Feasibility of allied health assistant management of people with acute hip fracture: protocol for a feasibility randomised controlled trial

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.

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Optimising implementation strategies of the first scaleup of a primary care psychological intervention for common mental disorders in Sub-Saharan Africa: a mixed methods study protocol for the optimised Friendship Bench (OptFB)

BMJ Open ◽

10.1136/bmjopen-2020-045481 ◽

2021 ◽

Vol 11 (9) ◽

pp. e045481

Author(s):

Ruth Verhey ◽

Charmaine Chitiyo ◽

Sandra Ngonidzashe Mboweni ◽

Ephraim Chiriseri ◽

Dixon Chibanda ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Mental Disorders ◽

Common Mental Disorders ◽

Psychological Intervention ◽

Controlled Trial ◽

Implementation Strategies ◽

Evaluation Framework ◽

Sub Saharan Africa ◽

Clinical Trial Registry ◽

Randomised Controlled

IntroductionCommon mental disorders (CMDs) are a leading cause of disability globally. CMDs are highly prevalent in Zimbabwe and have been addressed by an evidence-based, task-shifting psychological intervention called the Friendship Bench (FB). The task-shifted FB programme guides clients through problem-solving therapy. It was scaled up across 36 implementation sites in Zimbabwe in 2016.Methods and analysisThis study will employ a mixed-method framework. It aims to: (1) use quantitative survey methodologies organised around the Reach, Effectiveness, Adoption and Implementation and Maintenance evaluation framework to assess the current scaleup of the FB intervention and classify 36 clinics according to levels of performance; (2) use qualitative focus group discussions and semistructured interviews organised around the Consolidated Framework for Implementation Research to analyse determinants of implementation success, as well as elucidate heterogeneity in implementation strategies through comparing high-performing and low-performing clinics; and (3) use the results from aims 1 and 2 to develop strategies to optimise the Friendship Bench intervention and apply this model in a cluster randomised controlled trial to evaluate potential improvements among low-performing clinics. The trial will be registered with the Pan African Clinical Trial Registry (www.pactr.org). The planned randomised controlled trial for the third research aim will be registered after completing aims one and two because the intervention is dependent on knowledge generated during these phases.Ethics and disseminationThe research protocol received full authorisation from the Medical Research Council of Zimbabwe (MRCZ A/242). It is anticipated that changes in data collection tools and consent forms will take place at all three phases of the study and approval from MRCZ will be sought. All interview partners will be asked for informed consent. The research team will prioritise open-access publications to disseminate research results.

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Open-labelled randomised controlled trial of 12 hours versus 24 hours modified Pritchard regimen in the management of eclampsia and pre-eclampsia in Ghana (MOPEP Study): study protocol

BMJ Open ◽

10.1136/bmjopen-2019-032799 ◽

2019 ◽

Vol 9 (10) ◽

pp. e032799 ◽

Cited By ~ 1

Author(s):

Titus Beyuo ◽

Emma Lawrence ◽

Elizabeth S Langen ◽

Samuel A Oppong

Keyword(s):

