Clinical trial NCT06130813: Increased Perioperative Communication Program in Knee Arthroplasty
Official title: Effect of Increased Perioperative Communication Program on Short-Term Complications in Elective Primary Knee Arthroplasty Patients: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Arthroplasty
Postoperative Complications
Keywords: knee arthroplasty
communication program
complication
randomized controlled trial
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2023-11-14
Enrollment: 70
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: PREVENTION

Brief summary: Total knee replacement (TKA) is a surgical procedure to increase the function of the knee joint. However, in the postoperative period, it takes a long time for patients to gain independence and adapt to daily life, and they need information and support. The aim of this study is to determine the effect of the increased perioperative communication program (IPCP) in patients with TKA on early postoperative complications.

Detailed description: Total knee replacement (TKA) is a surgical procedure to increase the function of the knee joint. However, in the postoperative period, it takes a long time for patients to gain independence and adapt to daily life, and they need information and support. The aim of this study is to determine the effect of the increased perioperative communication program (IPCP) in patients with TKA on early postoperative complications. This study was approved by the Clinical Research Ethics Committee of Ankara Bilkent City Hospital (No:E1/3573/2023). The population of this study will consist of patients who applied to Ankara Bilkent City Hospital, Orthopedics and Traumatology Outpatient Clinic due to knee osteoarthritis and who are planned to undergo elective total knee arthroplasty. Patients who are planned for elective primary unilateral knee arthroplasty, have a smartphone, are literate, have no communication problems and agree to participate in the study will be included in the study; Patients with revision total knee arthroplasty, bilateral total knee arthroplasty, speech and hearing disabilities, cognitive problems such as Alzheimer's and dementia, and patients who do not agree to participate in the study will be excluded from the study. The sample of the research is; it was determined as 70 patients by G. Power analysis based on the correlation coefficients in a sample study. 35 of the patients will be assigned to the intervention group (IG) and 35 to the control group (CG). Patients in the CG will receive routine perioperative care, while patients in the IG will be included in the IPCP. All patients will be followed for one month after discharge. IPCP consists of 8 informative contents such as preoperative preparations, surgical procedure, pain management, first mobilization, knee joint movements, exercise, discharge process, wound care, showering, nutrition, daily living activities, driving, sexual life, postoperative routine control, unexpected situations and etc. These informative contents will send to patients on days 7th, 4t and 1th days before the surgery and on days 1th, 2th, 3th, 5th an 7th days after surgery via whatsapp. Additionally, all participants will follow postoperative one month. Data will collect using Personal Information Form and Problems Experienced After Discharge Form. Data will analyze using IBM SPSS version 23.0.

Eligibility criteria: Inclusion Criteria:

* Elective primary unilateral knee arthroplasty planned,
* Having a smartphone,
* Literate,
* Have no communication problems and
* Agreed to participate in the study were included.

Exclusion Criteria:

* Those with revision total knee arthroplasty
* Those with bilateral total knee arthroplasty
* Those with speech and hearing disabilities and cognitive problems such as Alzheimer's and dementia
* Patients who do not agree to participate in the study will be excluded from the study.

Primary outcomes:
measure: Postoperative complications
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Cigdem Canbolat Seyman
state: Altındağ
Study officials:
affiliation: Hacettepe University
name: Cigdem Canbolat Seyman, PHD
role: STUDY_DIRECTOR
References:
citation: Yoon RS, Nellans KW, Geller JA, Kim AD, Jacobs MR, Macaulay W. Patient education before hip or knee arthroplasty lowers length of stay. J Arthroplasty. 2010 Jun;25(4):547-51. doi: 10.1016/j.arth.2009.03.012. Epub 2009 May 8.
citation: Day MA, Anthony CA, Bedard NA, Glass NA, Clark CR, Callaghan JJ, Noiseux NO. Increasing Perioperative Communication With Automated Mobile Phone Messaging in Total Joint Arthroplasty. J Arthroplasty. 2018 Jan;33(1):19-24. doi: 10.1016/j.arth.2017.08.046. Epub 2017 Sep 19.
citation: Karimi AH, Shah AK, Hecht CJ 2nd, Burkhart RJ, Acuna AJ, Kamath AF. Readability of Online Patient Education Materials for Total Joint Arthroplasty: A Systematic Review. J Arthroplasty. 2023 Jul;38(7):1392-1399. doi: 10.1016/j.arth.2023.01.032. Epub 2023 Jan 27.
citation: Stewart MA. Effective physician-patient communication and health outcomes: a review. CMAJ. 1995 May 1;152(9):1423-33.
citation: Clarke HD, Timm VL, Goldberg BR, Hattrup SJ. Preoperative patient education reduces in-hospital falls after total knee arthroplasty. Clin Orthop Relat Res. 2012 Jan;470(1):244-9. doi: 10.1007/s11999-011-1951-6.