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Respiratory Disease Management

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RT management
Ususal care
Sponsored by
Barnes-Jewish Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Barnes-Jewish Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Control

Intervention

Arm Description

Ususal care.

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.

Outcomes

Primary Outcome Measures

The combined number of hospital admissions and ED visits for a COPD exacerbation
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
Number of times a subject is hospitalized or visit the ED during the study period.
Hospital and intensive care unit (ICU) lengths of stay
the number of days a subject is in the intensive care unit
Respiratory medication use
prescribed respiratory medications dose and usage
All causes of mortality
documentation of all causes of mortality

Full Information

First Posted
February 23, 2012
Last Updated
July 19, 2021
Sponsor
Barnes-Jewish Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01543217
Brief Title
Respiratory Disease Management
Official Title
Use of a Respiratory Care Practitioner Disease Management (RCP-DM) Program for Patients Hospitalized With COPD
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Barnes-Jewish Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
428 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
Ususal care.
Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
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 Type
Other
Intervention Name(s)
RT management
Intervention Description
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 Type
Other
Intervention Name(s)
Ususal care
Intervention Description
Routine respiratory care.
Primary Outcome Measure Information:
Title
The combined number of hospital admissions and ED visits for a COPD exacerbation
Description
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.
Time Frame
6-month follow-up period
Secondary Outcome Measure Information:
Title
Hospitalizations and ED visits for other causes
Description
Number of times a subject is hospitalized or visit the ED during the study period.
Time Frame
up to 3 months
Title
Hospital and intensive care unit (ICU) lengths of stay
Description
the number of days a subject is in the intensive care unit
Time Frame
6 months
Title
Respiratory medication use
Description
prescribed respiratory medications dose and usage
Time Frame
6 months
Title
All causes of mortality
Description
documentation of all causes of mortality
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marin Kollef, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barnes-Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34495549
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.
Results Reference
derived
PubMed Identifier
27899531
Citation
Silver PC, Kollef MH, Clinkscale D, Watts P, Kidder R, Eads B, Bennett D, Lora C, Quartaro M. A Respiratory Therapist Disease Management Program for Subjects Hospitalized With COPD. Respir Care. 2017 Jan;62(1):1-9. doi: 10.4187/respcare.05030. Epub 2016 Nov 29.
Results Reference
derived

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Respiratory Disease Management

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