BE-ACTIV for depression in nursing homes: primary outcomes of a randomized clinical trial.
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ABSTRACT:
SUBMITTER: Meeks S
PROVIDER: S-EPMC4342721 | biostudies-literature | 2015 Jan
REPOSITORIES: biostudies-literature
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BE-ACTIV for depression in nursing homes: primary outcomes of a randomized clinical trial.
Meeks Suzanne S Van Haitsma Kimberly K Schoenbachler Ben B Looney Stephen W SW
The journals of gerontology. Series B, Psychological sciences and social sciences 20140401 1
<h4>Objectives</h4>To report the primary outcomes of a cluster randomized clinical trial of Behavioral Activities Intervention (BE-ACTIV), a behavioral intervention for depression in nursing homes.<h4>Method</h4>Twenty-three nursing homes randomized to BE-ACTIV or treatment as usual (TAU); 82 depressed long-term care residents recruited from these nursing homes. BE-ACTIV participants received 10 weeks of individual therapy after a 2-week baseline. TAU participants received weekly research visits ...[more]
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Project description:BackgroundClose to half of all deaths in Norway occur in nursing homes, which signals a need for good communication on end-of-life care. Advance care planning (ACP) is one means to that end, but in Norwegian nursing homes, ACP is not common. This paper describes the protocol of a project evaluating an ACP-intervention in Norwegian nursing homes. The aims of this research project were to promote the possibility for conversations about the end of life with patients and relatives; promote patient autonomy; create a better foundation for important decisions in the case of medical emergencies and at the end of life; and gain experiences in order to find out what characterizes good ACP and good implementation strategies.Methods/designThis study was a mixed method study including a cluster-randomized clinical trial. Eight nursing home wards or "clusters" were pair-matched, and one ward from each pair was randomly selected for a 12-month intervention. The intervention consisted of implementing an ACP-guideline. Implementation strategies were training and supervision of project teams and staff in using the guideline, written information to patients and next of kin, and information meetings with nursing home staff. The project was evaluated using both quantitative and qualitative data, and both outcome and process evaluation. Quantitative data included patient chart reviews of ACP, diagnoses, patient preferences for decision-making and treatment, values and wishes that are more general, documented life-prolonging treatment and hospitalizations, and concordance between patient wishes and treatment. The primary outcome was documented ACP. Qualitative data included observations of conversations, interviews with patients, next of kin and health care personnel, logs from project coordinators and conversations, and transcripts from meetings with project teams in the intervention group.DiscussionThis project attempted to increase the quality and use of ACP in Norwegian nursing homes (NH). A mixed methods approach, inclusion of patients with dementia, attempts to involve, as many patients as possible, and a sustainable implementation plan adapted to real life in nursing homes were strengths of the project.
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Project description:AIMS:To determine whether ultrasound-assisted prompted voiding (USAPV) care is more efficacious than conventional prompted voiding (CPV) care for managing urinary incontinence in nursing homes. METHODS:Thirteen participating nursing homes in Japan were randomized to CPV (n?=?7) or USAPV care group (n?=?6). Residents of the allocated nursing homes received CPV (n?=?35) or USAPV (n?=?45) care for 8 weeks. In the CPV group, caregivers asked the elderly every 2-3?h whether they had a desire to void and prompted them to void when the response was yes. In the USAPV group, caregivers regularly monitored bladder urine volume by an ultrasound device and prompted them to void when the volume reached close to the individually optimized bladder capacity. Frequency-volume chart was recorded at the baseline and after the 8-week intervention to measure the daytime urine loss. RESULTS:The change in daytime urine loss was statistically greater in the USAPV (median, -80.0?g) than in the CPV (median, -9.0?g; P?=?.018) group. The proportion of elderly individuals whose daytime urine loss decreased by >25% was 51% and 26% in the USAPV and CPV group, respectively (P?=?.020). Quality-of-life measures of elderly participants showed no significant changes in both groups. The care burden scale score of caregivers was unchanged in the USAPV group (P?=?.59) but significantly worsened in the CPV group (P?=?.010) after the intervention. CONCLUSIONS:USAPV is efficacious and feasible for managing urinary incontinence in nursing homes.
