심한 고관절 또는 무릎 골관절염 환자에게 중요한 것은 무엇입니까? (PATI-Project)
심한 고관절 또는 무릎 골관절염 환자에게 중요한 것은 무엇입니까? 결정 품질, 환자 참여 및 건강 결과
This clinical trial aims to investigate if shared decision-making, and the use of an in-consultation patient decision aid (PtDA), increases the decisional quality and therefore treatment satisfaction and outcome of patients with severe hip or knee osteoarthritis.
Finally, an evaluation will be conducted on patient-reported outcomes on pain, physical function, quality of life (QoL), and patient satisfaction, up to one year after surgery.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
Osteoarthritis (OA) is the most common joint disease and a major cause of disability worldwide. The condition typically affects the hip or knee, and as the condition progresses it frequently causes debilitating pain and stiffness in the affected joints; thus impairing mobility, and decreasing function and quality of life(QoL).
Approximately 10,300 primary hip arthroplasties (THA) and 10,000 primary knee arthroplasties (TKA/UKA) were performed in Denmark in 2021.
For the majority of patients with severe osteoarthritis, evidence shows that joint replacement surgery is life-changing. Despite this documented effect, not all patients achieve optimal results. Patient dissatisfaction following THA and TKA has been reported as 7 % and 11-18%, respectively.
It is hypothesized that a lack of adequate information and patient involvement in the decision process might lead to the misalignment of patients' expectations and subsequent dissatisfaction. Considerable evidence shows that patients prefer more information and greater involvement. This strongly supports the concept that patients need to be actively involved in treatment decisions.
Accordingly, increasing patient involvement in healthcare decisions may be beneficial. Shared decision-making (SDM) supports patients' active involvement in the process and improves the quality of decisions. SDM can be facilitated using a PtDA, which has shown significant benefits in a range of patient groups. However, research on SDM and PtDAs in patients with severe hip or knee OA is lacking.
The overall aim of this project is to investigate if an in-consultation PtDA increases the decision quality for patients with severe OA of the hip or knee.
연구 유형
연구 유형
등록 (실제)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
-
Odense, 덴마크, 5000
- Odense University Hospital, OUH
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Svendborg, 덴마크, 5700
- Odense University Hospital, OUH
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Vejle, 덴마크, 7100
- Lillebaelt Hospital - Vejle
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-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Severe primary osteoarthritis eligible for primary total hip arthroplasty (THA) / primary total knee arthroplasty (TKA) / primary partial knee arthroplasty (UKA)
- Able to understand and read Danish
- Informed consent
Exclusion Criteria:
- Previous THA, TKA, or UKA on the contralateral side
- Cognitive impairment
- Non-OA-related reason for the visit
- No digital mailbox (E-boks)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: Shared decision-making (SDM)
Patients will be informed by a nurse before being consulted by the surgeon randomized to SDM and use the in-consultation PtDA during the consultation on patients with severe hip or knee osteoarthritis |
The intervention group has been involved in the development process of the PtDA. After receiving a training course in SDM and the use of a PtDA, the surgeons will practice SDM supported by an in-consultation PtDA during the consultations with the participant. |
|
간섭 없음: Usual practice
Patients will be informed by a nurse before being consulted by the surgeon randomized to usual practice during the consultation on patients with severe hip or knee osteoarthritis |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
The participant's decisional quality according to The Hip/Knee Osteoarthritis Decision Quality Instrument (HK-DQI).
기간: Within one week after inclusion in the consultation
|
Informed Patient-Centered (IPC) decision is calculated as the percentage of patients who are well-informed and received their preferred treatment. |
Within one week after inclusion in the consultation
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Participant's engagement in the decision-making process as measured by the CollaboRATE questionnaire
기간: Within one week after inclusion in the consultation
|
Minimum value: 0. Maximum value: 100. The higher the value the more shared decision-making |
Within one week after inclusion in the consultation
|
|
Participant's involvement in the decision-making process as measured by the HK-DQI questionnaire
기간: Within one week after inclusion in the consultation
|
HK-DQI, section 3, decision-making process: Minimum value: 0. Maximum value: 100. The higher the value the more shared decision-making |
Within one week after inclusion in the consultation
|
|
The duration of consultation when PtDA is used compared to standard consultation without the use of PtDA.
기간: Through study completion, an average of 1 year
|
The time duration will be documented by the surgeons |
Through study completion, an average of 1 year
|
기타 결과 측정
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Participant's Qol when undergoing hip or knee replacement surgery as measured by EuroQol (EQ-5D)
기간: Three months and one year following surgery.
|
QoL: EuroQol (EQ-5D): Measuring the health-related quality of life. Presenting in three levels; Level 1: Indicating no problem, to Level 3: Indicating extreme problems |
Three months and one year following surgery.
|
|
The participant's pain and physical function after undergoing hip replacement surgery as measured by the Oxford Hip Score (OHS) questionnaire
기간: Three months and one year following surgery
|
Oxford Hip Score (OHS): Measuring function and pain with patients undergoing hip replacement surgery. Total scores range from 0 (poorest function) to 48 (maximal function). |
Three months and one year following surgery
|
|
The participant's pain and physical function after undergoing knee replacement surgery as measured by the Oxford Knee Score (OKS) questionnaire
기간: Three months and one year following surgery
|
Oxford Knee Score (OKS): Measuring function and pain with patients undergoing knee replacement surgery. Total scores range from 0 (poorest function) to 48 (maximal function). |
Three months and one year following surgery
|
|
The participant's physical function after undergoing hip or knee replacement surgery as measured by Forgotten Joint Score (FJS) questionnaire
기간: Three months and one year following surgery.
|
Forgotten joint score (FJS): Measuring the participants' awareness of their artificial joint during activity of daily living (ADL). Minimum value: 0. Maximum value: 100. The higher score, the less the patient is aware of their affected joint. |
Three months and one year following surgery.
|
|
Participant's regret of the treatment decision as measured by the Decision Regret Scale questionnaire.
기간: Three months and one year following surgery.
|
The Decision Regret Scale: Minimum value: 0. Maximum value: 100. The higher the value the more regret. |
Three months and one year following surgery.
|
|
Participant's satisfaction after undergoing hip or knee replacement surgery as measured by the patient satisfaction questionnaire (PSQ)
기간: Three months and one year following surgery.
|
The patient satisfaction questionnaire (PSQ): The higher the value the more satisfaction. |
Three months and one year following surgery.
|
공동 작업자 및 조사자
협력자
협력자
수사관
수사관
- 수석 연구원: Trine Ahlmann, PhD stud, Vejle Hospital
- 연구 의자: Claus Varnum, Ass.Prof.MD, Vejle Hospital
- 연구 의자: Martin Lindberg-Larsen, Ass.Prof.MD., Odense University Hospital
- 연구 의자: Charlotte Myhre Jensen, Ass.Prof.RN, Odense University Hospital
- 연구 의자: Karina Dahl Steffensen, Prof.MD., Vejle Hospital
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (실제)
기본 완료
연구 완료 (실제)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- S-20200137
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
All data of the outcome measures will be available in an anonymized form if required by the scientific journal, in which the results of the trial will be published.
IPD 공유 기간
Data will be available after the publication of the trial
IPD 공유 액세스 기준
Data access will be reviewed by the author's group
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
- ANALYTIC_CODE
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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