- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Makkah
-
Jeddah, Makkah, Saudi-Arabia, 21423
- King Khalid National Guard Hospital
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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)
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Aktiv komparator: 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.
|
Ingen inngripen: Patients on Usual Care
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Decrease in length of hospital stay by two days
Tidsramme: During hospitalization period of 7 to 10 days
|
During hospitalization period of 7 to 10 days
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
30-Day Rehospitalization
Tidsramme: 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
Tidsramme: Upon admission until discharge
|
Upon admission until discharge
|
|
Pathway Care Specific Clinical Outcomes
Tidsramme: Upon admission until discharge
|
For pathway care, there are specific targeted outcomes that ought to be met.
|
Upon admission until discharge
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Mujtaba Quadri, MD, National Guard Health Affairs
- Hovedetterforsker: Sherine Esmail, PharmD, National Guard Health Affairs
- Hovedetterforsker: Saliman Karsou, MD, National Guard Health Affairs
- Hovedetterforsker: Abdulhameed Gasim, MD, National Guard Health Affairs
- Hovedetterforsker: Zeyad Zahrani, MD, National Guard Health Affairs
- Hovedetterforsker: Majed Al Jeraisy, PharmD, King Abdullah International Medical Research Center
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- RC 10/134/J
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