Improving Patient-Centered Care Delivery Among Patients With Chronic Obstructive Pulmonary Disease (BREATHE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Hanan Aboumatar, Johns Hopkins University

Brief Summary:

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

Detailed Description:

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:

  1. 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
  2. Tailored COPD self-management education and support program that starts during the hospital stay and continues post discharge in the community setting
  3. 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Usual Care
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 .

Primary Outcome Measures :
  1. 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.

  2. Mean change in patients' scores on the St. George Respiratory Questionnaire [ Time Frame: At 6 months post 'index-hospitalization' compared to baseline ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

  1. Admitted to the hospital with a diagnosis of an acute COPD exacerbation; OR has a previous COPD diagnosis* AND receiving treatment to control COPD symptoms - (e.g. nebulizer treatment, prednisone course, …) in the current hospitalization
  2. Age > 40 and >10 pack-yrs smoking
  3. English speaking
  4. Anticipated discharge back to home (rather than to Hospice or long term nursing home placement)

Exclusion criteria:

  1. Severe cognitive dysfunction
  2. Terminal illness (less than 6 months life expectancy) that is non-COPD related
  3. Homeless (no home address)

Information from the National Library of Medicine

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 identifier (NCT number): NCT02036294

Contact: Hanan Aboumatar, MD, MPH 410-6377152

United States, Maryland
Johns Hopkins Bayview Medical Center Recruiting
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
Patient-Centered Outcomes Research Institute
Principal Investigator: Hanan Aboumatar, MD, MPH Johns Hopkins University

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Hanan Aboumatar, Assistant Professor, Johns Hopkins University Identifier: NCT02036294     History of Changes
Other Study ID Numbers: IH-1304-7118
First Posted: January 15, 2014    Key Record Dates
Last Update Posted: August 30, 2016
Last Verified: August 2016

Keywords provided by Hanan Aboumatar, Johns Hopkins University:
Patient self-care behaviors
Patient activation
Family caregiver support
Patient-centered care

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases