Population-Health Management for COPD

(EQuiP COPD Trial)

Recruiting at 4 trial locations

Overseen By Christopher G Slatore, MD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Seattle Institute for Biomedical and Clinical Research

Disqualifiers: Diabetes, Hypertension, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

4000 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. It seems that the focus is on providing recommendations to your primary care provider, who may adjust your treatment as needed.

What data supports the effectiveness of the treatment Population-health management for COPD?

Research shows that disease management programs, which include education and self-management strategies, can improve the quality and efficiency of care for COPD patients, potentially reducing hospital visits and improving quality of life. ^{1 2 3 4 5}

How is the Population-Health Management treatment for COPD different from other treatments?

Population-Health Management for COPD is unique because it focuses on managing the disease at a community level, integrating self-management tools like eHealth platforms to improve patient outcomes and reduce hospital visits, unlike traditional treatments that may focus solely on medication or individual care. ^{1 6 7 8 9}

What is the purpose of this trial?

This trial tests whether clinical pharmacists can effectively manage COPD patients compared to pulmonary specialists. Specialists review patient records and send treatment recommendations to primary care providers electronically. The goal is to see if pharmacist-led management can achieve similar patient outcomes as specialist-led management.

Research Team

Lucas M Donovan, MD, MS

Principal Investigator

VA Puget Sound Health Care System

David H Au, MD, MS

Principal Investigator

VA Puget Sound Health Care System

Eligibility Criteria

This trial is for patients with COPD who are current smokers not on cessation aid, have had a recent exacerbation or hospital discharge due to COPD, or use inhaled corticosteroids without meeting criteria. Primary care providers at participating sites can also join.

Inclusion Criteria

I was recently discharged from the hospital for a COPD flare-up.

I recently had a flare-up that required an ER or primary care visit.

I am being treated for COPD but haven't had a lung function test in 10 years or my test shows no blockage.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Population management for COPD provided by either pharmacists or pulmonary specialists through E-consults

6 months

Follow-up

Participants are monitored for safety and effectiveness after intervention

6 months

Treatment Details

Interventions

• Population-health management

Trial Overview The study compares population management of COPD by pharmacists versus pulmonary specialists. Both will review patient cases and provide guideline-based recommendations through E-consults for primary care providers to act upon.

Participant Groups

Group I: Pulmonologist led Active Control 1 Intervention

Pulmonologists will conduct population health management for patients with COPD

Group II: Pharmacist led Active Control 1 Intervention

Pharmacists will conduct population health management for patients with COPD

Who Is Running the Clinical Trial?

Seattle Institute for Biomedical and Clinical Research

Lead Sponsor

Trials

55

Recruited

13,700+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Findings from Research

Chronic disease management programs for patients with COPD were found to improve quality of life, with 5 out of 10 randomized-controlled trials showing significant positive outcomes.

The studies varied widely in their methods and quality, indicating a need for more comprehensive research to better understand the effectiveness of these programs across different healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review of the effects of chronic disease management on quality-of-life in people with chronic obstructive pulmonary disease. Niesink, A., Trappenburg, JC., de Weert-van Oene, GH., et al.[2019]

A self-management program for patients with advanced COPD significantly reduced the need for hospital care due to exacerbations, with emergency visits and hospitalizations decreasing from 1.37 to 0.89 per patient per year after one year of follow-up.

The intervention led to a reduction in the total number of exacerbations from 52 to 42, indicating that self-management strategies can effectively improve health outcomes in severe COPD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a self-management plan in exacerbations for patients with advanced COPD. Sánchez-Nieto, JM., Andújar-Espinosa, R., Bernabeu-Mora, R., et al.[2018]

A comprehensive blended health education program significantly improved self-management practices in patients with mild-to-moderate COPD, as shown by statistically significant differences in COPD Self-Management Scale scores between the intervention and control groups after three months.

