scholarly journals Evaluating the Effectiveness of Diabetes Shared Medical Appointments (SMAs) as Implemented in Five Veterans Affairs Health Systems: a Multi-site Cluster Randomized Pragmatic Trial

Author(s):  
Michele Heisler ◽  
Jennifer Burgess ◽  
Jeffrey Cass ◽  
John F. Chardos ◽  
Alexander B. Guirguis ◽  
...  

Abstract Objective To examine whether diabetes shared medical appointments (SMAs) implemented as part of usual clinical practice in diverse health systems are more effective than usual care in improving and sustaining A1c improvements. Research Design and Methods A multi-site cluster randomized pragmatic trial examining implementation in clinical practice of diabetes SMAs in five Veterans Affairs (VA) health systems was conducted from 2016 to 2020 among 1537 adults with type 2 diabetes and elevated A1cs. Eligible patients were randomly assigned to either: (1) invitation to participate in a series of SMAs totaling 8–9 h; or (2) continuation of usual care. Relative change in A1c (primary outcome) and in systolic blood pressure, insulin starts, statin starts, and anti-hypertensive medication classes (secondary outcomes) were measured as part of usual clinical care at baseline, at 6 months and at 12 months (~7 months after conclusion of the final SMA in four of five sites). We examined outcomes in three samples of SMA participants: all those scheduled for a SMA, those attending at least one SMA, and those attending at least half of SMAs. Results Baseline mean A1c was 9.0%. Participants scheduled for an SMA achieved A1c reductions 0.35% points greater than the control group between baseline and 6-months follow up (p = .001). Those who attended at least one SMA achieved reductions 0.42 % points greater (p < .001), and those who attended at least half of scheduled SMAs achieved reductions 0.53 % points greater (p < .001) than the control group. At 12-month follow-up, the three SMA analysis samples achieved reductions from baseline ranging from 0.16 % points (p = 0.12) to 0.29 % points (p = .06) greater than the control group. Conclusions Diabetes SMAs as implemented in real-life diverse clinical practices improve glycemic control more than usual care immediately after the SMAs, but relative gains are not maintained. Our findings suggest the need for further study of whether a longer term SMA model or other follow-up strategies would sustain relative clinical improvements associated with this intervention. Trial Registration ClinicalTrials.gov ID NCT02132676

Author(s):  
Brian E Dixon ◽  
Kimberly M Judon ◽  
Ashley L Schwartzkopf ◽  
Vivian M Guerrero ◽  
Nicholas S Koufacos ◽  
...  

Abstract Objective To examine the effectiveness of event notification service (ENS) alerts on health care delivery processes and outcomes for older adults. Materials and methods We deployed ENS alerts in 2 Veterans Affairs (VA) medical centers using regional health information exchange (HIE) networks from March 2016 to December 2019. Alerts targeted VA-based primary care teams when older patients (aged 65+ years) were hospitalized or attended emergency departments (ED) outside the VA system. We employed a concurrent cohort study to compare postdischarge outcomes between patients whose providers received ENS alerts and those that did not (usual care). Outcome measures included: timely follow-up postdischarge (actual phone call within 7 days or an in-person primary care visit within 30 days) and all-cause inpatient or ED readmission within 30 days. Generalized linear mixed models, accounting for clustering by primary care team, were used to compare outcomes between groups. Results Compared to usual care, veterans whose primary care team received notification of non-VA acute care encounters were 4 times more likely to have phone contact within 7 days (AOR = 4.10, P &lt; .001) and 2 times more likely to have an in-person visit within 30 days (AOR = 1.98, P = .007). There were no significant differences between groups in hospital or ED utilization within 30 days of index discharge (P = .057). Discussion ENS was associated with increased timely follow-up following non-VA acute care events, but there was no associated change in 30-day readmission rates. Optimization of ENS processes may be required to scale use and impact across health systems. Conclusion Given the importance of ENS to the VA and other health systems, this study provides guidance for future research on ENS for improving care coordination and population outcomes. Trial Registration ClinicalTrials.gov NCT02689076. “Regional Data Exchange to Improve Care for Veterans After Non-VA Hospitalization.” Registered February 23, 2016.


PLoS ONE ◽  
2021 ◽  
Vol 16 (10) ◽  
pp. e0258406
Author(s):  
Mahesh Kumar Khanal ◽  
Pratiksha Bhandari ◽  
Raja Ram Dhungana ◽  
Pratik Bhandari ◽  
Lal B. Rawal ◽  
...  

Background Hypertension is a major global public health problem. Elevated blood pressure can cause cardiovascular and kidney diseases. We assessed the effectiveness of health education sessions and home support programs in reducing blood pressure among patients with uncontrolled hypertension in a suburban community of Nepal. Methods We conducted a community-based, open-level, parallel-group, cluster randomized controlled trial in Birendranagar municipality of Surkhet, Nepal. We randomly assigned four clusters (wards) into intervention and control arms. We provided four health education sessions, frequent home and usual care for intervention groups over six months. The participants of the control arm received only usual care from health facilities. The primary outcome of this study was the proportion of controlled systolic blood pressure (SBP). The analysis included all participants who completed follow-up at six months. Results 125 participants were assigned to either the intervention (n = 63) or the control (n = 62) group. Of them, 60 participants in each group completed six months follow-up. The proportion of controlled SBP was significantly higher among the intervention participants compared to the control (58.3% vs. 40%). Odds ratio of this was 2.1 with 95% CI: 1.01–4.35 (p = 0.046) and that of controlled diastolic blood pressure (DBP) was 1.31 (0.63–2.72) (p = 0.600). The mean change (follow-up minus baseline) in SBP was significantly higher in the intervention than in the usual care (-18.7 mmHg vs. -11.2 mmHg, p = 0.041). Such mean change of DBP was also higher in the intervention (-10.95 mmHg vs. -5.53 mmHg, p = 0.065). The knowledge score on hypertension improved by 2.38 (SD 2.4) in the intervention arm, which was significantly different from that of the control group, 0.13 (1.8) (p<0.001). Conclusions Multiple health education sessions complemented by frequent household visits by health volunteers can effectively improve knowledge on hypertension and reduce blood pressure among uncontrolled hypertensive patients at the community level in Nepal. Trial registration ClinicalTrial.gov: NCT02981251


2019 ◽  
Author(s):  
Sarah Dineen-Griffin ◽  
Victoria Garcia Cardenas ◽  
Kylie Williams ◽  
Shalom Isaac Benrimoj

BACKGROUND Internationally, governments have been investing in supporting pharmacists to take on an expanded role to support self-care for health system efficiency. There is consistent evidence that minor ailment schemes (MAS) promote efficiencies within the healthcare system. The cost savings and health outcomes demonstrated in the UK and Canada opens up new opportunities for pharmacists to effect sustainable changes through MAS delivery in Australia. OBJECTIVE This trial is evaluating the clinical, economic and humanistic impact of an Australian minor ailments service (AMAS), compared with usual pharmacy care in a cluster-randomized controlled trial in Western Sydney, Australia. METHODS The cluster-randomized controlled trial design has an intervention and a control group, comparing individuals receiving a structured intervention with those receiving usual care for specific common ailments. Participants will be community pharmacies, general practices and patients located in Western Sydney Primary Health Network region. 30 community pharmacies will be randomly assigned to either intervention or control group. Each will recruit 24 patients seeking, aged 18 years or older, presenting to the pharmacy in person with a symptom-based or product-based request for one of the following ailments (reflux, cough, common cold, headache (tension or migraine), primary dysmenorrhoea and low back pain). Intervention pharmacists will deliver protocolized care to patients using clinical treatment pathways with agreed referral points and collaborative systems boosting clinician-pharmacist communication. Patients recruited in control pharmacies will receive usual care. The co-primary outcomes are rates of appropriate use of nonprescription medicines and rates of appropriate medical referral. Secondary outcomes include self-reported symptom resolution, time to resolution of symptoms, health services resource utilization and EQ VAS. Differences in the primary outcomes between groups will be analyzed at the individual patient level accounting for correlation within clusters with generalized estimating equations. The economic impact of the model will be evaluated by cost analysis compared with usual care. RESULTS The study began in July 2018. At the time of submission, 30 community pharmacies have been recruited. Pharmacists from the 15 intervention pharmacies have been trained. 27 general practices have consented. Pharmacy patient recruitment began in August 2018 and is ongoing and monthly targets are being met. Recruitment will be completed March 31st, 2019. CONCLUSIONS This study may demonstrate the utilization and efficacy of a protocolized intervention to manage minor ailments in the community, and will assess the clinical, economic and humanistic impact of this intervention in Australian pharmacy practice. Pharmacists supporting patient self-care and self-medication may contribute greater efficiency of healthcare resources and integration of self-care in the health system. The proposed model and developed educational content may form the basis of a MAS national service, with protocolized care for common ailments using a robust framework for management and referral. CLINICALTRIAL Registered with Australian New Zealand Clinical Trials Registry (ANZCTR) and allocated the ACTRN: ACTRN12618000286246. Registered on 23 February 2018.


Author(s):  
Linda Gordon ◽  
Amanda Malecky ◽  
Andrew Althouse ◽  
Nicole Ansani

Background: Data demonstrate an adverse association between depression and coronary artery disease prognosis. Therefore, a depression screening program was initiated in the catheterization (cath) lab. The goals were to improve HEDIS depression compliance rates and determine the impact on clinical outcomes. Methods: Adult patients in an inpatient cath lab from 3 cardiology practices were screened for enrollment in a randomized controlled trial. All cath lab patients received a PHQ-9 depression screener. Those who screened positive for depression (score ≥ 10) were randomized to intervention or usual care. The usual care group received a follow-up phone call to re-administer the PHQ-9 at 6-8 weeks and within 210 days of discharge. The intervention group was administered the PHQ-9 and received intensive education at baseline, 6-8 weeks, and within 210 days of discharge. Education included targeted depression information with a mental health care provider and comprehensive disease management education with a cardiovascular nurse practitioner. Outcomes included: differences in HEDIS depression goal attainment; depression response/remission rates; and cardiovascular goals. Differences between groups were tested using chi-squared tests (categorical variables) and t-tests (continuous variables). Results: Baseline characteristics were similar between control (N=43) and intervention (N=40) groups, with the exception of significantly fewer African American patients in the control group (N=2, 4.7%) vs intervention (N=9, 22.5%). Changes in HEDIS goal attainment show that patients in the intervention group were slightly more likely to be referred to a provider to address depression (95.0% vs 86.0%, p=0.314), or receive meds for depression (65.0% vs 51.2%, p=0.219), but these differences are not statistically significant. More patients in the intervention group refused meds for depression compared to control (15.0% vs. 2.3%, p=0.041); have received blood work (65.0% vs 41.9%, p=0.030); and have received follow-up within 210 days (82.5% vs 46.5%, p<0.001). Treatment adjustment rate was higher in the intervention group compared to control (85.0% vs. 65.1%, p=0.037). Hospital readmission rate was similar between groups (p=0.896) and there was no difference in depression remission or response rates (p=0.426). Further, no differences were seen in cardiovascular surrogate outcome parameters, including cholesterol, A1c, CRP, or BNP between groups; except SGOT was significantly different between groups (-5.0 intervention vs 2.0 control p=0.045). Conclusions: These data demonstrate improvements in attaining a surrogate outcome measure of quality (HEDIS goals); however, this does not appear to translate to a significant clinical impact. Quality measures may need to be continuously reassessed to ensure efficiency and effectiveness of care.


2019 ◽  
Vol 107 (2) ◽  
Author(s):  
Marianne Burke ◽  
Benjamin Littenberg

Objective: Providers’ use of clinical evidence technologies (CETs) improves their diagnosis and treatment decisions. Despite these benefits, few studies have evaluated the impact of CETs on patient outcomes. The investigators evaluated the effect of one CET, VisualDx, on skin problem outcomes in primary care.Methods: A cluster-randomized controlled pragmatic trial was conducted in outpatient clinics at an academic medical center in the northeastern United States. Participants were primary care providers (PCPs), and their adult patients were seen for skin problems. The intervention was VisualDx, as used by PCPs. Outcomes were patient-reported time from index clinic visit to problem resolution, and the number of follow-up visits to any provider for the same problem. PCPs who were randomly assigned to the intervention agreed to use VisualDx as their primary evidence source for skin problems. Control group PCPs agreed not to use VisualDx. Investigators collected outcome data from patients by phone at thirty-day intervals. Cox proportional hazards models assessed time to resolution. Wilcoxon-rank sum tests and logistic regression compared the need for return appointments.Results: Thirty-two PCPs and 433 patients participated. In proportional hazards modelling adjusted for provider clusters, the time from index visit to skin problem resolution was similar in both groups (hazard ratio=0.92; 95% confidence interval [CI]=0.70, 1.21; p=0.54). Patient follow-up appointments did not differ significantly between groups (odds ratio=1.26; CI=0.94, 1.70; p=0.29).Conclusion: This pragmatic trial tested the effectiveness of VisualDx on patient-reported skin disease outcomes in a generalizable clinical setting. There was no difference in skin problem resolution or number of follow-up visits when PCPs used VisualDx.


Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Bethany M. Kwan ◽  
L. Miriam Dickinson ◽  
Russell E. Glasgow ◽  
Martha Sajatovic ◽  
Mark Gritz ◽  
...  

2020 ◽  
Vol 15 (1) ◽  
Author(s):  
Matthias Hoben ◽  
Liane R. Ginsburg ◽  
Adam Easterbrook ◽  
Peter G. Norton ◽  
Ruth A. Anderson ◽  
...  

Abstract Background Effective communication among interdisciplinary healthcare teams is essential for quality healthcare, especially in nursing homes (NHs). Care aides provide most direct care in NHs, yet are rarely included in formal communications about resident care (e.g., change of shift reports, family conferences). Audit and feedback is a potentially effective improvement intervention. This study compares the effect of simple and two higher intensity levels of feedback based on goal-setting theory on improving formal staff communication in NHs. Methods This pragmatic three-arm parallel cluster-randomized controlled trial included NHs participating in TREC (translating research in elder care) across the Canadian provinces of Alberta and British Columbia. Facilities with at least one care unit with 10 or more care aide responses on the TREC baseline survey were eligible. At baseline, 4641 care aides and 1693 nurses cared for 8766 residents in 67 eligible NHs. NHs were randomly allocated to a simple (control) group (22 homes, 60 care units) or one of two higher intensity feedback intervention groups (based on goal-setting theory): basic assisted feedback (22 homes, 69 care units) and enhanced assisted feedback 2 (23 homes, 72 care units). Our primary outcome was the amount of formal communication about resident care that involved care aides, measured by the Alberta Context Tool and presented as adjusted mean differences [95% confidence interval] between study arms at 12-month follow-up. Results Baseline and follow-up data were available for 20 homes (57 care units, 751 care aides, 2428 residents) in the control group, 19 homes (61 care units, 836 care aides, 2387 residents) in the basic group, and 14 homes (45 care units, 615 care aides, 1584 residents) in the enhanced group. Compared to simple feedback, care aide involvement in formal communications at follow-up was 0.17 points higher in both the basic ([0.03; 0.32], p = 0.021) and enhanced groups ([0.01; 0.33], p = 0.035). We found no difference in this outcome between the two higher intensity groups. Conclusions Theoretically informed feedback was superior to simple feedback in improving care aides’ involvement in formal communications about resident care. This underlines that prior estimates for efficacy of audit and feedback may be constrained by the type of feedback intervention tested. Trial registration ClinicalTrials.gov (NCT02695836), registered on March 1, 2016


2020 ◽  
Vol 8 (1) ◽  
Author(s):  
Virpi Kalakoski ◽  
Sanna Selinheimo ◽  
Teppo Valtonen ◽  
Jarno Turunen ◽  
Sari Käpykangas ◽  
...  

Abstract Background Cognitively straining conditions such as disruptions, interruptions, and information overload are related to impaired task performance and diminished well-being at work. It is therefore essential that we reduce their harmful consequences to individual employees and organizations. Our intervention study implements practices for managing the cognitive strain typical to office work tasks and working conditions in offices. We will examine the effects of a cognitive ergonomics intervention on working conditions, workflow, well-being, and productivity. Methods/design The study is a stratified cluster randomized trial. The clusters are work units, for example, teams or offices. The four participating organizations entered a total of 36 clusters, and we invited all 1169 knowledge employees of these units to participate. We randomly allocated the clusters into an intervention group (cognitive ergonomics) or an active control group (recovery supporting). We invited an additional 471 participants to join a passive control group only for baseline and follow-up measurements, with no intervention. The study consists of a baseline survey and interviews and observations at the workplace, followed by an intervention. It starts with a workshop defining the specific actions for the intervention implementation stage, during which we send task reminder questionnaires to all employees to support behaviour change at the individual and team levels. The primary outcome measure is perceived frequency of cognitive strain from working conditions; the secondary outcome measures include subjective cognitive load, well-being, workflow/productivity, and cognitive stress symptoms. Process evaluation uses the quantitative and qualitative data obtained during the implementation and evaluation phases. The baseline measurements, intervention phase, and end-of-treatment measurements are now complete, and follow-up will continue until November 2019. Discussion There is a need to expand the research of cognitive strain, which poses a considerable risk to work performance and employee well-being in cognitively demanding tasks. Our study will provide new information about factors that contribute to such strain. Most importantly, the results will show which evidence-based cognitive ergonomic practices support work performance in knowledge work, and the project will provide concrete examples of how to improve at work. Trial registration ClinicalTrials.gov, NCT03573674. Registered 29 June 2018.