Randomised Controlled Trial ◽

Health Outcomes ◽

Magnesium Sulfate ◽

Controlled Trial ◽

Secondary Outcome ◽

Control Group ◽

University Of Michigan ◽

Clinical Trial Registry ◽

Randomised Controlled ◽

Study Participants

IntroductionHypertensive disorders of pregnancy continue to be a major contributor to maternal and perinatal morbidity and mortality. Magnesium sulfate therapy is the standard of care for seizure prophylaxis and treatment for pre-eclampsia and eclampsia respectively, despite wide disparities in dosing regimens and routes of administration. This study compares the clinical efficacy of magnesium sulfate in the reduction of seizure occurrence or recurrence with the 12 hours versus 24 hours modified Pritchard regimens in the management of severe pre-eclampsia and eclampsia.Methods and analysisThis study is an open labelled randomised controlled trial. The study participants are patients admitted to the Korle Bu Teaching Hospital (KBTH) in Accra, Ghana with a diagnosis of antepartum, intrapartum or postpartum eclampsia or pre-eclampsia with severe features. All study participants will be administered a loading dose of magnesium sulfate, followed by maintenance dosing. Participants in the control group will receive magnesium sulfate for 24 hours after diagnosis, while those in the treatment group will receive magnesium sulfate for 12 hours after diagnosis. The primary outcome of this study is the occurrence of a seizure any time after the completion of treatment in the assigned group. Secondary outcome measures include maternal health outcomes, magnesium sulfate toxicities and fetal health outcomes. Data collection was started in October 2018 with a target enrolment of 1245 participants with severe pre-eclampsia and 844 participants with eclampsia with a projected study period of 2–3 years.Ethics and disseminationEthical approval was obtained from the KBTH Institutional Review Board (IRB) in Ghana. University of Michigan involvement is limited to protocol development and statistical analysis of de-identified data, and has been granted a Not Regulated Determination by the University of Michigan IRB. Results of the study will be shared at clinical forums at the KBTH and will be submitted for publication in an international peer-reviewed journal.Trial registration numberPan African Clinical Trial Registry through the South African Medical Research Council (PACTR201811515303983).

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Three short sessions of physiotherapy during rehabilitation after hip fracture were no more effective in improving mobility than a single longer session: a randomised controlled trial

Physiotherapy ◽

10.1016/j.physio.2020.12.002 ◽

2020 ◽

Author(s):

Catherine Senserrick ◽

Katherine Lawler ◽

Grant D. Scroggie ◽

Kim Williams ◽

Nicholas F. Taylor

Keyword(s):

Hip Fracture ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Randomised Controlled

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Effects of accelerated versus standard care surgery on the risk of acute kidney injury in patients with a hip fracture: a substudy protocol of the hip fracture Accelerated surgical TreaTment And Care tracK (HIP ATTACK) international randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2019-033150 ◽

2019 ◽

Vol 9 (9) ◽

pp. e033150 ◽

Cited By ~ 2

Author(s):

Flavia K Borges ◽

P J Devereaux ◽

Meaghan Cuerden ◽

Mohit Bhandari ◽

Ernesto Guerra-Farfán ◽

...

Keyword(s):

Acute Kidney Injury ◽

Surgical Treatment ◽

Hip Fracture ◽

Randomised Controlled Trial ◽

Standard Care ◽

Controlled Trial ◽

Kidney Injury ◽

Registration Number ◽

Randomised Controlled ◽

Care Surgery

IntroductionInflammation, dehydration, hypotension and bleeding may all contribute to the development of acute kidney injury (AKI). Accelerated surgery after a hip fracture can decrease the exposure time to such contributors and may reduce the risk of AKI.Methods and analysisHip fracture Accelerated surgical TreaTment And Care tracK (HIP ATTACK) is a multicentre, international, parallel-group randomised controlled trial (RCT). Patients who suffer a hip fracture are randomly allocated to either accelerated medical assessment and surgical repair with a goal of surgery within 6 hours of diagnosis or standard care where a repair typically occurs 24 to 48 hours after diagnosis. The primary outcome of this substudy is the development of AKI within 7 days of randomisation. We anticipate at least 1998 patients will participate in this substudy.Ethics and disseminationWe obtained ethics approval for additional serum creatinine recordings in consecutive patients enrolled at 70 participating centres. All patients provide consent before randomisation. We anticipate reporting substudy results by 2021.Trial registration numberNCT02027896; Pre-results.

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Accelerated surgery versus standard care in hip fracture (HIP ATTACK): an international, randomised, controlled trial

The Lancet ◽

10.1016/s0140-6736(20)30058-1 ◽

2020 ◽

Vol 395 (10225) ◽

pp. 698-708 ◽

Cited By ~ 34

Author(s):

Flavia K Borges ◽

Mohit Bhandari ◽

Ernesto Guerra-Farfan ◽

Ameen Patel ◽

Alben Sigamani ◽

...

Keyword(s):

Hip Fracture ◽

Randomised Controlled Trial ◽

Standard Care ◽

Controlled Trial ◽

Randomised Controlled

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Femoral nerve block in a representative sample of elderly people with hip fracture: A randomised controlled trial

Injury ◽

10.1016/j.injury.2017.04.043 ◽

2017 ◽

Vol 48 (7) ◽

pp. 1542-1549 ◽

Cited By ~ 17

Author(s):

Anna Unneby ◽

Olle Svensson ◽

Yngve Gustafson ◽

Birgitta Olofsson

Keyword(s):

Hip Fracture ◽

Randomised Controlled Trial ◽

Elderly People ◽

Nerve Block ◽

Representative Sample ◽

Femoral Nerve Block ◽

Controlled Trial ◽

Femoral Nerve ◽

Randomised Controlled

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Progressive strength training in older patients after hip fracture: a randomised controlled trial

Age and Ageing ◽

10.1093/ageing/afq167 ◽

2011 ◽

Vol 40 (2) ◽

pp. 221-227 ◽

Cited By ~ 49

Author(s):

H. Sylliaas ◽

T. Brovold ◽

T. B. Wyller ◽

A. Bergland

Keyword(s):

Hip Fracture ◽

Randomised Controlled Trial ◽

Strength Training ◽

Older Patients ◽

Controlled Trial ◽

Randomised Controlled ◽

Progressive Strength Training

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Effect of an intensive patient educational programme on the quality of bowel preparation for colonoscopy: a single-blind randomised controlled trial

BMJ Open Gastroenterology ◽

10.1136/bmjgast-2020-000376 ◽

2020 ◽

Vol 7 (1) ◽

pp. e000376

Author(s):

Sivakami Janahiraman ◽

Chan Yen Tay ◽

Jie Min Lee ◽

Wen Ling Lim ◽

Chun Hoe Khiew ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Bowel Preparation ◽

Controlled Trial ◽

Tertiary Hospital ◽

Educational Programme ◽

Control Group ◽

Randomised Controlled ◽

The Impact ◽

Experimental Group

ObjectivePreprocedural bowel preparation is necessary for optimal colonoscopy visualisation. However, it is challenging to achieve high-quality bowel preparation among patients scheduled for colonoscopy. This study aims to evaluate the impact of an intensive patient educational programme on the quality of bowel preparation.DesignAn accessor-blinded randomised controlled trial was carried out at the outpatient surgical clinic of a tertiary hospital. Patients were randomly assigned to the control group (received standard written and verbal instructions) or the experimental group (received an intensive and structured educational programme). All subjects completed a questionnaire before colonoscopy to assess their compliance, acceptability, and tolerability towards bowel preparation regime. Quality of bowel preparation was determined using the Boston Bowel Preparation Scale (BBPS).ResultsA total of 300 subjects who fulfilled the inclusion criteria were recruited. The experimental group had a significantly higher proportion of good quality bowel preparation than the control group (98.7% vs 52.3%, p<0.001). The median total BBPS score was also significantly higher in the experimental group (8 vs 5, p<0.001). Factors associated with good quality of bowel preparation included educational programme (OR: 22.79, 95% CI: 4.23 to 122.85, p<0.001), compliance to bowel cleansing agent (OR: 24.98, 95% CI 3.12 to 199.71, p<0.001), very difficult acceptability of preparation (OR: 0.11, 95% CI 0.03 to 0.38, p<0.001), tolerability towards bowel preparation (OR: 4.98, 95% CI 1.44 to 17.20, p<0.011) and hypomotility drugs (OR: 3.03, 95% CI 0.12 to 0.91, p<0.05).ConclusionAn intensive patient educational programme can significantly improve the quality of bowel preparation for colonoscopy.

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Rationale and design of the HIP fracture Accelerated surgical TreaTment And Care tracK (HIP ATTACK) Trial: a protocol for an international randomised controlled trial evaluating early surgery for hip fracture patients

BMJ Open ◽

10.1136/bmjopen-2018-028537 ◽

2019 ◽

Vol 9 (4) ◽

pp. e028537 ◽

Cited By ~ 4

Author(s):

Flavia K Borges ◽

Mohit Bhandari ◽

Ameen Patel ◽

Victoria Avram ◽

Ernesto Guerra-Farfán ◽

...

Keyword(s):

Surgical Treatment ◽

Hip Fracture ◽

Randomised Controlled Trial ◽

Standard Care ◽

Perioperative Complications ◽

Public Awareness ◽

Controlled Trial ◽

Early Surgery ◽

All Cause Mortality ◽

Randomised Controlled

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.

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