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

NCT02036294 | Completed Results DMC

• 2 other identifiers: NA_00090518IH-1304-7118
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Patient self-care behaviors; Patient activation; Family caregiver support; Patient-centered care

Outcome Measures

Primary Outcomes (2)

• 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'

• 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 Outcomes (4)

• 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'

• Mean Number of Chronic Obstructive Pulmonary Disease (COPD)-Related Hospitalizations and Emergency Department (ED) Visits Per Patient Within Each Study Arm

  Measured at 3 months post 'index-hospitalization'

• Mean Change in Patients' Score on the St. George Respiratory Questionnaire Within Each Study Arm

  Baseline to 3 months post index-hospitalization

• 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

Study Arms (2)

Usual Care

OTHER

Usual Care: Standard healthcare services will be received. Study participants in this arm will not receive any additional study interventions.

Other: Usual Care

BREATHE program

EXPERIMENTAL

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 .

Other: BREATHE program

Interventions

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 .

BREATHE program

Usual Care OTHER

Standard Healthcare Services

Usual Care

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Severe cognitive dysfunction
• Terminal illness (less than 6 months life expectancy) that is non-COPD related
• Homeless (no home address)

Sponsors & Collaborators

• Johns Hopkins University: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

Related Publications (3)

• 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.

  PMID: 34495549 DERIVED

• 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.

  PMID: 31593271 DERIVED

• 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.

  PMID: 30419103 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Patient Participation

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Principle Investigator
• Organization: Johns Hopkins University

habouma1@jhmi.edu

410-637-7152

Study Officials

• Hanan Aboumatar, MD, MPH

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2014
• First Posted: January 15, 2014
• Study Start: March 10, 2015
• Primary Completion: January 9, 2017
• Study Completion: January 9, 2017
• Last Updated: October 22, 2019
• Results First Posted: February 28, 2019

Record last verified: 2019-10

Locations

US (1)