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Evaluation of Multidisciplinary Recovery After Surgery Program in Orthopedics and Traumatology

Primary Purpose

Hip Fractures, Knee Fracture, Hip Arthritis

Status
Unknown status
Phase
Not Applicable
Locations
Croatia
Study Type
Interventional
Intervention
Multidisciplinary Recovery Program
Sponsored by
Klinički Bolnički Centar Zagreb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Fractures focused on measuring Recovery, Patient reported outcome measures, Hip fracture, Hip arthritis, Knee fracture, Knee arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • KBC ZagrebRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Multidisciplinary Recovery Program

Conventional Perioperative Care

Arm Description

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.

Patients undergoing conventional care

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Readmission rates
Rate of readmission to the hospital
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.
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).
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.
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.

Full Information

First Posted
January 27, 2019
Last Updated
February 16, 2019
Sponsor
Klinički Bolnički Centar Zagreb
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1. Study Identification

Unique Protocol Identification Number
NCT03822247
Brief Title
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

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
August 1, 2019 (Anticipated)
Study Completion Date
January 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Klinički Bolnički Centar Zagreb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures, Knee Fracture, Hip Arthritis, Knee Arthritis
Keywords
Recovery, Patient reported outcome measures, Hip fracture, Hip arthritis, Knee fracture, Knee arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Multidisciplinary Recovery Program
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional Perioperative Care
Arm Type
No Intervention
Arm Description
Patients undergoing conventional care
Intervention Type
Procedure
Intervention Name(s)
Multidisciplinary Recovery Program
Intervention Description
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
Primary Outcome Measure Information:
Title
Early Postoperative Complications
Description
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
Title
Late Postoperative Complications
Description
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
Secondary Outcome Measure Information:
Title
Readmission rates
Description
Rate of readmission to the hospital
Time Frame
30 days after surgery
Title
Patient-reported outcome after orthopedic surgery using The Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Description
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
Title
Pain assessment using Visual Analog Scale (VAS)
Description
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
Title
Assessment of health related quality of life using Euro Quality of Life Index (Euro QoL 5-D 5-L)
Description
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
Title
Evaluation of patients' satisfaction with the care provided using The Short-form patient satisfaction questionnaire (PSQ-18)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nikica Daraboš
Phone
+385 1 2388 203
Email
nikica.darabos@kbc-zagreb.hr
First Name & Middle Initial & Last Name or Official Title & Degree
Sara Medved
Phone
+385 1 2388 394
Email
smedved@kbc-zagreb.hr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nikica Daraboš
Organizational Affiliation
Head of Department of traumatology, bone and joint surgery
Official's Role
Study Chair
Facility Information:
Facility Name
KBC Zagreb
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nikica Daraboš
Phone
+385 1 2388 203
Email
nikica.darabos@kbc-zagreb.hr

12. IPD Sharing Statement

Plan to Share IPD
No

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Evaluation of Multidisciplinary Recovery After Surgery Program in Orthopedics and Traumatology

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