- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01561885
Collaborative Healthcare Professionals Approach in Monitoring of Patient Centered Outcomes Through Pathways (CHAMP-Path)
A Pragmatic Randomized Controlled Trial of Patient-Centered Integrated Clinical Pathways Based Versus Usual Care in an Academic Center: National Guard Health Affairs Western Region Experience
연구 개요
상세 설명
This study is a pragmatic randomized controlled trial. To date, there is a scarcity of randomized controlled trials looking at pathway-based, patient-centered healthcare versus usual care in several high-risk or high volume diagnoses that account for the vast majority of hospitalizations in medical settings.
In this study, the pathway care intervention is a collaborative effort that involves healthcare professionals from multiple departments, including pharmacists, health educators, nurses, social workers, nutritionists, and quality management.
For patients allocated to the usual care, these healthcare professionals will deliver standardized care when consulted. For pathway care patients, this collaborative healthcare will be default.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Makkah
-
Jeddah, Makkah, 사우디 아라비아, 21423
- King Khalid National Guard Hospital
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria (Overall Criteria):
- One principle diagnosis
- Hemodynamic Stability
Inclusion Criteria (Specific to each Diagnosis):
Acute Venous Thromboembolism:
- New onset / in-patient
Acute Kidney Injury:
- Patients with increased serum creatinine of more than 50% from baseline
Community Acquired Pneumonia:
- Age limit
Adult Left Ventricular Heart Failure:
- Age limit
Asthma
- Acute exacerbation of Asthma
Exclusion Criteria (Overall Criteria):
- Intensive Care Unit (ICU) patients
- Pregnancy
- Exclusion Criteria (Specific to each Diagnosis):
Acute Venous Thromboembolism:
- Hemodynamic instability (Systolic Blood Pressure (SBP) less than 90 mmHg or massive Pulmonary Embolism (PE)
- PE patients with an sPESI Score ≥ 1
Acute Kidney Injury:
- Critical care patients (ICU, Coronary Care Unit, burn units)
- Stage 4 and 5 chronic kidney diseases
- Kidney allograft recipients
- Obstructive uropathy
- Glomerulonephritis
- Interstitial nephritis
Community Acquired Pneumonia:
- Intensive Care Unit (ICU) patients
- Pregnancy
Adult Left Ventricular Heart Failure:
- All non-cardiogenic pulmonary edema
- Patients requiring Inotropic agents
Asthma
- Patients with Chronic Obstructive Pulmonary Disease (COPD) and Bronchiectasis
- Severe Asthma (Peak Expiratory Flow Rate (PEFR) less than 40 percent)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: Patients on Pathway Care
|
Patients who are randomly allocated to Pathway Care will be treated by the Pathway Clinical Teaching Unit as well as other collaborative healthcare professionals (pharmacists, nurses, health educators, nutritionists, and social workers).
The Pathway Care physicians will have access to the Clinical Care Plan on the QuadraMed, which is a detailed, organized, day-to-day treatment plan that includes pre-set orders and medications.
Physicians for the patients on Usual Care will not have access to this information, and the collaborative healthcare will only be provided upon consultation.
|
|
간섭 없음: Patients on Usual Care
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Decrease in length of hospital stay by two days
기간: During hospitalization period of 7 to 10 days
|
During hospitalization period of 7 to 10 days
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
30-Day Rehospitalization
기간: After discharge up to 30 days
|
To determine the effect of the pathway-based care versus usual care on 30-day rehospitalization rates for the same diagnosis
|
After discharge up to 30 days
|
|
Determinants of the Length of Stay
기간: Upon admission until discharge
|
Upon admission until discharge
|
|
|
Pathway Care Specific Clinical Outcomes
기간: Upon admission until discharge
|
For pathway care, there are specific targeted outcomes that ought to be met.
|
Upon admission until discharge
|
공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Mujtaba Quadri, MD, National Guard Health Affairs
- 수석 연구원: Sherine Esmail, PharmD, National Guard Health Affairs
- 수석 연구원: Saliman Karsou, MD, National Guard Health Affairs
- 수석 연구원: Abdulhameed Gasim, MD, National Guard Health Affairs
- 수석 연구원: Zeyad Zahrani, MD, National Guard Health Affairs
- 수석 연구원: Majed Al Jeraisy, PharmD, King Abdullah International Medical Research Center
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .