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1.
Food Insecurity and Weight Loss in an Underserved Primary Care Population: A Post Hoc Analysis of a Cluster Randomized Trial.
Myers, CA, Martin, CK, Apolzan, JW, Arnold, CL, Davis, TC, Johnson, WD, Katzmarzyk, PT, ,
Annals of internal medicine. 2021;(7):1032-1034
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2.
Effects of 2 Forms of Practice Facilitation on Cardiovascular Prevention in Primary Care: A Practice-randomized, Comparative Effectiveness Trial.
Persell, SD, Liss, DT, Walunas, TL, Ciolino, JD, Ahmad, FS, Brown, T, French, DD, Hountz, R, Iversen, K, Lindau, ST, et al
Medical care. 2020;(4):344-351
Abstract
BACKGROUND Effective quality improvement (QI) strategies are needed for small practices. OBJECTIVE The objective of this study was to compare practice facilitation implementing point-of-care (POC) QI strategies alone versus facilitation implementing point-of-care plus population management (POC+PM) strategies on preventive cardiovascular care. DESIGN Two arm, practice-randomized, comparative effectiveness study. PARTICIPANTS Small and mid-sized primary care practices. INTERVENTIONS Practices worked with facilitators on QI for 12 months to implement POC or POC+PM strategies. MEASURES Proportion of eligible patients in a practice meeting "ABCS" measures: (Aspirin) Aspirin/antiplatelet therapy for ischemic vascular disease, (Blood pressure) Controlling High Blood Pressure, (Cholesterol) Statin Therapy for the Prevention and Treatment of Cardiovascular Disease, and (Smoking) Tobacco Use: Screening and Cessation Intervention, and the Change Process Capability Questionnaire. Measurements were performed at baseline, 12, and 18 months. RESULTS A total of 226 practices were randomized, 179 contributed follow-up data. The mean proportion of patients meeting each performance measure was greater at 12 months compared with baseline: Aspirin 0.04 (95% confidence interval: 0.02-0.06), Blood pressure 0.04 (0.02-0.06), Cholesterol 0.05 (0.03-0.07), Smoking 0.05 (0.02-0.07); P<0.001 for each. Improvements were sustained at 18 months. At 12 months, baseline-adjusted difference-in-differences in proportions for the POC+PM arm versus POC was: Aspirin 0.02 (-0.02 to 0.05), Blood pressure -0.01 (-0.04 to 0.03), Cholesterol 0.03 (0.00-0.07), and Smoking 0.02 (-0.02 to 0.06); P>0.05 for all. Change Process Capability Questionnaire improved slightly, mean change 0.30 (0.09-0.51) but did not significantly differ across arms. CONCLUSION Facilitator-led QI promoting population management approaches plus POC improvement strategies was not clearly superior to POC strategies alone.
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3.
Efficacy of Three Low-Intensity, Internet-Based Psychological Interventions for the Treatment of Depression in Primary Care: Randomized Controlled Trial.
Gili, M, Castro, A, García-Palacios, A, Garcia-Campayo, J, Mayoral-Cleries, F, Botella, C, Roca, M, Barceló-Soler, A, Hurtado, MM, Navarro, M, et al
Journal of medical Internet research. 2020;(6):e15845
Abstract
BACKGROUND Primary care is a major access point for the initial treatment of depression, but the management of these patients is far from optimal. The lack of time in primary care is one of the major difficulties for the delivery of evidence-based psychotherapy. During the last decade, research has focused on the development of brief psychotherapy and cost-effective internet-based interventions mostly based on cognitive behavioral therapy (CBT). Very little research has focused on alternative methods of treatment for depression using CBT. Thus, there is a need for research into other therapeutic approaches. OBJECTIVE This study aimed to assess the effectiveness of 3 low-intensity, internet-based psychological interventions (healthy lifestyle psychoeducational program [HLP], focused program on positive affect promotion [PAPP], and brief intervention based on mindfulness [MP]) compared with a control condition (improved treatment as usual [iTAU]). METHODS A multicenter, 4-arm, parallel randomized controlled trial was conducted between March 2015 and March 2016, with a follow-up of 12 months. In total, 221 adults with mild or moderate major depression were recruited in primary care settings from 3 Spanish regions. Patients were randomly distributed to iTAU (n=57), HLP (n=54), PAPP (n=56), and MP (n=54). All patients received iTAU from their general practitioners. The main outcome was the Spanish version of the Patient Health Questionnaire-9 (PHQ-9) from pretreatment (time 1) to posttreatment (time 2) and up to 6 (time 3) and 12 (time 4) months' follow-up. Secondary outcomes included the visual analog scale of the EuroQol, the Short-Form Health Survey (SF-12), the Positive and Negative Affect Schedule (PANAS), and the Pemberton Happiness Index (PHI). We conducted regression models to estimate outcome differences along study stages. RESULTS A moderate decrease was detected in PHQ-9 scores from HLP (β=-3.05; P=.01) and MP (β=-3.00; P=.01) compared with iTAU at posttreatment. There were significant differences between all intervention groups and iTAU in physical SF-12 scores at 6 months after treatment. Regarding well-being, MP and PAPP reported better PHI results than iTAU at 6 months post treatment. PAPP intervention significantly decreased PANAS negative affect scores compared with iTAU 12 months after treatment. CONCLUSIONS The low-intensity, internet-based psychological interventions (HLP and MP) for the treatment of depression in primary care are more effective than iTAU at posttreatment. Moreover, all low-intensity psychological interventions are also effective in improving medium- and long-term quality of life. PAPP is effective for improving health-related quality of life, negative affect, and well-being in patients with depression. Nevertheless, it is important to examine possible reasons that could be implicated for PAPP not being effective in reducing depressive symptomatology; in addition, more research is still needed to assess the cost-effectiveness analysis of these interventions. TRIAL REGISTRATION ISRCTN Registry ISRCTN82388279; http://www.isrctn.com/ISRCTN82388279. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s12888-015-0475-0.
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4.
Nursing knowledge of the principles of self-care of heart failure in primary care: a multicentre study.
Dalfó-Pibernat, A, Duran, X, Garin, O, Enjuanes, C, Calero Molina, E, Hidalgo Quirós, E, Cladellas Capdevila, M, Rebagliato Nadal, O, Dalfó Baqué, A, Comin-Colet, J
Scandinavian journal of caring sciences. 2020;(3):710-718
Abstract
INTRODUCTION Nurses play an important part in the education of patients with HF. To prepare patients with HF for self-care maintenance behaviours, nurses must have knowledge of basic self-care maintenance principles. AIM STUDY The aim of this study was to determine the degree of knowledge of primary care (PC) nurses on the principles of self-management of HF and variables associated with this. METHODOLOGY This is an observational, cross-sectional descriptive study, carried out in 2014, in the city of Barcelona (Catalonia). Nurses' Knowledge of Heart Failure Education Principles questionnaire (NKHFEP) was used to assess the principles of HF self-care education. Instrument items assess knowledge of nurses on 5 themes: diet, liquids/weight, worsening signs or symptoms, medication and exercise. Factors related to adequate knowledge were evaluated. RESULTS Of 216 PC nurses, who completed the questionnaire, the average score was 15.6 (SD: 2.2). Only 36 (16.7%) obtained an adequate level of knowledge and defined as a score ≥ 18 points. In multivariate logistic regression, nurse factors associated with an adequate knowledge of principles of self-care of HF were having achieved a PhD degree (OR: 36.4, 95% CI: 2.8-468.2, p = 0.006) and previous specific training in HF (OR: 19.8, 95% CI: 1.4-279.3, p = 0.026). CONCLUSIONS The degree of knowledge of PC nurses in the principles of self-care in HF was higher among nurses who had completed the doctorate and in nurses who had received specific training in HF.
