Heart FailureCHAMP-PathNCT01561885
Collaborative Healthcare Professionals Approach in Monitoring of Patient Centered Outcomes Through Pathways
A study testing Pathway-Based Care in people with Heart Failure and Community Acquired Pneumonia, run by Majed Aljeraisy at 1 site in Saudi Arabia.
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… Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Heart Failure, Community Acquired Pneumonia, Venous Thromboembolism
- What is being tested?
- Pathway-Based Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 341 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Mar 2012to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
- 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)
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
King Khalid National Guard Hospital
Jeddah, Mecca Region, 21423
About this study
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
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.
Read the 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.
- Conditions
- Heart Failure, Community Acquired Pneumonia, Venous Thromboembolism, Acute Kidney Injury, Asthma
- Being tested
- Pathway-Based Care
- Keywords
- Clinical Pathways, Length of Stay, Patient-Centered Care, Pragmatic Randomized Controlled Trial
- Medical subject headings
- Heart Failure, Community-Acquired Pneumonia, Venous Thromboembolism, Acute Kidney Injury, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pathway-Based CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients on Pathway Care | Active comparator | Not described Receives: Other: Pathway-Based Care |
| Patients on Usual Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in length of hospital stay by two days
Measured: During hospitalization period of 7 to 10 days
Secondary outcomes (3)
30-Day Rehospitalization
To determine the effect of the pathway-based care versus usual care on 30-day rehospitalization rates for the same diagnosis
Measured: After discharge up to 30 days
Determinants of the Length of Stay
Measured: Upon admission until discharge
Pathway Care Specific Clinical Outcomes
For pathway care, there are specific targeted outcomes that ought to be met.
Measured: Upon admission until discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 341 participants (actual)
Sponsor and investigators
- Lead sponsor
- Majed Aljeraisy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Majed Aljeraisy, King Abdullah International Medical Research Center
- Investigators
- Mujtaba Quadri, MD, Principal investigator, National Guard Health AffairsSherine Esmail, PharmD, Principal investigator, National Guard Health AffairsSaliman Karsou, MD, Principal investigator, National Guard Health AffairsAbdulhameed Gasim, MD, Principal investigator, National Guard Health AffairsZeyad Zahrani, MD, Principal investigator, National Guard Health AffairsMajed Al Jeraisy, PharmD, Principal investigator, King Abdullah International Medical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01561885
- Sponsor's protocol ID
- RC 10/134/J
- Acronym
- CHAMP-Path
- Status last verified
- Apr 2017
- First submitted
- 18 Mar 2012
- Last updated
- 5 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01561885
- Acronym / sponsor ID
- CHAMP-Path / RC 10/134/J
- Conditions
- Heart Failure, Community Acquired Pneumonia, Venous Thromboembolism, Acute Kidney Injury, Asthma
- Keywords
- Clinical Pathways, Length of Stay, Patient-Centered Care, Pragmatic Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 341 participants (actual)
- Lead sponsor
- Majed AljeraisyUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 23 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients on Pathway Care | Active comparator | Other: Pathway-Based Care |
| Patients on Usual Care | No intervention | – |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pathway-Based CarePatients 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. | Other | Patients on Pathway Care |
Primary outcome
Decrease in length of hospital stay by two days
Time frame: During hospitalization period of 7 to 10 days
3 secondary outcomes
30-Day Rehospitalization
Time frame: After discharge up to 30 days
Determinants of the Length of Stay
Time frame: Upon admission until discharge
Pathway Care Specific Clinical Outcomes
Time frame: Upon admission until discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2017.
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mujtaba Quadri, MD principal investigator
National Guard Health Affairs
Sherine Esmail, PharmD principal investigator
National Guard Health Affairs
Saliman Karsou, MD principal investigator
National Guard Health Affairs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pathway-Based Care in people with Heart Failure and Community Acquired Pneumonia, run by Majed Aljeraisy at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease in length of hospital stay by two days (time frame: During hospitalization period of 7 to 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2017.