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

Chronic Obstructive Pulmonary Disease Clinical Trial

— BREATHE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02036294
• Other study ID #: NA_00090518
• Secondary ID: IH-1304-7118
• Status: Completed
• Phase: N/A
• Start date: March 10, 2015
• Est. completion date: January 9, 2017

Study information

• Verified date: October 2019
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: January 9, 2017
• Est. primary completion date: January 9, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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 .
• Usual Care
Standard Healthcare Services

Locations

Country	Name	City	State
United States	Johns Hopkins Bayview Medical Center	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Number of Chronic Obstructive Pulmonary Disease (COPD)-Related Hospitalizations and Emergency Department (ED) Visits Per Patient Within Each Study Arm	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.	Measured at 6 months post 'index-hospitalization'
Primary	Mean Change in Patients' Score on the St. George Respiratory Questionnaire Within Each Study Arm	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.	Baseline to 6 months post index-hospitalization
Secondary	Mean Number of Chronic Obstructive Pulmonary Disease (COPD)-Related Hospitalizations and Emergency Department (ED) Visits Per Patient Within Each Study Arm	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.	Measured at 1 month post 'index-hospitalization'
Secondary	Mean Number of Chronic Obstructive Pulmonary Disease (COPD)-Related Hospitalizations and Emergency Department (ED) Visits Per Patient Within Each Study Arm	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.	Measured at 3 months post 'index-hospitalization'
Secondary	Mean Change in Patients' Score on the St. George Respiratory Questionnaire Within Each Study Arm	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.	Baseline to 3 months post index-hospitalization
Secondary	Probability for Survival Without Death or a COPD- Related Acute Care Event at 6 Months Post Index-hospitalization, Estimated Using the Kaplan-Meier Method	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.	Measured at 180 days post-discharge from index hospitalization