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Falls are the most frequent adverse events that are reported in hospitals. We examined the effectiveness of individualised falls-prevention education for patients, supported by training and feedback for staff, delivered as a ward-level programme. Eight rehabilitation units in general hospitals in Australia participated in this stepped-wedge, cluster-randomised study, undertaken during a 50 week period. Units were randomly assigned to intervention or control groups by use of computer-generated, random allocation sequences. We included patients admitted to the unit during the study with a Mini-Mental State Examination (MMSE) score of more than 23/30 to receive individualised education that was based on principles of changes in health behaviour from a trained health professional, in addition to usual care. We provided information about patients' goals, feedback about the ward environment, and perceived barriers to engagement in falls-prevention strategies to staff who were trained to support the uptake of strategies by patients. The coprimary outcome measures were patient rate of falls per 1000 patient-days and the proportion of patients who were fallers. All analyses were by intention to treat. This trial is registered with the Australian New Zealand Clinical Trials registry, number ACTRN12612000877886). Between Jan 13, and Dec 27, 2013, 3606 patients were admitted to the eight units (n=1983 control period; n=1623 intervention period). There were fewer falls (n=196, 7·80/1000 patient-days vs n=380, 13·78/1000 patient-days, adjusted rate ratio 0·60 [robust 95% CI 0·42–0·94], p=0·003), injurious falls (n=66, 2·63/1000 patient-days vs 131, 4·75/1000 patient-days, 0·65 [robust 95% CI 0·42–0·88], p=0·006), and fallers (n=136 [8·38%] vs n=248 [12·51%] adjusted odds ratio 0·55 [robust 95% CI 0·38 to 0·81], p=0·003) in the intervention compared with the control group. There was no significant difference in length of stay (intervention median 11 days [IQR 7–19], control 10 days [6–18]). Individualised patient education programmes combined with training and feedback to staff added to usual care reduces the rates of falls and injurious falls in older patients in rehabilitation hospital-units. State Health Research Advisory Council, Department of Health, Government of Western Australia.

Objective To measure whether the benefits of a single education and self management structured programme for people with newly diagnosed type 2 diabetes mellitus are sustained at three years.Design Three year follow-up of a multicentre cluster randomised controlled trial in primary care, with randomisation at practice level.Setting 207 general practices in 13 primary care sites in the United Kingdom.Participants 731 of the 824 participants included in the original trial were eligible for follow-up. Biomedical data were collected on 604 (82.6%) and questionnaire data on 513 (70.1%) participants.Intervention A structured group education programme for six hours delivered in the community by two trained healthcare professional educators compared with usual care.Main outcome measures The primary outcome was glycated haemoglobin (HbA1c) levels. The secondary outcomes were blood pressure, weight, blood lipid levels, smoking status, physical activity, quality of life, beliefs about illness, depression, emotional impact of diabetes, and drug use at three years.Results HbA1c levels at three years had decreased in both groups. After adjusting for baseline and cluster the difference was not significant (difference −0.02, 95% confidence interval −0.22 to 0.17). The groups did not differ for the other biomedical and lifestyle outcomes and drug use. The significant benefits in the intervention group across four out of five health beliefs seen at 12 months were sustained at three years (P<0.01). Depression scores and quality of life did not differ at three years.Conclusion A single programme for people with newly diagnosed type 2 diabetes mellitus showed no difference in biomedical or lifestyle outcomes at three years although there were sustained improvements in some illness beliefs. Trial registration Current Controlled Trials ISRCTN17844016.

Many survivors of critical illness and their family members experience significant psychological distress after patient discharge. To compare the effects of a coping skills training (CST) program with an education program on patient and family psychological distress. In this five-center clinical trial, adult patients who received mechanical ventilation for more than 48 hours and one family member of each patient were randomized to six weekly CST telephone sessions plus access to a study website or a critical illness education program. The primary outcome was the patient Hospital Anxiety and Depression Scale (HADS) score at 3 months. Secondary outcomes included 3- and 6-month HADS subscales and the Impact of Events Scale-Revised. Among the 175 patients randomized to CST (n = 86) or education (n = 89), there was no significant difference between CST and education in either 3-month HADS scores (difference, 1.3; 95% confidence interval [CI], -0.9 to 3.4; P = 0.24) or secondary patient and family outcomes. In prespecified analyses, among patients with high baseline distress (n = 60), CST recipients had greater improvement in 6-month HADS score (difference, -4.6; 95% CI, -8.6 to -0.6; P = 0.02) than the education group. Among patients ventilated longer than 7 days (n = 47), education recipients had greater improvement in 3-month HADS score (difference, -4.0; 95% CI, -8.1 to -0.05; P = 0.047) than the CST group. CST did not improve psychological distress symptoms compared with an education program. However, CST improved symptoms of distress at 6 months among patients with high baseline distress, whereas the education program improved distress at 3 months among those ventilated for more than 7 days. Future efforts to address psychological distress among critical illness survivors should target high-risk populations. Clinical trial registered with www.clinicaltrials.gov (NCT01983254).

Objectives. We sought to estimate the return on investment of a streamlined version of an evidence-based community health worker (CHW) asthma home visit program. Methods. We used a randomized parallel group trial of home visits by CHWs to Medicaid-enrolled children with uncontrolled asthma versus usual care. Results. A total of 373 participants enrolled in the study (182 in the intervention group and 191 in the control group, of whom 154 and 179, respectively, completed the study). The intervention group had greater improvements in asthma symptom–free days (2.10 days more over 2 weeks; 95% CI =  1.17, 3.05; P < .001) and caretakers’ quality of life (0.43 units more; 95% CI = 0.20, 0.66; P < .001) and a larger reduction in urgent health care utilization events (1.31 events fewer over 12 months; 95% CI = −2.10, −0.52; P = .001). The intervention arm compared with the control arm saved$1340.92 for the $ 707.04 additional costs invested for the average participant. The return on investment was 1.90. Conclusions. A streamlined CHW asthma home visit program for children with uncontrolled asthma improved health outcomes and yielded a return on investment of 1.90.

Objectives. To compare asthma control for children receiving either community health worker (CHW) or certified asthma educator (AE-C) services. Methods. The Asthma Action at Erie Trial is a comparative effectiveness trial that ran from 2016 to 2019 in Cook County, Illinois. Participants (aged 5‒16 years with uncontrolled asthma) were randomized to 10 home visits from clinically integrated asthma CHWs or 2 in-clinic sessions from an AE-C. Results. Participants (n = 223) were mainly Hispanic (85%) and low-income. Both intervention groups showed significant improvement in asthma control scores over time. Asthma control was maintained after interventions ended. The CHW group experienced a greater improvement in asthma control scores. One year after intervention cessation, the CHW group had a 42% reduction in days of activity limitation relative to the AE-C group (b = 0.58; 95% confidence interval = 0.35, 0.96). Conclusions. Both interventions were associated with meaningful improvements in asthma control. Improvements continued for 1 year after intervention cessation and were stronger with the CHW intervention. Public Health Implications. Clinically integrated asthma CHW and AE-C services that do not provide home environmental remediation equipment may improve and sustain asthma control.

