial.

Tommelein Eline E Mehuys Els E Van Hees Thierry T Adriaens Els E Van Bortel Luc L Christiaens Thierry T Van Tongelen Inge I Remon Jean-Paul JP Boussery Koen K Brusselle Guy G

British journal of clinical pharmacology 20140501 5

<h4>Aims</h4>Few well-designed randomized controlled trials have been conducted regarding the impact of community pharmacist interventions on pharmacotherapeutic monitoring of patients with chronic obstructive pulmonary disease (COPD). We assessed the effectiveness of a pharmaceutical care programme for patients with COPD.<h4>Methods</h4>The pharmaceutical care for patients with COPD (PHARMACOP) trial is a single-blind 3 month randomized controlled trial, conducted in 170 community pharmacies in ...[more]

PMID: 24117908

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Project description:ObjectiveMucoactive drugs should increase the ability to expectorate sputum and, ideally, have anti-inflammatory properties. The aim of the study was to evaluate the mucolytic activity of Tyloxapol compared to saline (0.9%) in COPD.DesignA randomized, placebo-controlled, double-blinded crossover, clinical trial was carried out. Patients were randomly assigned to either inhale 5 ml Tyloxapol 1% or saline 0.9% solution three times daily for 3 weeks and vice versa for another 3 weeks. 28 patients (18 male, 10 female, 47 to 73 years old, median age 63.50) were screened, 21 were treated and 19 patients completed the study per protocol.ResultsA comparison of the two treatment phases showed that the primary endpoint sputum weight was statistically significant higher when patients inhaled Tyloxapol (mean 4.03 g, 95% CI: 2.34-5.73 g at week 3) compared to saline (mean 2.63 g, 95% CI: 1.73-3.53 g at week 3). The p-value at three weeks of treatment was 0.041 between treatment arms. Sputum cells decreased during the Tyloxapol treatment after 3 weeks, indicating that Tyloxapol might have some anti-neutrophilic properties. Lung function parameters (FVC, FEV1, RV, and RV/TLC) remained stable during the study, and no treatment effect was shown. Interestingly, there was a mean increase in all inflammatory cytokines (IL-1β, IL-6, and IL-8) during the saline treatment from day 1 to week 3, whereas during the Tyloxapol treatment, all cytokines decreased. Due to the small sample size and the large individual variation in sputum cytokines, these differences were not significant. However, analyses confirmed that Tyloxapol has significant anti-inflammatory properties in vitro. Despite the high number of inhalations (more than 1000), only 27 adverse events (20 during the Tyloxapol and seven during saline) were recorded. Eleven patients experienced AEs under Tyloxapol and six under saline treatment, which indicates that inhalation of saline or Tyloxapol is a very safe procedure.ConclusionOur study demonstrated that inhalation of Tyloxapol by patients with COPD is safe and superior to saline and has some anti-inflammatory effects.Trial registrationClinicalTrials.gov NCT02515799.

Project description:BackgroundSeveral feasibility studies show promising results of telehealthcare on health outcomes and health-related quality of life for patients suffering from chronic obstructive pulmonary disease, and some of these studies show that telehealthcare may even lower healthcare costs. However, the only large-scale trial we have so far - the Whole System Demonstrator Project in England - has raised doubts about these results since it conclude that telehealthcare as a supplement to usual care is not likely to be cost-effective compared with usual care alone.Methods/designThe present study is known as 'TeleCare North' in Denmark. It seeks to address these doubts by implementing a large-scale, pragmatic, cluster-randomized trial with nested economic evaluation. The purpose of the study is to assess the effectiveness and the cost-effectiveness of a telehealth solution for patients suffering from chronic obstructive pulmonary disease compared to usual practice. General practitioners will be responsible for recruiting eligible participants (1,200 participants are expected) for the trial in the geographical area of the North Denmark Region. Twenty-six municipality districts in the region define the randomization clusters. The primary outcomes are changes in health-related quality of life, and the incremental cost-effectiveness ratio measured from baseline to follow-up at 12 months. Secondary outcomes are changes in mortality and physiological indicators (diastolic and systolic blood pressure, pulse, oxygen saturation, and weight).DiscussionThere has been a call for large-scale clinical trials with rigorous cost-effectiveness assessments in telehealthcare research. This study is meant to improve the international evidence base for the effectiveness and cost-effectiveness of telehealthcare to patients suffering from chronic obstructive pulmonary disease by implementing a large-scale pragmatic cluster-randomized clinical trial.Trial registrationClinicaltrials.gov, http://NCT01984840, November 14, 2013.

Project description:RationaleSocioeconomically disadvantaged patients with chronic obstructive pulmonary disease (COPD) often face barriers to evidence-based care that are difficult to address in public care settings with limited resources.ObjectivesTo determine the benefit of health coaching for patients with moderate to severe COPD relative to usual care.MethodsWe conducted a randomized controlled trial of 9 months of health coaching versus usual care for English- or Spanish-speaking patients at least 40 years of age with moderate to severe COPD. Primary outcomes were COPD-related quality of life and the dyspnea subscale of the Chronic Respiratory Disease Questionnaire. Secondary outcomes were self-efficacy for managing COPD, exercise capacity (6-min walk test), and number of COPD exacerbations. Additional outcomes were COPD symptoms, lung function (forced expiratory volume in 1 s percent predicted), smoking status, bed days owing to COPD, quality of care (Patient Assessment of Chronic Illness Care), COPD knowledge, and symptoms of depression (Patient Health Questionnaire). Outpatient visits, emergency department visits, and hospitalizations were assessed by review of medical records. Generalized linear modeling was used to adjust for baseline values and account for clustering by clinic.ResultsOf 192 patients enrolled, 158 (82%) completed 9 months of follow-up. There were no significant differences between study arms for the primary or secondary outcomes. At 9 months, patients in the coached group reported better quality of care (mean Patient Assessment of Chronic Illness Care score, 3.30 vs. 3.18; adjusted P = 0.02) and were less likely to report symptoms of moderate to severe depression (Patient Health Questionnaire score, ≥15) than those in the usual care arm (6% vs. 20%; adjusted P = 0.01). During the study, patients in the coaching arm had 48% fewer hospitalizations related to COPD (0.27/patient/yr vs. 0.52/patient/yr), but this difference was not significant in the adjusted analysis.ConclusionsThese results help inform expectations regarding the limitations and benefits of health coaching for patients with COPD. They may be useful to health policy experts in assessing the potential value of reimbursement and incentives for health coaching-type activities for patients with chronic disease. Clinical trial registered with www.clinicaltrials.gov (NCT02234284).

Project description:BackgroundCachectic patients with chronic obstructive pulmonary disease (COPD) may benefit from nutritional support. This double-blind, randomized, controlled trial evaluated the safety and efficacy of targeted medical nutrition (TMN) vs. an isocaloric comparator in pre-cachectic and cachectic patients with COPD.MethodsPatients aged ≥50 years with moderate-to-severe COPD and involuntary weight loss or low body mass index (16-18 kg/m2 ) were randomized 1:1 to receive TMN (~230 kcal; 2 g omega-3 fatty acids; 10 μg 25-hydroxy-vitamin D3) or isocaloric comparator twice daily for 12 weeks (ClinicalTrials.gov Identifier: NCT02442908). Primary safety endpoints comprised adverse events and changes in vital signs, laboratory parameters, and concomitant medications. Secondary efficacy endpoints included changes in weight, body composition, exercise tolerance, metabolic biomarkers, and systemic inflammation.ResultsForty-five patients were randomized to receive TMN (n = 22; mean 69.2 years) or isocaloric comparator (n = 23; mean 69.7 years). TMN was well tolerated. Adverse events were similar in number and type in both groups. Compliance to both products was good (TMN, 79%; comparator, 77%). Both groups gained weight, but the TMN group gained comparatively more fat mass (P = 0.0013). Reductions in systolic blood pressure (P = 0.0418) and secondary endpoints of triglycerides (P = 0.0217) and exercise-induced fatigue (P = 0.0223) and dyspnoea (P = 0.0382), and increases in high-density lipoprotein cholesterol (P = 0.0254), were observed in the TMN vs. the comparator group by week 12.ConclusionsTargeted medical nutrition containing high-dose omega-3 fatty acids, vitamin D, and high-quality protein is well tolerated with a good safety profile and has positive effects on blood pressure and blood lipids and on exercise-induced fatigue and dyspnoea. Therefore, this TMN could be clinically beneficial in the nutritional and metabolic support of pre-cachectic and cachectic patients with COPD.

Project description:Background and objectivesAvailable evidence suggests that adults with chronic obstructive pulmonary disease (COPD) performed substantially worse than healthy controls on many balance measures and balance training can improve the balance measures in this population. We conducted this study to determine the effects of incorporating balance training into pulmonary rehabilitation (PR) on the incidence of falls at 12 months follow-up in high fall risk adults with COPD.MethodsWe conducted a prospective international multi-center randomized controlled trial. Eligible participants were adults with COPD at a high risk of future falls and were randomly assigned (1:1) to the intervention or control group. The intervention included personalized balance training for a targeted total of 90 min per week. Both the intervention and control groups received usual PR (2-3 times per week for 8-12 weeks). The primary outcome was the incidence of falls at 12-month follow-up using monthly fall diary calendars. Negative binomial regression or recurrent events models were used to examine the effects of the intervention on fall events. Multiple imputations were performed to deal with missing values.ResultsOf 258 participants who were enrolled in the trial, 178 provided falls information (intervention group = 91, control group = 87) and were included in the main analysis. Forty-one participants (45%) experienced at least one fall event in the intervention group and 33 (38%) in the control group (p = 0.34). The mean incidence of falls at 12 months was similar between the two groups (128 versus 128 per 100 person-years; mean difference: 0.30, 95% CI: -0.76 to 1.36 per 100 person-years). The results are robust after multiple imputations for missing data (n = 67).ConclusionsPR incorporating balance training compared to PR alone did not reduce the incidence of falls over the 12-month period in high fall risk adults with COPD.Trial registrationThe study was registered with ClinicalTrials.gov (NCT02995681) on 14/12/2016.

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Effectiveness of pharmaceutical care for patients with chronic obstructive pulmonary disease (PHARMACOP): a randomized controlled trial.

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Effectiveness of pharmaceutical care for patients with chronic obstructive pulmonary disease (PHARMACOP): a randomized controlled trial.

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