The study involved 60 patients in Jeddah City, Saudi Arabia, and highlighted the effectiveness of nurse-led education in enhancing patient self-management, suggesting a need for further collaboration among healthcare professionals to optimize COPD interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A quasi-experimental study of the effect of a comprehensive blended health educational program on self-management practices among patients with chronic obstructive pulmonary disease. ALHarbi, ER., Wazqar, DY., Sofar, SM.[2022]

The active implementation model for a disease-management program for COPD led to increased planned preventive consultations and reduced unnecessary hospital admissions, indicating improved healthcare utilization.

The study involved 1,372 patients with confirmed COPD and demonstrated that the intervention practices were more effective in managing patient care compared to control practices, suggesting a positive impact on patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of an active implementation of a disease management programme for chronic obstructive pulmonary disease on healthcare utilization--a cluster-randomised controlled trial. Smidth, M., Christensen, MB., Fenger-Grøn, M., et al.[2021]

Patients with chronic obstructive pulmonary disease (COPD) who participated in a Disease Management Program (DMP) experienced significantly lower mortality rates compared to matched control patients, with a 1-year survival rate of 91% versus 76%.

Despite the survival benefits, DMP participants had higher rates of hospital readmissions and longer total hospital days, indicating a complex relationship between program participation and healthcare utilization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a disease management program for COPD using propensity matched control group. George, PP., Heng, BH., Lim, TK., et al.[2020]

Implementing a Disease Management Program (DMP) for COPD can effectively improve the quality of life and care for patients, as demonstrated by the National Jewish Medical and Research Center's interventions.

Key strategies for a successful COPD DMP include risk identification, patient education, lifestyle modifications, and enhanced communication among healthcare providers, which can also lead to a significant reduction in healthcare utilization events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Operating a sustainable disease management program for chronic obstructive pulmonary disease. Endicott, L., Corsello, P., Prinzi, M., 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]

Integrated disease management (IDM) significantly improved health status in COPD patients over 24 months, with a clinically relevant increase in the Clinical COPD Questionnaire (CCQ) score, especially in those with higher baseline CCQ and MRC dyspnea scores.

Exercise capacity, measured by the six-minute walking distance (6MWD), improved significantly and was sustained over 24 months, particularly in patients with lower baseline 6MWD, indicating that IDM is effective for enhancing physical function in COPD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sustained effects of integrated COPD management on health status and exercise capacity in primary care patients. Kruis, AL., van Adrichem, J., Erkelens, MR., et al.[2021]

In a study involving 702 COPD patients, only 215 (30.6%) registered for eHealth programs, and the implementation of these programs showed no significant improvement in health status as measured by the Clinical COPD Questionnaire (CCQ).

The study found no differences in health outcomes between patients receiving high versus low levels of personal assistance, indicating that the eHealth-supported COPD programs did not effectively enhance patient management or health status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Integration of Self-Management Web Platforms on Health Status in Chronic Obstructive Pulmonary Disease Management in Primary Care (e-Vita Study): Interrupted Time Series Design. Talboom-Kamp, EP., Verdijk, NA., Kasteleyn, MJ., et al.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

Systematic review of the effects of chronic disease management on quality-of-life in people with chronic obstructive pulmonary disease. [2019]

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

Efficacy of a self-management plan in exacerbations for patients with advanced COPD. [2018]

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

A quasi-experimental study of the effect of a comprehensive blended health educational program on self-management practices among patients with chronic obstructive pulmonary disease. [2022]

4. England pubmed.ncbi.nlm.nih.gov

The effect of an active implementation of a disease management programme for chronic obstructive pulmonary disease on healthcare utilization--a cluster-randomised controlled trial. [2021]

5. China pubmed.ncbi.nlm.nih.gov

Evaluation of a disease management program for COPD using propensity matched control group. [2020]

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

Operating a sustainable disease management program for chronic obstructive pulmonary disease. [2019]

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

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

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

Sustained effects of integrated COPD management on health status and exercise capacity in primary care patients. [2021]

9. Canada pubmed.ncbi.nlm.nih.gov

The Effect of Integration of Self-Management Web Platforms on Health Status in Chronic Obstructive Pulmonary Disease Management in Primary Care (e-Vita Study): Interrupted Time Series Design. [2018]