Assessment of a Primary Support Program: family physicians and mental health professionals' perspective.

BACKGROUND: Mental health (MH) disorders are increasingly prevalent in primary care (PC) and this has generated, in recent years, the development of strategies based on the collaborative model and the stepped care model. The Primary Support Program (PSP) was implemented in the community of Catalonia (Spain) during 2006 to improve, from the first level of care, treatment of the population with mild-moderate complexity MH problems along with identification and referral of severe cases to specialized care. The aim of the present study was to identify the strengths and limitations of the PSP from the perspective of health professionals involved in the programme. METHODS: An explanatory qualitative study based on Grounded Theory. We conducted group semistructured interviews with 37 family physicians and 34 MH professionals. A constant comparative method of analysis was performed. RESULTS: Operation of the PSP is influenced by internal factors, such as the programme framework, MH liaison, management of service supply and demand, and the professional team involved. Additionally, external factors which had an impact were related to the patient, the professionals, the Health System, and community resources. CONCLUSIONS: The operation of the PSP could benefit from a review of the programme framework and optimization of MH liaison. Improvements are also proposed for MH training in PC, intraprofessional coordination, use of community resources, and creation of efficient continuous assessment systems.

Pediatric Medication Noninitiation in Spain.

OBJECTIVES: To estimate medication noninitiation prevalence in the pediatric population and identify the explanatory factors underlying this behavior. METHODS: Observational study of patients (<18 years old) receiving at least 1 new prescription (28 pharmaceutical subgroups; July 2017 to June 2018) in Catalonia, Spain. A prescription was considered new when there was no prescription for the same pharmaceutical subgroup in the previous 6 months. Noninitiation occurred when a prescription was not filled within 1 month or 6 months (sensitivity analysis). Prevalence was estimated as the proportion of total prescriptions not initiated. To identify explanatory factors, a multivariable multilevel logistic regression model was used, and adjusted odds ratios were reported. RESULTS: Overall, 1 539 003 new prescriptions were issued to 715 895 children. The overall prevalence of 1-month noninitiation was 9.0% (ranging from 2.6% [oral antibiotics] to 21.5% [proton pump inhibitors]), and the prevalence of 6-month noninitiation was 8.5%. Noninitiation was higher in the youngest and oldest population groups, in children from families with a 0% copayment rate (vulnerable populations) and those with conditions from external causes. Out-of-pocket costs of drugs increased the odds of noninitiation. The odds of noninitiation were lower when the prescription was issued by a pediatrician (compared with a primary or secondary care clinician). CONCLUSIONS: The prevalence of noninitiation of medical treatments in pediatrics is high and varies according to patients' ages and medical groups. Results suggest that there are inequities in access to pharmacologic treatments in this population that must be taken into account by health care planners and providers.

Cost-effectiveness of antidepressants versus active monitoring for mild-to-moderate major depressive disorder: a multisite non-randomized-controlled trial in primary care (INFAP study).

BACKGROUND: The purpose of this study was to evaluate the cost-effectiveness of antidepressants vs active monitoring (AM) for patients with mild-moderate major depressive disorder. METHODS: This was a 12-month observational prospective controlled trial. Adult patients with a new episode of major depression were invited to participate and assigned to AM or antidepressants according to General Practitioners' clinical judgment and experience. Patients were evaluated at baseline, and 6 and 12-month follow-up. Quality-adjusted life years (QALYs) gained were estimated and used to calculate incremental cost-utility ratios (ICUR) from the healthcare and government perspective. To minimize the bias resulting from non-randomization, a propensity score-based method was used. RESULTS: At 6 and 12-month follow-up, ICUR was 2549 €/QALY and 6,142 €/QALY, respectively, in favor of antidepressants. At 6 months, for a willingness to pay (WTP) of 25,000 €/QALY, antidepressants had a probability of 0.89 (healthcare perspective) and 0.81 (government perspective) of being more cost-effective than AM. At 12 months, this probability was 0.86 (healthcare perspective) and 0.73 (government perspective). CONCLUSIONS: Incremental cost-utility ratios favor pharmacological treatment as a first-line approach for patients with mild-moderate major depressive disorder. While our results should be interpreted with caution and further real world research is needed, clinical practice guidelines should consider antidepressant therapy for mild-moderate major depressive patients as an alternative to active monitoring in PC.

Effect of copayment policies on initial medication non-adherence according to income: a population-based study.

OBJECTIVE: Copayment policies aim to reduce the burden of medication expenditure but may affect adherence and generate inequities in access to healthcare. The objective was to evaluate the impact of two copayment measures on initial medication non-adherence (IMNA) in several medication groups and by income level. DESIGN: A population-based study was conducted using real-world evidence. SETTING: Primary care in Catalonia (Spain) where two separate copayment measures (fixed copayment and coinsurance) were introduced between 2011 and 2013. PARTICIPANT: Every patient with a new prescription issued between 2011 and 2014 (3 million patients and 10 million prescriptions). OUTCOMES: IMNA was estimated throughout dispensing and invoicing information. Changes in IMNA prevalence after the introduction of copayment policies (immediate level change and trend changes) were estimated through segmented logistic regression. The regression models were stratified by economic status and medication groups. RESULTS: Before changes to copayment policies, IMNA prevalence remained stable. The introduction of a fixed copayment was followed by a statistically significant increase in IMNA in poor population, low/middle-income pensioners and low-income non-pensioners (OR from 1.047 to 1.370). In high-income populations, there was a large statistically non-significant increase. IMNA decreased in the low-income population after suspension of the fixed copayment and the introduction of a coinsurance policy that granted this population free access to medications (OR=0.676). Penicillins were least affected while analgesics were affected to the greatest extent. IMNA to medications for chronic conditions increased in low/middle-income pensioners. CONCLUSION: Even nominal charge fixed copayment may generate inequities in access to health services. An anticipation effect and expenses associated with IMNA may have generated short-term costs. A reduction in copayment can protect from non-adherence and have positive, long-term effects. Copayment scenarios could have considerable long-term consequences for health and costs due to increased IMNA in medication for chronic physical conditions.

Impact of initial medication non-adherence on use of healthcare services and sick leave: a longitudinal study in a large primary care cohort in Spain.

BACKGROUND: Initial medication non-adherence is highly prevalent in primary care but no previous studies have evaluated its impact on the use of healthcare services and/or days on sick leave. AIM: To estimate the impact of initial medication non-adherence on the use of healthcare services, days of sick leave, and costs overall and in specific medication groups. DESIGN AND SETTING: A 3-year longitudinal register-based study of all primary care patients (a cohort of 1.7 million) who were prescribed a new medication in Catalonia (Spain) in 2012. METHOD: Thirteen of the most prescribed and/or costly medication subgroups were considered. All medication and medication subgroups (chronic, analgesics, and penicillin) were analysed. The number of healthcare services used and days on sick leave were considered. Multilevel multivariate linear regression was used. Three levels were included: patient, GP, and primary care centre. RESULTS: Initially adherent patients made more use of medicines and some healthcare services than non-adherent and partially adherent patients. They had lower productivity losses, producing a net economic return, especially when drugs for acute diseases (such as penicillins) were considered. Initial medication non-adherence resulted in a higher economic burden to the system in the short term. CONCLUSION: Initial medication non-adherence seems to have a short-term impact on productivity losses and costs. The clinical consequences and long-term economic consequences of initial medication non-adherence need to be assessed. Interventions to promote initial medication adherence in primary care may reduce costs and improve health outcomes.

Initial medication non-adherence: prevalence and predictive factors in a cohort of 1.6 million primary care patients.

AIMS: Adherence to medicines is vital in treating diseases. Initial medication non-adherence (IMNA) - defined as not obtaining a medication the first time it is prescribed - has been poorly explored. Previous studies show IMNA rates between 6 and 28% in primary care (PC). The aims of this study were to determine prevalence and predictive factors of IMNA in the most prescribed and expensive pharmacotherapeutic groups in the Catalan health system. METHODS: This is a retrospective, register-based cohort study which linked the Catalan PC System (Spain) prescription and invoicing databases. Medication was considered non-initiated when it was not collected from the pharmacy by the end of the month following the one in which it was prescribed. IMNA prevalence was calculated using July 2013-June 2014 prescription data. Predictive factors related to patients, general practitioners and PC centres were identified through multilevel logistic regression analyses. Missing data were attributed using simple imputation. RESULTS: Some 1.6 million patients with 2.9 million prescriptions were included in the study sample. Total IMNA prevalence was 17.6% of prescriptions. The highest IMNA rate was observed in anilides (22.6%) and the lowest in angiotensin-converting-enzyme (ACE) inhibitors (7.4%). Predictors of IMNA are younger age, American nationality, having a pain-related or mental disorder and being treated by a substitute/resident general practitioner in a resident-training centre. CONCLUSIONS: The rate of IMNA is high when all medications are taken into account. Attempts to strengthen trust in resident general practitioners and improve motivation to initiate a needed medication in the general young and older immigrant population should be addressed in Catalan PC.

