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Completed

NCT Number: NCT02036294

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

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Behavior Chronic Disease Disease Attributes Health Behavior Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Patient Participation Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Treatment Adherence and Compliance

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

BREATHE program

Other

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 .

Usual Care

Other

Standard Healthcare Services

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Patient-Centered Outcomes Research Institute

Registry information

Official study title

An Integrative Multilevel Study for Improving Patient-Centered Care Delivery Among Patients With Chronic Obstructive Pulmonary Disease

Acronym: BREATHE

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jan 15, 2014
Registry last updated
Oct 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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