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Respiratory Disease Management

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01543217
First Posted: March 2, 2012
Last Update Posted: October 7, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Peggy Watts, Barnes-Jewish Hospital
  Purpose
The aim of this study is to reduce the number of subsequent hospital admissions and/or emergency department (ED) visits for hospitalized patients with chronic obstructive pulmonary disease (COPD) by utilizing a respiratory care practitioner-led disease management (RCP-DM) program compared to standard discharge instructions and planning.

Condition Intervention
Chronic Obstructive Pulmonary Disease Other: RT management Other: Ususal care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Use of a Respiratory Care Practitioner Disease Management (RCP-DM) Program for Patients Hospitalized With COPD

Further study details as provided by Peggy Watts, Barnes-Jewish Hospital:

Primary Outcome Measures:
  • The combined number of hospital admissions and ED visits for a COPD exacerbation [ Time Frame: 6-month follow-up period ]
    Coordinators will use two strategies, First, they will monitor the automated medical record. All inpatient, outpatient, and ED visits to BJC affiliated institutions. Second coordinators will conduct bi-monthly telephone inquires to patients to determine if they had recent hospital or ED visits.


Secondary Outcome Measures:
  • Hospitalizations and ED visits for other causes [ Time Frame: up to 3 months ]
    Number of times a subject is hospitalized or visit the ED during the study period.

  • Hospital and intensive care unit (ICU) lengths of stay [ Time Frame: 6 months ]
    the number of days a subject is in the intensive care unit

  • Respiratory medication use [ Time Frame: 6 months ]
    prescribed respiratory medications dose and usage

  • All causes of mortality [ Time Frame: 6 months ]
    documentation of all causes of mortality


Enrollment: 428
Study Start Date: July 2012
Study Completion Date: December 2015
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control
Ususal care.
Other: Ususal care
Routine respiratory care.
Active Comparator: Intervention
Patients assigned to the RT management arm will receive a 1-hour educational in-service conducted by a respiratory therapist case manager. The patient education session will include general information about COPD, direct observation of inhaler techniques, a review and adjustment of outpatient COPD medications, smoking cessation counseling, recommendations concerning influenza and pneumococcal vaccinations, encouragement of regular exercise, and instruction in hand hygiene.
Other: RT management
Patients assigned to the RT management arm will receive a 1-hour educational in-service conducted by a respiratory therapist case manager. The patient education session will include general information about COPD, direct observation of inhaler techniques, a review and adjustment of outpatient COPD medications, smoking cessation counseling, recommendations concerning influenza and pneumococcal vaccinations, encouragement of regular exercise, and instruction in hand hygiene.

Detailed Description:
The investigators propose to carry out a prospective, randomized, trial at Barnes-Jewish Hospital (1250-bed urban academic hospital). Eligible patients will be identified by a senior study coordinator who will also obtain informed consent for study participation. Adults greater than 18 years of age and less than 65 years of age will be eligible for enrollment if the lead investigator and the treating physician agree that the patient meets the enrollment criteria which include the following: patients with spirometrically confirmed COPD at high risk for repeat hospitalization or ED visits as predicted by hospital admission or ED visit in the previous 12 months for a COPD exacerbation, chronic home use of oxygen, or a course of systemic corticosteroid therapy in the preceding 12 months. Exclusion criteria include patients not expected to survive their hospitalization, presence of metastatic cancer, bed-bound individuals, non-English speaking patients, and patients unable to provide informed consent.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults greater than 18 years of age and less than 64 years of age will be eligible for enrollment if the lead investigator and the treating physician agree that the patient meets the enrollment criteria which include the following:

    • patients with spirometrically confirmed COPD at high risk for repeat hospitalization or emergency department (ED) visits as predicted by hospital admission or ED visit in the previous 12 months for a COPD exacerbation,
    • chronic home use of oxygen, or
    • a course of systemic corticosteroid therapy in the preceding 12 months.

Exclusion Criteria:

  • patients not expected to survive their hospitalization,
  • presence of metastatic cancer,
  • bed-bound individuals,
  • non-English speaking patients, and
  • patients unable to provide informed consent.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01543217


Locations
United States, Missouri
Barnes-Jewish Hospital
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Barnes-Jewish Hospital
Investigators
Principal Investigator: Marin Kollef, MD Washington University School of Medicine
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Peggy Watts, Manager Respiratory Care Services, Barnes-Jewish Hospital
ClinicalTrials.gov Identifier: NCT01543217     History of Changes
Other Study ID Numbers: 201201116
First Submitted: February 23, 2012
First Posted: March 2, 2012
Last Update Posted: October 7, 2016
Last Verified: October 2016

Keywords provided by Peggy Watts, Barnes-Jewish Hospital:
COPD

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases