Respiratory Disease Management

This study is currently recruiting participants.
Verified January 2013 by Barnes-Jewish Hospital
Sponsor:
Information provided by (Responsible Party):
Peggy Watts, Barnes-Jewish Hospital
ClinicalTrials.gov Identifier:
NCT01543217
First received: February 23, 2012
Last updated: January 17, 2013
Last verified: January 2013

February 23, 2012
January 17, 2013
July 2012
July 2013   (final data collection date for primary outcome measure)
The combined number of hospital admissions and ED visits for a COPD exacerbation [ Time Frame: 6-month follow-up period ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01543217 on ClinicalTrials.gov Archive Site
  • Hospitalizations and ED visits for other causes [ Time Frame: up to 3 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    the number of days a subject is in the intensive care unit
  • Respiratory medication use [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    prescribed respiratory medications dose and usage
  • All causes of mortality [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    documentation of all causes of mortality
Same as current
Not Provided
Not Provided
 
Respiratory Disease Management
Use of a Respiratory Care Practitioner Disease Management (RCP-DM) Program for Patients Hospitalized With COPD

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Chronic Obstructive Pulmonary Disease
  • 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.
  • Other: Ususal care
    Routine respiratory care.
  • Active Comparator: Control
    Ususal care.
    Intervention: Other: Ususal 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.
    Intervention: Other: RT management
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
428
December 2013
July 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 64 Years
No
Contact: Marin Kollef, MD 314 454-8764 MKOLLEF@dom.wustl.edu
Contact: Peggy Watts, MS 314 362-3767 Peggy.Watts@bjc.org
United States
 
NCT01543217
201201116
Yes
Peggy Watts, Barnes-Jewish Hospital
Barnes-Jewish Hospital
Not Provided
Principal Investigator: Marin Kollef, MD Washington University Medical Center
Barnes-Jewish Hospital
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP