Patient-Centered Physical Activity Coaching in COPD: A Pragmatic Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- Sponsor
- Kaiser Permanente
- Enrollment
- 2707
- Locations
- 1
- Primary Endpoint
- Number of Participants With All-cause Hospitalizations, Emergency Department (ED) Visits, Observation Stays, and Deaths
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
Chronic obstructive pulmonary disease (COPD) is the third leading cause of the death in the US. The personal, social and economic costs of the disease are tremendous, with annual expenditures of nearly $50 billion, mostly from hospitalizations for exacerbations of COPD and associated sequelae. For the vast majority of patients, despite optimal pharmacological therapy, living with COPD is characterized by unrelieved dyspnea, physical inactivity, deconditioning, and an insidious downward spiral of social isolation and depression that has a profound impact on the lives of patients and their caregivers. There is mounting evidence that physical inactivity is significantly associated with more frequent hospitalizations and increased mortality in COPD even after adjusting for disease severity.
While practice guidelines recommend regular physical activity for all patients with COPD, health systems are challenged in operationalizing an effective and sustainable approach to assist patients in being physically active. The investigators propose a pragmatic randomized controlled trial to determine the effectiveness of a 12-month physical activity coaching intervention (Walk On!) compared to standard care for 1,650 COPD patients from a large integrated health care system.
Detailed Description
Physical inactivity is significantly associated with more frequent hospitalizations and increased mortality in COPD even after adjusting for disease severity. While practice guidelines recommend regular physical activity for all patients with COPD, health systems are challenged in operationalizing an effective and sustainable approach to assist patients in being physically active. A pragmatic randomized controlled trial design will be used to determine the effectiveness of a 12-month home and community-based physical activity coaching intervention (Walk On!) compared to standard care for 2,700 COPD patients from a large integrated health care system. Eligible patients with a COPD-related hospitalization, emergency department visit, or observational stay in the previous 12 months will be automatically identified from the electronic medical records (EMR) system and randomized to treatment arms. The Walk On! intervention includes collaborative monitoring of step counts, semi-automated step goal recommendations, individualized reinforcement from a physical activity coach, and peer/family support. The primary composite outcome includes all-cause hospitalizations, emergency department visits, observational stays, and death in the 12 months following randomization. Secondary outcomes include COPD-related utilization, cardio-metabolic markers, physical activity, symptoms, and health-related quality of life. With the exception of patient reported outcomes, all utilization and clinical variables will be automatically captured from the EMR. If successful, findings from this multi-stakeholder driven trial of a generalizable and scalable physical activity intervention model, carefully designed with sufficient flexibility, intensity, duration, and support for a large ethnically diverse sample could re-define the standard of care to effectively address physical inactivity in COPD.
Investigators
Huong Q2 Nguyen
Research Scientist
Kaiser Permanente
Eligibility Criteria
Inclusion Criteria
- •Patients with any COPD-related hospitalization, emergency department visit or observational stay in the previous 12 months are eligible for the study. COPD-related encounters are defined according to the Centers for Medicare and Medicaid Services (CMS) and National Quality Forum (NQF) criteria for the Hospital Readmission Reduction Program. The following principal discharge diagnoses of COPD (ICD-9 codes: 491.21, 491.22, 491.8, 491.9, 492.8, 493.20, 493.21, 493.22, and 496) or respiratory failure (ICD-9 codes: 518.81, 518.82, 518.84, 799.1) with a secondary diagnosis of COPD exacerbation (ICD-9 codes: 491.21, 491.22, 493.21, 493.22) will be used
- •Age \>40 years
- •On at least a bronchodilator or steroid inhaler prior to the encounter or if not on an inhaler, had a previous COPD diagnosis
- •Continuous health plan membership in the 12 months prior to the encounter
Exclusion Criteria
- •FEV1/FVC ratio \>0.70 at any point in the past year for those with spirometry data
- •Discharged to hospice, a skilled nursing facility, long term-care or another acute care hospital during the index admission
- •Level of function at admission or discharge during the index admission is bed bound
- •Has Alzheimers disease, dementia or metastatic cancer
- •Morbidly obese (BMI \>40)
- •Completed pulmonary rehabilitation in the last 6 months
- •Dis-enrolled from the health plan
Outcomes
Primary Outcomes
Number of Participants With All-cause Hospitalizations, Emergency Department (ED) Visits, Observation Stays, and Deaths
Time Frame: 12 months following randomization
Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site
Secondary Outcomes
- Personal Health Questionnaire, PHQ8 - 12 Months(12 months)
- General Anxiety Disorder, GAD-7 - 12 Months(12 months)
- Number of Participants With COPD-Related Hospitalizations, ED Visits, and Observation Stays(12 months following randomization)
- Number of Participants With All-cause Hospitalizations(12 months following randomization)
- Number of Participants With All-cause Emergency Department Visits(12 months following randomization)
- Number of Participants With All-cause Observation Stays(12 months following randomization)
- Physical Activity(12 months)
- PROMIS-10 HRQL , Mental Health - 12 Months(12 months)
- HbA1c Levels(12 months following randomization)
- HDL Levels(12 months following randomization)
- Triglycerides Levels(12 months post randomization)
- Number of Deaths Among Participants(12 months following randomization)
- Number of Participants With COPD Exacerbation(12 months following randomization)
- COPD Assessment Test, CAT - 12 Months(12 months)
- PROMIS-10 HRQL , Physical Health - 12 Months(12 months)
- Diastolic Blood Pressure(12 months following randomization)
- Systolic Blood Pressure(12 months following randomization)
- Body Mass Index(12 months following randomization)
- LDL Levels(12 months following randomization)
- Total Cholesterol Levels(12 months following randomization)