Improving community ambulation after hip fracture: protocol for a randomised, controlled trial.
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SUBMITTER: Orwig D
PROVIDER: S-EPMC5388063 | biostudies-literature | 2017 Jan
REPOSITORIES: biostudies-literature
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Improving community ambulation after hip fracture: protocol for a randomised, controlled trial.
Orwig D D Mangione K K KK Baumgarten M M Terrin M M Fortinsky R R Kenny A M AM Gruber-Baldini A L AL Beamer B B Tosteson Ana A Shardell M M Magder L L Binder E E Koval K K Resnick B B Craik R L RL Magaziner J J
Journal of physiotherapy 20161028 1
<h4>Introduction</h4>After a hip fracture in older persons, significant disability often remains; dependency in functional activities commonly persists beyond 3 months after surgery. Endurance, dynamic balance, quadriceps strength, and function are compromised, and contribute to an inability to walk independently in the community. In the United States, people aged 65 years and older are eligible to receive Medicare funding for physiotherapy for a limited time after a hip fracture. A goal of outp ...[more]
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Project description:IntroductionCommunity-dwelling people recovering from hip fracture have the physical capacity to walk in their community but lack the confidence to do so. The primary aim of this trial is to determine whether motivational interviewing increases time spent walking at 12 months in community-dwelling people after hip fracture compared with an attention placebo control group. Secondary aims are to evaluate cost effectiveness, patient and health service outcomes and to complete a process evaluation.Methods and analysisAn assessor-blinded parallel group randomised controlled design with embedded health economic evaluation and process evaluation will compare the effects of n=270 participants randomly allocated to an experimental group (motivational interviewing) or a control group (dietary advice). For inclusion, participants are aged ≥65 years, living at home independently within 6 months of discharge from hospital after hip fracture and able to walk independently and communicate with conversational English. Key exclusion criteria are severe depression or anxiety, impaired intellectual functioning and being medically unstable to walk. Participants allocated to the experimental group will receive 10 (8 weekly and 2 booster) telephone-based sessions of motivational interviewing to increase walking over 16 weeks. Participants allocated to the control group will receive an equivalent dose of telephone-based dietary advice. The primary outcome is daily time spent walking over 7 days assessed at weeks 0, 9, 26 and 52. Secondary outcomes include measures of psychological-related function, mobility-related function, community participation, health-related quality of life and falls. Health service utilisation and associated costs will be assessed. Process evaluation will assess the fidelity of the motivational interviewing intervention and explore contextual factors through semistructured interviews.Ethics and disseminationEthical approval obtained from Eastern Health (E19-002), Peninsula Health (50261/EH-2019), Alfred Health (617/20) and La Trobe University (E19/002/50261). The findings will be disseminated in peer-reviewed journals, conference presentations and public seminars.Trial registration numberACTRN12619000936123.
| S-EPMC8191622 | biostudies-literature
Project description:IntroductionHip fractures result in substantial health impacts for patients and costs to health systems. Many patients require prolonged hospital stays and up to 60% do not regain their prefracture level of mobility within 1 year. Physical rehabilitation plays a key role in regaining physical function and independence; however, there are no recommendations regarding the optimal intensity. This study aims to compare the clinical efficacy and cost-effectiveness of early intensive in-hospital physiotherapy compared with usual care in patients who have had surgery following a hip fracture.Methods and analysisThis two-arm randomised, controlled, assessor-blinded trial will recruit 620 participants who have had surgery following a hip fracture from eight hospitals. Participants will be randomised 1:1 to receive usual care (physiotherapy according to usual practice at the site) or intensive physiotherapy in the hospital over the first 7 days following surgery (two additional sessions per day, one delivered by a physiotherapist and the other by an allied health assistant). The primary outcome is the total hospital length of stay, measured from the date of hospital admission to the date of hospital discharge, including both acute and subacute hospital days. Secondary outcomes are functional mobility, health-related quality of life, concerns about falling, discharge destination, proportion of patients remaining in hospital at 30 days, return to preadmission mobility and residence at 120 days and adverse events. Twelve months of follow-up will capture data on healthcare utilisation. A cost-effectiveness evaluation will be undertaken, and a process evaluation will document barriers and facilitators to implementation.Ethics and disseminationThe Alfred Hospital Ethics Committee has approved this protocol. The trial findings will be published in peer-reviewed journals, submitted for presentation at conferences and disseminated to patients and carers.Trial registration numberACTRN12622001442796.
| S-EPMC10806657 | biostudies-literature
Project description:BackgroundRehabilitation in hospital is effective in reducing mortality after hip fracture. However, there is uncertainty over optimal in-hospital rehabilitation treatment ingredients, and the generalizability of trial findings to subgroups of patients systematically excluded from previous trials. The aim of this study is to determine the feasibility of a randomized controlled trial which aims to assess the clinical- and cost-effectiveness of adding a stratified care intervention to usual care designed to improve outcomes of acute rehabilitation for all older adults after hip fracture.MethodsThis is a protocol for a single site, feasibility and pilot, pragmatic, parallel group (allocation ratio 1:1) randomised controlled assessor-blind STRATIFY trial (Structured Tailored Rehabilitation AfTer HIp FragilitY Fracture). Adults aged 60 years or more, surgically treated for hip fracture following low energy trauma (fragility fracture), who are willing to provide consent or by consultee declaration (depending on capacity), are eligible. Individuals who experienced in-hospital hip fracture will be excluded. Screening, consent/assent, baseline assessment (demographics, patient reported outcome measures or PROMs [health related quality of life, activities of daily living, pain, falls related self-efficacy], and resource use), and randomization will take place within the first four days post-admission. Participants will then be offered usual care, or usual care plus STRATIFY intervention during their hospital stay. The STRATIFY intervention includes 1) a web-based algorithm to allocate participants to low- medium- or high-risk subgroups; and 2) matched interventions depending on subgroup allocation. The low-risk subgroup will be offered a self-management review, training in advocacy, and a self-managed exercise programme with support for progression, in addition to usual care (1-hour 40 minutes therapist time above usual care). The medium-risk subgroup will be offered education, a goal-orientated mobility programme (with carer training, as available and following carer consent), and early enhanced discharge planning, in addition to usual care (estimated 2-hours 15 minutes therapist time above usual care). The high-risk subgroup will be offered education, enhanced assessment, orientation, and a goal-orientated activities of daily living programme (with carer training, as available and following carer consent), in addition to usual care (estimated 2-hours 45minutes therapist time above usual care). All STRATIFY subgroup treatment interventions are specified using the Rehabilitation Treatment Specification System (RTSS) for treatment theory development and replication. Follow-up PROM data collection, RESOURCE USE alongside readmissions and mortality, will be collected on discharge and 12-weeks post-randomisation. Intervention acceptability will be determined by semi-structured interviews with participants, carers, and therapists at the end of the intervention.DisseminationThe trial findings will be disseminated to patients and the public, health professionals and researchers through publications, presentations and social media channels.Trial registrationThe trial has been registered at clinicaltrials.gov (NCT06014554).
| S-EPMC11651604 | biostudies-literature
Project description:IntroductionAnnually, millions of adults suffer hip fractures. The mortality rate post a hip fracture is 7%-10% at 30 days and 10%-20% at 90 days. Observational data suggest that early surgery can improve these outcomes in hip fracture patients. We designed a clinical trial-HIP fracture Accelerated surgical TreaTment And Care tracK (HIP ATTACK) to determine the effect of accelerated surgery compared with standard care on the 90-day risk of all-cause mortality and major perioperative complications.Methods and analysisHIP ATTACK is a multicentre, international, parallel group randomised controlled trial (RCT) that will include patients ≥45 years of age and diagnosed with a hip fracture from a low-energy mechanism requiring surgery. Patients are randomised to accelerated medical assessment and surgical repair (goal within 6 h) or standard care. The co-primary outcomes are (1) all-cause mortality and (2) a composite of major perioperative complications (ie, mortality and non-fatal myocardial infarction, pulmonary embolism, pneumonia, sepsis, stroke, and life-threatening and major bleeding) at 90 days after randomisation. All patients will be followed up for a period of 1 year. We will enrol 3000 patients.Ethics and disseminationAll centres had ethics approval before randomising patients. Written informed consent is required for all patients before randomisation. HIP ATTACK is the first large international trial designed to examine whether accelerated surgery can improve outcomes in patients with a hip fracture. The dissemination plan includes publishing the results in a policy-influencing journal, conference presentations, engagement of influential medical organisations, and providing public awareness through multimedia resources.Trial registration numberNCT02027896; Pre-results.
| S-EPMC6501985 | biostudies-literature
Project description:IntroductionProximal femoral (hip) fracture is common, serious and costly. Rehabilitation may improve functional recovery but evidence of effectiveness and cost-effectiveness are lacking. An enhanced rehabilitation intervention was previously developed and a feasibility study tested the methods used for this randomised controlled trial (RCT). The objectives are to compare the effectiveness and cost-effectiveness of the enhanced rehabilitation programme following surgical repair of proximal femoral fracture in older people compared with usual care.Methods and analysisProtocol for phase III, parallel-group, two-armed, superiority, pragmatic RCT with 1:1 allocation ratio; allocation sequence by minimisation programme with a built-in random element; secure web-based allocation concealment. The two treatments will be usual care (control) and usual care plus an enhanced rehabilitation programme (intervention). The enhanced rehabilitation will consist of a patient-held information workbook, goal setting diary and up to six additional therapy sessions. Outcome assessment and statistical analysis will be performed blind; patient and carer participants will be unblinded. Outcomes will be measured at baseline, 17 and 52 weeks' follow-up. Primary outcome at 52 weeks will be the Nottingham Extended Activities of Daily Living scale. Secondary outcomes will measure anxiety and depression, health utility, cognitive status, hip pain intensity, falls self-efficacy, fear of falling, grip strength and physical function. Carer strain, anxiety and depression will be measured in carers. All safety events will be recorded, and serious adverse events will be assessed to determine whether they are related to the intervention and expected. Concurrent economic evaluation will be a cost-utility analysis from a health service and personal social care perspective. An embedded process evaluation will determine the mechanisms and processes that explain the implementation and impacts of the enhanced rehabilitation programme.Ethics and disseminationNational Health Service research ethics approval reference 18/NE/0300. Results will be disseminated by peer-reviewed publication.Trial registration numberISRCTN28376407; Pre-results registered on 23 November 2018.
| S-EPMC7569930 | biostudies-literature
Project description:BackgroundHypotension during anaesthesia for hip fracture surgery is common. Recent data suggest that there is an association between the lowest intra-operative blood pressure and mortality, even when adjusted for co-morbidities. This is consistent with data derived from the wider surgical population, where magnitude and duration of hypotension are associated with mortality and peri-operative complications. However, there are no trial to data to support more aggressive blood pressure control.Methods/designWe are conducting a three-centre, randomised, double-blinded pilot study in three hospitals in the United Kingdom. The sample size will be 75 patients (25 from each centre). Randomisation will be done using computer-generated concealed tables. Both participants and investigators will be blinded to group allocation. Participants will be aged >70 years, cognitively intact (Abbreviated Mental Test Score 7 or greater), able to give informed consent and admitted directly through the emergency department with a fractured neck of the femur requiring operative repair. Patients randomised to tight blood pressure control or avoidance of intra-operative hypotension will receive active treatment as required to maintain both of the following: systolic arterial blood pressure >80% of baseline pre-operative value and mean arterial pressure >75 mmHg throughout. All participants will receive standard hospital care, including spinal or general anaesthesia, at the discretion of the clinical team. The primary outcome is a composite of the presence or absence of defined cardiovascular, renal and delirium morbidity within 7 days of surgery (myocardial injury, stroke, acute kidney injury, delirium). Secondary endpoints will include the defined individual morbidities, mortality, early mobility and discharge to usual residence.DiscussionThis is a small-scale pilot study investigating the feasibility of a trial of tight intra-operative blood pressure control in a frail elderly patient group with known high morbidity and mortality. Positive findings will provide the basis for a larger-scale study.Trial registrationISRCTN Registry identifier: ISRCTN89812075 . Registered on 30 August 2016.
| S-EPMC5526232 | biostudies-literature
Project description:BackgroundPatients undergoing proximal femur fracture surgery are at high risk of postoperative complications, with postoperative delirium occurring in 25%-40% of patients. Delirium has profound effects on patient outcome and recovery, the patient's family, caregivers and medical costs. Perioperative music has a beneficial effect on eliciting modifiable risk factors of delirium. Therefore, the aim of this trial was to evaluate the effect of perioperative recorded music on postoperative delirium in patients with proximal femur fracture undergoing surgery.Methods and analysisThe Music on Clinical Outcome after Hip Fracture Operations study is an investigator-initiated, multicentre, randomised controlled, open-label, clinical trial. Five hundred and eight patients with proximal femur fracture meeting eligibility criteria will be randomised to the music intervention or control group with concealed allocation in a 1:1 ratio, stratified by hospital site. The perioperative music intervention consists of preselected lists totalling 30 hours of music, allowing participants to choose their preferred music from these lists (classical, jazz and blues, pop and Dutch). The primary outcome measure is postoperative delirium rate. Secondary outcome measures include pain, anxiety, medication requirement, postoperative complications, hospital length of stay and 30-day mortality. A 90-day follow-up will be performed in order to assess nursing home length of stay, readmission rate and functional ability to perform daily living activities. Furthermore, the cost and cost-effectiveness of the music intervention will be assessed. Data will be analysed according to an intention-to-treat principle.Ethics and disseminationThe study protocol has been approved by the Medical Research Ethics Committee Erasmus MC on 8 October 2018 (MEC-2018-110, NL64721.078.18). The trial will be carried out following the Declaration of Helsinki principles, Good Clinical Practice guidelines and Dutch Medical Research Involving Human Subjects Act. Research data will be reported following Consolidated Standards of Reporting Trials guidelines and study results will be published in a peer-reviewed journal.Trial registration numberNTR7036.
| S-EPMC8705073 | biostudies-literature
Project description:IntroductionGuidelines for hip fracture care state that patients with hip fracture should be mobilised on the day after surgery and at least once a day thereafter. However, compliance with these guidelines is poor. One approach that would assist physiotherapists to meet mobility guidelines after hip fracture is to delegate the provision of daily mobilisation to allied health assistants under their supervision. Therefore, we plan to conduct a randomised controlled trial to determine the feasibility of an allied health assistant providing daily inpatient rehabilitation to patients with hip fracture.Methods and analysisUsing a parallel group randomised controlled design with one-to-one allocation, participants will be randomly allocated to an experimental group (allied health assistant management) or a comparison group (physiotherapist management). Inclusion criteria are: adult with diagnosis of hip fracture; inpatient in acute hospital; walked independently pre-hip fracture and able to communicate in conversational English. The experimental group will receive routine physiotherapy rehabilitation, including daily mobilisation, from an allied health assistant following initial physiotherapist assessment. The comparison group will receive routine rehabilitation from a physiotherapist. The primary outcome will be the feasibility of allied health assistant management of patients with hip fracture. Feasibility will be determined using the following areas of focus in Bowen's feasibility framework: acceptability (patient satisfaction), demand (proportion of patients who participate), implementation (time allied health assistant/physiotherapist spends with participant, occasions of service) and practicality (cost, adverse events). Staff involved in the implementation of allied health assistant care will be interviewed to explore their perspectives on feasibility. Secondary outcomes include compliance with daily mobilisation guidelines, discharge destination, hospital readmission, falls, functional activity and length of stay. We aim to recruit 50 participants. Descriptive statistics will be used to describe feasibility and mobilisation rates will be calculated using Cox proportional hazards regression to compare compliance with mobilisation guidelines.Ethics and disseminationEthics approval was obtained from the Peninsula Health human research ethics committee (HREC/63 005/PH-2020). The findings will be disseminated in peer-reviewed journals and conference presentations.Trail registration numberAustralian and New Zealand Clinical Trial Registry; ACTRN12620000877987; Pre-results.
| S-EPMC8611436 | biostudies-literature
Project description:IntroductionThere is a high incidence of blood transfusion following hip fractures in elderly patients. Tranexamic acid (TXA) has proven efficacy in decreasing blood loss in general trauma patients as well as patients undergoing elective orthopaedic surgery. A randomised controlled trial will measure the effect of TXA in a population of patients undergoing hip fracture surgery.MethodsThis is a double-blinded, randomised placebo-controlled trial. Patients admitted through the emergency room that are diagnosed with an intertrochanteric or femoral neck fracture will be eligible for enrolment and randomised to either treatment with 1 g of intravenous TXA or intravenous saline at the time of skin incision. Patients undergoing percutaneous intervention for non-displaced or minimally displaced femoral neck fractures will not be eligible for enrolment. Postoperative transfusion rates will be recorded and blood loss will be calculated from serial haematocrits.Ethics and disseminationThis protocol was approved by the Institutional Review Board (IRB) and is registered with clinicaltrials.gov. The findings of the trial will be disseminated through peer-reviewed journals and conference presentations.Trial registration numberNCT01940536.
| S-EPMC4916621 | biostudies-literature
Project description:IntroductionHip fractures are a leading cause of mortality and disability worldwide, and the number of hip fractures is expected to rise to over 6 million per year by 2050. The optimal approach for the surgical management of displaced femoral neck fractures remains unknown. Current evidence suggests the use of arthroplasty; however, there is lack of evidence regarding whether patients with displaced femoral neck fractures experience better outcomes with total hip arthroplasty (THA) or hemiarthroplasty (HA). The HEALTH trial compares outcomes following THA versus HA in patients 50 years of age or older with displaced femoral neck fractures.Methods and analysisHEALTH is a multicentre, randomised controlled trial where 1434 patients, 50 years of age or older, with displaced femoral neck fractures from international sites are randomised to receive either THA or HA. Exclusion criteria include associated major injuries of the lower extremity, hip infection(s) and a history of frank dementia. The primary outcome is unplanned secondary procedures and the secondary outcomes include functional outcomes, patient quality of life, mortality and hip-related complications-both within 2 years of the initial surgery. We are using minimisation to ensure balance between intervention groups for the following factors: age, prefracture living, prefracture functional status, American Society for Anesthesiologists (ASA) Class and centre number. Data analysts and the HEALTH Steering Committee are blinded to the surgical allocation throughout the trial. Outcome analysis will be performed using a χ(2) test (or Fisher's exact test) and Cox proportional hazards modelling estimate. All results will be presented with 95% CIs.Ethics and disseminationThe HEALTH trial has received local and McMaster University Research Ethics Board (REB) approval (REB#: 06-151).ResultsOutcomes from the primary manuscript will be disseminated through publications in academic journals and presentations at relevant orthopaedic conferences. We will communicate trial results to all participating sites. Participating sites will communicate results with patients who have indicated an interest in knowing the results.Trial registration numberThe HEALTH trial is registered with clinicaltrials.gov (NCT00556842).
| S-EPMC4330331 | biostudies-literature