Clinical trial NCT02036294: Improving Patient-Centered Care Delivery Among Patients With Chronic Obstructive Pulmonary Disease
Official title: An Integrative Multilevel Study for Improving Patient-Centered Care Delivery Among Patients With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Patient self-care behaviors
Patient activation
Family caregiver support
Patient-centered care
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2014-01-15
Enrollment: 240
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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)

Primary outcomes:
measure: Mean Number of Chronic Obstructive Pulmonary Disease (COPD)-Related Hospitalizations and Emergency Department (ED) Visits Per Patient Within Each Study Arm
timeFrame: Measured at 6 months post 'index-hospitalization'
measure: Mean Change in Patients' Score on the St. George Respiratory Questionnaire Within Each Study Arm
timeFrame: Baseline to 6 months post index-hospitalization
Secondary outcomes:
measure: Mean Number of Chronic Obstructive Pulmonary Disease (COPD)-Related Hospitalizations and Emergency Department (ED) Visits Per Patient Within Each Study Arm
timeFrame: Measured at 1 month post 'index-hospitalization'
measure: Mean Number of Chronic Obstructive Pulmonary Disease (COPD)-Related Hospitalizations and Emergency Department (ED) Visits Per Patient Within Each Study Arm
timeFrame: Measured at 3 months post 'index-hospitalization'
measure: Mean Change in Patients' Score on the St. George Respiratory Questionnaire Within Each Study Arm
timeFrame: Baseline to 3 months post index-hospitalization
measure: Probability for Survival Without Death or a COPD- Related Acute Care Event at 6 Months Post Index-hospitalization, Estimated Using the Kaplan-Meier Method
timeFrame: Measured at 180 days post-discharge from index hospitalization
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Hanan Aboumatar, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Poot CC, Meijer E, Kruis AL, Smidt N, Chavannes NH, Honkoop PJ. Integrated disease management interventions for patients with chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2021 Sep 8;9(9):CD009437. doi: 10.1002/14651858.CD009437.pub3.
citation: Aboumatar H, Naqibuddin M, Chung S, Chaudhry H, Kim SW, Saunders J, Bone L, Gurses AP, Knowlton A, Pronovost P, Putcha N, Rand C, Roter D, Sylvester C, Thompson C, Wolff JL, Hibbard J, Wise RA. Effect of a Hospital-Initiated Program Combining Transitional Care and Long-term Self-management Support on Outcomes of Patients Hospitalized With Chronic Obstructive Pulmonary Disease: A Randomized Clinical Trial. JAMA. 2019 Oct 8;322(14):1371-1380. doi: 10.1001/jama.2019.11982.
citation: Aboumatar H, Naqibuddin M, Chung S, Chaudhry H, Kim SW, Saunders J, Bone L, Gurses AP, Knowlton A, Pronovost P, Putcha N, Rand C, Roter D, Sylvester C, Thompson C, Wolff JL, Hibbard J, Wise RA. Effect of a Program Combining Transitional Care and Long-term Self-management Support on Outcomes of Hospitalized Patients With Chronic Obstructive Pulmonary Disease: A Randomized Clinical Trial. JAMA. 2018 Dec 11;320(22):2335-2343. doi: 10.1001/jama.2018.17933.