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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.
 
ClinicalTrials.gov Identifier: NCT02036294
Recruitment Status : Completed
First Posted : January 15, 2014
Results First Posted : February 28, 2019
Last Update Posted : October 22, 2019
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
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.

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Study Type : Interventional  (Clinical Trial)
Actual 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
Actual Study Start Date : March 10, 2015
Actual Primary Completion Date : January 9, 2017
Actual Study Completion Date : January 9, 2017

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 Number of Chronic Obstructive Pulmonary Disease (COPD)-Related Hospitalizations and Emergency Department (ED) Visits Per Patient Within Each Study Arm [ Time Frame: Measured at 6 months post 'index-hospitalization' ]
    The primary outcome measure in this study is the mean number of COPD-related hospitalizations and ED visits per patient within each study arm . The number of hospital and ED visits per patient were counted at 6 months post 'index-hospitalization'. Index-hospitalization refers to the hospitalization in which the patient was enrolled into the study. A COPD- related hospitalization was defined as a hospitalization with discharge diagnosis of COPD exacerbation or Pneumonia; a hospitalization where the participant was admitted for congestive heart failure but received treatment for COPD exacerbation (nebulizer treatment plus steroids) ; or, admitted for symptoms pertaining to COPD and received steroids. A COPD- related ED visit was defined as a visit where the treating physician stated that the visit reason is COPD; or, where the participant was discharged on treatment with oral steroids or on treatment for pneumonia.

  2. Mean Change in Patients' Score on the St. George Respiratory Questionnaire Within Each Study Arm [ Time Frame: Baseline to 6 months post index-hospitalization ]
    This outcome measures the mean change in patient participants' quality of life as measured by the Saint George's Respiratory Questionnaire (SGRQ) score over the 6 month study period within each study arm.The St. George Respiratory Questionnaire (SGRQ) is a widely used validated disease- specific instrument that measures health-related quality of life. The SGRQ measures, using patient self-report, disease impact on symptoms, patient activity, and daily life. The total score for SGRQ ranges from 0 to 100, with higher scores indicating more limitations. The change in a patient's quality of life was calculated as the difference in their total score at 6 months post index-hospitalization from baseline. A difference of 4 points in total score is considered a clinically meaningful difference.


Secondary Outcome Measures :
  1. Mean Number of Chronic Obstructive Pulmonary Disease (COPD)-Related Hospitalizations and Emergency Department (ED) Visits Per Patient Within Each Study Arm [ Time Frame: Measured at 1 month post 'index-hospitalization' ]
    The primary outcome measure in this study is the mean number of COPD-related hospitalizations and ED visits per patient within each study arm . The number of hospital and ED visits per patient were counted at 1 month post 'index-hospitalization'. Index-hospitalization refers to the hospitalization in which the patient was enrolled into the study. A COPD- related hospitalization was defined as a hospitalization with discharge diagnosis of COPD exacerbation or Pneumonia; a hospitalization where the participant was admitted for congestive heart failure but received treatment for COPD exacerbation (nebulizer treatment plus steroids) ; or, admitted for symptoms pertaining to COPD and received steroids. A COPD- related ED visit was defined as a visit where the treating physician stated that the visit reason is COPD; or, where the participant was discharged on treatment with oral steroids or on treatment for pneumonia.

  2. Mean Number of Chronic Obstructive Pulmonary Disease (COPD)-Related Hospitalizations and Emergency Department (ED) Visits Per Patient Within Each Study Arm [ Time Frame: Measured at 3 months post 'index-hospitalization' ]
    The primary outcome measure in this study is the mean number of COPD-related hospitalizations and ED visits per patient within each study arm. The number of hospital and ED visits per patient were counted at 3 months post 'index-hospitalization'. Index-hospitalization refers to the hospitalization in which the patient was enrolled into the study. A COPD- related hospitalization was defined as a hospitalization with discharge diagnosis of COPD exacerbation or Pneumonia; a hospitalization where the participant was admitted for congestive heart failure but received treatment for COPD exacerbation (nebulizer treatment plus steroids) ; or, admitted for symptoms pertaining to COPD and received steroids. A COPD- related ED visit was defined as a visit where the treating physician stated that the visit reason is COPD; or, where the participant was discharged on treatment with oral steroids or on treatment for pneumonia.

  3. Mean Change in Patients' Score on the St. George Respiratory Questionnaire Within Each Study Arm [ Time Frame: Baseline to 3 months post index-hospitalization ]
    This outcome measures the mean change in patient participants' quality of life as measured by the Saint George's Respiratory Questionnaire (SGRQ) score over the 3 month study period within each study arm.The St. George Respiratory Questionnaire (SGRQ) is a widely used validated disease- specific instrument that measures health-related quality of life. The SGRQ measures, using patient self-report, disease impact on symptoms, patient activity, and daily life. The total score for SGRQ ranges from 0 to 100, with higher scores indicating more limitations. The change in a patient's quality of life was calculated as the difference in their total score at 3 months post index-hospitalization from baseline. A difference of 4 points in total score is considered a clinically meaningful difference.

  4. Probability for Survival Without Death or a COPD- Related Acute Care Event at 6 Months Post Index-hospitalization, Estimated Using the Kaplan-Meier Method [ Time Frame: Measured at 180 days post-discharge from index hospitalization ]
    Kaplan-Meier probability estimates that a participant would have their first event (death or COPD- related hospitalization or ED visit) sometime after 6 months from their index- hospitalization. The estimates are provided as the proportion of participants who do not have an event at 6 months post their index hospitalization.



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
Criteria

Inclusion criteria:

  • 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
  • Age > 40 and >10 pack-yrs smoking
  • English speaking
  • Anticipated discharge back to home (rather than to Hospice or long term nursing home placement)

Exclusion criteria:

  • Severe cognitive dysfunction
  • Terminal illness (less than 6 months life expectancy) that is non-COPD related
  • 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 ClinicalTrials.gov identifier (NCT number): NCT02036294


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02036294    
Other Study ID Numbers: NA_00090518
IH-1304-7118 ( Other Identifier: Other )
First Posted: January 15, 2014    Key Record Dates
Results First Posted: February 28, 2019
Last Update Posted: October 22, 2019
Last Verified: October 2019
Keywords provided by Johns Hopkins University:
Patient self-care behaviors
Patient activation
Family caregiver support
Patient-centered care
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases