Interdisciplinary Physician-Pharmacist Medication Review for Outpatients With Heart Failure: A Subanalysis of the PHARM-CHF Randomized Controlled Trial.
Ontology highlight
ABSTRACT:
SUBMITTER: Schumacher PM
PROVIDER: S-EPMC8453145 | biostudies-literature |
REPOSITORIES: biostudies-literature
Similar Datasets
Project description:AimsPatients with heart failure (HF) have impaired quality of life (QoL). The randomized controlled trial PHARM-CHF investigated whether an interdisciplinary intervention consisting of regular contacts with the community pharmacy and weekly dosing aids improves medication adherence in patients with HF. It is unknown how an intervention involving frequent structured pharmacy visits affects QoL. Our aim was to explore adherence to the intervention and effects on QoL.Methods and resultsAmong 237 patients, n = 110 were randomized to pharmacy care and n = 127 to usual care. The pharmacy care group received a medication review followed by (bi-)weekly dose dispensing and counselling. The median follow-up was 2.0 years [inter-quartile range (IQR) 1.2-2.7]. Median interval between pharmacy visits was 8.4 days (IQR 8.0-10.3) and the visits lasted in median 14 min (IQR 10-15). Median adherence to the intervention was 96% (IQR 84-100). QoL at 365 days was predefined as a main secondary and at 730 days as another secondary endpoint in PHARM-CHF. QoL was measured by the Minnesota Living with Heart Failure Questionnaire; and for 111 patients (n = 47 in the pharmacy care group and n = 64 in the usual care group), data were available at baseline, and after 365 and 730 days (mean age 74 years; 41% female). Improvement in QoL was numerically higher in the pharmacy care group after 365 days and was significantly better after 730 days (difference in total scores -7.7 points [-14.5 to -1.0]; P = 0.026) compared to the usual care group. In all subgroups examined, this treatment effect was preserved. Improvements in the physical and emotional dimensions were numerically higher in the pharmacy care group after 365 days and were significantly better after 730 days: -4.0 points [-6.9 to -1.2]; P = 0.006, and -1.9 points [-3.7 to -0.1]; P = 0.039, respectively.ConclusionsA pharmacy-based interdisciplinary intervention was well received by the patients and suggests clinically important improvements in QoL.
| S-EPMC7754956 | biostudies-literature
Project description:This prospective study included patients with heart failure (HF) with reduced ejection fraction (HFrEF) with LVEF < = 40% to evaluate the impact of pharmacist on guideline directed medical therapy (GDMT). The primary outcome was to compare proportion of triple GDMT achieved for Angiotensin-Converting-Enzyme-Inhibitors (ACEI)/Angiotensin-Receptor-Blockers (ARB)/Angiotensin-Receptor-Neprilysin-Inhibitors (ARNI), beta-blockers, aldosterone antagonists (AA), and quadruple GDMT which in additional to triple therapy, included Sodium glucose co-transporter 2 inhibitor (SGLT2i) at 90-day post-enrollment compared to baseline. Secondary endpoints included achieving target and/or maximally tolerated ACEI/ARB/ARNI and beta-blockers combined and individually as well as SGLT2i and AA GDMT at 90-day post-enrollment compared to baseline. We also compared combined and individual HF-related hospitalization/emergency room (ER) visits 90 days pre-/post-enrollment. Of the total 974 patients screened, 80 patients seen at least once in the heart failure medication titration clinic (HMTC) were included in the analysis. Median (IQR) age was 71 (57-69) years with majority white male. There was a significant improvement in the proportion of patients who achieved quadruple GDMT (p = 0.001) and triple GDMT (p-value = 0.020) at 90-day post-enrollment compared to baseline. The secondary GDMT outcomes were also significantly increased at 90 days post-enrollment compared to baseline. Significant difference in mean as well as proportion of combined HF-related hospitalization/ER-visits was found 90 days pre-/post-enrollment (p = 0.047). Our study found that pharmacist's intervention increased the proportion of patients who achieved GDMT at 90 days.
| S-EPMC9060399 | biostudies-literature
Project description:AimsPatients with heart failure (HF) have poor outcomes, including poor quality of life, and high morbidity and mortality. In addition, they have a high medication burden due to the multiple drug therapies now recommended by guidelines. Previous reviews, including studies in hospital settings, provided evidence that pharmacist care improves outcomes in patients with HF. Because most HF is managed outside of hospitals, we aimed to synthesize the evidence for pharmacist care in outpatients with HF.Methods and resultsWe conducted a systematic literature search in PubMed of randomized controlled trials (RCTs) and integrated the evidence on patient outcomes in a meta-analysis. We found 24 RCTs performed in 10 countries, including 8029 patients. The data revealed consistent improvements in medication adherence (independent of the measuring instrument) and knowledge, physical function, and disease and medication management. Sixteen RCTs were included in meta-analyses. Differences in all-cause mortality (odds ratio (OR) = 0.97 [95% CI, 0.84-1.12], Q-statistic, P = 0.49, I2 = 0%), all-cause hospitalizations (OR = 0.86 [0.73-1.03], Q-statistic, P = 0.01, I2 = 45.5%), and HF hospitalizations (OR = 0.89 [0.77-1.02], Q-statistic, P = 0.11, I2 = 0%) were not statistically significant. We also observed an improvement in the standardized mean difference for generic quality of life of 0.75 ([0.49-1.01], P < 0.01), with no indication of heterogeneity (Q-statistic, P = 0.64; I2 = 0%).ConclusionsResults indicate that pharmacist care improves medication adherence and knowledge, symptom control, and some measures of quality of life in outpatients with HF. Given the increasing complexity of guideline-directed medical therapy, pharmacists' unique focus on medication management, titration, adherence, and patient teaching should be considered part of the management strategy for these vulnerable patients.
| S-EPMC8497358 | biostudies-literature
Project description:Hawthorn's efficacy when added to contemporary evidence-based heart failure therapy is unknown. We aimed to determine whether hawthorn increases submaximal exercise capacity when added to standard medical therapy.We performed a randomized, double-blind, placebo-controlled trial in 120 ambulatory patients aged > or = 18 years with New York Heart Association (NYHA) class II-III chronic heart failure. All patients received conventional medical therapy, as tolerated, and were randomized to either hawthorn 450 mg twice daily or placebo for 6 months. The primary outcome was change in 6 min walk distance at 6 months. Secondary outcomes included quality of life (QOL) measures, peak oxygen consumption, and anaerobic threshold during maximal treadmill exercise testing, NYHA classification, left ventricular ejection fraction (LVEF), neurohormones, and measures of oxidative stress and inflammation. There were no significant differences between groups in the change in 6 min walk distance (P = 0.61), or on measures of QOL, functional capacity, neurohormones, oxidative stress, or inflammation. A modest difference in LVEF favoured hawthorn (P = 0.04). There were significantly more adverse events reported in the hawthorn group (P = 0.02), although most were non-cardiac.Hawthorn provides no symptomatic or functional benefit when given with standard medical therapy to patients with heart failure. This trial is registered in ClinicalTrials.gov ID: NCT00343902.
| S-EPMC2754502 | biostudies-literature
Project description:Background:It is uncertain whether repeated measurements of a multi-target biomarker panel may help to personalize medical heart failure (HF) therapy to improve outcome in chronic HF. Methods:This analysis included 499 patients from the Trial of Intensified versus standard Medical therapy in Elderly patients with Congestive Heart Failure (TIME-CHF), aged ??60 years, LVEF ??45%, and NYHA ??II, who had repeated clinical visits within 19 months follow-up. The interaction between repeated measurements of biomarkers and treatment effects of loop diuretics, spironolactone, ?-blockers, and renin-angiotensin system (RAS) inhibitors on risk of HF hospitalization or death was investigated in a hypothesis-generating analysis. Generalized estimating equation (GEE) models were used to account for the correlation between recurrences of events in a patient. Results:One hundred patients (20%) had just one event (HF hospitalization or death) and 87 (17.4%) had at least two events. Loop diuretic up-titration had a beneficial effect for patients with high interleukin-6 (IL6) or high high-sensitivity C-reactive protein (hsCRP) (interaction, P?=?0.013 and P?=?0.001), whereas the opposite was the case with low hsCRP (interaction, P?=?0.013). Higher dosage of loop diuretics was associated with poor outcome in patients with high blood urea nitrogen (BUN) or prealbumin (interaction, P?=?0.006 and P?=?0.001), but not in those with low levels of these biomarkers. Spironolactone up-titration was associated with lower risk of HF hospitalization or death in patients with high cystatin C (CysC) (interaction, P?=?0.021). ?-Blockers up-titration might have a beneficial effect in patients with low soluble fms-like tyrosine kinase-1 (sFlt) (interaction, P?=?0.021). No treatment biomarker interactions were found for RAS inhibition. Conclusion:The data of this post hoc analysis suggest that decision-making using repeated biomarker measurements may be very promising in bringing treatment of heart failure to a new level in the context of predictive, preventive, and personalized medicine. Clearly, prospective testing is needed before this novel concept can be adopted. Clinical trial registration:isrctn.org, identifier: ISRCTN43596477.
| S-EPMC5972133 | biostudies-literature
Project description:BACKGROUND:Primary care needs to be patient-centered, integrated, and interprofessional to help patients with complex needs manage the burden of medication-related problems. Considering the growing problem of polypharmacy, increasing attention has been paid to how and when medication-related decisions should be coordinated across multidisciplinary care teams. Improved knowledge on how integrated electronic health records (EHRs) can support interprofessional shared decision-making for medication therapy management is necessary to continue improving patient care. OBJECTIVE:The objective of our study was to examine how physicians and pharmacists understand and communicate patient-focused medication information with each other and how this knowledge can influence the design of EHRs. METHODS:This study is part of a broader cross-Canada study between patients and health care providers around how medication-related decisions are made and communicated. We visited community pharmacies, team-based primary care clinics, and independent-practice family physician clinics throughout Ontario, Nova Scotia, Alberta, and Quebec. Research assistants conducted semistructured interviews with physicians and pharmacists. A modified version of the Multidisciplinary Framework Method was used to analyze the data. RESULTS:We collected data from 19 pharmacies and 9 medical clinics and identified 6 main themes from 34 health care professionals. First, Interprofessional Shared Decision-Making was not occurring and clinicians made decisions based on their understanding of the patient. Physicians and pharmacists reported indirect Communication, incomplete Information specifically missing insight into indication and adherence, and misaligned Processes of Care that were further compounded by EHRs that are not designed to facilitate collaboration. Scope of Practice examined professional and workplace boundaries for pharmacists and physicians that were internally and externally imposed. Physicians decided on the degree of the Physician-Pharmacist Relationship, often predicated by colocation. CONCLUSIONS:We observed limited communication and collaboration between primary care providers and pharmacists when managing medications. Pharmacists were missing key information around reason for use, and physicians required accurate information around adherence. EHRs are a potential tool to help clinicians communicate information to resolve this issue. EHRs need to be designed to facilitate interprofessional medication management so that pharmacists and physicians can move beyond task-based work toward a collaborative approach.
| S-EPMC6231837 | biostudies-literature
Project description:AimsFew data regarding the prevalence and prognostic impact of mitral regurgitation (MR) in patients with worsening chronic or new-onset acute heart failure (HF) are available. We investigated the role of MR in the BIOlogy Study to TAilored Treatment in Chronic Heart Failure (BIOSTAT-CHF).Methods and resultsWe performed a retrospective post-hoc analysis including patients from both the index and validation BIOSTAT-CHF cohorts with data regarding MR status. The primary endpoint was a composite of all-cause death or HF hospitalization. Among 4023 patients included, 1653 patients (41.1%) had moderate-severe MR. Compared to others, patients with moderate-severe MR were more likely to have atrial fibrillation and chronic kidney disease and had larger left ventricular (LV) dimensions, lower LV ejection fraction (LVEF), worse quality of life, and higher plasma concentrations of N-terminal pro-B-type natriuretic peptide (NT-proBNP). A primary outcome event occurred in 697 patients with, compared to 836 patients without, moderate-severe MR [Kaplan-Meier 2-year estimate: 42.2% vs. 35.3%; hazard ratio (HR) 1.28; 95% confidence interval (CI) 1.16-1.41; log-rank P < 0.0001]. The association between MR and the primary endpoint remained significant after adjusting for baseline variables and the previously validated BIOSTAT-CHF risk score (adjusted HR 1.11; 95% CI 1.00-1.23; P = 0.041). Subgroup analyses showed a numerically larger impact of MR on the primary endpoint in patients with lower LVEF, larger LV end-diastolic diameter, and higher plasma NT-proBNP.ConclusionsModerate-severe MR is common in patients with worsening chronic or new-onset acute HF and is strongly associated with outcome, independently of other features related to HF severity.
| S-EPMC9290728 | biostudies-literature
Project description:BackgroundOlder adults commonly face challenges in understanding, obtaining, administering, and monitoring medication regimens after hospitalization. These difficulties can lead to avoidable morbidity, mortality, and hospital readmissions. Pharmacist-led peri-discharge interventions can reduce adverse drug events, but few large randomized trials have examined their effectiveness in reducing readmissions. Demonstrating reductions in 30-day readmissions can make a financial case for implementing pharmacist-led programs across hospitals.Methods/designThe PHARMacist Discharge Care, or the PHARM-DC intervention, includes medication reconciliation at admission and discharge, medication review, increased communication with caregivers, providers, and retail pharmacies, and patient education and counseling during and after discharge. The intervention is being implemented in two large hospitals: Cedars-Sinai Medical Center and the Brigham and Women's Hospital. To evaluate the intervention, we are using a pragmatic, randomized clinical trial design with randomization at the patient level. The primary outcome is utilization within 30 days of hospital discharge, including unforeseen emergency department visits, observation stays, and readmissions. Randomizing 9776 patients will achieve 80% power to detect an absolute reduction of 2.5% from an estimated baseline rate of 27.5%. Qualitative analysis will use interviews with key stakeholders to study barriers to and facilitators of implementing PHARM-DC. A cost-effectiveness analysis using a time-and-motion study to estimate time spent on the intervention will highlight the potential cost savings per readmission.DiscussionIf this trial demonstrates a business case for the PHARM-DC intervention, with few barriers to implementation, hospitals may be much more likely to adopt pharmacist-led peri-discharge medication management programs.Trial registrationClinicalTrials.gov Identifier: NCT04071951.
| S-EPMC8276883 | biostudies-literature
Project description:BackgroundDue to a lack of an appropriate disease-specific patient-reported outcome (PRO) instrument for chronic heart failure including its social support and treatment aspects in China, this study was performed to develop a patient-reported outcome measure (PROM) for patients with chronic heart failure and evaluate its reliability, validity, and feasibility.MethodsAccording to the standard PROM guidelines established by the Food and Drug Administration, an item pool was formed by reviewing a large amount of relevant literature and interviewing patients with chronic heart failure about their main symptoms. Thus, the primary scale was created after adjusting the items and language with the help of patients and experts in the field. Next, 155 patients from 8 hospitals in different districts were recruited for a pilot survey using questionnaires containing these items. The patients' responses were analyzed using the classical test theory and item response theory to select high-quality items and determine the subdomains of the scale. This was followed by a formal investigation in the same eight hospitals. In total, 360 patients and 100 healthy subjects were included to evaluate the reliability, validity, and feasibility of the items. Through this process, the final scale was established.ResultsThe final scale comprised 12 subdomains with 57 items related to physical, psychological, social, and therapeutic areas. The data analysis results of the formal investigation showed that the PROM for chronic heart failure had good reliability, validity, and feasibility. Reliability was verified by Cronbach's alpha coefficient, which was 0.913 for the total scale, 0.903 for the physical domain, 0.941 for the psychological domain, 0.827 for the social domain, and 0.839 for the therapeutic domain. The construct validity results met the relative criteria of confirmatory factor analysis. Discriminant validity was represented by score comparisons of nine subdomains. The response rate and the effective rate of return of the CHF-PROM were 98.94% and 98.92%, respectively.ConclusionsThe final scale coincides with the theoretical framework and better reflects the overall quality of life of patients with chronic heart failure. This scale can be used as a valid instrument to evaluate clinical treatment and clinical trials of chronic heart failure.
| S-EPMC5859646 | biostudies-literature
Project description:AimsThe exploration of novel immunomodulatory interventions to improve outcome in heart failure (HF) is hampered by the complexity/redundancies of inflammatory pathways, which remain poorly understood. We thus aimed to investigate the associations between the activation of diverse immune processes and outcomes in patients with HF.Methods and resultsWe measured 355 biomarkers in 2022 patients with worsening HF and an independent validation cohort (n = 1691) (BIOSTAT-CHF index and validation cohorts), and classified them according to their functions into biological processes based on the gene ontology classification. Principal component analyses were used to extract weighted scores per process. We investigated the association of these processes with all-cause mortality at 2-year follow-up. The contribution of each biomarker to the weighted score(s) of the processes was used to identify potential therapeutic targets. Mean age was 69 (±12.0) years and 537 (27%) patients were women. We identified 64 unique overrepresented immune-related processes representing 188 of 355 biomarkers. Of these processes, 19 were associated with all-cause mortality (10 positively and 9 negatively). Increased activation of 'T-cell costimulation' and 'response to interferon-gamma/positive regulation of interferon-gamma production' showed the most consistent positive and negative associations with all-cause mortality, respectively, after external validation. Within T-cell costimulation, inducible costimulator ligand, CD28, CD70, and tumour necrosis factor superfamily member-14 were identified as potential therapeutic targets.ConclusionsWe demonstrate the divergent protective and harmful effects of different immune processes in HF and suggest novel therapeutic targets. These findings constitute a rich knowledge base for informing future studies of inflammation in HF.
| S-EPMC9239579 | biostudies-literature