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5.
Study protocol for the road to hierarchical diabetes management at primary care (ROADMAP) study in China: a cluster randomised controlled trial.
Jia, W, Zhang, P, Duolikun, N, Zhu, D, Li, H, Bao, Y, Li, X, Liu, Y, ,
BMJ open. 2020;(1):e032734
Abstract
INTRODUCTION Diabetes management in primary care remains suboptimal in China, despite its inclusion in the essential public health service (EPHS). We aimed to evaluate the effectiveness of a mobile health (mHealth) based and three-tiered diabetes management system in diverse Chinese contexts. METHODS AND ANALYSIS This is a cluster randomised controlled trial, named road to hierarchical diabetes management at primary care (ROADMAP). 19 008 patients with type 2 diabetes (T2D) were recruited from primary care clinics in 864 communities across 144 counties/districts of 24 provinces. Eligible participants were adult patients diagnosed with T2D and registered for diabetes management in communities. Patients within the same communities (clusters) were randomly allocated into the intervention or control arm for 1 year in a 2:1 ratio. The control arm patients received usual care as EPHS packaged: at least four blood glucose (BG) and blood pressure (BP) tests, and lifestyle and medication instruction, yearly, from primary care providers. The intervention arm patients received at least two BG and one BP tests, monthly, and lifestyle and treatment instruction from a three-tiered contracted team. A mHealth platform, Graded ROADMAP, enabled test results uploading and sharing, and patient referral within the team. The intervention participants will be further divided into basic or intensive intervention group according to whether they were actively using the Your Doctor App. The primary outcome is the BG control rate with glycated haemoglobin (HbA1c)<7.0%. Secondary outcomes include control rates and changes of ABC (HbA1c, BP and low-density lipoprotein cholesterol) and fasting BG, hypoglycaemia episodes and health-related quality of life (EuroQol (EQ-5D)). ETHICS AND DISSEMINATION The trial has been approved by the Institutional Review Board at Shanghai Sixth People's Hospital. Findings on the intervention effectiveness will be disseminated through peer-reviewed journals, conference presentations and other relevant mechanisms. TRIAL REGISTRATION NUMBER ChiCTR-IOC-17011325.
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6.
Impact of different models of improvement of continuity of care on lipid control and the delay of visits to cardiology.
Cosin-Sales, J, Freixa, R, Bravo, M, Ruvira, J, Gràcia, PB, Calvo Iglesias, FE, Escobar, C
Future cardiology. 2020;(1):33-41
Abstract
Aims: To analyze the impact of implementing three different models of continuity of care on the delay of first visits to the cardiologist (management end point) and on LDL-cholesterol control rates among patients with atherosclerotic vascular disease (clinical end point). Methods: Observational, longitudinal and retrospective study of patients with cardiovascular disease and LDL-cholesterol ≥70 mg/dl attended in three hospitals (H1/H2/H3). In H1 and H2, a virtual system (telecardiology) was developed (in H1, internal audits and specific medical education were also performed). In H3 a cardiologist was integrated into the primary care center. Results: The delay of visits to cardiologist significantly improved from 66.5 ± 29.1 days to 34.1 ± 14.1 days (p < 0.001), as well as the intensification of lipid-lowering treatment and the achievement of lipid goals. LDL-cholesterol control rates were higher in H1 and the reduction of the delay of visits in H3. Conclusion: Continuity of care is associated with improvements in management and clinical end points.
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7.
AgeWell.de - study protocol of a pragmatic multi-center cluster-randomized controlled prevention trial against cognitive decline in older primary care patients.
Zülke, A, Luck, T, Pabst, A, Hoffmann, W, Thyrian, JR, Gensichen, J, Kaduszkiewicz, H, König, HH, Haefeli, WE, Czock, D, et al
BMC geriatrics. 2019;(1):203
Abstract
BACKGROUND In the absence of treatment options, the WHO emphasizes the identification of effective prevention strategies as a key element to counteract the dementia epidemic. Regarding the complex nature of dementia, trials simultaneously targeting multiple risk factors should be particularly effective for prevention. So far, however, only few such multi-component trials have been launched, but yielding promising results. In Germany, comparable initiatives are lacking, and translation of these complex interventions into routine care was not yet done. Therefore, AgeWell.de will be conducted as the first multi-component prevention trial in Germany which is closely linked to the primary care setting. METHODS AgeWell.de will be designed as a multi-centric, cluster-randomized controlled multi-component prevention trial. Participants will be older community-dwelling general practitioner (GP) patients (60-77 years; n = 1,152) with increased dementia risk according to CAIDE (Cardiovascular Risk Factors, Aging, and Incidence of Dementia) Dementia Risk Score. Recruitment will take place at 5 study sites across Germany. GP practices will be randomized to either intervention A (advanced) or B (basic). GPs will be blinded to their respective group assignment, as will be the statistician conducting the randomization. The multi-component intervention (A) includes nutritional counseling, physical activity, cognitive training, optimization of medication, management of vascular risk factors, social activity, and, if necessary, further specific interventions targeting grief and depression. Intervention B includes general health advice on the intervention components and GP treatment as usual. We hypothesize that over the 2-year follow-up period the intervention group A will benefit significantly from the intervention program in terms of preserved cognitive function/delayed cognitive decline (primary outcome), and other relevant (secondary) outcomes (e.g. quality of life, social activities, depressive symptomatology, cost-effectiveness). DISCUSSION AgeWell.de will be the first multi-component trial targeting risk of cognitive decline in older adults in Germany. Compared to previous trials, AgeWell.de covers an even broader set of interventions suggested to be beneficial for the intended outcomes. The findings will add substantial knowledge on modifiable lifestyle factors to prevent or delay cognitive decline. TRIAL REGISTRATION German Clinical Trials Register (reference number: DRKS00013555 ).
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8.
A multimodal and multidisciplinary program to prevent loss of mobility in patients aged over 70 years: study protocol of a multicenter cluster randomized study in primary care (the PRISME-3P study).
Perrotin, S, Gilbert, T, Dupuis, M, Villeneuve, L, Bin-Dorel, S, Klich, A, Letrilliart, L, Bonnefoy, M
BMC geriatrics. 2019;(1):48
Abstract
BACKGROUND Reduced mobility is the first sign of functional decline and can lead to dependency in elderly people. Screening for the risk of mobility limitation in this population is an important public health issue to prevent further disabilities. Despite the current lack of guidelines, primary care healthcare providers may have a central role to play in this type of screening. Multi-domain physical exercise interventions in older persons have shown some efficacy/effectiveness on frailty status, yet, to the best of our knowledge, no published study has focused on patients screened in primary care. METHOD The PRISME-3P study is a national, interventional, multicenter, cluster randomized trial. Patients over 70 years of age will be systematically screened by their general practitioner (GP) on the basis of clinical criteria of mobility limitation. To avoid contamination bias, the unit of randomization will be the GP practice. In the intervention group, patients will consult a geriatrician and a dietician, and will receive a physical training program from a personal trainer who will demonstrate the exercises and provide follow-up coaching. The control group will receive standard care. The primary outcome will be the change in Short Physical Performance Battery (SPPB) scores between inclusion and 6-months follow-up. DISCUSSION We expect an improvement of the SPPB between inclusion and 6 months of follow-up. TRIAL REGISTRATION This study is registered in ClinicalTrials.gov ( NCT02847871 , 27 July 2016).
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9.
A multinational observational study identifying primary care patients at risk of overestimation of asthma control.
