Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01561885
Other study ID # RC 10/134/J
Secondary ID
Status Completed
Phase N/A
First received March 18, 2012
Last updated April 4, 2017
Start date March 2012
Est. completion date March 2016

Study information

Verified date April 2017
Source King Abdullah International Medical Research Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to determine if by providing a collaborative, integrated pathway-based healthcare compared to the usual healthcare, whether or not this would be superior in reducing the length of hospital stay across five high frequency /high risk medical diagnoses: Acute Venous Thromboembolism, Acute Kidney Injury, Community Acquired Pneumonia, Adult Left Ventricular Heart Failure, and Asthma.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 341
Est. completion date March 2016
Est. primary completion date March 2016
Accepts healthy volunteers No
Gender All
Age group 14 Years and older
Eligibility 1. Inclusion Criteria (Overall Criteria):

- One principle diagnosis

- Hemodynamic Stability

2. 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

3. Exclusion Criteria (Overall Criteria):

- Intensive Care Unit (ICU) patients

- Pregnancy

4. 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)

Study Design


Intervention

Other:
Pathway-Based 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.

Locations

Country Name City State
Saudi Arabia King Khalid National Guard Hospital Jeddah Makkah

Sponsors (1)

Lead Sponsor Collaborator
Majed Aljeraisy

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Decrease in length of hospital stay by two days During hospitalization period of 7 to 10 days
Secondary 30-Day Rehospitalization 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
Secondary Determinants of the Length of Stay Upon admission until discharge
Secondary Pathway Care Specific Clinical Outcomes For pathway care, there are specific targeted outcomes that ought to be met. Upon admission until discharge
See also
  Status Clinical Trial Phase
Terminated NCT04410523 - Study of Efficacy and Safety of CSJ117 in Patients With Severe Uncontrolled Asthma Phase 2
Completed NCT04624425 - Additional Effects of Segmental Breathing In Asthma N/A
Active, not recruiting NCT03927820 - A Pharmacist-Led Intervention to Increase Inhaler Access and Reduce Hospital Readmissions (PILLAR) N/A
Completed NCT04617015 - Defining and Treating Depression-related Asthma Early Phase 1
Recruiting NCT03694158 - Investigating Dupilumab's Effect in Asthma by Genotype Phase 4
Terminated NCT04946318 - Study of Safety of CSJ117 in Participants With Moderate to Severe Uncontrolled Asthma Phase 2
Completed NCT04450108 - Vivatmo Pro™ for Fractional Exhaled Nitric Oxide (FeNO) Monitoring in U.S. Asthmatic Patients N/A
Completed NCT03086460 - A Dose Ranging Study With CHF 1531 in Subjects With Asthma (FLASH) Phase 2
Completed NCT01160224 - Oral GW766944 (Oral CCR3 Antagonist) Phase 2
Completed NCT03186209 - Efficacy and Safety Study of Benralizumab in Patients With Uncontrolled Asthma on Medium to High Dose Inhaled Corticosteroid Plus LABA (MIRACLE) Phase 3
Completed NCT02502734 - Effect of Inhaled Fluticasone Furoate on Short-term Growth in Paediatric Subjects With Asthma Phase 3
Completed NCT01715844 - L-Citrulline Supplementation Pilot Study for Overweight Late Onset Asthmatics Phase 1
Terminated NCT04993443 - First-In-Human Study to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of LQ036 Phase 1
Completed NCT02787863 - Clinical and Immunological Efficiency of Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology Phase 4
Recruiting NCT06033833 - Long-term Safety and Efficacy Evaluation of Subcutaneous Amlitelimab in Adult Participants With Moderate-to-severe Asthma Who Completed Treatment Period of Previous Amlitelimab Asthma Clinical Study Phase 2
Completed NCT03257995 - Pharmacodynamics, Safety, Tolerability, and Pharmacokinetics of Two Orally Inhaled Indacaterol Salts in Adult Subjects With Asthma. Phase 2
Completed NCT02212483 - Clinical Effectiveness and Economical Impact of Medical Indoor Environment Counselors Visiting Homes of Asthma Patients N/A
Recruiting NCT04872309 - MUlti-nuclear MR Imaging Investigation of Respiratory Disease-associated CHanges in Lung Physiology
Withdrawn NCT01468805 - Childhood Asthma Reduction Study N/A
Recruiting NCT05145894 - Differentiation of Asthma/COPD Exacerbation and Stable State Using Automated Lung Sound Analysis With LungPass Device