Gender, smoking, and tobacco cessation with pharmacological treatment in a cluster randomized clinical trial.

INTRODUCTION: Whether men find it easier to quit smoking than women is still controversial. Different studies have reported that the efficacy of pharmacological treatments could be different between men and women. This study conducted a secondary analysis of 'Subsidized pharmacological treatment for smoking cessation by the Spanish public health system' (FTFT-AP study) to evaluate the effectiveness of a drug-funded intervention for smoking cessation by gender. METHODS: A pragmatic randomized clinical trial by clusters was used. The population included smokers aged ≥18 years, smoking >10 cigarettes per day, randomly assigned to an intervention group receiving regular practice and financed pharmacological treatment, or to a control group receiving only regular practice. The main outcome was continued abstinence at 12 months, self-reported and validated with CO-oximetry. The percentage, with 95% confidence intervals, of continued abstinence was compared between both groups at 12 months post-intervention, by gender and the pharmacological treatment used. Multilevel logistic regression analysis was performed. RESULTS: A total of 1154 patients from 29 healthcare centers were included. The average age was 46 years (SD=11.78) and 51.7% were men. Overall, the self-reported abstinence at 12 months was 11.1% (62) in women and 15.7% (93) in men (AOR=1.4; 95% CI: 1.0-2.0), and abstinence validated by CO-oximetry was 4.6% (26) and 5.9% (35) in women and men, respectively (OR=1.3; 95% CI: 0.7-2.2). In the group of smokers receiving nicotine replacement treatment, self-reported abstinence was higher in men compared to women (29.5% vs 13.5%, OR=2.7; 95% CI: 1.3-5.8). CONCLUSIONS: The effectiveness of a drug-financed intervention for smoking cessation was greater in men, who also showed better results in self-reported abstinence with nicotine replacement treatment.

Psychological impact of the COVID-19 pandemic on primary care workers: a cross-sectional study.

BACKGROUND: The COVID-19 pandemic has had a major impact on the mental health of healthcare workers, yet studies in primary care workers are scarce. AIM: To investigate the prevalence of and associated factors for psychological distress in primary care workers during the first COVID-19 outbreak. DESIGN AND SETTING: This was a multicentre, cross-sectional, web-based survey conducted in primary healthcare workers in Spain, between May and September 2020. METHOD: Healthcare workers were invited to complete a survey to evaluate sociodemographic and work-related characteristics, COVID-19 infection status, exposure to patients with COVID-19, and resilience (using the Connor-Davidson Resilience Scale), in addition to being screened for common mental disorders (depression, anxiety disorders, post-traumatic stress disorder, panic attacks, and substance use disorder). Positive screening for any of these disorders was analysed globally using the term 'any current mental disorder'. RESULTS: A total of 2928 primary care professionals participated in the survey. Of them, 43.7% (95% confidence interval [CI] = 41.9 to 45.4) tested positive for a current mental disorder. Female sex (odds ratio [OR] 1.61, 95% CI = 1.25 to 2.06), having previous mental disorders (OR 2.58, 95% CI = 2.15 to 3.10), greater occupational exposure to patients with COVID-19 (OR 2.63, 95% CI = 1.98 to 3.51), having children or dependents (OR 1.35, 95% CI = 1.04 to 1.76 and OR 1.59, 95% CI = 1.20 to 2.11, respectively), or having an administrative job (OR 2.24, 95% CI = 1.66 to 3.03) were associated with a higher risk of any current mental disorder. Personal resilience was shown to be a protective factor. CONCLUSION: Almost half of primary care workers showed significant psychological distress. Strategies to support the mental health of primary care workers are necessary, including designing psychological support and resilience-building interventions based on risk factors identified.

Effectiveness of a home-based nursing support and cognitive restructuring intervention on the quality of life of family caregivers in primary care: A pragmatic cluster-randomized controlled trial.

BACKGROUND: Caregivers of patients with chronic conditions or disability experience fatigue, burden and poor health-related quality of life. There is evidence of the effectiveness of support interventions for decreasing this impact. However, little is known about the benefits of home-based nursing intervention in primary health care. OBJECTIVES: To evaluate the effectiveness of a home-based, nurse-led-intervention (CuidaCare) on the quality of life of caregivers of individuals with disabilities or chronic conditions living in the community, measured at 12-month follow-up. METHODS: A pragmatic, two-arm, cluster-randomized controlled trial with a 1-year follow-up period was performed between June 2013 and December 2015. Consecutive caregivers aged 65 years or older, all of whom assumed the primary responsibility of caring for people with disabling conditions for at least 6 months a year, were recruited from 22 primary health care centers. Subsequently, 11 centers were randomly assigned to usual care group, and 11 were assigned to the intervention group. The caregivers in the intervention group received the usual care and additional support (cognitive restructuring, health education and emotional support). The primary outcome was quality of life, assessed with the EQ-5D instrument (visual analog scale and utility index score); the secondary outcome variables were perception of burden, anxiety, and depression. Data were collected at baseline, at the end of the intervention, and at the 6- and 12-month follow-up visits. We analyzed the primary outcome as intention-to-treat, and missing data were added using the conditional mean single imputation method. RESULTS: A total of 224 caregivers were included in the study (102 in the intervention group and 122 in the usual care group). Generalized Estimating Equation models showed that the CuidaCare intervention was associated with a 5.46 point (95% CI: 2.57; 8.35) change in the quality of life, as measured with the visual analog scale adjusted for the rest of the variables at 12 months. It also produced an increase of 0.04 point (95% CI: 0.01; 0.07) in the utilities. No statistically significant differences were found between the two groups at 12 months with respect to the secondary outcomes. CONCLUSIONS: The findings suggest that incorporating a home-based, nurse-led-intervention for caregivers into primary care can improve the health-related quality of life of caregivers of patients with chronic or disabling conditions.

