An interventional study of Multidisciplinary Recovery Program in Hip Fractures, Knee Fracture and Hip Arthritis, sponsored by Klinički Bolnički Centar Zagreb. Status unknown at 1 site in Croatia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-19.
Sponsored by Klinički Bolnički Centar Zagreb · Not applicable, Interventional, and Treatment
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.
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.
848 studies on the registry are indexed under Hip Fractures; 160 are open to participants now.
This study's planned enrollment of 100 is above the median of 90 across 540 interventional studies indexed under Hip Fractures.
Browse Hip Fractures studies →Klinički Bolnički Centar Zagreb is the lead sponsor of 9 studies on the registry; 2 are open to participants now.
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Two cohorts of patients will randomly be placed in either experimental od no intervention group. Patients undergoing Multidisciplinary Recovery After Surgery Program will gain better preparation for early mobilization after surgery, nutritional support, individually modified analgesia and psychological support during inpatient treatment. Program includes preoperative, intraoperative and postoperative multidisciplinary comprehensive interventions.
Procedure: Multidisciplinary Recovery Program
Patients undergoing conventional care
Preoperative care: * Patient's education * Providing respiratory training * Assessment of nutritional status * Application of compression stockings * Thromboembolism prophylaxis by low molecular weighted heparin * Induction of hemodynamic support 12 hours before the surgery * Oral carbohydrate solution loading until 2 hours before the surgery Intraoperative care: * Maintaining normothermia * Multimodal prevention of postoperative nausea and vomiting * Use of spinal anesthesia * Prevention of excessive blood loss * Local anesthetic infiltration Postoperative care: * Active pain control * Early mobilization * Early onset of oral nutrition * Early delirium detection * Application of compression stockings
Early Postoperative Complications
Occurrence of early complications: * Dislocation or malpositioning of joint replacement * Neurological deficit * Need for blood transfusion * Postoperative delirium * Nausea or vomiting * Pneumonia * Headache * Wound dehiscence, secretion, inflammation, bleeding
Time frame: 48 hours after surgery
Late Postoperative Complications
Occurrence of late complications: * Wound infection, healing by secundam * Decubitus * Fracture of joint replacement * Aseptic loosening of hip joint replacement * Infection of joint replacement * Thromboembolism * Need for a revision
Time frame: 10 days after surgery
Readmission rates
Rate of readmission to the hospital
Time frame: 30 days after surgery
Patient-reported outcome after orthopedic surgery using The Western Ontario and McMaster Universities Arthritis Index (WOMAC)
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is a self-administered questionnaire consisting of 24 items divided into 3 subscales (pain, stiffness and physical function). The questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. A sum of the scores for all three subscales gives a total WOMAC score; higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Time frame: 2 days, 60 days after surgery, 90 days after surgery
Pain assessment using Visual Analog Scale (VAS)
The Visual Analog Scale (VAS) is a unidimensional measure of pain intensity. It is a straight horizontal line of fixed length of 100 mm. The ends are defined as the extreme limits of pain orientated from the left (worst) to the right (best). The score represents the distance measured (mm) between the worst and best mark, providing a range of scores between 0-100. A higher score indicates greater pain intensity. The following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).
Time frame: 1 day, 2 days, 60 days after surgery, 90 days after surgery
Assessment of health related quality of life using Euro Quality of Life Index (Euro QoL 5-D 5-L)
The instrument Euro Quality of Life Index (Euro QoL 5-D 5-L) measures five dimensions, Mobility, Self-care, Daily activities, Pain/Discomfort, Anxiety/ Depression. Each dimension can be rated at five levels: from no problems to major problems. The five dimensions can be summed into a descriptive health state with 11111 representing no problems in any of the five health dimensions and 55555 indicating major problems in any of the five health dimensions. Second part of the instrument is the Visual Analogue Scale to assess health status at baseline, where 0 signifies worst imaginable health state, and 100 signifies best imaginable health state.
Time frame: baseline, 2 days, 60 days after surgery, 90 days after surgery
Evaluation of patients' satisfaction with the care provided using The Short-form patient satisfaction questionnaire (PSQ-18)
The Short-form patient satisfaction questionnaire (PSQ-18) contains 18 items tapping each of the seven dimension of satisfaction with medical care: general satisfaction, technical quality, interpersonal manner, communication, financial aspects, time spent with the doctor and accessibility and convenience. All items are scored so that high scores reflect satisfaction with medical care and after item scoring, items within the same subscale should be averaged together to create the seven subscale scores.
Time frame: 3 days after surgery
Plan to share: No
No publications or documents are linked to this record.
Started Dec 2018 (actual). Primary completion is estimated for Aug 2019, 8 months after the start.
Of 225 non-industry interventional studies with no phase under Hip Fractures, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 55. This study's planned 8 months is below that.
Counting every sponsor, half of 239 studies reached it within 29 months; a quarter within 10 and three quarters within 57.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Klinički Bolnički Centar Zagreb