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Multimodal intervention to improve osteoporosis care in home health settings: results from a cluster randomized trial.

ABSTRACT: We conducted a cluster randomized trial testing the effectiveness of an intervention to increase the use of osteoporosis medications in high-risk patients receiving home health care. The trial did not find a significant difference in medication use in the intervention arm.This study aims to test an evidence implementation intervention to improve the quality of care in the home health care setting for patients at high risk for fractures.We conducted a cluster randomized trial of a multimodal intervention targeted at home care for high-risk patients (prior fracture or physician-diagnosed osteoporosis) receiving care in a statewide home health agency in Alabama. Offices throughout the state were randomized to receive the intervention or to usual care. The primary outcome was the proportion of high-risk home health patients treated with osteoporosis medications. A t test of difference in proportions was conducted between intervention and control arms and constituted the primary analysis. Secondary analyses included logistic regression estimating the effect of individual patients being treated in an intervention arm office on the likelihood of a patient receiving osteoporosis medications. A follow-on analysis examined the effect of an automated alert built into the electronic medical record that prompted the home health care nurses to deploy the intervention for high-risk patients using a pre-post design.There were 11 offices randomized to each of the treatment and control arms; these offices treated 337 and 330 eligible patients, respectively. Among the offices in the intervention arm, the average proportion of eligible patients receiving osteoporosis medications post-intervention was 19.1 %, compared with 15.7 % in the usual care arm (difference in proportions 3.4 %, 95 % CI, -2.6 to 9.5 %). The overall rates of osteoporosis medication use increased from 14.8 % prior to activation of the automated alert to 17.6 % afterward, a nonsignificant difference.The home health intervention did not result in a significant improvement in use of osteoporosis medications in high-risk patients.

SUBMITTER: Kilgore ML

PROVIDER: S-EPMC4089895 | biostudies-literature | 2013 Oct

REPOSITORIES: biostudies-literature

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Multimodal intervention to improve osteoporosis care in home health settings: results from a cluster randomized trial.

Kilgore M L ML Outman R R Locher J L JL Allison J J JJ Mudano A A Kitchin B B Saag K G KG Curtis J R JR

Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA 20130328 10

<h4>Summary</h4>We conducted a cluster randomized trial testing the effectiveness of an intervention to increase the use of osteoporosis medications in high-risk patients receiving home health care. The trial did not find a significant difference in medication use in the intervention arm.<h4>Introduction</h4>This study aims to test an evidence implementation intervention to improve the quality of care in the home health care setting for patients at high risk for fractures.<h4>Methods</h4>We cond ...[more]

PMID: 23536256

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Project description:BackgroundFew studies have systematically examined whether knowledge translation (KT) strategies can be successfully implemented within the long-term care (LTC) setting. In this study, we examined the effectiveness of a multifaceted, interdisciplinary KT intervention for improving the prescribing of vitamin D, calcium and osteoporosis medications over 12-months.MethodsWe conducted a pilot, cluster randomized controlled trial in 40 LTC homes (21 control; 19 intervention) in Ontario, Canada. LTC homes were eligible if they had more than one prescribing physician and received services from a large pharmacy provider. Participants were interdisciplinary care teams (physicians, nurses, consultant pharmacists, and other staff) who met quarterly. Intervention homes participated in three educational meetings over 12 months, including a standardized presentation led by expert opinion leaders, action planning for quality improvement, and audit and feedback review. Control homes did not receive any additional intervention. Resident-level prescribing and clinical outcomes were collected from the pharmacy database; data collectors and analysts were blinded. In addition to feasibility measures, study outcomes were the proportion of residents taking vitamin D (≥800 IU/daily; primary), calcium ≥500 mg/day and osteoporosis medications (high-risk residents) over 12 months. Data were analyzed using the generalized estimating equations technique accounting for clustering within the LTC homes.ResultsAt baseline, 5,478 residents, mean age 84.4 (standard deviation (SD) 10.9), 71% female, resided in 40 LTC homes, mean size = 137 beds (SD 76.7). In the intention-to-treat analysis (21 control; 19 intervention clusters), the intervention resulted in a significantly greater increase in prescribing from baseline to 12 months between intervention versus control arms for vitamin D (odds ratio (OR) 1.82, 95% confidence interval (CI): 1.12, 2.96) and calcium (OR 1.33, 95% CI: 1.01, 1.74), but not for osteoporosis medications (OR 1.17, 95% CI: 0.91, 1.51). In secondary analyses, excluding seven nonparticipating intervention homes, ORs were 3.06 (95% CI: 2.18, 4.29), 1.57 (95% CI: 1.12, 2.21), 1.20 (95% CI: 0.90, 1.60) for vitamin D, calcium and osteoporosis medications, respectively.ConclusionsOur KT intervention significantly improved the prescribing of vitamin D and calcium and is a model that could potentially be applied to other areas requiring quality improvement.Trial registrationClinicalTrials.gov: NCT01398527 . Registered: 19 July 2011.

Project description:Although not always recognized as a pressing health care problem, wounds are a common, complex and costly condition. The burden of treating wounds is growing rapidly due to increasing health care costs, an aging population and a sharp rise in the incidence of diabetes and obesity worldwide. The Integrated Client Care (ICC) Project was a multi-year initiative to develop and test a new, integrated model of wound care within the home care sector in Ontario, Canada to improve health outcomes for patients and decrease system costs.Cluster randomized trial, with allocation of intervention randomized at the cluster level (14 home care centers) and analysis of outcomes based on individual-level data (patients). Primary analysis was an intention-to-treat (ITT) analysis. Two wound types, diabetic foot ulcers and pilonidal sinus, were selected as tracer conditions to assess the impact of the intervention on two different patient populations. Time to successful discharge from home care was analyzed using multivariable Cox proportional hazards regression. Hazard ratios (HRs) and 95% confidence intervals (CIs) are presented.A total of 12,063 diabetic foot ulcer patients and 1954 pilonidal sinus patient records were available for analysis. No appreciable differences were observed between patients in the control and intervention arms for either of the primary or secondary analyses in either condition group. In the diabetic foot ulcer group, 72.7% patients in the control arm and 73.6% patients in the intervention arm were discharged in the follow-up period (HR 1.05; 95% CI 0.94 to 1.17). In the pilonidal sinus group, 91.0% patients in the control arm and 89.0% patients in the intervention arm were discharged in the follow-up period (HR 0.96; 95% CI 0.82 to 1.12).As implemented, the ICC intervention was not effective, most likely due to failure of implementation, and is, therefore, not ready for widespread implementation in Ontario. Significant work remains to be done to correct the implementation process so that the concept of outcome-based health care can be properly evaluated.ClinicalTrials.gov, ID: NCT01573832 . Registered on 12 January 2012.

Project description:Osteoporosis treatment rates are declining, even among those with past fractures. Novel, low-cost approaches are needed to improve osteoporosis care. We conducted a parallel group, controlled, randomized clinical trial evaluating a behavioral intervention for improving osteoporosis medication use. A total of 2684 women with self-reported fracture history after age 45 years not using osteoporosis therapy from US Global Longitudinal Study of Osteoporosis in Women (GLOW) sites were randomized 1:1 to receive a multimodal, tailored, direct-to-patient, video intervention versus usual care. The primary study outcome was self-report of osteoporosis medication use at 6 months. Other outcomes included calcium and vitamin D supplementation, bone mineral density (BMD) testing, readiness for behavioral change, and barriers to treatment. In intent-to-treat analyses, there were no significant differences between groups (intervention versus control) in osteoporosis medication use (11.7% versus 11.4%, p = 0.8), calcium supplementation (31.8% versus 32.6%, p = 0.7), vitamin D intake (41.3% versus 41.9%, p = 0.8), or BMD testing (61.8% versus 57.1%, p = 0.2). In the intervention group, fewer women were in the precontemplative stage of behavior change, more women reported seeing their primary care provider, had concerns regarding osteonecrosis of the jaw, and difficulty in taking/remembering to take osteoporosis medications. We found differences in BMD testing among the subgroup of women with no prior osteoporosis treatment, those who provided contact information, and those with no past BMD testing. In per protocol analyses, women with appreciable exposure to the online intervention (n = 257) were more likely to start nonbisphosphonates (odds ratio [OR] = 2.70; 95% confidence interval [CI] 1.26-5.79) compared with the usual care group. Although our intervention did not increase the use of osteoporosis therapy at 6 months, it increased nonbisphosphonate medication use and BMD testing in select subgroups, shifted participants' readiness for behavior change, and altered perceptions of barriers to osteoporosis treatment. Achieving changes in osteoporosis care using patient activation approaches alone is challenging. © 2018 American Society for Bone and Mineral Research.

