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Collaborative Healthcare Professionals Approach in Monitoring of Patient Centered Outcomes Through Pathways (CHAMP-Path)

Primary Purpose

Heart Failure, Community Acquired Pneumonia, Venous Thromboembolism

Status

Completed

Phase

Not Applicable

Locations

Saudi Arabia

Study Type

Interventional

Intervention

Pathway-Based Care

About this trial

This is an interventional health services research trial for Heart Failure focused on measuring Clinical Pathways, Length of Stay, Patient-Centered Care, Pragmatic Randomized Controlled Trial

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

King Khalid National Guard Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Patients on Pathway Care

Patients on Usual Care

Arm Description

Outcomes

Primary Outcome Measures

Decrease in length of hospital stay by two days

Secondary Outcome Measures

30-Day Rehospitalization

To determine the effect of the pathway-based care versus usual care on 30-day rehospitalization rates for the same diagnosis

Determinants of the Length of Stay

Pathway Care Specific Clinical Outcomes

For pathway care, there are specific targeted outcomes that ought to be met.

Full Information

NCT ID

NCT01561885

First Posted

March 18, 2012

Last Updated

April 4, 2017

Sponsor

Majed Aljeraisy

1. Study Identification

Unique Protocol Identification Number

NCT01561885

Brief Title

Collaborative Healthcare Professionals Approach in Monitoring of Patient Centered Outcomes Through Pathways

Acronym

CHAMP-Path

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Completed

Study Start Date

March 2012 (undefined)

Primary Completion Date

March 2016 (Actual)

Study Completion Date

March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Majed Aljeraisy

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure, Community Acquired Pneumonia, Venous Thromboembolism, Acute Kidney Injury, Asthma

Keywords

Clinical Pathways, Length of Stay, Patient-Centered Care, Pragmatic Randomized Controlled Trial

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

341 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Patients on Pathway Care

Arm Type

Active Comparator

Arm Title

Patients on Usual Care

Arm Type

No Intervention

Intervention Type

Other

Intervention Name(s)

Pathway-Based Care

Intervention Description

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.

Primary Outcome Measure Information:

Title

Decrease in length of hospital stay by two days

Time Frame

During hospitalization period of 7 to 10 days

Secondary Outcome Measure Information:

Title

30-Day Rehospitalization

Description

To determine the effect of the pathway-based care versus usual care on 30-day rehospitalization rates for the same diagnosis

Time Frame

After discharge up to 30 days

Title

Determinants of the Length of Stay

Time Frame

Upon admission until discharge

Title

Pathway Care Specific Clinical Outcomes

Description

For pathway care, there are specific targeted outcomes that ought to be met.

Time Frame

Upon admission until discharge

10. Eligibility

Sex

All

Minimum Age & Unit of Time

14 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials: