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:ImportanceExperts recommend that alcohol use disorders (AUDs) be managed in primary care, but effective approaches are unclear.ObjectiveTo 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 participantsThis 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).InterventionsNurse 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 measuresPrimary 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.ResultsOf 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 relevanceThe CHOICE intervention did not decrease heavy drinking or related problems despite increased engagement in alcohol-related care.Trial registrationclinicaltrials.gov Identifier: NCT01400581.
| S-EPMC5885256 | biostudies-literature
Project description:BackgroundImplementing 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).MethodsIn 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.ResultsThe 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.ConclusionsSafety-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 registrationClinicalTrials.gov Identifier: NCT00851201 . Registered 23 February 2009.
| S-EPMC5778780 | biostudies-literature
Project description:ImportanceLong-term evidence for the effectiveness and cost-effectiveness of collaborative dementia care management (CDCM) is lacking.ObjectiveTo evaluate whether 6 months of CDCM is associated with improved patient clinical outcomes and caregiver burden and is cost-effective compared with usual care over 36 months.Design, setting, and participantsThis was a prespecified secondary analysis of a general practitioner (GP)-based, cluster randomized, 2-arm clinical trial conducted in Germany from January 1, 2012, to December 31, 2014, with follow-up until March 31, 2018. Participants were aged 70 years or older, lived at home, and screened positive for dementia. Data were analyzed from March 2011 to March 2018.InterventionThe intervention group received CDCM, comprising a comprehensive needs assessment and individualized interventions by nurses specifically qualified for dementia care collaborating with GPs and health care stakeholders over 6 months. The control group received usual care.Main outcomes and measuresMain outcomes were neuropsychiatric symptoms (Neuropsychiatric Inventory [NPI]), caregiver burden (Berlin Inventory of Caregivers' Burden in Dementia [BIZA-D]), health-related quality of life (HRQOL, measured by the Quality of Life in Alzheimer Disease scale and 12-Item Short-Form Health Survey [SF-12]), antidementia drug treatment, potentially inappropriate medication, and cost-effectiveness (incremental cost per quality-adjusted life year [QALY]) over 36 months. Outcomes between groups were compared using multivariate regression models adjusted for baseline scores.ResultsA total of 308 patients, of whom 221 (71.8%) received CDCM (mean [SD] age, 80.1 [5.3] years; 142 [64.3%] women) and 87 (28.2%) received usual care (mean [SD] age, 79.2 [4.5] years; 50 [57.5%] women), were included in the clinical effectiveness analyses, and 428 (303 [70.8%] CDCM, 125 [29.2%] usual care) were included in the cost-effectiveness analysis (which included 120 patients who had died). Participants receiving CDCM showed significantly fewer behavioral and psychological symptoms (adjusted mean difference [AMD] in NPI score, -10.26 [95% CI, -16.95 to -3.58]; P = .003; Cohen d, -0.78 [95% CI, -1.09 to -0.46]), better mental health (AMD in SF-12 Mental Component Summary score, 2.26 [95% CI, 0.31-4.21]; P = .02; Cohen d, 0.26 [95% CI, -0.11 to 0.51]), and lower caregiver burden (AMD in BIZA-D score, -0.59 [95% CI, -0.81 to -0.37]; P < .001; Cohen d, -0.71 [95% CI, -1.03 to -0.40]). There was no difference between the CDCM group and usual care group in use of antidementia drugs (adjusted odds ratio, 1.91 [95% CI, 0.96-3.77]; P = .07; Cramér V, 0.12) after 36 months. There was no association with overall HRQOL, physical health, or use of potentially inappropriate medication. The CDCM group gained QALYs (0.137 [95% CI, 0.000 to 0.274]; P = .049; Cohen d, 0.20 [95% CI, -0.09 to 0.40]) but had no significant increase in costs (437€ [-5438€ to 6313€] [US $476 (95% CI, -$5927 to $6881)]; P = .87; Cohen d, 0.07 [95% CI, -0.14 to 0.28]), resulting in a cost-effectiveness ratio of 3186€ (US $3472) per QALY. Cost-effectiveness was significantly better for patients living alone (CDCM dominated, with lower costs and more QALYs gained) than for those living with a caregiver (47 538€ [US $51 816] per QALY).Conclusions and relevanceIn this secondary analysis of a cluster randomized clinical trial, CDCM was associated with improved patient, caregiver, and health system-relevant outcomes over 36 months beyond the intervention period. Therefore, it should become a health policy priority to initiate translation of CDCM into routine care.Trial registrationClinicalTrials.gov Identifier: NCT01401582.