Project description:ImportanceRealizing the benefits of cancer screening requires testing of eligible individuals and processes to ensure follow-up of abnormal results.ObjectiveTo test interventions to improve timely follow-up of overdue abnormal breast, cervical, colorectal, and lung cancer screening results.Design, setting, and participantsPragmatic, cluster randomized clinical trial conducted at 44 primary care practices within 3 health networks in the US enrolling patients with at least 1 abnormal cancer screening test result not yet followed up between August 24, 2020, and December 13, 2021.InterventionAutomated algorithms developed using data from electronic health records (EHRs) recommended follow-up actions and times for abnormal screening results. Primary care practices were randomized in a 1:1:1:1 ratio to (1) usual care, (2) EHR reminders, (3) EHR reminders and outreach (a patient letter was sent at week 2 and a phone call at week 4), or (4) EHR reminders, outreach, and navigation (a patient letter was sent at week 2 and a navigator outreach phone call at week 4). Patients, physicians, and practices were unblinded to treatment assignment.Main outcomes and measuresThe primary outcome was completion of recommended follow-up within 120 days of study enrollment. The secondary outcomes included completion of recommended follow-up within 240 days of enrollment and completion of recommended follow-up within 120 days and 240 days for specific cancer types and levels of risk.ResultsAmong 11 980 patients (median age, 60 years [IQR, 52-69 years]; 64.8% were women; 83.3% were White; and 15.4% were insured through Medicaid) with an abnormal cancer screening test result for colorectal cancer (8245 patients [69%]), cervical cancer (2596 patients [22%]), breast cancer (1005 patients [8%]), or lung cancer (134 patients [1%]) and abnormal test results categorized as low risk (6082 patients [51%]), medium risk (3712 patients [31%]), or high risk (2186 patients [18%]), the adjusted proportion who completed recommended follow-up within 120 days was 31.4% in the EHR reminders, outreach, and navigation group (n = 3455), 31.0% in the EHR reminders and outreach group (n = 2569), 22.7% in the EHR reminders group (n = 3254), and 22.9% in the usual care group (n = 2702) (adjusted absolute difference for comparison of EHR reminders, outreach, and navigation group vs usual care, 8.5% [95% CI, 4.8%-12.0%], P < .001). The secondary outcomes showed similar results for completion of recommended follow-up within 240 days and by subgroups for cancer type and level of risk for the abnormal screening result.Conclusions and relevanceA multilevel primary care intervention that included EHR reminders and patient outreach with or without patient navigation improved timely follow-up of overdue abnormal cancer screening test results for breast, cervical, colorectal, and lung cancer.Trial registrationClinicalTrials.gov Identifier: NCT03979495.

Project description:BACKGROUND:Unhealthy lifestyle behaviours contribute to alarming cardiometabolic risk in patients with serious mental illness (SMI). Evidence-based practical lifestyle tools supporting patients and staff in improving patient lifestyle are lacking. METHODS:This multi-site randomized controlled pragmatic trial determined the effectiveness of a twelve-month multimodal lifestyle approach, including a web-based tool to improve patients' cardiometabolic health, versus care-as-usual. Using the web tool, nurses (trained in motivational interviewing) assisted patients in assessing their lifestyle behaviours, creating a risk profile and constructing lifestyle goals, which were discussed during fortnightly regular care visits. Twenty-seven community-care and sheltered-living teams were randomized into intervention (N?=?17) or control (N?=?10) groups, including 244 patients (140 intervention/104 control, 49.2% male, 46.1?±?10.8?years) with increased waist circumference (WC), BMI or fasting glucose. The primary outcomes concerned differences in WC after six and twelve months intervention, while BMI and metabolic syndrome Z-score were secondary outcome measures. RESULTS:General multilevel linear mixed models adjusted for antipsychotic medication showed that differences in WC change between intervention and control were?-?0.15?cm (95%CI: -?2.49; 2.19) after six and?-?1.03?cm (95%CI: -?3.42; 1.35) after twelve months intervention; however, the differences were not statistically significant. No intervention effects were found for secondary outcome measures. The intervention increased patients' readiness to change dietary behaviour. CONCLUSION:A multimodal web-based intervention facilitating nurses to address lifestyle changes in SMI patients did not improve patient cardiometabolic health. Web-tool use was lower than expected and nurses need more lifestyle coaching knowledge and skills. The type of intervention and delivery mode need optimization to realize effective lifestyle care for SMI patients. TRIAL REGISTRATION:Dutch Trial Registry, www.trialregister.nl , NTR3765, 21 December 2012.