2019 ◽  
Vol 30 (5) ◽  
pp. 890-903 ◽  
Author(s):  
Laura M. Dember ◽  
Eduardo Lacson ◽  
Steven M. Brunelli ◽  
Jesse Y. Hsu ◽  
Alfred K. Cheung ◽  
...  

BackgroundData from clinical trials to inform practice in maintenance hemodialysis are limited. Incorporating randomized trials into dialysis clinical care delivery should help generate practice-guiding evidence, but the feasibility of this approach has not been established.MethodsTo develop approaches for embedding trials into routine delivery of maintenance hemodialysis, we performed a cluster-randomized, pragmatic trial demonstration project, the Time to Reduce Mortality in ESRD (TiME) trial, evaluating effects of session duration on mortality (primary outcome) and hospitalization rate. Dialysis facilities randomized to the intervention adopted a default session duration ≥4.25 hours (255 minutes) for incident patients; those randomized to usual care had no trial-driven approach to session duration. Implementation was highly centralized, with no on-site research personnel and complete reliance on clinically acquired data. We used multiple strategies to engage facility personnel and participating patients.ResultsThe trial enrolled 7035 incident patients from 266 dialysis units. We discontinued the trial at a median follow-up of 1.1 years because of an inadequate between-group difference in session duration. For the primary analysis population (participants with estimated body water ≤42.5 L), mean session duration was 216 minutes for the intervention group and 207 minutes for the usual care group. We found no reduction in mortality or hospitalization rate for the intervention versus usual care.ConclusionsAlthough a highly pragmatic design allowed efficient enrollment, data acquisition, and monitoring, intervention uptake was insufficient to determine whether longer hemodialysis sessions improve outcomes. More effective strategies for engaging clinical personnel and patients are likely required to evaluate clinical trial interventions that are fully embedded in care delivery.


Author(s):  
Nicolás Martínez-Velilla ◽  
Pedro L Valenzuela ◽  
Mikel L Sáez de Asteasu ◽  
Fabricio Zambom-Ferraresi ◽  
Robinson Ramírez-Vélez ◽  
...  

Abstract Objective To analyze the effects of a tailored exercise intervention in acutely hospitalized elderly diabetic patients. Research Design and Methods This is an ancillary analysis of a randomized controlled trial (RCT). A total of 103 acutely hospitalized elderly adults (mean age ~87 years) with type II diabetes were randomized to an intervention (exercise, n = 54) or control group (usual care, n = 49). The primary endpoint was change in functional status from baseline to hospital discharge as assessed with the Barthel Index and the Short Physical Performance Battery (SPPB). Secondary endpoints comprised cognitive function and mood status, quality of life (QoL), incidence of delirium, and handgrip strength. Exercise-related side effects, length of hospital stay, and incidence of falls during hospitalization were also assessed, as well as transfer to nursing homes, hospital readmission, and mortality during a 3-month follow-up. Results The median length of stay was 8 days (interquartile range, 4) for both groups. The intervention was safe and provided significant benefits over usual care on SPPB (2.7 [95% confidence interval (CI) 1.8, 3.5]) and Barthel Index (8.5 [95% CI: 3.9, 13.1]), as well as on other secondary endpoints such as cognitive status, depression, QoL, and handgrip strength (all P &lt; 0.05). No significant between-group differences were found for the remainder of secondary endpoints. Conclusions An in-hospital individualized multicomponent exercise intervention was safe and effective for the prevention of functional and cognitive decline in acutely hospitalized elderly diabetic patients, although it had no influence on other endpoints assessed during hospitalization or at the 3-month follow-up after discharge.


Sign in / Sign up

Export Citation Format

Share Document