Program of Care for COPD

Overseen by Robert Wu, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University Health Network, Toronto

Disqualifiers: Bronchiectasis, Asthma, Cognitive impairment, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing a program for COPD patients. The program includes online exercises, coordinated care from different healthcare providers, and remote health monitoring to help them stay healthy at home.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the CHARM-COPD Program of Care treatment for COPD?

Research suggests that management programs for COPD, which include comprehensive care and patient education, can improve the quality of care and potentially reduce hospital readmissions. However, more trials are needed to clearly demonstrate the effectiveness of these programs. ^{1 2 3 4 5}

Is the Program of Care for COPD safe for humans?

The available research does not provide specific safety data for the Program of Care for COPD, but it discusses general methods for monitoring and managing adverse drug events, which are important for ensuring treatment safety. ^{6 7 8 9 10}

How is the CHARM-COPD Program of Care treatment different from other COPD treatments?

The CHARM-COPD Program of Care is unique because it likely involves an integrated care model, which combines both monodisciplinary and multidisciplinary non-drug interventions, focusing on comprehensive diagnostic and non-pharmacological treatment strategies to improve patient outcomes. ^{2 11 12 13 14}

Research Team

Robert Wu, MD

Principal Investigator

University Health Network, Toronto

Eligibility Criteria

This trial is for patients with COPD who were recently discharged after a severe flare-up and referred to Virtual Pulmonary Rehabilitation or Remote Clinical Monitoring at Toronto Grace Health Centre. It's not for those with other major lung diseases, very short life expectancy, or significant cognitive issues without caregiver support.

Inclusion Criteria

I was referred for virtual lung rehab or remote monitoring after leaving the hospital for a severe lung flare-up.

Exclusion Criteria

Projected life expectancy ≤ 2 months, as determined by the clinical team

My main lung problem is not COPD, but another condition like asthma.

I have severe memory or thinking problems and no family caregiver to help with study requirements.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive virtual pulmonary rehabilitation, integrated care, and remote clinical monitoring, including the use of a FitBit, Hyfe cough monitoring smartwatch, home spirometer, and audio recordings for 90 days

12 weeks

Continuous remote monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on readmissions within 30 days

4 weeks

Treatment Details

Interventions

• CHARM-COPD Program of Care (Behavioral Intervention)

Trial Overview The CHARM-COPD program includes virtual pulmonary rehabilitation, integrated care, and remote monitoring using tools like the Hyfe Smartwatch, Home Spirometer, FitBit Versa 2, and audio recording to manage COPD after hospital discharge.

Participant Groups

Group I: Full study intervention Experimental Treatment 4 Interventions

In addition to the standard of care at the institutions which includes virtual pulmonary rehabilitation, remote clinical monitoring and integrated care, patients will have the option to use the following interventions: * FitBit wearable device with continuous monitoring for oxygen saturation and respiratory rate for 90 days * Hyfe cough monitoring smartwatch with continuous monitoring for 90 days * Home spirometer used once daily for 90 days * Audio recordings on a tablet once daily for 90 days

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Dr. Brad Wouters

University Health Network, Toronto

Chief Medical Officer since 2020

MD from University of Toronto

Dr. Kevin Smith

University Health Network, Toronto

Chief Executive Officer since 2018

Professor at McMaster University and University of Toronto

University of Toronto

Collaborator

Trials

739

Recruited

1,125,000+

Allison Brown

University of Toronto

Chief Medical Officer

PhD in Chemical Engineering from the University of Toronto

Michael Sefton

University of Toronto

Chief Executive Officer since 2017

PhD in Chemical Engineering from the University of Toronto and MIT

The Salvation Army Toronto Grace Health Centre

Collaborator

Trials

1

Recruited

100+

Findings from Research

The integrated management program (I1) for COPD patients led to a significant reduction in smoking rates and a decrease in exacerbations compared to the isolated intervention (I2), indicating its effectiveness in managing the disease over a follow-up period of 31.2 months.

While lung function and quality of life did not show significant changes in either group, the correct use of inhalers improved, suggesting that both management strategies can enhance patient adherence to treatment, which is crucial for managing COPD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Is the introduction of clinical management programs for patients with chronic obstructive pulmonary disease useful? Comparison of the effectiveness of two interventions on the clinical progress and care received]. Solanes, I., Bolíbar, I., Llauger, MA., et al.[2019]

Disease-management programs for COPD significantly improved exercise capacity by an average of 32.2 meters and reduced the risk of hospitalization, indicating their effectiveness in enhancing patient care.

While these programs improved health-related quality of life, they did not have a significant impact on all-cause mortality, suggesting that while they are beneficial, they may not reduce overall death rates in COPD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of chronic obstructive pulmonary disease-management programs: systematic review and meta-analysis. Peytremann-Bridevaux, I., Staeger, P., Bridevaux, PO., et al.[2018]

Current COPD patient education programs have shown limited success, indicating a need for more effective designs that go beyond just providing medical information.

Future programs should focus on improving patients' self-efficacy in disease management and include a broader range of health behavior determinants to enhance their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient education programs--can they improve outcomes in COPD? Harris, M., Smith, BJ., Veale, A.[2021]

A comprehensive care program for patients recently discharged after an acute exacerbation of COPD significantly reduced hospital readmission rates by 33.2% compared to usual care over 12 months.

Patients in the comprehensive care group also experienced a shorter length of hospital stay and improved symptoms, as indicated by better scores on the Modified Medical Research Council Dyspnoea Scale and the St George's Respiratory Questionnaire.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comprehensive care programme for patients with chronic obstructive pulmonary disease: a randomised controlled trial. Ko, FW., Cheung, NK., Rainer, TH., et al.[2022]

A total of 11,999 Adverse Drug Events (ADEs) were identified from 244,992 hospital admissions, indicating a prevalence of 4.9 ADEs per 100 admissions, particularly affecting older adults and linked to longer hospital stays.

Clinical Coding Surveillance (CCS) proved to be a reliable method for monitoring ADEs, with 91% accuracy in classifying ADEs based on clinical documentation, suggesting it can effectively enhance patient safety in hospitals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and reliability of clinical coding surveillance for the routine monitoring of adverse drug events in New Zealand hospitals. Ng, J., Andrew, P., Muir, P., et al.[2019]

The Copenhagen Hospital Corporation successfully implemented a reporting system for adverse events, resulting in 6011 reported incidents over three years, indicating a strong safety culture among staff.

The organization conducted 92 root cause analyses during this period, focusing on both optional and mandatory reports, which highlights their commitment to understanding and preventing future adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Adverse events management. Methods and results of a development project]. Rabøl, LI., Jensen, EB., Hellebek, AH., et al.[2006]

A multifaceted program implemented in a respiratory ICU significantly reduced adverse events, including accidental extubation, pneumothorax, and atelectasis, among 1662 patients over a 7-year period.

The program's components, which included strategic planning, training on hand hygiene, and care bundles, also led to a decrease in ICU mortality, demonstrating the efficacy of comprehensive interventions in improving patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of strategic planning, organizational culture imprint and care bundles to reduce adverse events in the ICU. Álvarez-Maldonado, P., Reding-Bernal, A., Hernández-Solís, A., et al.[2020]

The Aggregate Safety Assessment Plan (ASAP) is designed to enhance safety planning and ongoing data review throughout a drug's life-cycle, promoting a systematic approach to understanding product safety.

By implementing the ASAP process, drug developers can improve early detection of safety signals, better characterize risks, and ensure consistent safety messaging across studies, ultimately aiding in informed decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aggregate Safety Assessment Planning for the Drug Development Life-Cycle. Hendrickson, BA., Wang, W., Ball, G., et al.[2021]

Out of 1,244 reported adverse drug events, 208 were medication-related, with anticoagulants being the most frequently implicated class (46% of events), highlighting a significant area for safety improvement in ambulatory care.

Key recommendations for reducing harm include better follow-up on anticoagulant therapy, improved prescribing practices for antibiotics, enhanced patient education for hypoglycemics, and alerts to prevent dangerous drug interactions between opioids and benzodiazepines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medication adverse events in the ambulatory setting: A mixed-methods analysis. Wong, J., Lee, SY., Sarkar, U., et al.[2022]

The implementation of a COPD nurse navigator program significantly reduced emergency department visits and hospitalizations related to respiratory issues among 202 patients, indicating improved patient management.

The program not only enhanced patient outcomes but also resulted in estimated annual savings of over $260,000, demonstrating its cost-effectiveness in managing chronic obstructive pulmonary disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated interdisciplinary care for patients with chronic obstructive pulmonary disease reduces emergency department visits, admissions and costs: a quality assurance study. Dajczman, E., Robitaille, C., Ernst, P., et al.[2021]

A comprehensive COPD care program developed in a rural community in Western Canada from 2012 to 2021 successfully improved access and quality of care through team-based approaches and local resource integration, as evaluated through stakeholder interviews and document reviews.

Key innovations included securing physician compensation and enhancing patient and provider self-efficacy, which built the capacity of the healthcare system and emphasized the importance of relationships and collaboration in delivering effective rural healthcare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and evaluation of the Rural and Northern Community Focused Model of COPD Care (RaNCoM). Freeman, S., Peach, L., Ross, C., et al.[2023]

In a study involving 191 patients with asthma and COPD, an additional nursing care program did not significantly improve knowledge, inhalation technique, self-management, or quality of life compared to standard care.

However, the program did lead to a significant reduction in exacerbation rates, with an odds ratio of 0.35, indicating that patients receiving the additional care experienced fewer severe episodes of their condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of additional care by a pulmonary nurse for asthma and COPD patients at a respiratory outpatient clinic: results from a double blind, randomized clinical trial. Rootmensen, GN., van Keimpema, AR., Looysen, EE., et al.[2019]

The COPDnet integrated care model significantly improved health status in patients with COPD, as measured by the Clinical COPD Questionnaire, with scores decreasing from 1.94 to 1.73 over 7-9 months in 154 patients.

The most notable improvements were seen in patients who participated in interdisciplinary pulmonary rehabilitation, while those receiving only pharmacotherapy or other forms of care did not show significant changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The clinical effectiveness of the COPDnet integrated care model. Koolen, EH., van den Borst, B., de Man, M., et al.[2021]

References

1. Spain pubmed.ncbi.nlm.nih.gov

[Is the introduction of clinical management programs for patients with chronic obstructive pulmonary disease useful? Comparison of the effectiveness of two interventions on the clinical progress and care received]. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of chronic obstructive pulmonary disease-management programs: systematic review and meta-analysis. [2018]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Patient education programs--can they improve outcomes in COPD? [2021]

4. Russia (Federation) pubmed.ncbi.nlm.nih.gov

Chronic obstructive pulmonary disease patients electronic register analysis: the effectiveness of patient's dynamic follow up and evaluation of treatment program. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Comprehensive care programme for patients with chronic obstructive pulmonary disease: a randomised controlled trial. [2022]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Feasibility and reliability of clinical coding surveillance for the routine monitoring of adverse drug events in New Zealand hospitals. [2019]

7. Denmark pubmed.ncbi.nlm.nih.gov

[Adverse events management. Methods and results of a development project]. [2006]

8. England pubmed.ncbi.nlm.nih.gov

Impact of strategic planning, organizational culture imprint and care bundles to reduce adverse events in the ICU. [2020]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Aggregate Safety Assessment Planning for the Drug Development Life-Cycle. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Medication adverse events in the ambulatory setting: A mixed-methods analysis. [2022]

11. Egypt pubmed.ncbi.nlm.nih.gov

Integrated interdisciplinary care for patients with chronic obstructive pulmonary disease reduces emergency department visits, admissions and costs: a quality assurance study. [2021]

12. England pubmed.ncbi.nlm.nih.gov

Development and evaluation of the Rural and Northern Community Focused Model of COPD Care (RaNCoM). [2023]

13. Ireland pubmed.ncbi.nlm.nih.gov

The effects of additional care by a pulmonary nurse for asthma and COPD patients at a respiratory outpatient clinic: results from a double blind, randomized clinical trial. [2019]

14. England pubmed.ncbi.nlm.nih.gov

The clinical effectiveness of the COPDnet integrated care model. [2021]