BackgroundReduction in 30-day readmission rates following hospitalization for acute coronary syndrome (ACS) and acute decompensated heart failure (ADHF) is a national goal.ObjectiveThe aim of this study was to determine the effect of a tailored, pharmacist-delivered, health literacy intervention on unplanned health care utilization, including hospital readmission or emergency room (ER) visit, following discharge.DesignRandomized, controlled trial with concealed allocation and blinded outcome assessorsSettingTwo tertiary care academic medical centersParticipantsAdults hospitalized with a diagnosis of ACS and/or ADHFInterventionPharmacist-assisted medication reconciliation, inpatient pharmacist counseling, low-literacy adherence aids, and individualized telephone follow-up after dischargeMain MeasuresThe primary outcome was time to first unplanned health care event, defined as hospital readmission or an ER visit within 30 days of discharge. Pre-specified analyses were conducted to evaluate the effects of the intervention by academic site, health literacy status (inadequate versus adequate), and cognition (impaired versus not impaired). Adjusted hazard ratios (aHR) and 95 % confidence intervals (CI) are reported.Key ResultsA total of 851 participants enrolled in the study at Vanderbilt University Hospital (VUH) and Brigham and Women’s Hospital (BWH). The primary analysis showed no statistically significant effect on time to first unplanned hospital readmission or ER visit among patients who received interventions compared to controls (aHR = 1.04, 95 % CI 0.78-1.39). There was an interaction of treatment effect by site (p = 0.04 for interaction); VUH aHR = 0.77, 95 % CI 0.51-1.15; BWH aHR = 1.44 (95 % CI 0.95-2.12). The intervention reduced early unplanned health care utilization among patients with inadequate health literacy (aHR 0.41, 95 % CI 0.17-1.00). There was no difference in treatment effect by patient cognition.ConclusionA tailored, pharmacist-delivered health literacy-sensitive intervention did not reduce post-discharge unplanned health care utilization overall. The intervention was effective among patients with inadequate health literacy, suggesting that targeted practice of pharmacist intervention in this population may be advantageous.

OBJECTIVE: To conduct a 1-year randomized clinical trial to evaluate a remote comprehensive diabetes self-management education (DSME) intervention, Diabetes TeleCare, administered by a dietitian and nurse/certified diabetes educator (CDE) in the setting of a federally qualified health center (FQHC) in rural South Carolina. RESEARCH DESIGN AND METHODS: Participants were recruited from three member health centers of an FQHC and were randomized to either Diabetes TeleCare, a 12-month, 13-session curriculum delivered using telehealth strategies, or usual care. RESULTS: Mixed linear regression model results for repeated measures showed a significant reduction in glycated hemoglobin (GHb) in the Diabetes TeleCare group from baseline to 6 and 12 months (9.4 ± 0.3, 8.3 ± 0.3, and 8.2 ± 0.4, respectively) compared with usual care (8.8 ± 0.3, 8.6 ± 0.3, and 8.6 ± 0.3, respectively). LDL cholesterol was reduced at 12 months in the Diabetes TeleCare group compared with usual care. Although not part of the original study design, GHb was reduced from baseline to 12 and 24 months in the Diabetes TeleCare group (9.2 ± 0.4, 7.4 ± 0.5, and 7.6 ± 0.5, respectively) compared with usual care (8.7 ± 0.4, 8.1 ± 0.4, and 8.1 ± 0.5, respectively) in a post hoc analysis of a subset of the randomized sample who completed a 24-month follow-up visit. CONCLUSIONS: Telehealth effectively created access to successfully conduct a 1-year remote DSME by a nurse CDE and dietitian that improved metabolic control and reduced cardiovascular risk in an ethnically diverse and rural population.

Background The Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) and Care Transitions Measure (CTM-3) scores are patient experience measures used to determine hospital value-based purchasing reimbursement. Interventions to improve 30-day readmissions have met with mixed results, but less is known about their potential to improve the patient experience among older ethnically and linguistically diverse adults receiving care at safety-net hospitals. In this study, we assessed the effect of a nurse-led hospital-based care transition intervention on discharge-related patient experience in an older multilingual population of adults hospitalized at a safety-net hospital. Methods We randomized 700 inpatients aged 55 and older at an academic urban safety-net hospital. In addition to usual care, intervention participants received inpatient visits by a language-concordant study nurse and post-discharge phone calls from a language-concordant nurse practitioner to reinforce the care plan and to address acute complaints. We measured HCAHPS nursing, medication, and discharge communication domain scores and CTM-3 scores at 30 days after hospital discharge. Results Of 685 participants who survived to 30 days, 90 % ( n  = 616) completed follow-up interviews. The mean age was 66.2 years; over half (54.2 %) of the participants had cognitive impairment, and 33.8 % had moderate to severe depression. The majority (62.1 %) of interviews were conducted in English; 23.3 % were conducted in Chinese and 14.6 % in Spanish. Study nurses spent an average of 157 min with intervention participants. Between intervention and usual care participants, CTM-3 scores (80.5 % vs 78.5 %; p  = 0.18) and HCAHPS discharge communication domain scores (74.8 % vs 68.7 %; p  = 0.11) did not differ, nor did HCAHPS scores in medication (44.5 % vs 53.1 %; p  = 0.13) and nursing domains (67.9 % vs 64.9 %; p  = 0.43). When stratified by language, no significant differences were seen. Conclusion An inpatient standalone transition-of-care intervention did not improve patient discharge experience. Older multi-lingual and cognitively impaired populations may require higher-intensity interventions post-hospitalization to improve discharge experience outcomes.