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Project description:BACKGROUND:Adolescent depression carries a high burden of disease worldwide, but access to care for this population is limited. Prevention is one solution to curtail the negative consequences of adolescent depression. Internet interventions to prevent adolescent depression can overcome barriers to access, but few studies examine long-term outcomes. OBJECTIVE:This study compares CATCH-IT (Competent Adulthood Transition with Cognitive Behavioral Humanistic and Interpersonal Training), an internet-based intervention, to a general health education active control for depression onset at 12 and 24 months in adolescents presenting to primary care settings. METHODS:A 2-site randomized trial, blinded to the principal investigators and assessors, was conducted comparing Competent Adulthood Transition with Cognitive Behavioral Humanistic and Interpersonal Training to health education to prevent depressive episodes in 369 adolescents (193 youths were randomly assigned to Competent Adulthood Transition with Cognitive Behavioral Humanistic and Interpersonal Training and 176 to health education) with subthreshold depressive symptoms or prior depressive episodes. Participants were recruited from primary care settings in the United States. The primary outcome was the occurrence of a depressive episode, determined by the Depression Symptom Rating. The secondary outcome was functioning, measured by the Global Assessment Scale. RESULTS:In intention-to-treat analyses, the adjusted hazard ratio favoring Competent Adulthood Transition with Cognitive Behavioral Humanistic and Interpersonal Training for first depressive episode was not statistically significant at 12 months (hazard ratio 0.77, 95% CI 0.42-1.40, P=.39) and 24 months (hazard ratio 0.87, 95% CI 0.52-1.47, P=.61). Competent Adulthood Transition with Cognitive Behavioral Humanistic and Interpersonal Training provided preventive benefit for first depressive episode for those with mild hopelessness or at least moderate paternal monitoring at baseline. Global Assessment Scale scores improved comparably in both groups (intention-to-treat). CONCLUSIONS:A technology-based intervention for adolescent depression prevention implemented in primary care did not have additional benefit at 12 or 24 months. Further research is necessary to determine whether internet interventions have long-term benefit. TRIAL REGISTRATION:ClinicalTrials.gov NCT01893749; http://clinicaltrials.gov/ct2/show/NCT01893749.
| S-EPMC7657722 | biostudies-literature
Project description:ObjectiveWe developed a primary care/Internet-based intervention for adolescents at risk for depression (CATCH-IT, Competent Adulthood Transition with Cognitive-behavioral, Humanistic and Interpersonal Training). This phase II clinical trial compares two forms of primary care provider (PCP) engagement (motivational interview [MI] and brief advice [BA]) for adolescents using the Internet program.MethodADOLESCENTS SCREENING POSITIVE FOR DEPRESSION WERE RECRUITED FROM PRIMARY CARE PRACTICES AND RANDOMLY ASSIGNED TO A VERSION OF THE INTERVENTION: PCP MI + Internet program or PCP BA + Internet program. Between-group and within-group comparisons were conducted on depressive disorder outcome measures at baseline and one-year post-enrollment. Regression analyses examined factors predicting declines in depressed mood.ResultsBoth groups demonstrated significant within-group decreases in depressed mood, loneliness, and self-harm ideation. While no between-group differences were noted in depressed mood or depressive disorder measures at one-year, fewer participants in the MI group had experienced a depressive episode. Greater participant automatic negative thoughts and more favorable ratings of a component of the Internet-based training experience predicted declines in depressed mood at one-year.ConclusionsA primary care/Internet-based intervention for depression prevention demonstrated sustained reductions in depressed mood, and, when coupled with motivational interviewing, reduction in the likelihood of being diagnosed with a depressive episode. This tool may help extend the services at the disposal of a primary care provider and can provide a bridge for adolescents at risk for depression prior to referral to mental health specialists.
| S-EPMC3647626 | biostudies-literature
Project description:ObjectiveTo assess longitudinally whether a change in registered nurse (RN) staffing and skill mix leads to a change in nursing home resident outcomes while controlling for the potential endogeneity of staffing.Data sourcesMinimum Data Set (MDS) nursing home resident assessment data from five states merged with Online Survey Certification and Reporting (OSCAR) data from 1996 through 2000.Study designResident-level longitudinal analysis with facility fixed effects and instrumental variables. Outcomes studied are incidence of pressure sores and urinary tract infections. RN staffing was measured as the care hours per resident-day and skill mix was measured as RN staffing hours as a proportion of total staffing hours.Data extraction methodWe use all quarterly MDS assessments that fall within 120 days of an annual OSCAR data point, resulting in 399,206 resident-level observations.Principal findingsControlling for endogeneity of staffing increases the estimated impact of staffing on outcomes in nursing homes. Greater RN staffing significantly decreases the likelihood of both adverse outcomes. Increasing skill mix only reduces the incidence of urinary tract infections.ConclusionsResearch that fails to account for endogeneity of the staffing-outcomes relationship may underestimate the benefit from increased RN staffing. Increases in RN staffing are likely to reduce adverse outcomes in some nursing homes. More research using a broader array of instruments and a national sample would be beneficial.
| S-EPMC2442239 | biostudies-literature
Project description:Bacteriuria plus pyuria is highly prevalent among older women living in nursing homes. Cranberry capsules are an understudied, nonantimicrobial prevention strategy used in this population.To test the effect of 2 oral cranberry capsules once a day on presence of bacteriuria plus pyuria among women residing in nursing homes.Double-blind, randomized, placebo-controlled efficacy trial with stratification by nursing home and involving 185 English-speaking women aged 65 years or older, with or without bacteriuria plus pyuria at baseline, residing in 21 nursing homes located within 50 miles (80 km) of New Haven, Connecticut (August 24, 2012-October 26, 2015).Two oral cranberry capsules, each capsule containing 36 mg of the active ingredient proanthocyanidin (ie, 72 mg total, equivalent to 20 ounces of cranberry juice) vs placebo administered once a day in 92 treatment and 93 control group participants.Presence of bacteriuria (ie, at least 105 colony-forming units [CFUs] per milliliter of 1 or 2 microorganisms in urine culture) plus pyuria (ie, any number of white blood cells on urinalysis) assessed every 2 months over the 1-year study surveillance; any positive finding was considered to meet the primary outcome. Secondary outcomes were symptomatic urinary tract infection (UTI), all-cause death, all-cause hospitalization, all multidrug antibiotic-resistant organisms, antibiotics administered for suspected UTI, and total antimicrobial administration.Of the 185 randomized study participants (mean age, 86.4 years [SD, 8.2], 90.3% white, 31.4% with bacteriuria plus pyuria at baseline), 147 completed the study. Overall adherence was 80.1%. Unadjusted results showed the presence of bacteriuria plus pyuria in 25.5% (95% CI, 18.6%-33.9%) of the treatment group and in 29.5% (95% CI, 22.2%-37.9%) of the control group. The adjusted generalized estimating equations model that accounted for missing data and covariates showed no significant difference in the presence of bacteriuria plus pyuria between the treatment group vs the control group (29.1% vs 29.0%; OR, 1.01; 95% CI, 0.61-1.66; P?=?.98). There were no significant differences in number of symptomatic UTIs (10 episodes in the treatment group vs 12 in the control group), rates of death (17 vs 16 deaths; 20.4 vs 19.1 deaths/100 person-years; rate ratio [RR], 1.07; 95% CI, 0.54-2.12), hospitalization (33 vs 50 admissions; 39.7 vs 59.6 hospitalizations/100 person-years; RR, 0.67; 95% CI, 0.32-1.40), bacteriuria associated with multidrug-resistant gram-negative bacilli (9 vs 24 episodes; 10.8 vs 28.6 episodes/100 person-years; RR, 0.38; 95% CI, 0.10-1.46), antibiotics administered for suspected UTIs (692 vs 909 antibiotic days; 8.3 vs 10.8 antibiotic days/person-year; RR, 0.77; 95% CI, 0.44-1.33), or total antimicrobial utilization (1415 vs 1883 antimicrobial days; 17.0 vs 22.4 antimicrobial days/person-year; RR, 0.76; 95% CI, 0.46-1.25).Among older women residing in nursing homes, administration of cranberry capsules vs placebo resulted in no significant difference in presence of bacteriuria plus pyuria over 1 year.clinicaltrials.gov Identifier: NCT01691430.
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Project description:Importance:High-quality evidence on how to improve palliative care in nursing homes is lacking. Objective:To investigate the effect of the Palliative Care for Older People (PACE) Steps to Success Program on resident and staff outcomes. Design, Setting, and Participants:A cluster-randomized clinical trial (2015-2017) in 78 nursing homes in 7 countries comparing PACE Steps to Success Program (intervention) with usual care (control). Randomization was stratified by country and median number of beds in each country in a 1:1 ratio. Interventions:The PACE Steps to Success Program is a multicomponent intervention to integrate basic nonspecialist palliative care in nursing homes. Using a train-the-trainer approach, an external trainer supports staff in nursing homes to introduce a palliative care approach over the course of 1 year following a 6-steps program. The steps are (1) advance care planning with residents and family, (2) assessment, care planning, and review of needs and problems, (3) coordination of care via monthly multidisciplinary review meetings, (4) delivery of high-quality care focusing on pain and depression, (5) care in the last days of life, and (6) care after death. Main Outcomes and Measures:The primary resident outcome was comfort in the last week of life measured after death by staff using the End-of-Life in Dementia Scale Comfort Assessment While Dying (EOLD-CAD; range, 14-42). The primary staff outcome was knowledge of palliative care reported by staff using the Palliative Care Survey (PCS; range, 0-1). Results:Concerning deceased residents, we collected 551 of 610 questionnaires from staff at baseline and 984 of 1178 postintervention in 37 intervention and 36 control homes. Mean (SD) age at time of death ranged between 85.22 (9.13) and 85.91 (8.57) years, and between 60.6% (160/264) and 70.6% (190/269) of residents were women across the different groups. Residents' comfort in the last week of life did not differ between intervention and control groups (baseline-adjusted mean difference, -0.55; 95% CI, -1.71 to 0.61; P?=?.35). Concerning staff, we collected 2680 of 3638 questionnaires at baseline and 2437 of 3510 postintervention in 37 intervention and 38 control homes. Mean (SD) age of staff ranged between 42.3 (12.1) and 44.1 (11.7) years, and between 87.2% (1092/1253) and 89% (1224/1375) of staff were women across the different groups. Staff in the intervention group had statistically significantly better knowledge of palliative care than staff in the control group, but the clinical difference was minimal (baseline-adjusted mean difference, 0.04; 95% CI, 0.02-0.05; P?<?.001). Data analyses began on April 20, 2018. Conclusions and Relevance:Residents' comfort in the last week of life did not improve after introducing the PACE Steps to Success Program. Improvements in staff knowledge of palliative care were clinically not important. Trial Registration:ISRCTN Identifier: ISRCTN14741671.
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Project description:ImportanceMultidrug-resistant organisms (MDROs) can cause significant morbidity and mortality. Preventing MDROs can reduce the risk of subsequent transmission and infection.ObjectiveTo determine whether a multicomponent infection prevention intervention can reduce MDRO prevalence in nursing homes (NHs).Design, setting, and participantsThis cluster randomized clinical trial of a multicomponent intervention was conducted in 6 NHs in Michigan from September 2016 to August 2018. Three NHs adopted a multicomponent intervention, while 3 control NHs continued without investigator intervention. Study visits were conducted at baseline; days 7, 14, 21, and 30; and monthly thereafter for up to 6 months or discharge. Visits included clinical data collection and MDRO surveillance culturing of multiple body sites and high-touch surfaces in patient rooms. Any patients who provided informed consent within 14 days of admission to the NH were enrolled in this study. Non-English speakers and patients receiving hospice care were ineligible. Analysis was performed from November 2018 to February 2020.InterventionsIntervention NHs adopted a multicomponent intervention that included enhanced barrier precautions, chlorhexidine bathing, MDRO surveillance, environmental cleaning education and feedback, hand hygiene promotion, and health care worker education and feedback. Control nursing homes continued standard care practices.Main outcomes and measuresThe primary outcome, presence of MDROs, was measured longitudinally in the patient and room environment and was evaluated using generalized mixed effect models. The secondary outcome, time to new MDRO acquisition, was assessed using Cox proportional hazard models.ResultsA total of 6 NHs were included, with 245 patients (mean [SD] age, 72.5 [13.6] years; 134 [54.7%] women) enrolled; 3 NHs with 113 patients (46.1%) were randomized to the intervention group and 3 NHs with 132 patients (53.9%) were randomized to the control group. A total of 132 patients (53.9%) were White, and 235 patients (95.9%) were receiving postacute care. Over 808 study visits, 3654 patient cultures and 5606 environmental cultures were obtained. The intervention reduced the odds of MDRO prevalence in patients' environment by 43% (aOR, 0.57; 95% CI, 0.35-0.94), but there was no statistically significant difference on the patient level before or after adjustment (aOR, 0.57; 95% CI, 0.29-1.14). There were no significant reductions in time to new acquisition for methicillin-resistant Staphylococcus aureus (hazard ratio [HR], 0.20; 95% CI, 0.04-1.09), vancomycin-resistant enterococci (HR, 0.84; 95% CI, 0.46-1.53), or resistant gram-negative bacilli (HR, 1.14; 95% CI, 0.73-1.78).Conclusions and relevanceThis cluster randomized clinical trial found that the multicomponent intervention reduced the prevalence of MDROs in the environment of NH patients. Our findings highlight the potential for multicomponent interventions to directly and indirectly reduce MDRO prevalence in NHs.Trial registrationClinicalTrials.gov Identifier: NCT02909946.
