Trial Outcomes & Findings for Improving Patient-Centered Care Delivery Among Patients With Chronic Obstructive Pulmonary Disease (NCT NCT02036294)

NCT ID: NCT02036294

Last Updated: 2019-10-22

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

240 participants

Primary outcome timeframe

Measured at 6 months post 'index-hospitalization'

Results posted on

2019-10-22

Participant Flow

Participant milestones

Participant milestones
Measure	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	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 .
Overall Study STARTED	120	120
Overall Study COMPLETED	111	109
Overall Study NOT COMPLETED	9	11

Reasons for withdrawal

Reasons for withdrawal
Measure	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	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 .
Overall Study Death	7	8
Overall Study Withdrawal by Subject	2	3

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Usual Care n=120 Participants 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	BREATHE Program n=120 Participants 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 .	Total n=240 Participants Total of all reporting groups
Age, Continuous	66.0 years STANDARD_DEVIATION 10.0 • n=5 Participants	63.9 years STANDARD_DEVIATION 9.6 • n=7 Participants	64.9 years STANDARD_DEVIATION 9.8 • n=5 Participants
Sex: Female, Male Female	76 Participants n=5 Participants	72 Participants n=7 Participants	148 Participants n=5 Participants
Sex: Female, Male Male	44 Participants n=5 Participants	48 Participants n=7 Participants	92 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	116 Participants n=5 Participants	116 Participants n=7 Participants	232 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	18 Participants n=5 Participants	20 Participants n=7 Participants	38 Participants n=5 Participants
Race (NIH/OMB) White	100 Participants n=5 Participants	98 Participants n=7 Participants	198 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Total score of St. George's Respiratory Questionnaire (SGRQ)	63.6 units on a scale STANDARD_DEVIATION 17.4 • n=5 Participants	62.3 units on a scale STANDARD_DEVIATION 18.8 • n=7 Participants	62.9 units on a scale STANDARD_DEVIATION 19.6 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Usual Care n=113 Participants 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	BREATHE Program n=112 Participants 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 .
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	1.40 COPD-related visits per participant Standard Deviation 2.08

PRIMARY outcome

Timeframe: Baseline to 6 months post index-hospitalization

Population: Not all participants could be reached to complete the survey

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.

Outcome measures

Outcome measures
Measure	Usual Care n=91 Participants 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	BREATHE Program n=88 Participants 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 .
Mean Change in Patients' Score on the St. George Respiratory Questionnaire Within Each Study Arm	-2.69 units on a scale Interval -9.34 to 3.96	2.81 units on a scale Interval -3.73 to 9.34

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Usual Care n=119 Participants 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	BREATHE Program n=118 Participants 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 .
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	0.27 COPD-related visits per participant Standard Deviation 0.59

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Usual Care n=115 Participants 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	BREATHE Program n=116 Participants 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 .
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 0.90	0.78 COPD-related visits per participant Standard Deviation 1.24

SECONDARY outcome

Timeframe: Baseline to 3 months post index-hospitalization

Population: Not all participants could be reached to complete the survey

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.

Outcome measures

Outcome measures
Measure	Usual Care n=90 Participants 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	BREATHE Program n=82 Participants 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 .
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	-0.85 units on a scale Standard Deviation 19.44

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure	Usual Care n=120 Participants 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	BREATHE Program n=119 Participants 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 .
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 Interval 0.49 to 0.66	0.45 Proportion of participants Interval 0.35 to 0.53

Adverse Events

Usual Care

Serious events: 69 serious events

Other events: 0 other events

Deaths: 7 deaths

BREATHE Program

Serious events: 76 serious events

Other events: 0 other events

Deaths: 8 deaths

Serious adverse events

Serious adverse events
Measure	Usual Care n=120 participants at risk 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	BREATHE Program n=120 participants at risk 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 .
General disorders Hospitalization for any cause	57.5% 69/120 • Number of events 137 • Between study enrollment and 6 months Deaths were assessed systematically via medical records and vital statistics records review. All hospitalization events were assessed systematically via patient report and medical records review. Other serious adverse events voluntarily reported by patient or nurse	63.3% 76/120 • Number of events 202 • Between study enrollment and 6 months Deaths were assessed systematically via medical records and vital statistics records review. All hospitalization events were assessed systematically via patient report and medical records review. Other serious adverse events voluntarily reported by patient or nurse
General disorders Other serious unanticipated events	0.00% 0/120 • Between study enrollment and 6 months Deaths were assessed systematically via medical records and vital statistics records review. All hospitalization events were assessed systematically via patient report and medical records review. Other serious adverse events voluntarily reported by patient or nurse	0.00% 0/120 • Between study enrollment and 6 months Deaths were assessed systematically via medical records and vital statistics records review. All hospitalization events were assessed systematically via patient report and medical records review. Other serious adverse events voluntarily reported by patient or nurse

Other adverse events

Adverse event data not reported

Additional Information

Principle Investigator

Johns Hopkins University

Phone: 410-637-7152

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place