Functional Status, Quality of Life, and Costs Associated With Fibromyalgia Subgroups: A Latent Profile Analysis.

OBJECTIVES: Although fibromyalgia syndrome (FM) is considered a heterogeneous condition, there is no generally accepted subgroup typology. We used hierarchical cluster analysis and latent profile analysis to replicate Giesecke's classification in Spanish FM patients. The second aim was to examine whether the subgroups differed in sociodemographic characteristics, functional status, quality of life, and in direct and indirect costs. MATERIALS AND METHODS: A total of 160 FM patients completed the following measures for cluster derivation: the Center for Epidemiological Studies-Depression Scale, the Trait Anxiety Inventory, the Pain Catastrophizing Scale, and the Control over Pain subscale. Pain threshold was measured with a sphygmomanometer. In addition, the Fibromyalgia Impact Questionnaire-Revised, the EuroQoL-5D-3L, and the Client Service Receipt Inventory were administered for cluster validation. RESULTS: Two distinct clusters were identified using hierarchical cluster analysis ("hypersensitive" group, 69.8% and "functional" group, 30.2%). In contrast, the latent profile analysis goodness-of-fit indices supported the existence of 3 FM patient profiles: (1) a "functional" profile (28.1%) defined as moderate tenderness, distress, and pain catastrophizing; (2) a "dysfunctional" profile (45.6%) defined by elevated tenderness, distress, and pain catastrophizing; and (3) a "highly dysfunctional and distressed" profile (26.3%) characterized by elevated tenderness and extremely high distress and catastrophizing. We did not find significant differences in sociodemographic characteristics between the 2 clusters or among the 3 profiles. The functional profile was associated with less impairment, greater quality of life, and lower health care costs. DISCUSSION: We identified 3 distinct profiles which accounted for the heterogeneity of FM patients. Our findings might help to design tailored interventions for FM patients.

Cost-effectiveness of active monitoring versus antidepressants for major depression in primary health care: a 12-month non-randomized controlled trial (INFAP study).

BACKGROUND: Clinical practice guidelines for the treatment of major depressive disorder (MDD) recommend antidepressants for patients with moderate-severe depression and active monitoring for patients with mild-moderate symptoms. The feasibility and efficiency of active monitoring has not been proven conclusively. The aim of this study is to evaluate the cost-effectiveness of active monitoring in comparison to antidepressants for primary care patients with mild-moderate MDD. METHODS/DESIGN: This is a 12-month follow-up multicenter observational prospective controlled trial. Patients are enrolled in 12 primary care centers in Barcelona (Spain). Eligible patients are adults (≥18 years-old) with a new episode of MDD that sign a written consent to participate. This is a naturalistic study in which general practitioners (GPs) use their professional judgment to allocate patients into active monitoring or antidepressants groups. GPs treat the patients following their clinical criteria. At baseline, GPs complete a questionnaire (sociodemographic/job characteristics, training, attitude towards depression, interest on mental health and participation in communication groups). Patients' measurements take place at baseline and after six and 12 months. Main outcome measures include severity of depression (PHQ-9), health-related quality of life (EuroQol-5D) and use of healthcare and social care services (Client Service Receipt Inventory). Secondary outcomes include diagnosis of MDD according to DSM-IV diagnostic criteria (SCID-I), disability (WHO-DAS), anxiety (BAI), comorbidities, medication side-effects and beliefs about medicines (BMQ). The analysis will be done according to the intention to treat analysis. Missing data will be imputed using multiple imputation by chained equations. To minimize the bias resulting from the lack of randomization, a propensity score will be used. Incremental effects and costs between groups will be modelled in each of the imputed databases using multivariate generalized linear models and then combined as per Rubin's rules. Propensity scores will be used to adjust the models. Incremental cost-effectiveness ratios will be calculated by dividing the difference in costs between groups by the difference in effects. To deal with the uncertainty, resampling techniques with bootstrapping will be used and cost-effectiveness planes and cost-effectiveness acceptability curves will be constructed. A series of sensitivity analyses will be performed. DISCUSSION: Given the high burden and costs generated by depressive disorder, it is important that general practitioners treat major depression efficiently. Recent evidence has suggested that antidepressants have low benefits for patients with mild to moderate major depression. For such cases of depression, active monitoring exists as a treatment option, but it is not without difficulties for implementation and its effectiveness and efficiency have not been demonstrated conclusively. The results of the study will provide information on which is the most efficient approach to treat patients with mild to moderate major depression in primary care. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02245373.