RESUMO
BACKGROUND: Heart failure (HF) is a progressive disease associated with a high burden of symptoms, high morbidity and mortality, and low quality of life (QoL). This study aimed to evaluate the feasibility and potential outcomes of a novel multicomponent complex intervention, to inform a future full-scale randomized controlled trial (RCT) in Switzerland. METHODS: We conducted a pilot RCT at a secondary care hospital for people with HF hospitalized due to decompensated HF or with a history of HF decompensation over the past 6 months. We randomized 1:1; usual care for the control (CG) and intervention group (IG) who received the intervention as well as usual care. Feasibility measures included patient recruitment rate, study nurse time, study attrition, the number and duration of consultations, intervention acceptability and intervention fidelity. Patient-reported outcomes included HF-specific self-care and HF-related health status (KCCQ-12) at 3 months follow-up. Clinical outcomes were all-cause mortality, hospitalization and days spent in hospital. RESULTS: We recruited 60 persons with HF (age mean = 75.7 years, ± 8.9) over a 62-week period, requiring 1011 h of study nurse time. Recruitment rate was 46.15%; study attrition rate was 31.7%. Follow-up included 2.14 (mean, ± 0.97) visits per patient lasting a total of 166.96 min (mean, ± 72.55), and 3.1 (mean, ± 1.7) additional telephone contacts. Intervention acceptability was high. Mean intervention fidelity was 0.71. We found a 20-point difference in mean self-care management change from baseline to 3 months in favour of the IG (Cohens' d = 0.59). Small effect sizes for KCCQ-12 variables; less IG participants worsened in health status compared to CG participants. Five deaths occurred (IG = 3, CG = 2). There were 13 (IG) and 18 (CG) all-cause hospital admissions; participants spent 8.90 (median, IQR = 9.70, IG) and 15.38 (median, IQR = 18.41, CG) days in hospital. A subsequent full-scale effectiveness trial would require 304 (for a mono-centric trial) and 751 participants (for a ten-centre trial) for HF-related QoL (effect size = 0.3; power = 0.80, alpha = 0.05). CONCLUSION: We found the intervention, research methods and outcomes were feasible and acceptable. We propose increasing intervention fidelity strategies for a full-scale trial. TRIAL REGISTRATION: ISRCTN10151805 , retrospectively registered 04/10/2019.
RESUMO
BACKGROUND: Increased awareness of the world's problematic growing health care expenditure and health care shortages requires sustainable use of available resources. To promote cultural changes in medical mindsets, societies representing medical specialties have developed new Choosing Wisely strategies. The Valais Medical Society and the Valais Pharmacy Association have developed an interprofessional collaboration project entitled "Less-is-more Together-PPI" to analyze and optimize change management practices focusing on the prescription and deprescription of proton pump inhibitors (PPIs). OBJECTIVE: This study aims to enhance interprofessional collaboration between physicians, pharmacists, and patients to optimize PPI use, avoid unnecessary treatments and improve therapeutic adherence to indicated therapies, and to analyze hindrances and facilitators to implementing interprofessional Less-is-more strategies in the field. METHODS: Home-dwelling adults domiciled in Valais and prescribed PPIs in the last 6 months will be invited to participate in this observational study. The studied subpopulation will be constituted of consenting patients whose physicians and pharmacists also voluntarily agree to participate. The process of collecting, pooling, transmitting, evaluating, and protecting data has been validated by the Human Research Ethics Committee of the Canton Vaud. RESULTS: The Primary Triple Aim outcome measures will be (1) population health: patient's assessment of their own health, functional status, and disease burden using a monthly questionnaire for 6 months; Behavioral/physiological factors will be investigated using a final questionnaire at 6 months, (2) experience of care: assessment using a final questionnaire for participating patients, pharmacists and physicians, and an analysis of negative/positive experiences via 6 follow-up questionnaires, and (3) Per capita cost: participants' fluctuating or decreasing PPI intake (number of pills/dosage) and an analysis of participants' different categories following their medical prescription, in relation to possible bias effects on the overall drug intake of the population studied. Secondary outcomes will be participation rates; patient, physician, and pharmacist follow-up; and evaluations of participants' experiences and their perceived benefits, as well as whether the interprofessional process can be improved. CONCLUSIONS: This project seeks a deeper understanding of how Less-is-more and smarter-medicine strategies are perceived by patients and health care providers in their daily lives in a very specific context. It will reveal some of the hindrances to and facilitators for efficient cultural change toward a more sustainable health care system. The results will be useful to optimize and scale up further Choosing Wisely approaches. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/13896.
