Effectiveness and Safety of Dementia Care Management in Primary Care: A Randomized Clinical Trial.
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SUBMITTER: Thyrian JR
PROVIDER: S-EPMC5710469 | biostudies-literature | 2017 Oct
REPOSITORIES: biostudies-literature
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Effectiveness and Safety of Dementia Care Management in Primary Care: A Randomized Clinical Trial.
Thyrian Jochen René JR Hertel Johannes J Wucherer Diana D Eichler Tilly T Michalowsky Bernhard B Dreier-Wolfgramm Adina A Zwingmann Ina I Kilimann Ingo I Teipel Stefan S Hoffmann Wolfgang W
JAMA psychiatry 20171001 10
<h4>Importance</h4>Dementia care management (DCM) can increase the quality of care for people with dementia. Methodologically rigorous clinical trials on DCM are lacking.<h4>Objective</h4>To test the effectiveness and safety of DCM in the treatment and care of people with dementia living at home and caregiver burden (when available).<h4>Design, setting, and participants</h4>This pragmatic, general practitioner-based, cluster-randomized intervention trial compared the intervention with care as us ...[more]
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Project description:BACKGROUND:Fostering a culture of safety is an essential step in ensuring patient safety and quality in primary care. We aimed to evaluate the effectiveness of an educational intervention to improve the safety culture in the family and community medicine teaching units in an Atlantic European Region. METHODS:Randomized study conducted in family and community medicine teaching units in Galicia (Spain). Participants were all fourth-year residents and their tutors (N?=?138). Those who agreed to participate were randomized into one of two groups (27 tutors/26 residents in the intervention group, 23 tutors/ 23 residents in the control one).All were sent the Survey on Patient Safety Culture. After that, the intervention group received specific training in safety; they also recorded incidents over 15?days, documented them following a structured approach, and had feedback on their performance. The control group did not receive any action. All participants completed the same survey four months later. Outcome measures were the changes in safety culture as quantified by the results variables of the Survey: Patient Safety Grade and Number of events reported. We conducted bivariate and adjusted analyses for the outcome measures. To explore the influence of participants' demographic characteristics and their evaluation of the 12 dimensions of the safety culture, we fitted a multivariate model for each outcome. RESULTS:Trial followed published protocol. There were 19 drop outs. The groups were comparable in outcome and independent variables at start. The experiment did not have any effect on Patient safety grade (-?0.040) in bivariate analysis. The odds of reporting one to two events increased by 1.14 (0.39-3.35), and by 13.75 (2.41-354.37) the odds of reporting 3 or more events. Different dimensions had significant independent effects on each outcome variable. CONCLUSION:A educational intervention in family and community medicine teaching units may improve the incidents reported. The associations observed among organizational dimensions and outcomes evidence the complexity of patient safety culture measurement and, also, show the paths for improvement. In the future, it would be worthwhile to replicate this study in teaching units from different settings and with different health professionals engaged. TRIAL REGISTRATION:It was retrospectively registered with ( ISRCTN41911128 , 31/12/2010).
| S-EPMC6337818 | biostudies-other
Project description:Importance:Experts recommend that alcohol use disorders (AUDs) be managed in primary care, but effective approaches are unclear. Objective:To test whether 12 months of alcohol care management, compared with usual care, improved drinking outcomes among patients with or at high risk for AUDs. Design, Setting, and Participants:This randomized clinical trial was conducted at 3 Veterans Affairs (VA) primary care clinics. Between October 11, 2011, and September 30, 2014, the study enrolled 304 outpatients who reported heavy drinking (?4 drinks per day for women and ?5 drinks per day for men). Interventions:Nurse care managers offered outreach and engagement, repeated brief counseling using motivational interviewing and shared decision making about treatment options, and nurse practitioner-prescribed AUD medications (if desired), supported by an interdisciplinary team (CHOICE intervention). The comparison was usual primary care. Main Outcomes and Measures:Primary outcomes, assessed by blinded telephone interviewers at 12 months, were percentage of heavy drinking days in the prior 28 days measured by timeline follow-back interviews and a binary good drinking outcome, defined as abstinence or drinking below recommended limits in the prior 28 days (according to timeline follow-back interviews) and no alcohol-related symptoms in the past 3 months as measured by the Short Inventory of Problems. Results:Of 304 participants, 275 (90%) were male, 206 (68%) were white, and the mean (SD) age was 51.4 (13.8) years. At baseline, both the CHOICE intervention (n?=?150) and usual care (n?=?154) groups reported heavy drinking on 61% of days (95% CI, 56%-66%). During the 12-month intervention, 137 of 150 patients in the intervention group (91%) had at least 1 nurse visit, and 77 of 150 (51%) had at least 6 nurse visits. A greater proportion of patients in the intervention group than in the usual care group received alcohol-related care: 42% (95% CI, 35%-49%; 63 of 150 patients) vs 26% (95% CI, 19%-35%; 40 of 154 patients). Alcohol-related care included more AUD medication use: 32% (95% CI, 26%-39%; 48 of 150 patients in the intervention group) vs 8% (95% CI, 5%-13%; 13 of 154 patients in the usual care group). No significant differences in primary outcomes were observed at 12 months between patients in both groups. The percentages of heavy drinking days were 39% (95% CI, 32%-47%) and 35% (95% CI, 28%-42%), and the percentages of patients with a good drinking outcome were 15% (95% CI, 9%-22%; 18 of 124 patients) and 20% (95 % CI, 14%-28%; 27 of 134 patients), in the intervention and usual care groups, respectively (P?=?.32-.44). Findings at 3 months were similar. Conclusions and Relevance:The CHOICE intervention did not decrease heavy drinking or related problems despite increased engagement in alcohol-related care. Trial Registration:clinicaltrials.gov Identifier: NCT01400581.
| S-EPMC5885256 | biostudies-literature
Project description:BACKGROUND:Implementing evidence-based recommendations for treating pediatric overweight and obesity is challenging in low-resource settings. We conducted a randomized controlled trial to evaluate the effects of implementing the American Academy of Pediatrics overweight/obesity recommendations using a Standard Care approach alone or with the addition of an enhanced program in a safety-net pediatric primary care setting (located in Bronx, New York, United States). METHODS:In a 12-month trial, families of children (age 7-12 years; body mass index ?85th American percentile for age and sex; 74% self-identified as Hispanic/Latino; n?=?360) were randomly assigned to receive Standard Care Alone or Standard Care + Enhanced Program. An English/Spanish bilingual staff provided the Standard Care Alone consisting of quarterly semi-structured pediatrician visits targeting family-based behavioral changes. The Standard Care + Enhanced Program was enriched with eight Skill-Building Core and monthly Post-Core Support sessions. RESULTS:The mean body mass index Z-score declined in both arms (P?<?0.01) with no significant difference between the Standard Care Alone (0.12 kg [SE: 0.03]) and Standard Care + Enhanced Program (0.15 kg [SE: 0.03]) arm (P?=?0.15). Compared to the Standard Care Alone, the Standard Care + Enhanced Program resulted in significantly greater improvements in total cholesterol (P?=?0.05), low-density lipoprotein cholesterol (P?=?0.04), aspartate aminotransferase (P?=?0.02), and alanine transaminase (P?=?0.03) concentrations. CONCLUSIONS:Safety-net primary care settings can provide efficacious pediatric weight management services. Targeted family-based behavioral counseling helps overweight/obese children achieve a modest body mass index Z-score improvement. A more intensive lifestyle intervention program may improve some metabolic parameters. TRIAL REGISTRATION:ClinicalTrials.gov Identifier: NCT00851201 . Registered 23 February 2009.
| S-EPMC5778780 | biostudies-literature
Project description:Importance:Collaborative care for depression and anxiety is superior to usual care from primary care physicians for these conditions; however, challenges limit its provision in routine practice and at scale. Advances in technology may overcome these barriers but have yet to be tested. Objective:To examine the effectiveness of combining an internet support group (ISG) with an online computerized cognitive behavioral therapy (CCBT) provided via a collaborative care program for treating depression and anxiety vs CCBT alone and whether providing CCBT in this manner is more effective than usual care. Design, Setting, and Participants:In this 3-arm randomized clinical trial with blinded outcome assessments, primary care physicians from 26 primary care practices in Pittsburgh, Pennsylvania, referred 2884 patients aged 18 to 75 years in response to an electronic medical record prompt from August 2012 to September 2014. Overall, 704 patients (24.4%) met all eligibility criteria and were randomized to CCBT alone (n?=?301), CCBT+ISG (n?=?302), or usual care (n?=?101). Intent-to-treat analyses were conducted November 2015 to January 2017. Interventions:Six months of guided access to an 8-session CCBT program provided by care managers who informed primary care physicians of their patients' progress and promoted patient engagement with our online programs. Main Outcomes and Measures:Mental health-related quality of life (12-Item Short-Form Health Survey Mental Health Composite Scale) and depression and anxiety symptoms (Patient-Reported Outcomes Measurement Information System) at 6-month follow-up, with treatment durability assessed 6 months later. Results:Of the 704 randomized patients, 562 patients (79.8%) were female, and the mean (SD) age was 42.7 (14.3) years. A total of 604 patients (85.8%) completed our primary 6-month outcome assessment. At 6-month assessment, 254 of 301 patients (84.4%) receiving CCBT alone started the program (mean [SD] sessions completed, 5.4 [2.8]), and 228 of 302 patients (75.5%) in the CCBT+ISG cohort logged into the ISG at least once, of whom 141 (61.8%) provided 1 or more comments or posts (mean, 10.5; median [range], 3 [1-306]). Patients receiving CCBT+ISG reported similar 6-month improvements in mental health-related quality of life, mood, and anxiety symptoms compared with patients receiving CCBT alone. However, compared with patients receiving usual care, patients in the CCBT alone cohort reported significant 6-month effect size improvements in mood (effect size, 0.31; 95% CI, 0.09-0.53) and anxiety (effect size, 0.26; 95% CI, 0.05-0.48) that persisted 6 months later, and completing more CCBT sessions produced greater effect size improvements in mental health-related quality of life and symptoms. Conclusions and Relevance:While providing moderated access to an ISG provided no additional benefit over guided CCBT at improving mental health-related quality of life, mood, and anxiety symptoms, guided CCBT alone is more effective than usual care for these conditions. Trial Registration:clinicaltrials.gov Identifier: NCT01482806.
| S-EPMC5833533 | biostudies-literature
Project description:Among older home health care patients, depression is highly prevalent, is often inadequately treated, and contributes to hospitalization and other poor outcomes. Feasible and effective interventions are needed to reduce this burden of depression.To determine whether, among older Medicare Home Health recipients who screen positive for depression, patients of nurses receiving randomization to an intervention have greater improvement in depressive symptoms during 1 year than patients receiving enhanced usual care.This cluster randomized effectiveness trial conducted at 6 home health care agencies nationwide assigned nurse teams to an intervention (12 teams) or to enhanced usual care (9 teams). Between January 13, 2009, and December 6, 2012, Medicare Home Health patients 65 years and older who screened positive for depression on routine nursing assessments were recruited, underwent assessment, and were followed up at 3, 6, and 12 months by research staff blinded to intervention status. Patients were interviewed at home and by telephone. Of 502 eligible patients, 306 enrolled in the study.The Depression Care for Patients at Home (Depression CAREPATH) trial requires nurses to manage depression at routine home visits by weekly symptom assessment, medication management, care coordination, education, and goal setting. Nurses' training totaled 7 hours (4 onsite and 3 via the web). Researchers telephoned intervention team supervisors every other week.Depression severity, assessed by the 24-item Hamilton Scale for Depression (HAM-D).The 306 participants were predominantly female (69.6%), were racially/ethnically diverse (18.0% black and 16.0% Hispanic), and had a mean (SD) age of 76.5 (8.0) years. In the full sample, the intervention had no effect (P = .13 for intervention × time interaction). Adjusted HAM-D scores (Depression CAREPATH vs control) did not differ at 3 months (10.5 vs 11.4, P =?.26) or at 6 months (9.3 vs 10.5, P = .12) but reached significance at 12 months (8.7 vs 10.6, P = .05). In the subsample with mild depression (HAM-D score, <10), the intervention had no effect (P = .90), and HAM-D scores did not differ at any follow-up points. Among 208 participants with a HAM-D score of 10 or higher, the Depression CAREPATH demonstrated effectiveness (P = .02), with lower HAM-D scores at 3 months (14.1 vs 16.1, P = .04), at 6 months (12.0 vs 14.7, P = .02), and at 12 months (11.8 vs 15.7, P = .005).Home health care nurses can effectively integrate depression care management into routine practice. However, the clinical benefit seems to be limited to patients with moderate to severe depression.clinicaltrials.gov Identifier: NCT01979302.