| S-EPMC11227088 | biostudies-literature
Project description:DesignProspective, double-blind clinical trial comparing tetanus-diphtheria vaccine administration routes, intramuscular (IM) vs. subcutaneous (SC) injection, in patients with oral anticoagulants. ISRCTN69942081.Study populationPatients treated with oral anticoagulants, 15 health centers, Vigo (Spain). Sample size, 117 in each group.Outcome variablesSafety analysis: systemic reactions and, at the vaccine administration site, erythematic, swelling, hematoma, granuloma, pain.Effectiveness analysis: differences in tetanus toxoid antibody titers.Independent variables: route, sex, age, baseline serology, number of doses administered.AnalysisFollowing the CONSORT guidelines, we performed an intention-to-treat analysis. We conducted a descriptive study of the variables included in both groups (117 in each group) and a bivariate analysis. Fewer than 5% of missing values. Imputation in baseline and final serology with the median was performed. Lost values were assumed to be values missing at random. We conducted a descriptive study of the variables and compared routes. For safety, multivariate logistic regression was applied, with each safety criterion as outcome and the independent variables. Odds ratios (ORs) were calculated. For effectiveness, a generalized additive mixed model, with the difference between final and initial antibody titers as outcome. Due to the bimodal distribution of the outcome, the normal mixture fitting with gamlssMX was used. All statistical analyses were performed with the gamlss.mx and texreg packages of the R free software environment.ResultsA previously published protocol was used across the 6-year study period. The breakdown by sex and route showed: 102 women and 132 men; and 117 IM and 117 SC, with one dose administered in over 80% of participants. There were no differences between groups in any independent variable. The second and third doses administered were not analyzed, due to the low number of cases. In terms of safety, there were no severe general reactions. Locally, significant adjusted differences were observed: in pain, by sex (male, OR: 0.39) and route (SC, OR: 0.55); in erythema, by sex (male, OR: 0.34) and route (SC, OR: 5.21); and in swelling, by sex (male, OR: 0.37) and route (SC, OR: 2.75). In terms of effectiveness, the model selected was the one adjusted for baseline serology.
| S-EPMC9813590 | biostudies-literature
Project description:BackgroundFostering 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.MethodsRandomized 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.ResultsTrial 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.ConclusionA 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 registrationIt was retrospectively registered with ( ISRCTN41911128 , 31/12/2010).
| S-EPMC6337818 | biostudies-literature
Project description:BackgroundClinical decision support systems (CDSS) are low-cost, scalable tools with the potential to improve guideline-based antihypertensive treatment in primary care, but their effectiveness needs to be tested, especially in low- and middle-income countries such as China.MethodsThe Learning Implementation of Guideline-based decision support system for Hypertension Treatment (LIGHT) trial is a pragmatic, four-stage, cluster-randomized trial conducted in 94 primary care sites in China. For each city-based stage, sites are randomly assigned to either implementation of the CDSS for hypertension management (which guides doctors' treatment recommendations based on measured blood pressure and patient characteristics), or usual care. Patients are enrolled during the first 3 months after site randomization and followed for 9 months. The primary outcome is the proportion of hypertension management visits at which guideline-based treatment is provided. In a nested trial conducted within the CDSS, with the patient as the unit of randomization, the LIGHT-ACD trial, patients are randomized to receive different initial mono- or dual-antihypertensive therapy. The primary outcome of the LIGHT-ACD trial is the changes in blood pressure.DiscussionThe LIGHT trial will provide evidence on the effectiveness of a CDSS for improving guideline adherence for hypertension management in primary care in China. The nested trial, the LIGHT-ACD trial, will provide data on the effect of different initial antihypertensive regimens for blood pressure management in this setting.Trial registrationClinicalTrials.gov, identifier: LIGHT (NCT03636334) and LIGHT-ACD (NCT03587103). Registered on 3 July 2018.
| S-EPMC9109449 | biostudies-literature
Project description:ImportanceCollaborative 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.ObjectiveTo 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 participantsIn 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.InterventionsSix 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 measuresMental 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.ResultsOf 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 relevanceWhile 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 registrationclinicaltrials.gov Identifier: NCT01482806.
| S-EPMC5833533 | 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:ImportanceAmong 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.ObjectiveTo 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.Design, setting, and participantsThis 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.InterventionsThe 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.Main outcomes and measuresDepression severity, assessed by the 24-item Hamilton Scale for Depression (HAM-D).ResultsThe 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).Conclusion and relevanceHome 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.Trial registrationclinicaltrials.gov Identifier: NCT01979302.
| S-EPMC4516039 | 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.
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