Assessing guideline-concordant care for patients with multimorbidity treated in a care management setting.

BACKGROUND: Disease-specific guidelines are not aligned with multimorbidity care complexity. Meeting all guideline-recommended care for multimorbid patients has been estimated but not demonstrated across multiple guidelines. OBJECTIVE: Measure guideline-concordant care for patients with multimorbidity; assess in what types of care and by whom (clinician or patient) deviation from guidelines occurs and evaluate whether patient characteristics are associated with concordance. METHODS: A retrospective cohort study of care received over 1 year, conducted across 11 primary care clinics within the context of multimorbidity-focused care management program. Patients were aged 45+ years with more than two common chronic conditions and were sampled based on either being new (≤6 months) or veteran to the program (≥1 year). MEASURES: Three guideline concordance measures were calculated for each patient out of 44 potential guideline-recommended care processes for nine chronic conditions: overall score; referral score (proportion of guideline-recommended care referred) and patient-only score (proportion of referred care completed by patients). Guideline concordance was stratified by care type. RESULTS: 4386 care processes evaluated among 204 patients, mean age = 72.3 years (standard deviation = 9.7). Overall, 79.2% of care was guideline concordant, 87.6% was referred according to guidelines and patients followed 91.4% of referred care. Guideline-concordant care varied across care types. Age, morbidity burden and whether patients were new or veteran to the program were associated with guideline concordance. CONCLUSIONS: Patients with multimorbidity do not receive ~20% of guideline recommendations, mostly due to clinicians not referring care. Determining the types of care for which the greatest deviation from guidelines exists can inform the tailoring of care for multimorbidity patients.

Long-term effectiveness of the Diabetes Conversation Map™ Program on health outcomes: A case-control retrospective cohort study.

AIM: To evaluate the clinical and health behavioural outcomes of a large sample of participants from the Diabetes Conversation Map™ Program. DESIGN: A matched-case-control study that was performed on a retrospective cohort study. METHODS: Participants were 11,053 Clalit Health Services members with type 2 diabetes who enrolled in the Diabetes Conversation Map™ Program between January 2010 - April 2016. The matched-control group was formulated using sequential matching, by matching cases to controls at a ratio of 1:3, based on age, sex, and HbA1c level. The associations between the programme group and annual clinical and health behaviours were assessed between cases and controls at five time points using linear and Poisson regression analyses. RESULTS: The intervention group had significantly lower HbA1c, glucose, and low-density lipoprotein levels and more frequent glucose blood testing each year up to 36 month post-enrolment compared with the matched controls. Other outcomes were significantly different for shorter time periods, including higher high-density lipoprotein and lower triglyceride levels at 6- and 12-month follow-up and lower diastolic blood pressure and greater medication adherence at 6-month follow-up. CONCLUSIONS: Enrolment in the programme was associated with improved clinical and health behaviour outcomes for at least 6 months and most outcomes persisted for up to 36 months. IMPACT: This is the first study to evaluate the Diabetes Conversation Map™ Program with a large sample over long period of time. This nurse-led group intervention evaluation adds to the literature on health outcomes on the lives of patients with type 2 diabetes. STUDY REGISTRATION: This study was registered retrospectively to the Open Science Framework, the registration form can be found at: https://osf.io/63cse.

Influenza Vaccine Effectiveness Against Hospitalization in Fully and Partially Vaccinated Children in Israel: 2015-2016, 2016-2017, and 2017-2018.

BACKGROUND: Influenza vaccine effectiveness (VE) varies by season, circulating influenza strain, age, and geographic location. There have been few studies of influenza VE among hospitalized children, particularly in Europe and the Middle East. METHODS: We estimated VE against influenza hospitalization among children aged 6 months to 8 years at Clalit Health Services hospitals in Israel in the 2015-2016, 2016-2017, and 2017-2018 influenza seasons, using the test-negative design. Estimates were computed for full and partial vaccination. RESULTS: We included 326 influenza-positive case patients and 2821 influenza-negative controls (140 case patients and 971 controls from 2015-2016, 36 case patients and 1069 controls from 2016-2017, and 150 case patients and 781 controls from 2017-2018). Over all seasons, VE was 53.9% for full vaccination (95% confidence interval [CI], 38.6%-68.3%), and 25.6% for partial vaccination (-3% to 47%). In 2015-2016, most viruses were influenza A(H1N1) and vaccine lineage-mismatched influenza B/Victoria; the VE for fully vaccinated children was statistically significant for influenza A (80.7%; 95% CI, 40.3%-96.1%) but not B (23.0%; -38.5% to 59.4%). During 2016-2017, influenza A(H3N2) predominated, and VE was (70.8%; 95% CI, 17.4%-92.4%). In 2017-2018, influenza A(H3N2), H1N1 and lineage-mismatched influenza B/Yamagata cocirculated; VE was statistically significant for influenza B (63.0%; 95% CI, 24.2%-83.7%) but not influenza A (46.3%; -7.2% to 75.3%). CONCLUSIONS: Influenza vaccine was effective in preventing hospitalizations among fully vaccinated Israeli children over 3 influenza seasons, but not among partially vaccinated children. There was cross-lineage protection in a season where the vaccine contained B/Victoria and the circulating strain was B/Yamagata, but not in a season with the opposite vaccine-circulating strain distribution.

Disease Management plus Recommended Care versus Recommended Care Alone for Ambulatory Patients with Chronic Obstructive Pulmonary Disease.

Rationale: The efficacy of disease management programs in the treatment of patients with chronic obstructive pulmonary disease (COPD) remains uncertain.Objectives: To study the effect of disease management (DM) added to recommended care (RC) in ambulatory patients with COPD.Measurements and Main Results: In this trial, 1,202 patients with COPD (age, ≥40 yr), with moderate to very severe airflow limitation were randomly assigned either to DM plus RC (study intervention) or to RC alone (control intervention). RC included follow-up by pulmonologists, inhaled long-acting bronchodilators and corticosteroids, smoking cessation intervention, nutritional advice and psychosocial support when indicated, and supervised physical activity sessions. DM, delivered by trained nurses during patients' visits to the designated COPD centers and by remote contacts with the patients between these visits, included patient self-care education, monitoring patients' symptoms and adherence to treatment, provision of advice in case of acute disease exacerbation, and coordination of care vis-à-vis other healthcare providers. The primary composite endpoint was first hospital admission for respiratory symptoms or death from any cause. During 3,537 patient-years, 284 patients (47.2%) in the control group and 264 (44.0%) in the study intervention group had a primary endpoint event. The median (range) time elapsed until a primary endpoint event was 1.0 (0-4.0) years among patients assigned to the study intervention and 1.1 (0-4.1) years among patients assigned to the control intervention; adjusted hazard ratio, 0.92 (95% confidence interval, 0.77-1.08).Conclusions: DM added to RC was not superior to RC alone in delaying first hospital admission or death among ambulatory patients with COPD.

Mixed Methods Evaluation of Reasons Why Care Deviates From Clinical Guidelines Among Patients With Multimorbidity.

Reasons why care does not conform to single-disease guideline recommendations for multimorbid patients have not been systematically measured in practice. Using a mixed methods approach, we identified and quantified types of reasons why care deviates from nine sets of disease guideline recommendations for multimorbid patients. Utilizing a focus group concept mapping technique, we built on a categorization of reasons explaining guideline deviation, and surveyed treating nurses about these reasons for patients' specific care processes. Directed content analysis was conducted to classify the responses into reasons categories. Of 4,386 guideline-recommended care processes evaluated, 920 were not guideline-concordant (944 reasons). Three broad categories of reasons and 18 specific reasons were identified: Biomedical-related occurred 35.2% of the time, patient personal-related (30.4%), context-related (18.4%), and unknown (16.0%). Patient- and context-related factors are prevalent drivers for guideline deviation in multimorbidity, demonstrating that patient-centered aspects are as much a part of care decisions as biomedical aspects.

Reducing infantile anemia: insight on patterns of process and outcome indicators by ethnicity and socioeconomic class during a 10-year intervention program and 5 years after.

BACKGROUND: In 2005, Clalit Health Services (CHS), the largest health maintenance organization in Israel, initiated an intervention program aimed at reducing the prevalence rate of infantile anemia (IA). This study evaluated the progress made during the intervention (2005-2014) and its yield 5 years after it ended (2019). METHODS: The CHS database was retrospectively reviewed twice yearly from 2005 to 2014 for repetitive samples of children aged 9 to 18 months regarding the previous half-year interval, and a single sample in 2019. Data were collected on gender, ethnicity (Jewish/non-Jewish), socioeconomic class (SEC; low/intermediate/high), hemoglobin testing (yes/no), and hemoglobin level (if tested). Excluded were infants with documented or suspected hemoglobinopathy. RESULTS: At study initiation, the rate of performance of hemoglobin testing was 54.7%, and the IA prevalence rate was 7.8%. The performance rate was lower in the Jewish than the non-Jewish subpopulation. The low-SEC subpopulation had a similar hemoglobin testing rate to the high-SEC subpopulation but double the IA prevalence rate. Overall, by the end of the intervention (2014), the performance rate increased to 87.5%, and the AI prevalence rate decreased to 3.4%. In 2019, there was little change in the performance rate from the end of the intervention (88%) and the IA prevalence was further reduced to 2.7%. The non-Jewish and low-SEC subpopulations showed the most improvement which was maintained and even bettered 5 years after the intervention ended. CONCLUSIONS: The 10-year IA intervention program introduced by CHS in 2005 led to a reduction in IA prevalence rate to about 3.5% in all sub-populations evaluated. By program end, the results in the weaker subpopulations, which had the highest prevalence of IA at baseline, were not inferior to those in the stronger subpopulations. We recommended to the Israel Ministry of Health to adopt the intervention countrywide, and we challenge other countries to consider similar interventions.

Guideline deviation and its association with specific chronic diseases among patients with multimorbidity: a cross-sectional cohort study in a care management setting.

OBJECTIVES: To assess whether the extent of deviation from chronic disease guideline recommendations is more prominent for specific diseases compared with combined-care across multiple conditions among multimorbid patients, and to examine reasons for this deviation. DESIGN: A cross-sectional cohort. SETTING: Multimorbidity care management programme across 11 primary care clinics. PATIENTS: Patients aged 45-95 years with at least two common chronic conditions, sampled according to being new (≤6 months) or veteran (≥1 year) to the programme. MAIN OUTCOME MEASURES: Deviation from guideline-recommended care was measured for each patient's relevant conditions, aggregated and stratified across disease groups, calculated as measures of 'disease-specific' guideline deviation and 'combined-care' (all conditions) guideline deviation for: atrial fibrillation, congestive heart failure, chronic kidney disease, chronic obstructive pulmonary disorder, depression, diabetes, dyslipidaemia, hypertension and ischaemic heart disease. Combined-care deviation was evaluated for its association with specific diseases. Frequencies of previously derived reason types for deviation (biomedical, patient personal and contextual) were reported by nurse care managers, assessed across diseases and evaluated for their association with specific diseases. RESULTS: Among 204 patients, disease-specific deviation varied more (from 14.7% to 48.2%) across diseases than combined-care deviation (from 14.7% to 25.6%). Depression and diabetes were significantly associated with more deviation (mean: 6% (95% CI: 2% to 10%) and 5% (95% CI: 2% to 9%), respectively). For some conditions, assessments were among small patient samples. Guideline deviation was often attributed to non-disease-specific reasons, such as physical limitations or care burden, as much as disease-specific reasons, which was reflected in the likelihood for guideline deviation to be due to different types of reasons for some diseases. CONCLUSIONS: When multimorbid patients are considered in disease groups rather than as 'whole persons', as in many quality of care studies, the cross-cutting factors in their care delivery can be missed. The types of reasons more likely to occur for specific diseases may inform improvement strategies. TRIAL REGISTRATION NUMBER: NCT01811173; Pre-results.

Effectiveness of the BNT162b2 mRNA COVID-19 vaccine in pregnancy.

To evaluate the effectiveness of the BNT162b2 messenger RNA vaccine in pregnant women, we conducted an observational cohort study of pregnant women aged 16 years or older, with no history of SARS-CoV-2, who were vaccinated between 20 December 2020 and 3 June 2021. A total of 10,861 vaccinated pregnant women were matched to 10,861 unvaccinated pregnant controls using demographic and clinical characteristics. Study outcomes included documented infection with SARS-CoV-2, symptomatic COVID-19, COVID-19-related hospitalization, severe illness and death. Estimated vaccine effectiveness from 7 through to 56 d after the second dose was 96% (95% confidence interval 89-100%) for any documented infection, 97% (91-100%) for infections with documented symptoms and 89% (43-100%) for COVID-19-related hospitalization. Only one event of severe illness was observed in the unvaccinated group and no deaths were observed in either group. In summary, the BNT162b2 mRNA vaccine was estimated to have high vaccine effectiveness in pregnant women, which is similar to the effectiveness estimated in the general population.

Effectiveness of Managing Diabetes During Ramadan Conversation Map intervention: A difference-in-differences (self-comparison) design.

BACKGROUND: Some individuals with diabetes fast during Ramadan despite medical concerns for risk of adverse outcomes. The Managing Diabetes During Ramadan Conversation Map is a self-management education group-based intervention for Muslim individuals with type 2 diabetes, specifically addressing diabetes management during Ramadan. OBJECTIVE: The aim of this study was to evaluate the effectiveness of the Managing Diabetes During Ramadan Conversation Map intervention in improving short-term clinical outcomes and reducing healthcare utilization following Ramadan. DESIGN: This was a retrospective rolling cohort study. SETTINGS: Participants were Clalit Health Services members with type 2 diabetes who participated in the intervention between 2014 and 2017 across Israel. PARTICIPANTS: This study included 1732 participants who enrolled in the intervention over the five-year study period. The cohort was mainly between the ages of 45 and 74 years (83.3%), female (71.9%), of lower socioeconomic status (92.1%), with a diabetes duration of 10 years or more (51.7%), obese (64.0%), and had never smoked (73.8%). METHODS: The data used in this study came from Clalit Health Services' electronic health records, which are integrated in a central data warehouse. We used a difference-in-differences (self-comparison) design to examine the effect of the intervention on changes in laboratory results and healthcare utilization over a six month baseline and follow-up. Mixed model linear regressions and Poisson regressions were used to estimate continuous and count outcomes, respectively. RESULTS: Post intervention, participants experienced a reduction of 8.61 mg/dL in their glucose levels (p = 0.005) and 0.34% in their HbA1c levels (p < 0.001). In a sub-group analysis of participants with HbA1c > 7%, larger reductions in glucose (17.02 mg/dL [p < 0.001]) and HbA1c (0.63% [p < 0.001]) levels were recorded. This sub-group also experienced a reduction of 4.83 mg/dL in LDL level (p = 0.007) and had 0.2 fewer primary care visits (p < 0.001). CONCLUSIONS: Participation in the Managing Diabetes During Ramadan Conversation Map improved patient glucose and HbA1c levels. A greater benefit was reported in those individuals with HbA1c > 7%. These findings hold important global health implications for the millions of individuals with type 2 diabetes for whom Ramadan can pose a challenge in disease control.

Patterns of Patients' Interactions With a Health Care Organization and Their Impacts on Health Quality Measurements: Protocol for a Retrospective Cohort Study.

BACKGROUND: Data collected by health care organizations consist of medical information and documentation of interactions with patients through different communication channels. This enables the health care organization to measure various features of its performance such as activity, efficiency, adherence to a treatment, and different quality indicators. This information can be linked to sociodemographic, clinical, and communication data with the health care providers and administrative teams. Analyzing all these measurements together may provide insights into the different types of patient behaviors or more accurately to the different types of interactions patients have with the health care organizations. OBJECTIVE: The primary aim of this study is to characterize usage profiles of the available communication channels with the health care organization. The main objective is to suggest new ways to encourage the usage of the most appropriate communication channel based on the patient's profile. The first hypothesis is that the patient's follow-up and clinical outcomes are influenced by the patient's preferred communication channels with the health care organization. The second hypothesis is that the adoption of newly introduced communication channels between the patient and the health care organization is influenced by the patient's sociodemographic or clinical profile. The third hypothesis is that the introduction of a new communication channel influences the usage of existing communication channels. METHODS: All relevant data will be extracted from the Clalit Health Services data warehouse, the largest health care management organization in Israel. Data analysis process will use data mining approach as a process of discovering new knowledge and dealing with processing data extracted with statistical methods, machine learning algorithms, and information visualization tools. More specifically, we will mainly use the k-means clustering algorithm for discretization purposes and patients' profile building, a hierarchical clustering algorithm, and heat maps for generating a visualization of the different communication profiles. In addition, patients' interviews will be conducted to complement the information drawn from the data analysis phase with the aim of suggesting ways to optimize existing communication flows. RESULTS: The project was funded in 2016. Data analysis is currently under way and the results are expected to be submitted for publication in 2019. Identification of patient profiles will allow the health care organization to improve its accessibility to patients and their engagement, which in turn will achieve a better treatment adherence, quality of care, and patient experience. CONCLUSIONS: Defining solutions to increase patient accessibility to health care organization by matching the communication channels to the patient's profile and to change the health care organization's communication with the patient to a highly proactive one will increase the patient's engagement according to his or her profile. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/10734.

Evaluating an organization-wide disparity reduction program: Understanding what works for whom and why.