| S-EPMC4516039 | biostudies-literature
Project description:BACKGROUND:There is evidence about the benefits of early detection of dementia and subsequent provision of adequate treatment and care. However, there is a lack of knowledge about the acceptance of detection and intervention procedures. These analyses describe the attitudes of general physicians [GPs] toward 1) dementia in general, 2) systematic detection of people with dementia, and 3) an intervention approach after they have experienced both. Comparisons are made based on experience with systematic screening and dementia-specific intervention. METHODS:Postal, cross-sectional survey to all n=1,252 GPs in the Mecklenburg-Western Pomerania, Germany. A subsample was drawn based on participation in the randomized, controlled, prospective intervention DelpHi-MV trial (Dementia: life- and person-centered help in Mecklenburg-Western Pomerania). In this trial, systematic screening is implemented and an intervention group receives support through dementia care management (DCM). GPs were categorized into either GPs with DCM and systematic screening (DCM-GP), GPs with systematic screening only (DelpHi-GP), or GPs not participating in the trial. Data from n=257 GPs were available. Attitudes toward dementia were assessed using a validated questionnaire. RESULTS:There was strong agreement toward the helpfulness of implementing a brief cognitive screening test (89.9% agreed). Approximately two-thirds of the respondents indicated that they had identified at least some patients as being cognitively impaired for the first time. The majority of the respondents indicated agreement toward DCM. It was described as supportive and helpful. The qualified nurses were perceived as competent in dementia care and 79.3% would like to be supported with DCM. Attitudes toward dementia are positive and do not differ between groups. CONCLUSION:The results indicate that early recognition and DCM is highly appreciated by GPs and is considered feasible or wanted to be implemented in routine care.
| S-EPMC4844257 | biostudies-literature
Project description:BackgroundEarly diagnosis of dementia is important because this allows those with dementia and their families to engage support and plan ahead. However, dementia remains underdetected and suboptimally managed in general practice. Our objective was to test the effect of a workplace-based tailored educational intervention developed for general practice on the clinical management of people with dementia.MethodsThe tailored educational intervention was tested in an unblinded cluster randomized controlled trial with a pre/post-intervention design, with two arms: usual/normal care control versus educational intervention. The primary outcome measure was an increase in the proportion of patients with dementia who received at least two documented dementia-specific management reviews per year. Case identification was a secondary outcome measure.Results23 practices in South-East England participated. A total of 1,072 patients with dementia (intervention: 512, control: 560) had information in their medical records showing the number of reviews within 12 months (or a proportion of) before intervention or randomization and within 12 months (or a proportion of) after. The mean total number of dementia management reviews after the educational intervention for people with dementia was 0.89 (SD 1.09; minimum 0; median 1; maximum 8) compared with 0.89 (SD 0.92; minimum 0; median 1; maximum 4) before intervention. In the control group prior to randomization the mean total number of dementia management reviews was 1.66 (SD 1.87; minimum 0; median 1; maximum 12) and in the period after randomization it was 1.56 (SD 1.79; minimum 0; median 1; maximum 11). Case detection rates were unaffected. The estimated incidence rate ratio for intervention versus control group was 1.03 (P = 0.927, 95% CI 0.57 to 1.86).ConclusionsThe trial was timely, coinciding with financial incentives for dementia management in general practice (through the Quality Outcomes Framework); legal imperatives (in the form of the Mental Capacity Act 2005); policy pressure (The National Dementia Strategy 2009); and new resources (such as dementia advisors) that increased the salience of dementia for general practitioners. Despite this the intervention did not alter the documentation of clinical management of patients with dementia in volunteer practices, nor did it increase case identification.Trial registrationNCT00866099/Clinical Trials.
| S-EPMC4222692 | biostudies-literature
Project description:Hypertension is a public health problem and a major risk factor for cardiovascular disease. The purpose of this study is to compare the effectiveness of a multidisciplinary program based on group and individual care versus group-only care, to promote blood pressure control in hypertensive patients in primary health care.Randomized controlled clinical trial. The study was conducted within the primary health care, in two units of the Family Health Strategy, covering 11,000 individuals, in Porto Alegre, Brazil. Two hundred and 56 patients, older than 40 years old and with uncontrolled hypertension, systolic blood pressure (BP) ?140 mmHg and/or diastolic BP ?90 mmHg or ?130 mmHg and/or diastolic BP ?80 mmHg for individuals with diabetes. Eligible patients were randomly assigned to a health care program aiming for blood pressure control, with the multidisciplinary program group or with the multidisciplinary program plus personalized care group. Primary outcome measures were reduction in systolic BP from baseline to 6 months. Secondary measures included proportion of patients with systolic or diastolic BP controlled. Student t test, Pearson's chi-squared test, Fisher's exact test, Mann-Whitney U test, Wilcoxon signed-ranks test and generalized estimating equation (GEE) model were used in the analysis.The baseline characteristics of participants were similar between groups. After 6 months of follow-up, systolic BP decreased markedly in both groups (? - 11.8 mmHg [SD, 20.2] in the multidisciplinary program group and ? - 12.9 mmHg [SD, 19.2] in the personalized care group; p?<?0.001). Similarly, we noted a significant change in diastolic BP over time in both groups (? - 8.1 mmHg [SD, 10.8] in the multidisciplinary program group and ? - 7.0 mmHg [SD, 11.5] in the personalized care group; p?<?0.001).The study demonstrates similar effectiveness of a group intervention in comparison to a personalized education program in hypertension patients to achieve BP control. These findings indicate that the intervention can be for all hypertensive patients assisted in primary health care.ClinicalTrials.gov Identifier NCT01696318 (May 2013).
| S-EPMC5006538 | biostudies-literature
Project description:BACKGROUND:Comorbid depression is a significant challenge for safety-net primary care systems. Team-based collaborative depression care is effective, but complex system factors in safety-net organizations impede adoption and result in persistent disparities in outcomes. Diabetes-Depression Care-management Adoption Trial (DCAT) evaluated whether depression care could be significantly improved by harnessing information and communication technologies to automate routine screening and monitoring of patient symptoms and treatment adherence and allow timely communication with providers. OBJECTIVE:The aim of this study was to compare 6-month outcomes of a technology-facilitated care model with a usual care model and a supported care model that involved team-based collaborative depression care for safety-net primary care adult patients with type 2 diabetes. METHODS:DCAT is a translational study in collaboration with Los Angeles County Department of Health Services, the second largest safety-net care system in the United States. A comparative effectiveness study with quasi-experimental design was conducted in three groups of adult patients with type 2 diabetes to compare three delivery models: usual care, supported care, and technology-facilitated care. Six-month outcomes included depression and diabetes care measures and patient-reported outcomes. Comparative treatment effects were estimated by linear or logistic regression models that used generalized propensity scores to adjust for sampling bias inherent in the nonrandomized design. RESULTS:DCAT enrolled 1406 patients (484 in usual care, 480 in supported care, and 442 in technology-facilitated care), most of whom were Hispanic or Latino and female. Compared with usual care, both the supported care and technology-facilitated care groups were associated with significant reduction in depressive symptoms measured by scores on the 9-item Patient Health Questionnaire (least squares estimate, LSE: usual care=6.35, supported care=5.05, technology-facilitated