Clinical trial NCT03822247: Evaluation of Multidisciplinary Recovery After Surgery Program in Orthopedics and Traumatology
Official title: A Prospective, Randomized Comparison of Multidisciplinary Recovery After Surgery Program and Conventional Protocol for Perioperative Care in Orthopedics and Traumatology
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hip Fractures
Knee Fracture
Hip Arthritis
Knee Arthritis
Keywords: Recovery
Patient reported outcome measures
Hip fracture
Hip arthritis
Knee fracture
Knee arthritis
Lead sponsor: Klinički Bolnički Centar Zagreb
Sponsor class: OTHER
First posted: 2019-01-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the recovery protocol is to reduce surgical trauma, postoperative pain, and complications, shorten hospital treatment and improve postoperative recovery. Orthopedic and traumatology surgeries are often followed by a long-lasting recovery with difficulties of everyday functioning. Up to this time, only a few publications of multidisciplinary protocol in orthopedics and traumatology have been published, mostly to improve the care of patients after elective surgical procedures. The goal of multidisciplinary after surgery recovery program in orthopedics and traumatology is to improve the care of both urgent and elective patients using standardized, multi-professional care programs. It focuses on patient education, preoperative respiratory training, adequate nutritive and hemodynamic support, modified anesthesia protocol, prevention of postoperative pain, nausea and vomiting, and early postoperative delirium detection. The implementation of the program will reduce the rate of postoperative complications and the rate of rehospitalization, enhance the recovery after surgery and increase the satisfaction with the treatment.

Detailed description: The protocol combines scientifically proven interventions to standardize medical care, improve treatment outcomes and reduce healthcare costs. The aim is to reduce surgical trauma and postoperative pain, reduce complications, shorten hospital treatment and improve postoperative recovery. Moreover, it has been shown that using standardized, patient oriented recovery protocol significantly improves the outcomes and quality of care, but also brings financial benefit for the hospital as well as for the health system in general. Studies about implementing multidisciplinary recovery protocol in orthopedic and traumatology are scarce. Orthopedic and traumatology surgeries are often followed by a long-lasting and demanding recovery characterized by the difficulties of everyday functioning. Recovery is therefore multidisciplinary: for example, it is necessary to monitor the nutritional status of a patient, decrease postoperative pain, monitor cognitive status, etc. Until now only a few publications of recovery protocols in orthopedics and traumatology have been published, mostly to improve the care of patients after elective surgical procedures. The goal of this protocol in orthopedics and traumatology is to improve the care of both urgent and elective patients using standardized, multi-professional care programs. It was created based on evidence-based practice and modified by multidisciplinary team of orthopedic and traumatology surgeons, anesthesiologists, physiatrist, physiotherapists, specialized medical nurses, nutritionists, and psychiatrists. It focuses on patient preoperative education, preoperative respiratory training, adequate nutritive and hemodynamic support, modified local and regional anesthesia protocol, prevention of postoperative pain, nausea and vomiting, and early postoperative delirium detection. The investigators postulate that the implementation of this program will reduce the rate of postoperative complications and the rate of rehospitalization, enhance the recovery after surgery and increase the satisfaction with the treatment.

Eligibility criteria: Inclusion Criteria:

* Fracture od proximal femur or knee fracture requiring surgery
* Hip or knee arthrosis requiring joint replacement
* American Society of Anesthesiologists (ASA) score II or III
* Ability to provide informed consent

Exclusion Criteria:

* Severe cognitive impairment
* Pregnancy
* End stage of malignant disease
* Decompensated heart or liver disease

Primary outcomes:
measure: Early Postoperative Complications
timeFrame: 48 hours after surgery
measure: Late Postoperative Complications
timeFrame: 10 days after surgery
Secondary outcomes:
measure: Readmission rates
timeFrame: 30 days after surgery
measure: Patient-reported outcome after orthopedic surgery using The Western Ontario and McMaster Universities Arthritis Index (WOMAC)
timeFrame: 2 days, 60 days after surgery, 90 days after surgery
measure: Pain assessment using Visual Analog Scale (VAS)
timeFrame: 1 day, 2 days, 60 days after surgery, 90 days after surgery
measure: Assessment of health related quality of life using Euro Quality of Life Index (Euro QoL 5-D 5-L)
timeFrame: baseline, 2 days, 60 days after surgery, 90 days after surgery
measure: Evaluation of patients' satisfaction with the care provided using The Short-form patient satisfaction questionnaire (PSQ-18)
timeFrame: 3 days after surgery
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: KBC Zagreb
Study officials:
affiliation: Head of Department of traumatology, bone and joint surgery
name: Nikica Daraboš
role: STUDY_CHAIR
References: