Does regional implementation of a clinical pathway for older adult patients with pelvic fragility fractures after low-energy trauma improve patient outcomes (PELVIC): a multicentre, stepped-wedge, randomised controlled trial
Introduction Patients with pelvic fragility fractures suffer from high morbidity and mortality rates. Despite the high incidence, there is currently no regional or nationwide treatment protocol which results in a wide variety of clinical practices. Recently, there have been new insights into treatme...
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BMJ Publishing Group
2024-08-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/14/8/e083809.full |
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| author | Robert Hemke Mario Maas Frank W Bloemers Anna H M Mennen Daphne van Embden Hanna C Willems Marte Lommerse Kees Jan Ponsen |
| author_facet | Robert Hemke Mario Maas Frank W Bloemers Anna H M Mennen Daphne van Embden Hanna C Willems Marte Lommerse Kees Jan Ponsen |
| author_sort | Robert Hemke |
| collection | DOAJ |
| description | Introduction Patients with pelvic fragility fractures suffer from high morbidity and mortality rates. Despite the high incidence, there is currently no regional or nationwide treatment protocol which results in a wide variety of clinical practices. Recently, there have been new insights into treatment strategies, such as early diagnosis and minimally invasive operative treatment. The aim of this study is to implement an evidence-based and experience-based treatment clinical pathway to improve outcomes in this fragile patient population.Methods and analysis This study will be a regional stepped-wedge cluster randomised controlled trial. All older adult patients (≥50 years old) who suffered a pelvic fragility fracture after low-energetic trauma are eligible for inclusion. The pathway aims to optimise the diagnostic process, to guide the decision-making process for further treatment (eg, operative or conservative), to structure the follow-up and to provide guidelines on pain management, weight-bearing and osteoporosis workup. The primary outcome is mobility, measured by the Parker Mobility Score. Secondary outcomes are mobility measured by the Elderly Mobility Scale, functional performance, quality of life, return to home rate, level of pain, type and dosage of analgesic medications, the number of falls after treatment, the number of (fracture-related) complications, 1-year and 2-year mortality. Every 6 weeks, a cluster will switch from current practice to the clinical pathway. The aim is a total of 393 inclusions, which provides an 80% statistical power for an improvement in mobility of 10%, measured by the Parker mobility score.Ethics and dissemination The Medical Research Ethics Committee of Academic Medical Center has exempted the PELVIC study from the Medical Research Involving Human Subjects Act (WMO). Informed consent will be obtained using the opt-out method and research data will be stored in a database and handled confidentially. The final study report will be shared via publication without restrictions from funding parties and regardless of the outcome.Trial registration number NCT06054165.Protocol version V.1.0, 19 July 2022 |
| format | Article |
| id | doaj-art-06aa7c601d334b0988fc24aa1a665854 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2024-08-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-06aa7c601d334b0988fc24aa1a6658542024-12-16T23:45:14ZengBMJ Publishing GroupBMJ Open2044-60552024-08-0114810.1136/bmjopen-2023-083809Does regional implementation of a clinical pathway for older adult patients with pelvic fragility fractures after low-energy trauma improve patient outcomes (PELVIC): a multicentre, stepped-wedge, randomised controlled trialRobert Hemke0Mario Maas1Frank W Bloemers2Anna H M Mennen3Daphne van Embden4Hanna C Willems5Marte Lommerse6Kees Jan Ponsen7Department of Radiology and Nuclear Medicine, Amsterdam UMC Location AMC, Amsterdam, The NetherlandsDepartment of Radiology and Nuclear Medicine, Amsterdam UMC Location AMC, Amsterdam, The NetherlandsDepartment of Surgery, Amsterdam UMC Location AMC, Amsterdam, The NetherlandsDepartment of Surgery, Amsterdam UMC Location AMC, Amsterdam, The NetherlandsDepartment of Surgery, Amsterdam UMC Location AMC, Amsterdam, The NetherlandsDepartment of Internal Medicine and Geriatrics, Amsterdam UMC Locatie AMC, Amsterdam, The NetherlandsDepartment of Surgery, Amsterdam UMC Location AMC, Amsterdam, The NetherlandsDepartment of Surgery, Noordwest Ziekenhuisgroep, Alkmaar, The NetherlandsIntroduction Patients with pelvic fragility fractures suffer from high morbidity and mortality rates. Despite the high incidence, there is currently no regional or nationwide treatment protocol which results in a wide variety of clinical practices. Recently, there have been new insights into treatment strategies, such as early diagnosis and minimally invasive operative treatment. The aim of this study is to implement an evidence-based and experience-based treatment clinical pathway to improve outcomes in this fragile patient population.Methods and analysis This study will be a regional stepped-wedge cluster randomised controlled trial. All older adult patients (≥50 years old) who suffered a pelvic fragility fracture after low-energetic trauma are eligible for inclusion. The pathway aims to optimise the diagnostic process, to guide the decision-making process for further treatment (eg, operative or conservative), to structure the follow-up and to provide guidelines on pain management, weight-bearing and osteoporosis workup. The primary outcome is mobility, measured by the Parker Mobility Score. Secondary outcomes are mobility measured by the Elderly Mobility Scale, functional performance, quality of life, return to home rate, level of pain, type and dosage of analgesic medications, the number of falls after treatment, the number of (fracture-related) complications, 1-year and 2-year mortality. Every 6 weeks, a cluster will switch from current practice to the clinical pathway. The aim is a total of 393 inclusions, which provides an 80% statistical power for an improvement in mobility of 10%, measured by the Parker mobility score.Ethics and dissemination The Medical Research Ethics Committee of Academic Medical Center has exempted the PELVIC study from the Medical Research Involving Human Subjects Act (WMO). Informed consent will be obtained using the opt-out method and research data will be stored in a database and handled confidentially. The final study report will be shared via publication without restrictions from funding parties and regardless of the outcome.Trial registration number NCT06054165.Protocol version V.1.0, 19 July 2022https://bmjopen.bmj.com/content/14/8/e083809.full |
| spellingShingle | Robert Hemke Mario Maas Frank W Bloemers Anna H M Mennen Daphne van Embden Hanna C Willems Marte Lommerse Kees Jan Ponsen Does regional implementation of a clinical pathway for older adult patients with pelvic fragility fractures after low-energy trauma improve patient outcomes (PELVIC): a multicentre, stepped-wedge, randomised controlled trial BMJ Open |
| title | Does regional implementation of a clinical pathway for older adult patients with pelvic fragility fractures after low-energy trauma improve patient outcomes (PELVIC): a multicentre, stepped-wedge, randomised controlled trial |
| title_full | Does regional implementation of a clinical pathway for older adult patients with pelvic fragility fractures after low-energy trauma improve patient outcomes (PELVIC): a multicentre, stepped-wedge, randomised controlled trial |
| title_fullStr | Does regional implementation of a clinical pathway for older adult patients with pelvic fragility fractures after low-energy trauma improve patient outcomes (PELVIC): a multicentre, stepped-wedge, randomised controlled trial |
| title_full_unstemmed | Does regional implementation of a clinical pathway for older adult patients with pelvic fragility fractures after low-energy trauma improve patient outcomes (PELVIC): a multicentre, stepped-wedge, randomised controlled trial |
| title_short | Does regional implementation of a clinical pathway for older adult patients with pelvic fragility fractures after low-energy trauma improve patient outcomes (PELVIC): a multicentre, stepped-wedge, randomised controlled trial |
| title_sort | does regional implementation of a clinical pathway for older adult patients with pelvic fragility fractures after low energy trauma improve patient outcomes pelvic a multicentre stepped wedge randomised controlled trial |
| url | https://bmjopen.bmj.com/content/14/8/e083809.full |
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