Background and purpose — Knee and hip replacement are common and increasing procedures, and an optimized care process that could be implemented in different settings would be useful. The PROMISE trial investigates whether a new care process works equally in different German settings and how the results compare with current non-standardized care. Patients and methods — This multi-center prospective mixed-method study includes 2,000 German patients receiving arthritis-related hip or knee endoprostheses. An interdisciplinary and cross-sectoral care process was developed and implemented in 3 German hospitals with different levels of care, and corresponding rehabilitation centers were included to bridge the gap after acute care. Duration and outcome — The PROMISE trial recruited patients between May 2018 and March 2020. Follow-up will end in February 2021. Assessments are performed at: examination on clinical indication, 1 week before surgery, on the day of surgery, at the end of hospitalization, end of the rehabilitation program, and 3 months, 6 months, and 12 months after surgery. Outcomes include patient-reported outcomes, medical examination findings, and routinely collected data regarding the surgery and complications. Guideline-based interviews are conducted with selected patients and care partners. The primary endpoint is the presence of chronic pain at 12 months after surgery. Secondary endpoints are the number of recognized pre-existing conditions, physical activity at 12 months after surgery, use of medical services, quality of life, and interactions between care partners. Trial registration — The trial is registered with the German Clinical Trials Register ( https://www.drks.de ; DRKS00013972; March 23, 2018).
Background: While there is evidence on the effectiveness of optimized treatment processes for patients receiving hip and knee endoprostheses, feasibility in various settings has not been adequately investigated. The multicenter PROMISE Trial (Process optimization by interdisciplinary and cross-sectoral care using the example of patients with hip and knee prostheses) was set up to fill this gap. Methods: A complex optimized process was implemented in three German hospitals offering different levels of care and five cooperating rehabilitation centers. For the feasibility question, data on 19 parameters characterizing the defined process were collected. The extent of cross-sectoral collaboration was a special focus. Results: The data show, for almost all parameters in all facilities, an implementation rate of more than 80% with missing data below 5%, n = 1887 study participants. A total of 96.8% attended a rehabilitation program, and for 29.2% rehabilitation took place in a PROMISE-collaborating facility. Conclusions: Adherence to the defined and well-documented process was very high in all three organizationally very different hospitals, so that feasibility is given and transferability of the concept can be assumed. An exception was the targeted integration of rehabilitation into the treatment process. The goal of cross-sectoral networking could only be partially achieved.
Zusammenfassung Hintergrund Für Deutschland werden im Rahmen optimierter Behandlungsprozesse rund um die Implantation einer Knie- oder Hüftendoprothese stationäre Aufenthaltszeiten angegeben, die die international publizierten Zeiten deutlich übertreffen. Die vorliegende Analyse von Daten der PROMISE-Studie beschäftigt sich in diesem Zusammenhang mit dem Verhältnis von Entlassbarkeit und Entlassung. Methode In drei Krankenhäusern unterschiedlicher Versorgungsstufen wurde ein gemeinsam entwickelter, optimierter Versorgungsstandard etabliert und für eine weitgehend unselektionierte Patientenkohorte umgesetzt. Unter anderem wurden Daten zum Erreichen der Entlasskriterien (EK) und der tatsächlichen Entlassung erhoben. Univariate Vergleiche wurden durch Chi-Quadrat-Tests oder Mann-Whitney-U-Tests durchgeführt. Ergebnisse Insgesamt konnten 1782 Patienten eingeschlossen werden, von denen 85,3 % nach im Mittel (MW) 2,4 Tagen (Median 2) postoperativ alle zuvor definierten EK erreicht haben. Die Entlassung für diese Gruppe erfolgte nach 5,4 (MW) Tagen (Median 5). Die restlichen Probanden (14,7 %) hatten bei Entlassung nach 6,5 (MW) Tagen (Median 6) mindestens ein EK nicht erreicht. Für verschiedene Subgruppen konnten signifikante Unterschiede festgestellt werden. Fazit Die sogenannten EK werden als relative Kriterien eingesetzt. Das Erreichen führt im Allgemeinen nicht zu einer zeitnahen Entlassung der Patienten aus dem Krankenhaus. Wäre dies der Fall, wären auch in Deutschland international übliche Aufenthaltszeiten Realität. Was die Entlassung tatsächlich bestimmt, bleibt offen. Eine Vielzahl von medizinischen, organisatorischen, strukturellen und finanziellen Einflussfaktoren könnten bedeutend sein.
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