Respiratory Disease Management

NCT01543217 | Completed DMC

• 1 other identifier: 201201116
• Study Type: interventional
• Target: 428
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD

Outcome Measures

Primary Outcomes (1)

• 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.

  6-month follow-up period

Secondary Outcomes (4)

• Hospitalizations and ED visits for other causes

  up to 3 months

• Hospital and intensive care unit (ICU) lengths of stay

  6 months

• Respiratory medication use

  6 months

• All causes of mortality

  6 months

Study Arms (2)

Control

ACTIVE COMPARATOR

Ususal care.

Other: Ususal care

Intervention

ACTIVE COMPARATOR

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

Interventions

RT management OTHER

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

Ususal care OTHER

Routine respiratory care.

Control

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Barnes-Jewish Hospital: lead

Study Sites (1)

Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Related Publications (2)

• 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

• 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.

  PMID: 27899531 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marin Kollef, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Manager Respiratory Care Services

Study Record Dates

• First Submitted: February 23, 2012
• First Posted: March 2, 2012
• Study Start: July 1, 2012
• Primary Completion: October 1, 2015
• Study Completion: December 1, 2015
• Last Updated: July 23, 2021

Record last verified: 2016-10

Locations

US (1)