Project description:Widespread implementation of palliative care treatment plans could reduce suffering in the last days of life by adopting best practices of traditionally home-based hospice care in inpatient settings.To evaluate the effectiveness of a multi-modal intervention strategy to improve processes of end-of-life care in inpatient settings.Implementation trial with an intervention staggered across hospitals using a multiple-baseline, stepped wedge design.Six Veterans Affairs Medical Centers (VAMCs).Staff training was targeted to all hospital providers and focused on identifying actively dying patients and implementing best practices from home-based hospice care, supported with an electronic order set and paper-based educational tools.Several processes of care were identified as quality endpoints for end-of-life care (last 7 days) and abstracted from electronic medical records of veterans who died before or after intervention (n?=?6,066). Primary endpoints were proportion with an order for opioid pain medication at time of death, do-not-resuscitate order, location of death, nasogastric tube, intravenous line infusing, and physical restraints. Secondary endpoints were administration of opioids, order/administration of antipsychotics, benzodiazepines, and scopolamine (for death rattle); sublingual administration; advance directives; palliative care consultations; and pastoral care services. Generalized estimating equations were conducted adjusting for longitudinal trends.Significant intervention effects were observed for orders for opioid pain medication (OR: 1.39), antipsychotic medications (OR: 1.98), benzodiazepines (OR: 1.39), death rattle medications (OR: 2.77), sublingual administration (OR: 4.12), nasogastric tubes (OR: 0.71), and advance directives (OR: 1.47). Intervention effects were not significant for location of death, do-not-resuscitate orders, intravenous lines, or restraints.This broadly targeted intervention strategy led to modest but statistically significant changes in several processes of care, indicating its potential for widespread dissemination to improve end-of-life care for thousands of patients who die each year in inpatient settings.

Project description:ImportanceStandardized, evidenced-based approaches to conducting advance care planning (ACP) in nursing homes are lacking.ObjectiveTo test the effect of an ACP video program on hospital transfers, burdensome treatments, and hospice enrollment among long-stay nursing home residents with and without advanced illness.Design, setting, and participantsThe Pragmatic Trial of Video Education in Nursing Homes was a pragmatic cluster randomized clinical trial conducted between February 1, 2016, and May 31, 2019, at 360 nursing homes (119 intervention and 241 control) in 32 states owned by 2 for-profit corporations. Participants included 4171 long-stay residents with advanced dementia or cardiopulmonary disease (hereafter referred to as advanced illness) in the intervention group and 8308 long-stay residents with advanced illness in the control group, 5764 long-stay residents without advanced illness in the intervention group, and 11 773 long-stay residents without advanced illness in the control group. Analyses followed the intention-to-treat principle.InterventionsFive 6- to 10-minute ACP videos were made available on tablet computers or online. Designated champions (mostly social workers) in intervention facilities were instructed to offer residents (or their proxies) the opportunity to view a video(s) on admission and every 6 months. Control facilities used usual ACP practices.Main outcomes and measuresTwelve-month outcomes were measured for each resident. The primary outcome was hospital transfers per 1000 person-days alive in the advanced illness cohort. Secondary outcomes included the proportion of residents with or without advanced illness experiencing 1 or more hospital transfer, 1 or more burdensome treatment, and hospice enrollment. To monitor fidelity, champions completed reports in the electronic record whenever they offered to show residents a video.ResultsThe study included 4171 long-stay residents with advanced illness in the intervention group (2970 women [71.2%]; mean [SD] age, 83.6 [9.1] years), and 8308 long-stay residents with advanced illness in the control group (5857 women [70.5%]; mean [SD] age, 83.6 [8.9] years), 5764 long-stay residents without advanced illness in the intervention group (3692 women [64.1%]; mean [SD] age, 81.5 [9.2] years), and 11 773 long-stay residents without advanced illness in the control group (7467 women [63.4%]; mean [SD] age, 81.3 [9.2] years). There was no significant reduction in hospital transfers per 1000 person-days alive in the intervention vs control groups (rate [SE], 3.7 [0.2]; 95% CI, 3.4-4.0 vs 3.9 [0.3]; 95% CI, 3.6-4.1; rate difference [SE], -0.2 [0.3]; 95% CI, -0.5 to 0.2). Secondary outcomes did not significantly differ between trial groups among residents with and without advanced illness. Based on champions' reports, 912 of 4171 residents with advanced illness (21.9%) viewed ACP videos. Facility-level rates of showing ACP videos ranged from 0% (14 of 119 facilities [11.8%]) to more than 40% (22 facilities [18.5%]).Conclusions and relevanceThis study found that an ACP video program was not effective in reducing hospital transfers, decreasing burdensome treatment use, or increasing hospice enrollment among long-stay residents with or without advanced illness. Intervention fidelity was low, highlighting the challenges of implementing new programs in nursing homes.Trial registrationClinicalTrials.gov Identifier: NCT02612688.

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Multimodal intervention to improve osteoporosis care in home health settings: results from a cluster randomized trial.

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Multimodal intervention to improve osteoporosis care in home health settings: results from a cluster randomized trial.

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