care=5.16; P value: supported care vs usual care=.02, technology-facilitated care vs usual care=.02); decreased prevalence of major depression (odds ratio, OR: supported care vs usual care=0.45, technology-facilitated care vs usual care=0.33; P value: supported care vs usual care=.02, technology-facilitated care vs usual care=.007); and reduced functional disability as measured by Sheehan Disability Scale scores (LSE: usual care=3.21, supported care=2.61, technology-facilitated care=2.59; P value: supported care vs usual care=.04, technology-facilitated care vs usual care=.03). Technology-facilitated care was significantly associated with depression remission (technology-facilitated care vs usual care: OR=2.98, P=.04); increased satisfaction with care for emotional problems among depressed patients (LSE: usual care=3.20, technology-facilitated care=3.70; P=.05); reduced total cholesterol level (LSE: usual care=176.40, technology-facilitated care=160.46; P=.01); improved satisfaction with diabetes care (LSE: usual care=4.01, technology-facilitated care=4.20; P=.05); and increased odds of taking an glycated hemoglobin test (technology-facilitated care vs usual care: OR=3.40, P<.001). CONCLUSIONS:Both the technology-facilitated care and supported care delivery models showed potential to improve 6-month depression and functional disability outcomes. The technology-facilitated care model has a greater likelihood to improve depression remission, patient satisfaction, and diabetes care quality.
| S-EPMC5938593 | biostudies-literature
Project description:Although brief intervention is effective for reducing problem alcohol use, few data exist on its effectiveness for reducing problem drug use, a common issue in disadvantaged populations seeking care in safety-net medical settings (hospitals and community health clinics serving low-income patients with limited or no insurance).To determine whether brief intervention improves drug use outcomes compared with enhanced care as usual.A randomized clinical trial with blinded assessments at baseline and at 3, 6, 9, and 12 months conducted in 7 safety-net primary care clinics in Washington State. Of 1621 eligible patients reporting any problem drug use in the past 90 days, 868 consented and were randomized between April 2009 and September 2012. Follow-up participation was more than 87% at all points.Participants received a single brief intervention using motivational interviewing, a handout and list of substance abuse resources, and an attempted 10-minute telephone booster within 2 weeks (n?=?435) or enhanced care as usual, which included a handout and list of substance abuse resources (n?=?433).The primary outcomes were self-reported days of problem drug use in the past 30 days and Addiction Severity Index-Lite (ASI) Drug Use composite score. Secondary outcomes were admission to substance abuse treatment; ASI composite scores for medical, psychiatric, social, and legal domains; emergency department and inpatient hospital admissions, arrests, mortality, and human immunodeficiency virus risk behavior.Mean days used of the most common problem drug at baseline were 14.40 (SD, 11.29) (brief intervention) and 13.25 (SD, 10.69) (enhanced care as usual); at 3 months postintervention, means were 11.87 (SD, 12.13) (brief intervention) and 9.84 (SD, 10.64) (enhanced care as usual) and not significantly different (difference in differences, ??=?0.89 [95% CI, -0.49 to 2.26]). Mean ASI Drug Use composite score at baseline was 0.11 (SD, 0.10) (brief intervention) and 0.11 (SD, 0.10) (enhanced care as usual) and at 3 months was 0.10 (SD, 0.09) (brief intervention) and 0.09 (SD, 0.09) (enhanced care as usual) and not significantly different (difference in differences, ??=?0.008 [95% CI, -0.006 to 0.021]). During the 12 months following intervention, no significant treatment differences were found for either variable. No significant differences were found for secondary outcomes.A one-time brief intervention with attempted telephone booster had no effect on drug use in patients seen in safety-net primary care settings. This finding suggests a need for caution in promoting widespread adoption of this intervention for drug use in primary care.clinicaltrials.gov Identifier: NCT00877331.
| S-EPMC4599980 | biostudies-literature