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Comparative effectiveness of fragility fracture integrated rehabilitation management for elderly individuals after hip fracture surgery: A study protocol for a multicenter randomized controlled trial.

ABSTRACT: Although it is essential to provide comprehensive rehabilitation after hip fracture to restore the patient to preoperative physical functioning, feasibility issues remain. Here, we describe a protocol for a randomized controlled trial (RCT) to evaluate the effectiveness of fragility fracture integrated rehabilitation management (FIRM) for elderly individuals after hip fracture surgery. We also examine the feasibility of applying FIRM in a chronic-care hospital or community-based setting.Elderly patients will be randomly assigned to either the FIRM, conventional, or control group for a 2-week intervention period following hip fracture surgery. The primary outcome of this study is Koval walking ability. All functional outcomes will be measured 1 and 3 weeks, 3, 6, and 12 months after the surgical intervention. Researchers will be blind to group allocation, and participants will be blind to outcome. A sample size of 282 participants will be necessary to demonstrate the effect of the FIRM program. After the RCT has been conducted in 3 core hospitals, FIRM will be applied in 6 community-based local hospitals to investigate the feasibility of the program. The data will be analyzed using the intention-to-treat principle.NCT03430193.

SUBMITTER: Lee SY

PROVIDER: S-EPMC5976332 | biostudies-literature | 2018 May

REPOSITORIES: biostudies-literature

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Comparative effectiveness of fragility fracture integrated rehabilitation management for elderly individuals after hip fracture surgery: A study protocol for a multicenter randomized controlled trial.

Lee Sang Yoon SY Beom Jaewon J Kim Bo Ryun BR Lim Seung-Kyu SK Lim Jae-Young JY

Medicine 20180501 20

<h4>Introduction</h4>Although it is essential to provide comprehensive rehabilitation after hip fracture to restore the patient to preoperative physical functioning, feasibility issues remain. Here, we describe a protocol for a randomized controlled trial (RCT) to evaluate the effectiveness of fragility fracture integrated rehabilitation management (FIRM) for elderly individuals after hip fracture surgery. We also examine the feasibility of applying FIRM in a chronic-care hospital or community-b ...[more]

PMID: 29768364

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Project description:BackgroundStrategies to protect the brain from postoperative delirium (POD) after hip fracture are urgently needed. The development of delirium often is associated with the loss of independence, poor functional recovery, and increased morbidity, as well as increases in length of hospital stay, discharges to nursing facilities, and healthcare costs. We hypothesize that xenon may reduce the burden of POD, (i) by avoiding the need to provide anesthesia with a drug that targets the γ-amino-butyric acid (GABA)A receptor and (ii) through beneficial anesthetic and organ-protective effects.Methods and designAn international, multicenter, phase 2, prospective, randomized, blinded, parallel group and controlled trial to evaluate the incidence of POD, diagnosed with the Confusion Assessment Method (CAM), in older patients undergoing hip fracture surgery under general anesthesia with xenon or sevoflurane, for a period of 4 days post surgery (primary outcome) is planned. Secondary objectives are to compare the incidence of POD between xenon and sevoflurane, to evaluate the incidence of POD from day 5 post surgery until discharge from hospital, to determine the time to first POD diagnosis, to evaluate the duration of POD, to evaluate the evolution of the physiological status of the patients in the postoperative period, to evaluate the recovery parameters, to collect preliminary data to evaluate the economical impact of POD in the postoperative period and to collect safety data. Patients are eligible if they are older aged (≥ 75 years) and assigned to a planned hip fracture surgery within 48 h after the hip fracture. Furthermore, patients need to be willing and able to complete the requirements of this study including the signature of the written informed consent. A total of 256 randomized patients in the 10 participating centers will be recruited, that is, 128 randomized patients in each of the 2 study groups (receiving either xenon or sevoflurane).Trial registrationEudraCT Identifier: 2009-017153-35; ClinicalTrials.gov Identifier: NCT01199276.

Project description:BackgroundUnderstanding mortality risk factors is critical to reducing mortality among elderly hip fracture patients. To investigate the effects of admission and post-operative levels of distribution width of red blood cells (RDW), albumin, and RDW/albumin (RA) ratio on predicting 1-year mortality following hip fracture surgery.MethodsA retrospective study was conducted on 275 elderly patients who underwent hip fracture surgery in a tertiary hospital between January 2018 and January 2022. Deaths within one year of hip fracture were defined as the deceased group. The survivors were defined as those who survived for at least one year. The relationship between admission and post-operative levels of RDW, albumin, RA, and mortality within one year after hip surgery was assessed statistically, including binary logistic regression analysis. The study also assessed other factors related to mortality.ResultsOne-year mortality was 34.7%. There was a 3.03-year (95% CI [1.32-4.75]) difference between the deceased (79.55 ± 8.36 years) and survivors (82.58 ± 7.41 years) (p < 0.001). In the deceased group, the mean hemoglobin (HGB) values at admission (p = 0.022) and post-operative (p = 0.04) were significantly lower. RDW values at admission (p = 0.001) and post-op (p = 0.001) were significantly lower in the survivor group. The mean albumin values at admission (p < 0.001) and post-operative (p < 0.001) in the survivor group were significantly higher than in the deceased group. A significant difference was found between the survivor group and the deceased group in terms of mean RA ratio at admission and post-operative (p < 0.001). Based on binary logistic regression analysis, presence of chronic obstructive pulmonary disease (COPD) (OR 3.73, 95% CI [1.8-7.76]), RDW (OR 1.78, 95% CI [1.48-2.14]), and albumin (OR 0.81, 95% CI [0.75-0.87]), values at admission were found to be independent predictors of 1-year mortality in elderly patients with hip fracture.ConclusionBased on this study, presence of COPD, higher RDW, and lower albumin levels at admission were independent predictors of 1-year mortality following hip fracture surgery in the elderly.

Project description:BackgroundMalnutrition after hip fracture is associated with increased rehabilitation time, complications, and mortality. We assessed the effect of intensive 3 month nutritional intervention in elderly after hip fracture on length of stay (LOS).MethodsOpen-label, randomized controlled trial. Exclusion criteria: age < 55 years, bone disease, life expectancy < 1 year, bedridden, using oral nutritional supplements (ONS) before hospitalization, and cognitive impairment. Intervention: weekly dietetic consultation, energy-protein-enriched diet, and ONS (400 mL per day) for 3 months. Control: usual nutritional care. Primary outcome: total LOS in hospital and rehabilitation clinic, including readmissions over 6 months (Cox regression adjusted for confounders); hazard ratio (HR) < 1.0 reflects longer LOS in the intervention group. Secondary outcomes: nutritional and functional status, cognition, quality of life, postoperative complications (6 months); subsequent fractures and all-cause mortality (1 and 5 years). Effect modification by baseline nutritional status was also tested.ResultsOne hundred fifty-two patients were randomized (73 intervention, 79 control). Median total LOS was 34.0 days (range 4-185 days) in the intervention group versus control 35.5 days (3-183 days; plogrank = .80; adjusted hazard ratio (adjHR): 0.98; 95% CI: 0.68-1.41). Hospital LOS: 12.0 days (4-56 days) versus 11.0 days (3-115 days; p = .19; adjHR: 0.75; 95% CI: 0.53-1.06) and LOS in rehabilitation clinics: 19.5 days (0-174 days) versus 18.5 days (0-168 days; p = .82; adjHR: 1.04; 95% CI: 0.73-1.48). The intervention improved nutritional intake/status at 3, but not at 6 months, and did not affect any other outcome. No difference in intervention effect between malnourished and well-nourished patients was found.ConclusionsIntensive nutritional intervention after hip fracture improved nutritional intake and status, but not LOS or clinical outcomes. Paradigms underlying nutritional intervention in elderly after hip fracture may have to be reconsidered.

Project description:UnlabelledHip fracture patients can benefit from nutritional supplementation during their recovery. Up to now, cost-effectiveness evaluation of nutritional intervention in these patients has not been performed. Costs of nutritional intervention are relatively low as compared with medical costs. Cost-effectiveness evaluation shows that nutritional intervention is likely to be cost-effective.IntroductionPrevious research on the effect of nutritional intervention on clinical outcome in hip fracture patients yielded contradictory results. Cost-effectiveness of nutritional intervention in these patients remains unknown. The aim of this study was to evaluate cost-effectiveness of nutritional intervention in elderly subjects after hip fracture from a societal perspective.MethodsOpen-label, multi-centre randomized controlled trial investigating cost-effectiveness of intensive nutritional intervention comprising regular dietetic counseling and oral nutritional supplementation for 3 months postoperatively. Patients allocated to the control group received care as usual. Costs, weight and quality of life were measured at baseline and at 3 and 6 months postoperatively. Incremental cost-effectiveness ratios (ICERs) were calculated for weight at 3 months and quality adjusted life years (QALYs) at 6 months postoperatively.ResultsOf 152 patients enrolled, 73 were randomized to the intervention group and 79 to the control group. Mean costs of the nutritional intervention was 613 Euro. Total costs and subcategories of costs were not significantly different between both groups. Based on bootstrapping of ICERs, the nutritional intervention was likely to be cost-effective for weight as outcome over the 3-month intervention period, regardless of nutritional status at baseline. With QALYs as outcome, the probability for the nutritional intervention being cost-effective was relatively low, except in subjects aged below 75 years.ConclusionIntensive nutritional intervention in elderly hip fracture patients is likely to be cost-effective for weight but not for QALYs. Future cost-effectiveness studies should incorporate outcome measures appropriate for elderly patients, such as functional limitations and other relevant outcome parameters for elderly.

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Comparative effectiveness of fragility fracture integrated rehabilitation management for elderly individuals after hip fracture surgery: A study protocol for a multicenter randomized controlled trial.

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Comparative effectiveness of fragility fracture integrated rehabilitation management for elderly individuals after hip fracture surgery: A study protocol for a multicenter randomized controlled trial.

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