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Completed

NCT Number: NCT01543217

Respiratory Disease Management

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.

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Key information

Conditions

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

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Ususal care

Other

Routine respiratory care.

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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

  3. Respiratory medication use

    Time frame: 6 months

    prescribed respiratory medications dose and usage

  4. All causes of mortality

    Time frame: 6 months

    documentation of all causes of mortality

Sponsors and collaborators

Lead sponsor

Barnes-Jewish Hospital

Other

Registry information

Official study title

Use of a Respiratory Care Practitioner Disease Management (RCP-DM) Program for Patients Hospitalized With COPD

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Mar 2, 2012
Registry last updated
Jul 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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