Improving Patient-Centered Care Delivery Among Patients With Chronic Obstructive Pulmonary Disease (BREATHE)
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|ClinicalTrials.gov Identifier: NCT02036294|
Recruitment Status : Unknown
Verified August 2016 by Hanan Aboumatar, Johns Hopkins University.
Recruitment status was: Recruiting
First Posted : January 15, 2014
Last Update Posted : August 30, 2016
This study involves development and testing of a patient and family-centered transitional care program for patients who are hospitalized with Chronic Obstructive Pulmonary Disease (COPD) exacerbations. The study intervention includes tailored services to address individual patients' biopsychosocial needs, starting early during hospital stay and continuing for 3 months post hospital discharge.
The study hypothesis is that compared to usual care, the study intervention will : a) Improve patient health- related quality of life and survival, and reduce use of hospital and emergency room visits; b) result in improved patient experience, self- confidence, and self-care behaviors; c) result in improved family caregivers coping skills, self-confidence, and problem solving skills to address patient barriers to care and treatment.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Obstructive Pulmonary Disease||Other: BREATHE program Other: Usual Care||Not Applicable|
This study evaluates using a randomized controlled trial design the impact of a patient and family-centered transitional care program named the BREATHE program. The BREATHE program stands for 'Better Respiratory Education and Treatment Help Empower'. The BREATHE program offers the following:
- Individualized transition support services to help ensure that the patient (and family caregiver if available) are prepared for discharge, understand the discharge plan of care, and receive post discharge follow up to help meet their needs
- Tailored COPD self-management education and support program that starts during the hospital stay and continues post discharge in the community setting
- Facilitated access to community based services.
The intervention is delivered by a new team member called "COPD Nurse Transition Guide". The new team member works with both the hospital and outpatient care teams, is a registered nurse with homecare services experience, and have received additional training in COPD self-management and motivational interviewing. The nurse meets participants in the hospital and then follows up with them via home visits and phone calls.The intervention involves both patients and family caregivers (if available), is literacy adapted, and follows a tailored approach based on patient needs, priorities, and preferences.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||An Integrative Multilevel Study for Improving Patient-Centered Care Delivery Among Patients With Chronic Obstructive Pulmonary Disease|
|Study Start Date :||March 2015|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||December 2016|
Usual Care: Standard healthcare services will be received. Study participants in this arm will not receive any additional study interventions.
Other: Usual Care
Standard Healthcare Services
Experimental: BREATHE program
Study participants randomized to this arm will be offered the BREATHE program an integrated multifaceted intervention that includes comprehensive biopsychosocial assessment, a tailored treatment plan, a tailored disease management program, and care management support services .
Other: BREATHE program
A patient and family- centered transitional care intervention that includes a comprehensive biopsychosocial assessment, a tailored treatment plan, a tailored disease management program, and care management support services .
- Mean combined number of COPD-related hospitalizations and emergency room visits per patient [ Time Frame: Measured at 6 months post 'index-hospitalization' ]'Index -hospitalization' is the hospitalization during which a patient is enrolled into the study.
- Mean change in patients' scores on the St. George Respiratory Questionnaire [ Time Frame: At 6 months post 'index-hospitalization' compared to baseline ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02036294
|Contact: Hanan Aboumatar, MD, MPHemail@example.com|
|United States, Maryland|
|Johns Hopkins Bayview Medical Center||Recruiting|
|Baltimore, Maryland, United States, 21224|
|Principal Investigator:||Hanan Aboumatar, MD, MPH||Johns Hopkins University|