Background Pain self-management support interventions were effective in controlled clinical trials and meta analyses. However, implementation of these complex interventions may not translate into identical effects. This paper evaluates the implementation of ANtiPain, a cancer pain self-management support intervention in routine clinical practice according to the R each E fficacy- A doption I mplementation M aintenance framework. Methods In this cluster randomized study with a stepped wedge design, N  = 153 adult patients with cancer-related pain were recruited from 01/17 to 05/18 on 17 wards of 3 hospitals in Vienna, Austria. ANtiPain entailed a face-to-face in-hospital session by a trained nurse to prepare discharge according to key strategies, information on pain self-management, and skills building. After discharge, cancer-pain self-management was coached via phone calls. Patient-level data were collected at recruitment, and 2, 4 and 8 weeks after discharge via postal or online questionnaire. Primary outcome was pain interference with daily activities. Secondary outcomes included pain intensity, self-efficacy, and patient satisfaction. Organizational-level data (e.g., on implementation procedures) were collected by study or intervention nurses. The mixed model to analyze patient-level data included a random intercept and a random slope for individual and a random intercept for ward. Results Recruitment was slower than expected and unevenly distributed over wards and hospitals. The face-to-face session was clinically feasible (mean duration = 33 min) as well as the mean amount ( n  = 2) and duration of phone calls (mean = 17 min). Only 16 (46%) of 35 trained nurses performed the intervention on nine wards. To deal with the loss of power, analyses were adapted. Overall effects on pain interference were not significant. However, effects were significant in sub analyses of the nine wards that recruited patients in the intervention period ( p  = .009). Regarding secondary outcomes, the group-by-time effect was significant for self-efficacy ( p  = .033), and patient satisfaction with information on pain-self-management ( p  = .002) and in-hospital pain management ( p  = .018). Conclusions The implementation of ANtiPain improved meaningful patient outcomes on wards that applied the intervention routinely. Our analyses showed that the implementation benefited from being embedded in larger scale projects to improve cancer pain management and that the selection of wards with a high percentage of oncology patients may be crucial. Trial registration ClinicalTrials.gov Identifier: NCT02891785 Date of registration: September 8, 2016.

Not providing adequate patient education interventions to asthma patients remains a major care gap. To help asthma patients and caregivers discuss inhaled controller medication use, our team has previously developed a decision aid (DA). We sought to assess whether adding this DA to education interventions improved knowledge, decisional conflict, and asthma control among adults with asthma. A parallel clinical trial (NCT02516449). We recruited adults with asthma, aged 18 to 65 years, prescribed inhaled controller medication to optimize asthma control. Educators randomly allocated participants either to the education + DA or to the education group. At baseline and two-month follow-up, we measured asthma knowledge (primary outcome) with a validated self-administered questionnaire (score -37 to +37). Secondary outcomes included decisional conflict and asthma control. Blinded assessors collected data. Between the two time points, the within- and between-group changes were estimated by generalized linear mixed models. Fifty-one participants (response rate: 53%; age: 44 ± 13 years; women: n = 32) were randomized either to the education + DA group (n = 26) or to the education group (n = 25), and included in statistical analyses. Between baseline and follow-up, mean [95% CI] knowledge scores increased from 21.5 [19.9-23.2] to 25.1 [23.1-27.0] in the education + DA group (P = 0.0002) and from 24.0 [22.3-25.7] to 26.0 [24.0-28.0] in the education group (P = 0.0298). In both of the groups, decisional conflict and asthma control improved. There were no differences between groups. Education improved knowledge, decisional conflict, and asthma control whether the DA was added or not.