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Actively Recruiting

Researchers are evaluating a complex intervention aimed at implementing advance care planning (ACP) for severely ill elderly patients who live at home and are acutely admitted to hospital. The study uses a cluster randomized design involving twelve Norwegian hospital units specializing in geriatric care. It seeks to understand current ACP implementation, identify barriers and facilitators at multiple levels, explore ethical dilemmas, and assess the benefits and challenges experienced by patients, relatives, and healthcare staff. The project also aims to measure the impact of an implementation support program on communication quality, decision-making, and healthcare outcomes, as well as its cost-effectiveness. The intervention includes a comprehensive implementation support program featuring leadership commitment, responsive evaluation, a whole ward approach, and a train-the-trainer model to ensure sustainability. This program provides an implementation team and ACP coordinators, along with training, supervision, network conferences, and shared resources such as guidelines and teaching materials. The clinical intervention involves routine information and invitation to ACP for eligible patients, written materials for patients and relatives, and documentation with collaboration across healthcare levels. Half of the hospital units receive this support immediately, while the others receive it after the intervention period. Participants are involved through questionnaires to staff, clinicians, patients, and relatives, as well as patient record reviews and qualitative interviews. The study measures fidelity to the ACP model at multiple time points and evaluates patient-reported, relative-reported, and clinician outcomes during the intervention period, which spans 10 to 18 months after starting the support. Researchers also assess barriers and facilitators in wider healthcare contexts and perform economic analyses. The total involvement includes baseline and follow-up assessments up to 18 months.

Age: 70Years +All GendersPhase Not Applicable
12 locations
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Actively Recruiting

Ankle fractures are common injuries, occurring in about 1 in 800 people each year. The deep deltoid ligament plays a crucial role in stabilizing the ankle joint and influences treatment decisions. Researchers aim to find out if repairing the deltoid ligament in unstable ankle fractures leads to better function and may help prevent long-term osteoarthritis compared to treating only the lateral malleolus fracture. This study is a multicenter randomized controlled trial focusing on patients with complex ankle fractures requiring surgery. Participants will be randomly assigned to receive either the standard surgical repair of the lateral malleolus alone or with an additional procedure to suture the deep deltoid ligament. The ligament repair involves a curved incision to access and suture the ligament to an anchor in the talus bone. This treatment may also help compensate for related syndesmotic injuries. The study will compare functional outcomes and ankle stability between these treatments over time. Participants will be followed for up to five years after injury, with key assessments at one and two years, including patient-reported function and radiological evaluations of ankle stability. Data on function at five years will also be collected. Researchers will monitor recovery, ankle joint condition, and any signs of arthritis to determine if ligament repair offers long-term benefits. The total participation time involves initial treatment and multiple follow-up visits for evaluations and imaging.

Age: 18Years - 65YearsAll GendersPhase Not Applicable
9 locations
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