Usual Care Group Research Articles

Electronic Patient-Reported Outcome-Based Symptom Management Versus Usual Care After Lung Cancer Surgery: Long-Term Results of a Multicenter, Randomized, Controlled Trial.

Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported.We previously reported superior symptom control of electronic patient-reported outcome (ePRO)-based symptom management after lung cancer surgery for up to 1 month postdischarge. Here, we present the long-term results (1-12 months) of this multicenter, randomized trial, where patients were assigned 1:1 to receive postoperative ePRO-based symptom management or usual care daily postsurgery, twice weekly postdischarge until 1 month, and at 3, 6, 9, and 12 months postdischarge. Long-term patient-reported outcomes were assessed with MD Anderson Symptom Inventory-Lung Cancer module. Per-protocol analyses were performed with 55 patients in the ePRO group and 57 in the usual care group. At 12 months postdischarge, the ePRO group reported significantly fewer symptom threshold events (any of the five target symptom scored ≥4; median [IQR], 0 [0-0] v 0 [0-1]; P = .040) than the usual care group. From 1 to 12 months postdischarge, the ePRO group consistently reported significantly lower composite scores for physical interference (estimate, -0.86 [95% CI, -1.32 to -0.39]) and affective interference (estimate, -0.70 [95% CI, -1.14 to -0.26]). Early intensive ePRO-based symptom management after lung cancer surgery reduced symptom burden and improved functional status for up to 1 year postdischarge, supporting its integration into standard care.

Pragmatic Trial of Hospitalization Rate in Chronic Kidney Disease

BackgroundDespite the availability of effective therapies for patients with chronic kidney disease, type 2 diabetes, and hypertension (the kidney-dysfunction triad), the results of large-scale trials examining the implementation of guideline-directed therapy to reduce the risk of death and complications in this population are lacking.MethodsIn this open-label, cluster-randomized trial, we assigned 11,182 patients with the kidney-dysfunction triad who were being treated at 141 primary care clinics either to receive an intervention that used a personalized algorithm (based on the patient’s electronic health record [EHR]) to identify patients and practice facilitators to assist providers in delivering guideline-based interventions or to receive usual care. The primary outcome was hospitalization for any cause at 1 year. Secondary outcomes included emergency department visits, readmissions, cardiovascular events, dialysis, and death.ResultsWe assigned 71 practices (enrolling 5690 patients) to the intervention group and 70 practices (enrolling 5492 patients) to the usual-care group. The hospitalization rate at 1 year was 20.7% (95% confidence interval [CI], 19.7 to 21.8) in the intervention group and 21.1% (95% CI, 20.1 to 22.2) in the usual-care group (between-group difference, 0.4 percentage points; P=0.58). The risks of emergency department visits, readmissions, cardiovascular events, dialysis, or death from any cause were similar in the two groups. The risk of adverse events was also similar in the trial groups, except for acute kidney injury, which was observed in more patients in the intervention group (12.7% vs. 11.3%).ConclusionsIn this pragmatic trial involving patients with the triad of chronic kidney disease, type 2 diabetes, and hypertension, the use of an EHR-based algorithm and practice facilitators embedded in primary care clinics did not translate into reduced hospitalization at 1 year. (Funded by the National Institutes of Health and others; ICD-Pieces ClinicalTrials.gov number, NCT02587936.)

Efficacy of electro-acupuncture versus sham acupuncture for diabetic peripheral neuropathy: study protocol for a three-armed randomised controlled trial

IntroductionSpecific treatment for diabetic peripheral neuropathy (DPN) is still lacking, and acupuncture may relieve the symptoms. We intend to investigate the efficacy and safety of electro-acupuncture (EA) in alleviating symptoms...

The Effectiveness of Telemedicine Consultation in Improving Outcomes of Asthma in the Paediatric Population: A Systematic Review and Meta-Analysis

Abstract Telemedicine facilitates clinicians in providing virtual consultations and assessments to paediatric patients, offering a more convenient and efficient healthcare delivery. The aim of this study was to assess the efficacy of telemedicine compared with usual care in paediatric asthma. A systematic literature search was conducted in PubMed, Scopus, Embase, and Ovid SP. Risk ratios (RRs) were used for dichotomous outcomes, and standardised mean differences (SMDs) were used for continuous outcomes with 95% confidence intervals (CIs). A total of 10 studies were included in the meta-analysis. The telemedicine group had more asthma symptom-free days compared with the usual care group with an SMD of 0.18 (95% CI = 0.04–0.32). The telemedicine group had a higher rate of well-controlled asthma in telemedicine compared with the usual care group with an RR of 1.27 (95% CI = 1.14–1.42). The present findings suggest that telemedicine may be an effective alternative to in-person visits for improving asthma control.

Liver fat as a dietary target by Chinese Medical Nutrition Therapy (CMNT) diet for treating type 2 diabetes with non-alcoholic fatty liver disease: study protocol for a randomised controlled trial

IntroductionType 2 diabetes and non-alcoholic fatty liver disease (NAFLD) often coexist and increase risk for developing liver fibrosis and diabetes complications if no effective measures are taken. Dietary intervention is...

Six-month combined aerobic and resistance exercise program enhances 6-minute walk test and physical fitness in people with peripheral arterial disease: A pilot study

BackgroundExercise therapy is a recognized non-pharmacological intervention for peripheral arterial disease (PAD); however, the effects of combined exercise remain under investigation. This study aimed to compare the effects of a 6-month combined supervised exercise program (SUP) with a usual care (UC) approach on walking ability, physical fitness, and peripheral blood flow in people with PAD and claudication. MethodsTwenty-three male participants (Age=64.1 ± 6.2years and ABI=0.58±0.07) with PAD and claudication were assigned to either the SUP group (n = 10), engaging in structured supervised treadmill walking combined with three resistance exercises, three times a week, or the UC group (n = 13), receiving advice to walk. The primary outcome measure was walking ability, with assessments conducted at baseline (M0), after 3 months (M3), and 6 months (M6). ResultsAfter the 6-month intervention, the SUP group exhibited significant improvements in absolute claudication time (ACT, p = 0.045), maximal walking time (MWT, p = 0.045), maximal walking distance (MWD, p = 0.027), and pause duration (p = 0.045) during the 6-minute walk test (6MWT), when compared to the UC group. Over time, a significant increase in walking speed during the 6MWT (Speed6MWT, p = 0.001) and walking speed without claudication (SpeedNoC, p < 0.001) was found, although no significant differences were found between the groups. The SUP group increased by 0.8 km/h in both Speed6MWT and SpeedNoC, while the UC group increased by 0.3 km/h and 0.6 km/h, respectively. Despite claudication consistently occurring at the same time, the SUP group demonstrated an improved tolerance to pain or a better understanding of pain, enabling them to walk longer distances at higher speeds. A positive effect of SUP was found for chair sit-and-reach test (p = 0.023), percentage of fat mass (p = 0.048), fat-free mass (p = 0.040), and total body water (p = 0.026), suggesting potential benefits attributed to the resistance strength exercises. ConclusionA 6-month combined treadmill and resistance exercise program improved walking ability, walking speed, lower body and lower back flexibility, and body composition in people with PAD and claudication.

Unraveling the Mechanisms Behind Exercise Intolerance and Recovery in Long COVID

BackgroundPatients suffering from long COVID may exhibit autonomic dysregulation. However, the association between autonomic dysregulation and exercise intolerance and the impact of therapeutic interventions on its modulation remains unclear. This study investigated the relationship between heart rate recovery at the first minute (HRR1), a proxy for autonomic imbalance, and exercise intolerance in patients with long COVID. Additionally, the study aimed to assess the effects of a 12-week home-based inspiratory muscle training program on autonomic modulation in this patient population. MethodsThis study is a post hoc subanalysis of a randomized trial in which 26 patients with long COVID were randomly assigned to receive either a 12-week inspiratory muscle training program or usual care alone (NCT05279430). The data were analyzed using Pearson's correlation and linear mixed regression analysis. ResultsThe mean age was 50.4 ± 12.2 years, and 11 (42.3%) were women. Baseline HRR1 was significantly correlated with maximal functional capacity (peakVO2) (r = 0.402, P = .041). Patients with lower baseline HRR1 (≤22 bpm) exhibited higher resting heart rates and lower peakVO2. Inspiratory muscle training led to a more substantial increase in peakVO2 in patients with lower HRR1 at baseline (P = .019). Additionally, a significant improvement in HRR1 was observed in the IMT group compared to the usual care group after 12-week (Δ +9.39, 95% CI = 2.4-16.4, P = .010). ConclusionLower baseline HRR1 is associated with exercise intolerance in long COVID patients and may serve as a valuable criterion for identifying individuals likely to benefit more from a home-based inspiratory muscle training program.

A primary care-led weight management intervention for adults with diabetes and obesity: quantitative results from a randomised controlled trial of total meal replacement (DiRECT)

Methods to reduce obesity and type 2 diabetes in Aotearoa New Zealand are desperately needed, with obesity one of the greatest predisposing factors for type 2 diabetes as well as heart disease, and certain cancers.1 A recent New Zealand report2 identified several interventions that might benefit people with established diabetes, the most promising being a period of rapid weight loss, followed by supported weight-loss maintenance. Such weight loss has shown to achieve what was previously thought impossible, diabetes remission,3 as well as appreciably reduce the risk of cardiovascular disease and prevent diabetes-related chronic kidney disease, retinopathy, nephropathy, and lower limb amputation.2 While the findings from the studies of low energy total meal replacement diets have stimulated great interest, their use in Aotearoa New Zealand has not been considered. The purpose of this primary-care led intervention therefore was to consider the acceptability and efficacy of such a weight loss programme, DiRECT, in Aotearoa New Zealand. Te Kāika DiRECT is a 12-month study conducted within a Māori primary healthcare provider in O¯tepoti Dunedin. The DiRECT protocol is three months of total meal replacement for rapid weight loss followed by food reintroduction and a longer period of supported weight loss maintenance. Participants were adults with prediabetes or T2 diabetes and obesity wanting to lose weight. Twenty participants (70% female, age 46 (SD 10), BMI 41 (9), HbA1c 51 (11)) were randomised to receive the DiRECT protocol, twenty more (70% female, age 50 (SD 8), BMI 40 (7), HbA1c 54 (14)) were randomised to receive best practice weight loss support (usual care). All participants had the same number of visits with the in-house Dietitian and free access to the onsite gym. Participants in the control group also received regular grocery vouchers to purchase the foods encouraged by healthy eating guidelines. Recruitment began in February, 2022. After the initial three month study period, DiRECT participants reported consuming 3.0MJ (95% CI 1.2 to 4.8MJ) less energy per day than those in usual care. Mean weight loss was 6kg (2.3-9.6kg) greater for DiRECT participants than usual care participants, while medication use and systolic blood pressure (12mmHg (0-24mmHg)) were lower. Continuous glucose monitoring identified that at baseline, participants on average only spent 10% of the day with a blood glucose reading under 8mmol/L (normoglycaemia). After three months, the usual care group spent on average 48% of the day within the normoglycaemic range, while DiRECT participants spent 78% of the day within the normoglycaemic range. Results at 12 months will enable comment on longer term markers of blood glucose control (HbA1c) and diabetes remission rates, as well as indicate if the body weight, medication, and blood pressure improvements observed at three months are sustained.

Intravenous iron and SGLT2 inhibitors in iron-deficient patients with heart failure and reduced ejection fraction.

To explore the potential interaction between use of SGLT2 inhibitors and the increase in haemoglobin in patients randomized to intravenous iron or the control group in the IRONMAN (Effectiveness of Intravenous Iron Treatment versus Standard Care in Patients with Heart Failure and Iron Deficiency) trial. This was a post hoc exploratory analysis of the IRONMAN trial which randomized patients with heart failure, a left ventricular ejection fraction (LVEF)≤45% and iron deficiency (transferrin saturation <20% or ferritin <100μg/L) to open label intravenous ferric derisomaltose or usual care. Of the 1137 randomized patients, 29 (2.6%) were taking an SGLT2 inhibitor at baseline. The mean (SD) change in haemoglobin from baseline at 4weeks in those taking an SGLT2 inhibitor at baseline was 1.3 (1.2) g/dL in patients randomized to ferric derisomaltose and 0.1 (0.7) g/dL in the usual care group; between-group difference=1.0g/dL (95% CI 0.1, 1.8). The equivalent numbers in the no SGLT2 inhibitor group were 0.6 (0.9) g/dL in those randomized to ferric derisomaltose and 0.1 (0.8) g/dL in the usual care group; between-group difference=0.4g/dL (95% CI 0.3, 1.6); interaction P value=0.10. No patient receiving an SGLT2 inhibitor at baseline developed polycythaemia during follow-up (defined as haemoglobin >16.5g/dL [men] or >16g/dL [women]). In the IRONMAN trial, there was a trend to a greater increase in haemoglobin with ferric derisomaltose in iron-deficient patients taking an SGLT2 inhibitor at baseline, as compared with those not taking one.

Access to a pre-sleep protein snack increases daily energy and protein intake in surgical hospitalized patients

