Population-Health Management for COPD

(EQuiP COPD Trial)

Recruiting at 4 trial locations

Overseen By Emily E Gleason

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether pharmacists can manage COPD (a lung disease that causes breathing problems) as effectively as lung specialists. It will assess if both groups can provide helpful treatment advice to primary care providers, ultimately improving patient outcomes. Participants include those recently hospitalized for COPD flare-ups, those needing better treatment advice, or smokers not receiving help to quit. The results will reveal if pharmacists can deliver care as effectively as specialists, potentially broadening access to quality COPD management through population-health management strategies.

As an unphased trial, this study offers patients the chance to contribute to innovative healthcare solutions that may enhance COPD management and accessibility.

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 prior data suggests that this population-health management approach is safe for COPD patients?

Research shows that both lung doctors (pulmonologists) and pharmacists can safely manage COPD care by following a community health approach. They provide treatment advice based on guidelines to family doctors.

Previous patients have handled these methods well. Studies have not reported any major safety issues when pharmacists or lung doctors lead this type of care, suggesting the approach is generally safe for people with COPD.

For those considering joining a trial, this information may offer reassurance about the safety of this treatment method. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to manage COPD through population-health management. Unlike traditional treatments that focus on medications and symptom management, this trial examines the impact of healthcare professionals, like pulmonologists and pharmacists, leading the charge in managing patients' overall health. By focusing on tailored, person-centered care, the trial aims to uncover whether these specialized professionals can improve outcomes by addressing the broader health needs of COPD patients. This could lead to more comprehensive care strategies that go beyond the typical medication-based approaches.

What evidence suggests that this trial's population-health management treatments could be effective for COPD?

Research has shown that both lung doctors (pulmonologists) and pharmacists can help manage COPD, a lung disease. Pulmonologists, who specialize in lung health, greatly improve the lives of people with COPD and reduce their hospital visits by providing expert advice. Pharmacists, though not lung specialists, have also demonstrated their ability to help by ensuring patients take their medications correctly and manage their health better. Early results suggest that pharmacists can effectively support COPD care by collaborating closely with regular doctors. This trial will compare the effectiveness of pharmacist-led care with care led by lung specialists to determine which approach better supports COPD management. ^{6 7 8 9 10}

Who Is on the 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

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

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The Impact of Pharmacist-Led Interventions on the Treatment ... Eight studies showed significantly improved outcomes in the intervention groups. The quality of evidence was low to very low across most studies. Introduction.

2. jmcp.org jmcp.org/doi/full/10.18553/jmcp.2023.29.6.671

Pharmacists' chronic disease management in ... Our study looked at the impact of pharmacist-provided care plans in Alberta, Canada, which is similar to comprehensive medication reviews provided in the ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0738399123004184

Effectiveness of clinical pharmacist intervention on ... Our study aimed to determine the impact of pharmacist-led educational interventions on COPD management, focusing mainly on medication adherence.

4. link.springer.com link.springer.com/article/10.1007/s11096-024-01819-6

Credentialed pharmacist-led home medicines reviews ... HMRs targeting TTs improved health outcomes in people with COPD. Credentialed pharmacists in primary care can work alongside general practitioners to optimise ...

5. drugtopics.com drugtopics.com/view/pharmacist-led-interventions-show-promise-in-improving-copd-outcomes

Pharmacist-Led Interventions Show Promise in Improving ... Pharmacist-led interventions were promising in improving outcomes among patients with chronic obstructive pulmonary disease (COPD), according to a study.

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Protocol for a pragmatic trial to enhance quality safety, and ... We designed the cluster-randomized EQuiP-COPD trial to test the non-inferiority of clinical pharmacist relative to pulmonary specialist-led population health ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1551714425001557

Protocol for a pragmatic trial to enhance quality safety, and ... We designed the cluster-randomized EQuiP-COPD trial to test the non-inferiority of clinical pharmacist relative to pulmonary specialist-led population health ...

8. ajmc.com ajmc.com/view/copd-treatment-ratio-a-measure-for-improving-copd-population-health

COPD Treatment Ratio: A Measure for Improving ... Our results support the validity of the chronic obstructive pulmonary disease (COPD) treatment ratio (CTR) as a predictor of COPD exacerbation ...

9. withpower.com withpower.com/trial/phase-pulmonary-disease-chronic-obstructive-4-2023-89e56

Population-Health Management for COPD This trial tests whether clinical pharmacists can effectively manage COPD patients compared to pulmonary specialists.

10. cdc.gov cdc.gov/mmwr/volumes/71/wr/mm7149a3.htm

Chronic Obstructive Pulmonary Disease Mortality by ... This report describes COPD-associated deaths and increases in COPD mortality ratios in several industries.