Social support, social context and nonadherence to treatment in young senior patients with multimorbidity and polypharmacy followed-up in primary care. MULTIPAP Study.

OBJECTIVE: To estimate the prevalence of nonadherence to treatment and its relationship with social support and social context in patients with multimorbidity and polypharmacy followed-up in primary care. METHODS: This was an observational, descriptive, cross-sectional, multicenter study with an analytical approach. A total of 593 patients between 65-74 years of age with multimorbidity (≥3 diseases) and polypharmacy (≥5 drugs) during the last three months and agreed to participate in the MULTIPAP Study. The main variable was adherence (Morisky-Green). The predictors were social support (structural support and functional support (DUFSS)); sociodemographic variables; indicators of urban objective vulnerability; health-related quality of life (EQ-5D-5L-VAS & QALY); and clinical variables. Descriptive, bivariate and multivariate analyses with logistic regression models and robust estimators were performed. RESULTS: Four out of ten patients were nonadherent, 47% had not completed primary education, 28.7% had an income ≤1050 €/month, 35% reported four or more IUVs, and the average perceived health-related quality of life (HRQOL) EQ-5D-5L-VAS was 65.5. The items that measure functional support, with significantly different means between nonadherent and adherent patients were receiving love and affection (-0.23; 95%CI: -0.40;-0.06), help when ill (-0.25; 95%CI: -0.42;-0.08), useful advice (-0.20; 95%CI: -0.37;-0.02), social invitations (-0.22; 95%CI:-0.44;-0.01), and recognition (-0.29; 95%CI:-0.50;-0.08). Factors associated with nonadherence were belonging to the medium vs. low tertile of functional support (0.62; 95%CI: 0.42;0.94), reporting less than four IUVs (0.69; 95%CI: 0.46;1.02) and higher HRQOL perception (0.98; 95%CI: 0.98;0.99). CONCLUSIONS: Among patients 65-74 years of age with multimorbidity and polypharmacy, lower functional support was related to nonadherence to treatment. The nonadherence decreased in those patients with higher functional support, lower urban vulnerability and higher perceived health status according to the visual analog scale of health-related quality of life.

MULTIPAP Study: Improving healthcare for patients with multimorbidity.

BACKGROUND: The steady rise in multimorbidity entails serious consequences for our populations, challenges healthcare systems, and calls for specific clinical approaches of proven effectiveness. The MULTIPAP Study comprises three sequential projects (MULTIPAP and MULTIPAP Plus RCTs, and the MULTIPAP Cohort). Results of MULTIPAP RCT are presented. AIM: To evaluate the effectiveness of a complex, patient-centred intervention in young-old patients with multimorbidity and polypharmacy. METHOD: Pragmatic cluster-randomised clinical trial in a primary healthcare setting. GPs were randomly allocated to either conventional care or the MULTIPAP intervention based on the Ariadne Principles with two components: GPs e-training (that is, eMULTIPAP addresses specific, key concepts on multimorbidity, polypharmacy and shared decision-making) and GP-patient-centred interview. Young-old patients aged 65-74 years with multimorbidity and polypharmacy were included. MAIN OUTCOME: difference in the Medication Appropriateness Index (MAI) after 6-month follow-up between groups. SECONDARY OUTCOMES: MAI, quality of life, patient perception, health services use, treatment adherence and cost-effectiveness after 12-month follow-up. RESULTS: 117 GPs from 38 Spanish primary health care recruited 593 patients randomly assigned to the intervention/control groups. Difference in MAI scores between groups in the intention-to-treat analysis after 6 months' follow-up: -2.42 (-4.27 to -0.59), P = 0.009 (adjusted difference in mean MAI score -1.81(-3.35 to -0.27), P = 0.021). SECONDARY OUTCOMES: not significant, including quality of life (adjusted difference in mean EQ-5D-5L (VAS) 2.94 (-1.39 to 7.28), P = 0.183, EQ-5D-5L (index) -0.006(-0.034 to 0.022), P = 0.689). CONCLUSION: The intervention significantly improved medication appropriateness. The observed quality of life improvement was not significant. GPs e-training in multimorbidity has shown to be feasible and well accepted by the professionals. Future studies may test whether this format facilitates implementation.