Background & aimIn hospitalized patients, daily protein intake remains far below WHO requirements for healthy adults (0.8 g·kg-1·d-1) as well as ESPEN guidelines for patients (1.2-1.5 g·kg-1·d-1). Providing access to a pre-sleep protein dense snack between dinner and going to bed may serve as a great opportunity to increase daily energy and protein intake in hospitalized patients. However, it remains to be assessed whether protein provision prior to sleep effectively increases protein intake, or may reduce food intake throughout the remainder of the day(s). The present study evaluated the impact of giving access to a pre-sleep snack on daily energy and protein intake in patients throughout their hospitalization. MethodsPatients admitted to the surgical wards of the Maastricht University Medical Centre+ were randomly allocated to usual care (n=51) or given access to a pre-sleep snack (n=50). The pre-sleep snack consisted of 103 g cheese cubes (30 g protein) provided between 7:30 and 9:30 PM, prior to sleep. All food provided and all food consumed was weighed and recorded throughout (2-7 days) hospitalization. Daily energy and protein intake and distribution were calculated. Data were analyzed by independent T-Tests with P<0.05 considered as statistically significant. ResultsDaily energy intake was higher in the pre-sleep group (1353±424 kcal·d-1) when compared to the usual care group (1190±402 kcal·d-1; P=0.049). Providing patients access to a pre-sleep snack resulted in a 17% (11±9 g) higher daily protein intake (0.81±0.29 g·kg-1·d-1) when compared to the usual care group (0.69±0.28 g·kg-1·d-1; P=0.045). Protein intake at breakfast, lunch, and dinner did not differ between the pre-sleep and usual care groups (all P>0.05). ConclusionProviding access to a pre-sleep protein snack, in the form of protein dense food items such as cheese, represents an effective dietary strategy to increase daily energy and protein intake in hospitalized patients. Patients consuming pre-sleep protein snacks do not compensate by lowering energy or protein intake throughout the remainder of the days. Pre-sleep protein dense food provision should be implemented in hospital food logistics to improve the nutritional intake of patients. Trial register noNL8507 (https://trialsearch.who.int/)

The Australian Health Care Homes trial: quality of care and patient outcomes. A propensity score-matched cohort study.

To assess the impact of the Health Care Homes (HCH) primary health care initiative on quality of care and patient outcomes. Quasi-experimental, matched cohort study; analysis of general practice data extracts and linked administrative data from ten Australian primary health networks, 1 October 2017 - 30 June 2021. People with chronic health conditions (practice data extracts: 9811; linked administrative data: 10 682) enrolled in the HCH 1 October 2017 - 30 June 2019; comparison groups of patients receiving usual care (1:1 propensity score-matched). Participants were involved in shared care planning, provided enhanced access to team care, and encouraged to seek chronic condition care at the HCH practice where they were enrolled. Participating practices received bundled payments based on clinical risk tier. Access to care, processes of care, diabetes-related outcomes, hospital service use, risk of death. During the first twelve months after enrolment, the mean numbers of general practitioner encounters (rate ratio, 1.14; 95% confidence interval [CI], 1.11-1.17) and Medicare Benefits Schedule claims for allied health services (rate ratio, 1.28; 95% CI, 1.24-1.33) were higher for the HCH than the usual care group. Annual influenza vaccinations (relative risk, 1.20; 95% CI, 1.17-1.22) and measurements of blood pressure (relative risk, 1.09; 95% CI, 1.08-1.11), blood lipids (relative risk, 1.19; 95% CI, 1.16-1.21), glycated haemoglobin (relative risk, 1.06; 95% CI, 1.03-1.08), and kidney function (relative risk, 1.13; 95% CI, 1.11-1.15) were more likely in the HCH than the usual care group during the twelve months after enrolment. Similar rate ratios and relative risks applied in the second year. The numbers of emergency department presentations (rate ratio, 1.09; 95% CI, 1.02-1.18) and emergency admissions (rate ratio, 1.13; 95% CI, 1.04-1.22) were higher for the HCH group during the first year; other differences in hospital use were not statistically significant. Differences in glycaemic and blood pressure control in people with diabetes in the second year were not statistically significant. By 30 June 2021, 689 people in the HCH group (6.5%) and 646 in the usual care group (6.1%) had died (hazard ratio, 1.07; 95% CI, 0.96-1.20). The HCH program was associated with greater access to care and improved processes of care for people with chronic diseases, but not changes in diabetes-related outcomes, most measures of hospital use, or risk of death.

Clinical Outcomes With Electronic Nudges to Increase Influenza Vaccination : A Prespecified Analysis of a Nationwide, Pragmatic, Registry-Based, Randomized Implementation Trial.

In the NUDGE-FLU (Nationwide Utilization of Danish Government Electronic letter system for increasing inFLUenza vaccine uptake) trial, electronic letters incorporating cardiovascular (CV) gain-framing and repeated messaging increased influenza vaccination by approximately 1 percentage point. To evaluate the effects of the successful nudging interventions on downstream clinical outcomes. Prespecified exploratory analysis of a nationwide randomized implementation trial. (ClinicalTrials.gov: NCT05542004). The 2022 to 2023 influenza season. 964 870 Danish citizens aged 65 years or older. Usual care or 9 different electronically delivered behavioral nudging letters. Cardiovascular, respiratory, and other clinical end points during follow-up from intervention delivery (16 September 2022) through 31 May 2023. The analysis set included 691 820 participants. Hospitalization for pneumonia or influenza occurred in 3354 of 346 327 (1.0%) participants in the usual care group, 396 of 38 586 (1.0%) in the CV gain-framing group (hazard ratio [HR], 1.06 [95% CI, 0.95 to 1.18]; versus usual care), and 403 of 38 231 (1.1%) in the repeated letter group (HR, 1.09 [CI, 0.98 to 1.21]; versus usual care). In the usual care group, 44 682 (12.9%) participants were hospitalized for any cause, compared with 5002 (13.0%) in the CV gain-framing group (HR, 1.00 [CI, 0.97 to 1.03]; versus usual care) and 4965 (13.0%) in the repeated letter group (HR, 1.01 [CI, 0.98 to 1.04]; versus usual care). A total of 6341 (1.8%) participants died in the usual care group, compared with 721 (1.9%) in the CV gain-framing group (HR, 1.02 [CI, 0.94 to 1.10]; versus usual care) and 646 (1.7%) in the repeated letter group (HR, 0.92 [CI, 0.85 to 1.00]; versus usual care). Prespecified but exploratory analysis, potential misclassification of events in routinely collected registry data, and results may not be generalizable to other health systems or countries with other racial compositions and/or cultural or societal norms. In a prespecified exploratory analysis, modest increases in influenza vaccination rates seen with electronic nudges did not translate into observable improvements in clinical outcomes. Seasonal influenza vaccination should remain strongly recommended. Sanofi.

The Impact of Preoperative Medical Evaluation in an Orthopaedic Perioperative Medical Clinic on Total Joint Arthroplasty Outcomes: An Observational Study.

A preoperative medical evaluation (PME) in total joint arthroplasty (TJA) is routine despite considerable variation and uncertainty regarding its benefits. The orthopaedic department in our academic health system established a perioperative medical clinic (PMC) to standardize perioperative management and to study the effect of this intervention on total hip arthroplasty (THA) and total knee arthroplasty (TKA) outcomes. This observational study compared the impact of a PME within 30 days prior to surgery at the PMC (Periop30) versus elsewhere ("Usual Care") on postoperative length of stay (LOS), extended LOS (i.e., a stay of >3 days), and Patient-Reported Outcomes Measurement Information System-10 (PROMIS-10) Global Physical Health (GPH) score improvement in TJA. We stratified adult patients (≥18 years of age) who underwent primary TJA between January 2015 and December 2020 into Periop30 or Usual Care. We utilized univariate tests (a chi-square test for categorical variables and a t test for continuous variables) to assess for differences in patient characteristics. For both TKA and THA, LOS was assessed with use of multivariable negative binomial regression models; extended LOS, with use of binary logistic regression; and PROMIS-10 GPH score, with use of mixed-effects models with random intercept and slope. Interaction terms between the focal predictor (Periop30, yes or no) and year of surgery were included in all models. Periop30 comprised 82.3% of TKAs (1,911 of 2,322 ) and 73.8% of THAs (1,876 of 2,541). For THA, the Periop30 group tended to be male (p = 0.005) and had a higher body mass index (p = 0.001) than the Usual Care group. The Periop30 group had a higher rate of staged bilateral THA (10.6% versus 7.5%; p = 0.028) and a lower rate of simultaneous bilateral TKA (5.1% versus 12.2%; p < 0.001) than the Usual Care group. Periop30 was associated with a lower mean LOS for both TKA (43.46 versus 54.15 hours; p < 0.001) and THA (41.07 versus 57.94 hours; p < 0.001). The rate of extended LOS was lower in the Periop30 group than in the Usual Care group for both TKA (15% versus 26.5%; p < 0.001) and THA (13.3% versus 27.4%; p < 0.001). There was no significant difference in GPH score improvement between Periop30 and Usual Care for either TKA or THA. Periop30 decreased mean LOS and the rate of extended LOS for TJA without an adverse effect on PROMIS-10 GPH scores. Therapeutic Level III . See Instructions for Authors for a complete description of levels of evidence.

A Decision Aid to Support Tubal Sterilization Decision-Making Among Pregnant Women

Tubal sterilization is common, especially among individuals with low income. There is substantial misunderstanding about sterilization among those who have undergone the procedure, suggesting suboptimal decision-making about a method that permanently ends reproductive capacity. To test the efficacy of a web-based decision aid for improving tubal sterilization decision quality. This randomized clinical trial conducted between March 2020 and November 2023 included English- or Spanish-speaking pregnant cisgender women aged 21 to 45 years who had Medicaid insurance and were contemplating tubal sterilization after delivery. Participants were recruited from outpatient obstetric clinics in 3 US cities. Participants were randomized 1:1 to usual care (control arm) or to usual care plus a web-based decision aid (MyDecision/MiDecisión) (intervention arm). The aid includes written, audio, and video information about tubal sterilization procedures; an interactive table comparing contraceptive options; values-clarifying exercises; knowledge checks; and a summary report. The co-primary outcomes were tubal sterilization knowledge and decisional conflict regarding the contraceptive decision. Knowledge was measured as the percentage of correct responses to 10 true-false items. Decisional conflict was measured using the low-literacy Decision Conflict Scale, with lower scores on a range from 0 to 100 indicating less conflict. Among the 350 participants, mean (SD) age was 29.7 (5.1) years. Compared with the usual care group, participants randomized to the decision aid had significantly higher tubal sterilization knowledge (mean [SD] proportion of questions answered correctly, 76.5% [16.9%] vs 55.6% [22.6%]; P < .001) and lower decisional conflict scores (mean [SD], 12.7 [16.6] vs 18.7 [20.8] points; P = .002). The greatest knowledge differences between the 2 groups were for items about permanence, with more participants in the intervention arm answering correctly that tubal sterilization is not easily reversible (90.1% vs 39.3%; odds ratio [OR], 14.2 [95% CI, 7.9-25.4]; P < .001) and that the tubes do not spontaneously "come untied" (86.6% vs 33.7%; OR, 13.0 [95% CI, 7.6-22.4]; P < .001). MyDecision/MiDecisión significantly improved tubal sterilization decision-making quality compared with usual care only. This scalable decision aid can be implemented into clinical practice to supplement practitioner counseling. These results are particularly important given the recent increase in demand for permanent contraception after the US Supreme Court decision overturning federal abortion protections. ClinicalTrials.gov Identifier: NCT04097717.

IT-assisted comprehensive geriatric assessment for residents in care homes: quasi-experimental longitudinal study

BackgroundFrailty interventions such as Comprehensive Geriatric Assessment (CGA) can provide significant benefits for older adults living with frailty. However, incorporating such proactive interventions into primary care remains a challenge. We developed an IT-assisted CGA (i-CGA) process, which includes advance care planning (ACP). We assessed if, in older care home residents, particularly those with severe frailty, i-CGA could improve access to advance care planning discussions and reduce unplanned hospitalisations.MethodAs a quality improvement project we progressively incorporated our i-CGA process into routine primary care for older care home residents, and used a quasi-experimental approach to assess its interim impact. Residents were assessed for frailty by General Practitioners. Proactive i-CGAs were completed, including consideration of traditional CGA domains, deprescribing and ACP discussions. Interim analysis was conducted at 1 year: documented completion, preferences and adherence to ACPs, unplanned hospital admissions, and mortality rates were compared for i-CGA and control (usual care) groups, 1-year post-i-CGA or post-frailty diagnosis respectively. Documented ACP preferences and place of death were compared using the Chi-Square Test. Unplanned hospital admissions and bed days were analysed using the Mann-Whitney U test. Survival was estimated using Kaplan-Meier survival curves.ResultsAt one year, the i-CGA group comprised 196 residents (severe frailty 111, 57%); the control group 100 (severe frailty 56, 56%). ACP was documented in 100% of the i-CGA group, vs. 72% of control group, p < 0.0001. 85% (94/111) of severely frail i-CGA residents preferred not to be hospitalised if they became acutely unwell. For those with severe frailty, mean unplanned admissions in the control (usual care) group increased from 0.87 (95% confidence interval ± 0.25) per person year alive to 2.05 ± 1.37, while in the i-CGA group they fell from 0.86 ± 0.24 to 0.68 ± 0.37, p = 0.22. Preferred place of death was largely adhered to in both groups, where documented. Of those with severe frailty, 55% (62/111) of the i-CGA group died, vs. 77% (43/56) of the control group, p = 0.0013.ConclusionsProactive, community-based i-CGA can improve documentation of care home residents’ ACP preferences, and may reduce unplanned hospital admissions. In severely frail residents, a mortality reduction was seen in those who received an i-CGA.

Abstract P145: Randomized Trial of an Integrated Care Intervention Among Latino Adults: Sustained Effects on Diabetes Management

Purpose: Adequate diabetes management is challenging to sustain. In healthcare practices serving under-resourced communities, the development of cost-efficient interventions with a sustainable impact are crucial. We examined the 12-month maintenance effects of a previously successful integrated model of diabetes care at improving glycemic management and psychological well-being among Latino adults with type 2 diabetes (T2D). Methods: A randomized controlled trial (2015-2019) compared an Integrated Care Intervention (ICI) with Usual Care (UC) among 456 adults with T2D. The ICI included integrated medical and behavioral care and health education over 6 months. Assessments were completed at baseline, 3-, 6-, 9-, and 12-months. Results: Most participants were female (63.7%), with a mean age of 55.7 years. In multi-level models, significant group x time (quadratic) interaction effects were found for HbA1c ( ß = .10, 95% CI .02,.17, p &lt; .01) and anxiety ( ß = .20, 95% CI .05,.35, p &lt; .009), but not depression symptoms ( ß = .15, 95% CI -.01,.31, p &lt; .07). Analyses of instantaneous rate of change in the ICI group showed significant decreases at 3- and 6-months for HbAc1 ( ß = -.31 at 3-months; ß = -.12 at 6-months) and anxiety symptoms ( ß = -.92 at 3-months; ß = -.46 at 6-months), and no significant changes at 9- or 12-months, suggesting that initial improvements were largely maintained. The UC group showed a small decrease in anxiety symptoms at 6 months ( ß = -.17), but no other significant changes (all ps &gt; .05). (See Figure 1). Conclusions: This culturally tailored integrated care model that included both medical and behavioral care and health education programs, shows potential in producing and sustaining positive effects on clinical and psychological outcomes above standard care. Findings have implications for practice and policies that facilitate implementing these models in healthcare organizations.

Health coaching intervention with or without the support of an exercise buddy to increase physical activity of people with chronic low back pain compared to usual care: a feasibility and pilot randomised controlled trial

BackgroundExercise buddies (people to exercise together with) might support people with low back pain (LBP) to become active. However, involving buddies in randomised controlled trials (RCT) might challenge recruitment, data collection and follow-up. ObjectivesTo explore the feasibility of the intervention, recruitment and data collection approaches and potential effects of a health coaching intervention (focused on physical activity) with or without exercise buddies’ support on physical activity of people with chronic LBP versus usual discharge care. DesignFeasibility and pilot RCT. MethodsAdults (n = 30) discharged from LBP treatment were randomised to the Buddy-Assisted (health coaching intervention with exercise buddy's support), Individual-Only (health coaching only), or usual care groups. Data were collected at baseline, three and six months. The feasibility of trial's procedures was assessed through recruitment rate (acceptable if >70%), data completion rate (acceptable if ≤ 20% missing data), and follow-up rate (successful if ≥ 85%). The intervention's acceptability was assessed via feedback questionnaires. Preliminary effects on physical activity and other outcomes were also explored. ResultsRecruitment and baseline data completion were acceptable. However, data collection and follow-up rates post-randomisation were not. 85% of the Buddy-Assisted Group believed the buddies helped them to increase physical activity and would recommend the intervention. 70% of the Individual-Only and Control groups believed exercise buddies would help them to become further active. ConclusionThe data collection and follow-up approaches were not successful and need amending before a large-scale RCT. Nonetheless, the buddy-assisted intervention was well-accepted. A future RCT will focus on differences in clinical outcomes. Trial registrationThe study was registered at the Australian New Zealand Clinical Trial Registry (ACTRN12620001118998).

Late-stage rehabilitation after anterior cruciate ligament reconstruction: A multicentre randomised controlled trial (PReP)

BackgroundAt the completion of formal rehabilitation after anterior cruciate ligament reconstruction, functional capacity is only restored in a small proportion of affected individuals. Therefore, the end of formal rehabilitation is not the end of functional rehabilitation. ObjectiveTo compare adherence to and effectiveness of a late-stage rehabilitation programme with usual care after anterior cruciate ligament (ACL) reconstruction. MethodsThis prospective, double-blind, multicentre, parallel group, randomised controlled trial, included people aged 18 to 35 years after formal rehabilitation completion (mean [SD] 241 [92] days post-reconstruction). Participants were block-randomised to a 5-month neuromuscular performance intervention (Stop-X group) or usual care (medically prescribed standard physiotherapy, individual formal rehabilitation, home-exercises). All outcomes were measured once/month. Primary outcome was the normalised knee separation distance on landing after drop jump. Baseline-adjusted linear mixed models were calculated. ResultsIn total, 112 participants (Stop-X: 57; Usual care: 55,) were analysed. Initially, mean (SD) intervention frequency (units/week) was higher in the Stop-X than the Usual care group: 2.65 (0.96) versus 2.48 (1.14) units/week in the first and 2.28 (1.02) versus 2.14 (1.31) units/week in the second month. No between-group*time(*baseline)-differences were found for the primary outcome. Between-group*time-effects favoured the Stop-X-group at 2 months (fewer self-reported knee problems during sport, KOOS-SPORT) (estimate = 64.3, 95 % CI 24.4–104.3 for the Stop-X), more confidence to return to sport (ACL-RSI) (62.4, 10.7–114.2), fewer pain-associated knee problems (KOOS-PAIN) (82.8, 36.0–129.6), improved everyday activity abilities (KOOS-ADL) (71.1, 6.4–135.7), and improved limb symmetry index in the front hop for distance at 3 and 4 months (0.34, 0.10–0.57; 0.31, 0.08–0.54). No between-group*time-effects occurred for kinesiophobia, symptom-associated knee problems or balance hops performance. At the end of the intervention, 79 % of the Stop-X and 70 % of the Usual care participants (p < 0.05) had successfully returned to their pre-injury sport type and level. ConclusionsThe Stop-X intervention was slightly superior to usual care as part of late-stage rehabilitation after ACL-reconstruction. The small benefit might justify its use after formal rehabilitation completion.

