Chronic Obstructive Pulmonary Disease
Conditions
Keywords
Patient self-care behaviors, Patient activation, Family caregiver support, Patient-centered care
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.
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.
Interventions
OTHERBREATHE 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 .
OTHERUsual Care
Standard Healthcare Services
Sponsors
Patient-Centered Outcomes Research Institute
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Number of Chronic Obstructive Pulmonary Disease (COPD)-Related Hospitalizations and Emergency Department (ED) Visits Per Patient Within Each Study Arm | 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. |
| Mean Change in Patients' Score on the St. George Respiratory Questionnaire Within Each Study Arm | 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
| Measure | Time frame | Description |
|---|---|---|
| Mean Number of Chronic Obstructive Pulmonary Disease (COPD)-Related Hospitalizations and Emergency Department (ED) Visits Per Patient Within Each Study Arm | 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. |
| Mean Change in Patients' Score on the St. George Respiratory Questionnaire Within Each Study Arm | 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. |
| Probability for Survival Without Death or a COPD- Related Acute Care Event at 6 Months Post Index-hospitalization, Estimated Using the Kaplan-Meier Method | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Usual Care Usual Care: Standard healthcare services will be received. Study participants in this arm will not receive any additional study interventions.
Usual Care: Standard Healthcare Services | 120 |
| 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 .
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 . | 120 |
| Total | 240 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 7 | 8 |
| Overall Study | Withdrawal by Subject | 2 | 3 |
Baseline characteristics
| Characteristic | Usual Care | Total | BREATHE Program |
|---|---|---|---|
| Age, Continuous | 66.0 years STANDARD_DEVIATION 10 | 64.9 years STANDARD_DEVIATION 9.8 | 63.9 years STANDARD_DEVIATION 9.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 8 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 116 Participants | 232 Participants | 116 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 18 Participants | 38 Participants | 20 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 100 Participants | 198 Participants | 98 Participants |
| Sex: Female, Male Female | 76 Participants | 148 Participants | 72 Participants |
| Sex: Female, Male Male | 44 Participants | 92 Participants | 48 Participants |
| Total score of St. George's Respiratory Questionnaire (SGRQ) | 63.6 units on a scale STANDARD_DEVIATION 17.4 | 62.9 units on a scale STANDARD_DEVIATION 19.6 | 62.3 units on a scale STANDARD_DEVIATION 18.8 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 7 / 120 | 8 / 120 |
| other Total, other adverse events | 0 / 120 | 0 / 120 |
| serious Total, serious adverse events | 69 / 120 | 76 / 120 |
Outcome results
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.
Time frame: Baseline to 6 months post index-hospitalization
Population: Not all participants could be reached to complete the survey
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care | Mean Change in Patients' Score on the St. George Respiratory Questionnaire Within Each Study Arm | -2.69 units on a scale |
| BREATHE Program | Mean Change in Patients' Score on the St. George Respiratory Questionnaire Within Each Study Arm | 2.81 units on a scale |
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.
Time frame: Measured at 6 months post 'index-hospitalization'
Population: Data was analyzed for all participants unless: 1) participant died during the 6 months study period (we have to exclude deaths from this analysis because we cannot calculate a full count of hospital or ED visits during the 6 months period if the participant had died before the 6 months has elapsed ) ; 2) participant withdrew from the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Mean Number of Chronic Obstructive Pulmonary Disease (COPD)-Related Hospitalizations and Emergency Department (ED) Visits Per Patient Within Each Study Arm | 0.72 COPD-related visits per participant | Standard Deviation 1.38 |
| BREATHE Program | Mean Number of Chronic Obstructive Pulmonary Disease (COPD)-Related Hospitalizations and Emergency Department (ED) Visits Per Patient Within Each Study Arm | 1.40 COPD-related visits per participant | Standard Deviation 2.08 |
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.
Time frame: Baseline to 3 months post index-hospitalization
Population: Not all participants could be reached to complete the survey
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Mean Change in Patients' Score on the St. George Respiratory Questionnaire Within Each Study Arm | -1.13 units on a scale | Standard Deviation 17.14 |
| BREATHE Program | Mean Change in Patients' Score on the St. George Respiratory Questionnaire Within Each Study Arm | -0.85 units on a scale | Standard Deviation 19.44 |
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.
Time frame: Measured at 1 month post 'index-hospitalization'
Population: Data was analyzed for all participants unless: 1) participant died during the 1 month study period (we have to exclude deaths from this analysis because we cannot calculate a full count of hospital or ED visits during the 1 month period if the participant had died before the 1 month have elapsed ) ; 2) participant withdrew from the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Mean Number of Chronic Obstructive Pulmonary Disease (COPD)-Related Hospitalizations and Emergency Department (ED) Visits Per Patient Within Each Study Arm | 0.12 COPD-related visits per participant | Standard Deviation 0.32 |
| BREATHE Program | Mean Number of Chronic Obstructive Pulmonary Disease (COPD)-Related Hospitalizations and Emergency Department (ED) Visits Per Patient Within Each Study Arm | 0.27 COPD-related visits per participant | Standard Deviation 0.59 |
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.
Time frame: Measured at 3 months post 'index-hospitalization'
Population: Data was analyzed for all participants unless: 1) participant died during the 3 months study period (we have to exclude deaths from this analysis because we cannot calculate a full count of hospital or ED visits during the 3 months period if the participant had died before the 3 months have elapsed ) ; 2) participant withdrew from the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Mean Number of Chronic Obstructive Pulmonary Disease (COPD)-Related Hospitalizations and Emergency Department (ED) Visits Per Patient Within Each Study Arm | 0.43 COPD-related visits per participant | Standard Deviation 0.9 |
| BREATHE Program | Mean Number of Chronic Obstructive Pulmonary Disease (COPD)-Related Hospitalizations and Emergency Department (ED) Visits Per Patient Within Each Study Arm | 0.78 COPD-related visits per participant | Standard Deviation 1.24 |
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.
Time frame: Measured at 180 days post-discharge from index hospitalization
Population: All participants whose medical records were available to confirm whether a hospitalization or ED visit is COPD-related
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care | Probability for Survival Without Death or a COPD- Related Acute Care Event at 6 Months Post Index-hospitalization, Estimated Using the Kaplan-Meier Method | 0.58 Proportion of participants |
| BREATHE Program | Probability for Survival Without Death or a COPD- Related Acute Care Event at 6 Months Post Index-hospitalization, Estimated Using the Kaplan-Meier Method | 0.45 Proportion of participants |