BACKGROUND: Disparity-reduction programs have been shown to vary in the degree to which they achieve their goal; yet the causes of these variations is rarely studied. We investigated a broad-scale program in Israel's largest health plan, aimed at reducing disparities in socially disadvantaged groups using a composite measure of seven health and health care indicators. METHODS: A realistic evaluation was conducted to evaluate the program in 26 clinics and their associated managerial levels. First, we performed interviews with key stakeholders and an ethnographic observation of a regional meeting to derive the underlying program theory. Next, semi-structured interviews with 109 clinic teams, subregional headquarters, and regional headquarters personnel were conducted. Social network analysis was performed to derive measures of team interrelations. Perceived team effectiveness (TE) and clinic characteristics were assessed to elicit contextual characteristics. Interventions implemented by clinics were identified from interviews and coded according to the mechanisms each clinic employed. Assessment of each clinic's performance on the seven-indicator composite measure was conducted at baseline and after 3 years. Finally, we reviewed different context-mechanism-outcome (CMO) configurations to understand what works to reduce disparity, and under what circumstances. RESULTS: Clinics' inner contextual characteristics varied in both network density and perceived TE. Successful CMO configurations included 1) highly dense clinic teams having high perceived TE, only a small gap to minimize, and employing a wide range of interventions; (2) clinics with a large gap to minimize with high clinic density and high perceived TE, focusing efforts on tailoring services to their enrollees; and (3) clinics having medium to low density and perceived TE, and strong middle-management support. CONCLUSIONS: Clinics that achieved disparity reduction had high clinic density, close ties with middle management, and tailored interventions to the unique needs of the populations they serve.

Which patients with Type 2 diabetes will have greater compliance to participation in the Diabetes Conversation Map™ program? A retrospective cohort study.

AIM: To investigate the characteristics of participants in the Diabetes Conversation Map™ (Map™) program who had higher vs. lower compliance to the program, to determine if program tailoring and monitoring is needed among these groups. METHODS: This was a retrospective cohort study of 8990 patients enrolled in the Map™ program (low compliance [attending 0-1 sessions, n = 2759] and high compliance [attending ≥2 sessions, n = 6231]). Socio-demographic, clinical, health behaviors, and healthcare utilization characteristics were extracted. Multivariable stepwise logistic regression was used as the analysis strategy. RESULTS: Those who were of higher socio-economic status (OR = 1.567, 95%CI:1.317-1.865), who lived in urban area (OR = 1.501, 95%CI:1.254-1.798), with greater frequency of primary care visits (OR = 1.012, 95%CI:1.002-1.021), with medium (OR = 1.176, 95%CI:1.013-1.365) or high oral medication adherence (OR = 1.198, 95%CI:1.059-1.356), and with a greater frequency of blood glucose tests (OR = 1.102, 95%CI:1.033-1.175) had greater odds of being in the high compliance group. Conversely, those aged 35-44 (OR = 0.538, 95%CI:0.402-0.721) and 45-54 years (OR = 0.763, 95%CI:0.622-0.937), with longer Type 2 diabetes duration (OR = 0.980, 95%CI:0.967-0.993), with higher blood glucose levels (OR = 0.999, 95%CI:0.998-1.000), and current (OR = 0.659, 95%CI:0.569-0.762) or former smokers (OR = 0.831, 95%CI:0.737-0.938) had reduced odds for being in the higher compliance group. CONCLUSIONS: Instructors in advance can target sub-groups to increase their attendance rates, and consequently improve their outcomes.

Diabetes Conversation Map™ and health outcomes: A systematic literature review.

OBJECTIVES: To identify, describe, and assess the evidence regarding the effects that the Diabetes Conversation Map™ program, an educational tool that engages patients with diabetes in group discussions about diabetes-related topics, has over a range of patient outcomes. STUDY DESIGN: A systematic review. DATA SOURCES: Five databases, including PubMed, CINAHL, Scopus, EMBASE, and Cochrane Collaboration, were utilized to identify studies that evaluated the Conversation Map™ program. Additionally, the reference lists of the identified studies were manually reviewed. REVIEW METHODS: Studies that evaluated the Conversation Map™ program since 2005 were included. Non-English languages, non-journal papers, and studies that only included a description of the program were excluded. A quality assessment of relevant studies was performed. Outcomes were grouped into: objective (e.g., HbA1c levels), subjective (e.g., self-efficacy), and health behaviors (e.g., medication adherence). RESULTS: Of the 85 studies originally identified, 24 studies were included in the final sample. The overall methodological quality of the studies was intermediate (score: 17 of 28). Almost all studies examined objective health measures, with most indicating non-significant differences between the Conversation Map™ intervention and the control groups. Conflicting results were found regarding the influence the program had on HbA1c. The majority of studies reported no significant change in blood pressure and mixed results were found regarding other health indicators. Twelve studies examined subjective measures and 11 assessed the effects on health behaviors, mostly reporting non-significant or positive findings. CONCLUSIONS: Our review shows that although the Diabetes Conversation Map™ program holds the potential to improve patient behaviors and outcomes, current research on the program provides limited support as to their relationship with positive patient outcomes. Larger, more sophisticated studies are needed in order to determine the potential influence Conversation Map™ can have on long-term health outcomes.