Effect of a Coordinated Primary-care-Based MDT-model on the Treatment of Hard-to-heal Ulcers

Официальное название

Effect of a Coordinated Primary-care-Based MDT-model on the Treatment of Hard-to-heal Ulcers; a Randomized Clinically Controlled Trial

Обзор

The TSS project is a study of the effects of treating hard-to-heal ulcers in a multidisciplinary cross sectional team, meaning that nurse and doctor from a hospital based wound healing clinic and wound care nurse from the primary care sector treat the patient in collaboration rather than the current form where care in municipalities and hospital setting, communicate but treat the patient on their own. The study is designed as a randomized study, meaning that individuals with hard-to-heal ulcers are randomly designated to standard care or the multidis-ciplinary team. We measure several aspects of the new format, but the main outcome com-pared between the two groups (standard care and multidisciplinary care) is number of ulcers healed. Participants are followed for a year after inclusion in the study, and have 6 fixed visits in the clinic, with the possibility of more visits if necessary. There is no "new" medicine, surgery or other treatments planned in the study, but the multi-disciplinary team can offer and implement any treatment deemed appropriate for the individ-ual that is allocated to the multidisciplinary team, of course the individual has the opportunity to decline any treatment offered by the team. The control group, i.e. individuals allocated to standard care, will receive the treatment that is normally available to individuals with hard-to-heal ulcers treated in the municipality, including referral to hospital based treatments.

Вмешательства

• Другое coordinated primary-care-based MDT-model
  The proposed intervention consists of an MDT with an orthopedic surgeon (Jonas Askø Andersen) and a wound care nurse from the wound clinical at North Zealand Hospital as well as a wound care nurse from the primary sector. Participants who are randomized to intervention is offered treatment in the team as deemed appropriate by the MDT. The participant will be seen in the clinic (in the primary sector) for planned study visits at. 1\. Week 1 2. Week 4 3. 3 months 4. 6 months 5. 12 months 6. Extra
• Другое Standard Care (in control arm)
  Participants randomized to control are not invited to be seen by the MDT team but are attended by the wound care nurse from the primary sector as part of the standard treatment offered to individuals with ulcers in the municipality. Apart from planned visits at 3, 6 and 12 months, the frequency and number of visits in the study period is performed as deemed appropriate by the wound care nurses from the primary sector. If any outcomes relevant for the study occurs outside of the planned study vis

Первичные конечные точки

• Ulcer healing [Срок оценки: Ulcer healing at 12 months]

Вторичные конечные точки (12)

• Time to ulcer healing [Срок оценки: 12 moths]
• Ulcer recurrence [Срок оценки: 12 months]
• Infections [Срок оценки: 12 months]
• Amputations [Срок оценки: 12 months]
• Visits [Срок оценки: 12 months]
• Hospital admissions [Срок оценки: 12 months]
• Patient related outcomes [Срок оценки: 12 months]
• Cost effectiveness [Срок оценки: 12 months]
• RE-AIM [Срок оценки: 12 months]
• RE-AIM [Срок оценки: 12 months]
• RE-AIM [Срок оценки: 12 months]
• RE-AIM [Срок оценки: 12 months]

Критерии участия

Критерии включения

• Patients aged 18 years or above
• Hard-to-heal ulcer(s)
• Able to understand written and oral information
• Ability to follow planned visits and treatment
• Able to provide informed consent in Danish and/or English

Критерии исключения

Revascularization procedure in the affected limb planned, or undertaken within the 4 weeks prior to screening

• Toe blood pressure < 35mmHg
• Infections of the ulcer needing acute or sub-acute (defined as within seven days) surgical treatment
• Prior major amputations on affected or contralateral leg
• Current treatment with cytotoxic drugs or with systemically administered glucocorticoids
• Likely inability to comply with the need for planned visits because of planned activities
• Participation in another interventional ulcer-healing trial within the 4 weeks prior to screening
• Prior enrolment in this trial
• Judgement by the investigator that the patient does not have the capacity to understand the study procedures or provide written informed consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Дания · 1 центр

• North Zealand Hospital — Hillerød

Идентификаторы

NCT: NCT07747896 · H-26016816 · H-26016816

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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