| S-EPMC8285736 | biostudies-literature
Project description:Importance:Nonadherence to antidepressant medication is common and leads to poor outcomes. Early nonadherence is especially problematic. Objective:To test the effectiveness of a psychosocial intervention to improve early adherence among older patients whose primary care physician newly initiated an antidepressant for depression. Design, Setting, and Participants:The Treatment Initiation and Participation Program (TIP) was offered in a 2-site randomized clinical effectiveness study between January 2011 and December 2014 at primary care practices in New York, New York, and Ann Arbor, Michigan. Analyses began in February 2016. All participants were middle-aged and older adults (aged ?55 years) who received newly initiated depression treatment by their primary care physician and recruited within 10 days of their prescription. Analyses were intention-to-treat. Interventions:Participants were randomly assigned to the intervention (TIP) or treatment as usual. Participants in the TIP group identified and addressed barriers to adherence, including stigma, misconceptions, and fears about treatment, before developing a personalized adherence strategy. The Treatment Initiation and Participation Program was delivered in three 30-minute contacts scheduled during a 6-week period just after the antidepressant was prescribed. Main Outcomes and Measures:The primary outcome was self-reported adherence on the Brief Medication Questionnaire, with adequate early adherence defined as taking 80% or more of the prescribed doses at 6 and 12 weeks. The secondary outcome was depression severity. Results:In total, 231 middle-aged and older adults (167 women [72.3%] and 64 men [27.7%]) without significant cognitive impairment were randomly assigned to the TIP intervention (n?=?115) or treatment as usual (n?=?116). Participants had a mean (SD) age of 67.3 (8.4) years. Participants in the TIP group were 5 times more likely to be adherent at 6 weeks (odds ratio,?5.54; 95% CI, 2.57 to 11.96; ?21?=?19.05; P?<?.001) and 3 times more likely to be adherent at both 6 and 12 weeks (odds ratio,?3.27; 95% CI, 1.73 to 6.17; ?21?=?13.34; P?<?.001). Participants in the TIP group showed a significant earlier reduction (24.9%) in depressive symptoms (95% CI, 13.9 to 35.9; t337?=?4.46; adjusted P?<?.001). In both groups, participants who were 80% adherent at weeks 6 and 12 had a 15% greater improvement in depressive symptoms from baseline over the course of treatment (95% CI, -0.2 to -30; t369?=?1.93; P?=?.051). Conclusions and Relevance:The Treatment Initiation and Participation Program is an effective intervention to improve early adherence to pharmacotherapy. Improved adherence can promote improvement in depression. Trial Registration:clinicaltrials.gov Identifier: NCT01301859.
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Project description:One in four Americans, and 70% of people who have dementia, will spend their final days in nursing home care. Clinical research, particularly clinical trials, rarely includes this population due to unique challenges in research methods and ethics. Families of advanced dementia patients make choices about tube feeding and other feeding options with limited access to information or communication. The cluster randomized trial, Improving Decision Making about Feeding Options for Dementia Patients, tests a decision aid intervention to improve the quality of decision making for this choice.Our objectives are (1) to describe the methods used in this trial; (2) to describe challenges and strategies for effective nursing home and nursing home resident recruitment and retention; and (3) to describe research ethics approaches to minimize harms and maximize benefits for this population.The study is a cluster randomized trial of a decision aid to inform and support the choice between tube feeding and assisted oral feeding in advanced dementia. Study subjects are paired surrogate decision makers and residents with advanced dementia and feeding problems, enrolled from nursing homes in North Carolina.This trial enrolled 256 paired surrogate decision makers and residents in 24 nursing home sites, and 99% completed participation through the 3-month study period. The research team had prior clinical and investigative experience in this setting, and used multiple strategies to recruit and retain nursing home sites, providers, surrogates, and the residents for whom they spoke. Informed consent and human subjects' protections were designed to address the vulnerability of this population.Cluster randomization was necessary to avoid contamination between control and intervention subjects, but may introduce confounding by site and intracluster correlation effects in analyses.Strategies that facilitate nursing home recruitment, participant recruitment and protection of human subjects for a vulnerable population may be used by future investigators to expand the research evidence base for nursing home and dementia care.
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