Kritikos, V, Price, D, Papi, A, Infantino, A, Ställberg, B, Ryan, D, Lavorini, F, Chrystyn, H, Haughney, J, Lisspers, K, et al
NPJ primary care respiratory medicine. 2019;(1):43
Abstract
Factors related to the discrepancy between patient-perceived and actual disease control remain unclear. Identifying patients at risk of overestimation of asthma control remains elusive. This study aimed to (i) investigate the relationship between patient-reported and actual level of asthma control (ii), compare the characteristics between patients who believe their asthma is well controlled that accurately report 'well-controlled' asthma with those that do not, and (iii) identify factors associated with inaccurately reported 'well-controlled' asthma. A historical, multinational, cross-sectional study using data from the iHARP (initiative Helping Asthma in Real-life Patients) review service for adults with asthma prescribed fixed-dose combination therapy. Data from 4274 patients were analysed. A major discrepancy between patient-reported and Global Initiative for Asthma defined asthma control was detected; 71.1% of patients who reported 'well-controlled' asthma were inaccurate in their perception despite receiving regular maintenance therapy. Significant differences were noted in age, gender, body mass index, education level, medication use, side effects, attitudes to preventer inhaler use, inhaler technique review and respiratory specialist review between patients who accurately reported 'well-controlled' asthma and those who did not. Independent risk factors associated with inaccurately reported 'well-controlled' asthma were: having taken a maximum of 5-12 puffs or more of reliever inhaler on at least one day within the previous 4 weeks; being female; having seen a respiratory specialist more than a year ago (rather than in the previous year); and having required oral corticosteroids for worsening asthma in the previous year. The study highlighted the significant hidden burden associated with under-recognition of poor asthma control, on the part of the patient and the need for targeted interventions designed to address the continuing discrepancy between perceived and actual disease control.
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10.
Cost-effectiveness of the SLIMMER diabetes prevention intervention in Dutch primary health care: economic evaluation from a randomised controlled trial.
Duijzer, G, Bukman, AJ, Meints-Groenveld, A, Haveman-Nies, A, Jansen, SC, Heinrich, J, Hiddink, GJ, Feskens, EJM, de Wit, GA
BMC health services research. 2019;(1):824
Abstract
BACKGROUND Although evidence is accumulating that lifestyle modification may be cost-effective in patients with prediabetes, information is limited on the cost-effectiveness of interventions implemented in public health and primary health care settings. Evidence from well-conducted pragmatic trials is needed to gain insight into the realistic cost-effectiveness of diabetes prevention interventions in real-world settings. The aim of this study is to assess the cost-effectiveness of the SLIMMER lifestyle intervention targeted at patients at high risk of developing type 2 diabetes compared with usual health care in a primary care setting in the Netherlands. METHODS Three hundred and sixteen high-risk subjects were randomly assigned to the SLIMMER lifestyle intervention or to usual health care. Costs and outcome assessments were performed at the end of the intervention (12 months) and six months thereafter (18 months). Costs were assessed from a societal perspective. Patients completed questionnaires to assess health care utilisation, participant out-of-pocket costs, and productivity losses. Quality Adjusted Life Years (QALY) were calculated based on the SF-36 questionnaire. Cost-effectiveness planes and acceptability curves were generated using bootstrap analyses. RESULTS The cost-effectiveness analysis showed that the incremental costs of the SLIMMER lifestyle intervention were €547 and that the incremental effect was 0.02 QALY, resulting in an incremental cost-effectiveness ratio (ICER) of €28,094/QALY. When cost-effectiveness was calculated from a health care perspective, the ICER decreased to €13,605/QALY, with a moderate probability of being cost-effective (56% at a willingness to pay, WTP, of €20,000/QALY and 81% at a WTP of €80,000/QALY). CONCLUSIONS The SLIMMER lifestyle intervention to prevent type 2 diabetes had a low to moderate probability of being cost-effective, depending on the perspective taken. TRIAL REGISTRATION The SLIMMER study is retrospectively registered with ClinicalTrials.gov (Identifier NCT02094911) since March 19, 2014.