Clinical Decision Support for Hypertension Management in Chronic Kidney Disease

Chronic kidney disease (CKD) affects 37 million adults in the United States, and for patients with CKD, hypertension is a key risk factor for adverse outcomes, such as kidney failure, cardiovascular events, and death. To evaluate a computerized clinical decision support (CDS) system for the management of uncontrolled hypertension in patients with CKD. This multiclinic, randomized clinical trial randomized primary care practitioners (PCPs) at a primary care network, including 15 hospital-based, ambulatory, and community health center-based clinics, through a stratified, matched-pair randomization approach February 2021 to February 2022. All adult patients with a visit to a PCP in the last 2 years were eligible and those with evidence of CKD and hypertension were included. The intervention consisted of a CDS system based on behavioral economic principles and human-centered design methods that delivered tailored, evidence-based recommendations, including initiation or titration of renin-angiotensin-aldosterone system inhibitors. The patients in the control group received usual care from PCPs with the CDS system operating in silent mode. The primary outcome was the change in mean systolic blood pressure (SBP) between baseline and 180 days compared between groups. The primary analysis was a repeated measures linear mixed model, using SBP at baseline, 90 days, and 180 days in an intention-to-treat repeated measures model to account for missing data. Secondary outcomes included blood pressure (BP) control and outcomes such as percentage of patients who received an action that aligned with the CDS recommendations. The study included 174 PCPs and 2026 patients (mean [SD] age, 75.3 [0.3] years; 1223 [60.4%] female; mean [SD] SBP at baseline, 154.0 [14.3] mm Hg), with 87 PCPs and 1029 patients randomized to the intervention and 87 PCPs and 997 patients randomized to usual care. Overall, 1714 patients (84.6%) were treated for hypertension at baseline. There were 1623 patients (80.1%) with an SBP measurement at 180 days. From the linear mixed model, there was a statistically significant difference in mean SBP change in the intervention group compared with the usual care group (change, -14.6 [95% CI, -13.1 to -16.0] mm Hg vs -11.7 [-10.2 to -13.1] mm Hg; P = .005). There was no difference in the percentage of patients who achieved BP control in the intervention group compared with the control group (50.4% [95% CI, 46.5% to 54.3%] vs 47.1% [95% CI, 43.3% to 51.0%]). More patients received an action aligned with the CDS recommendations in the intervention group than in the usual care group (49.9% [95% CI, 45.1% to 54.8%] vs 34.6% [95% CI, 29.8% to 39.4%]; P < .001). These findings suggest that implementing this computerized CDS system could lead to improved management of uncontrolled hypertension and potentially improved clinical outcomes at the population level for patients with CKD. ClinicalTrials.gov Identifier: NCT03679247.

Impact of pharmacist-supported transition of care services in the Middle East and North Africa: a systematic review and meta-analysis.

Transition of care (TOC) is associated with an increased risk of medication-related problems. Despite recent advancements in pharmacy practice and research in the Middle East and North Africa (MENA), the characteristics and impact of regional pharmacy-supported TOC interventions remain unclear.This systematic review and meta-analysis aimed to describe pharmacist-supported TOC interventions in the MENA region and evaluate their effectiveness. PubMed, CINAHL, EMBASE, Web of Science, World Health Organization's International Clinical Trials Registry Platform (ICTRP) were searched from their inception to March 9, 2023, for experimental studies published in English, comparing pharmacist-supported TOC interventions with usual care for adults (age ≥18 years) discharged from the hospital. The risk of bias was evaluated using Cochrane's risk-of-bias tool for randomised trials (ROB2) and the risk of bias in non-randomised studies of interventions (ROBINS-I) tool for randomised and non-randomised studies respectively. Narrative syntheses and meta-analysis methods were employed depending on the outcomes evaluated. Twelve studies (n = 2377 subjects), 10 randomised controlled trials and 2 quasi-experimental studies, were included. Most studies had high or serious risk of bias. The included studies were quite heterogeneous in terms of nature and the delivery of intervention, and assessment of outcome measures. Compared to the usual care group, pharmacist-led TOC interventions contributed to a significant reduction in preventable drug-related (N = 2) and cardiac-related healthcare utilisation (N = 1), a significant reduction in preventable adverse drug events (ADEs) (Odds ratio (OR) 0.34, 95% CI: 0.13-0.94) and an improvement in medication adherence. However, all-cause hospitalisation and medication discrepancies were not significantly reduced. Pharmacy-supported TOC interventions may improve patient outcomes in the MENA region. However, considering the limited quality of evidence and the variability in intervention delivery, future well-designed clinical trials are needed.