Applying the pragmatic-explanatory continuum indicator summary to the implementation of a physical activity coaching trial in chronic obstructive pulmonary disease.

BACKGROUND: Observational studies show that physical inactivity is associated with worse outcomes in chronic obstructive pulmonary disease (COPD). Despite practice guidelines recommending regular physical activity (PA), there are no large-scale experimental studies to confirm that patients at high risk for COPD exacerbations can increase their PA and consequently, have improved outcomes. PURPOSE: The purpose of this case study is to describe the use of a widely accepted pragmatic trials framework for the design and implementation of a pragmatic clinical trial (PCT) of PA coaching for COPD in a real-world setting. METHOD: The aim of the trial was to determine the effectiveness of a 12-month PA coaching intervention (Walk On!) compared to standard care for 2,707 patients at high risk for COPD exacerbations from a large integrated health care system. The descriptions of our implementation experiences are anchored within the pragmatic-explanatory continuum indicator summary (PRECIS-2) framework. DISCUSSION: Facilitators of PCT implementation include early and ongoing engagement and support of multiple stakeholders including patients, health system leaders, administrators, physician champions, and frontline clinicians, an organizational/setting that prioritizes positive lifestyle behaviors, and a flexible intervention that allows for individualization. Pragmatic challenges include reliance on electronic data that are not complete or available in real-time for patient identification, timing of outreach may not synchronize with patients' readiness for change, and high turnover of clinical staff drawn from the existing workforce. DISCUSSION: PRECIS-2 is a useful guide for organizing decisions about study designs and implementation approaches to help diverse stakeholders recognize the compromises between internal and external validity with those decisions.

Patient-centered physical activity coaching in COPD (Walk On!): A study protocol for a pragmatic randomized controlled trial.

BACKGROUND: 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. METHODS: A pragmatic randomized controlled trial design was used to determine the effectiveness of a 12-month home and community-based physical activity coaching intervention (Walk On!) compared to standard care for 1650 patients at high risk for COPD exacerbations from a large integrated health care system. Eligible patients with a COPD-related hospitalization, emergency department visit, or observational stay in the previous 12months were automatically identified from the electronic medical records (EMR) system and randomized to treatment arms. The Walk On! intervention included collaborative monitoring of step counts, semi-automated step goal recommendations, individualized reinforcement from a physical activity coach, and peer/family support. RESULTS: The primary composite outcome included all-cause hospitalizations, emergency department visits, observational stays, and death in the 12months following randomization. Secondary outcomes included 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 were automatically captured from the EMR. CONCLUSIONS: If successful, findings from this multi-stakeholder driven trial of a generalizable and scalable physical activity intervention, carefully designed with sufficient flexibility, intensity, and support for a large ethnically diverse sample could re-define the standard of care to effectively address physical inactivity in COPD.

Functional status at discharge and 30-day readmission risk in COPD.

BACKGROUND: Efforts to reduce 30-day readmissions are resource intensive. Healthcare systems need to target interventions at patients with the highest risk. Information on physical functioning has been found to increase the performance of previously published risk prediction models. We examined whether functional status documented during routine nursing care in the 24 h prior to discharge was an independent predictor of 30-day readmission risk in patients with COPD. METHODS: Patients from a large integrated healthcare system were included in this retrospective cohort study if they were hospitalized for COPD and discharged between January 1, 2011, and December 31, 2012, age 40+, on a bronchodilator or steroid inhaler, alive at discharge, and continuously enrolled in the health plan 12 months prior to the index admission and at least 30-days post discharge. Our main outcome was 30-day all-cause readmission. Functional status was documented as part of routine nursing care within 24 h prior to discharge as follows: bed bound (Level I), able to sit (Level II), stand next to bed (Level III), walk <50 feet (Level IV), and walk >50 feet (Level V). RESULTS: The sample included 2910 patients (n = 3631 index admissions) with a mean age of 72 ± 11. The 30-day readmission rate was 19%. Multivariate analyses showed that patients who were non-ambulatory at discharge (Levels I-III) were more than twice as likely to be re-admitted within 30-days compared to patients who were able to walk more than 50 feet (RR: 2.14, 95% CI 1.62-2.84, p < .001). There was no significant difference in readmission risk between patients classified as Level IV or V (p > .05). CONCLUSION: Patients with COPD who were non-ambulatory within 24 h prior to discharge were at significantly greater risk of readmission compared to ambulatory patients. Functional status should be used to risk stratify patients for more intensive supportive interventions post discharge.

Associations between physical activity and 30-day readmission risk in chronic obstructive pulmonary disease.

RATIONALE: Efforts to reduce 30-day readmission have mostly concentrated on addressing deficiencies in care transitions and outpatient management after discharge. There is growing evidence to suggest that physical inactivity is associated with increased hospitalizations. OBJECTIVES: We examined whether or not a potentially modifiable factor such as regular physical activity at baseline was associated with lower risk of 30-day readmission in patients with chronic obstructive pulmonary disease (COPD). METHODS: Patients from a large integrated health system were included in this retrospective cohort study if they were hospitalized for COPD (following the Centers for Medicare and Medicaid Services and National Quality Forum proposed criteria) and discharged between January 1, 2011 and December 31, 2012, aged 40 years or older, on a bronchodilator or steroid inhaler, alive at discharge, and continuously enrolled in the health plan 12 months before the index admission and at least 30 days post discharge. Our main outcome was 30-day all-cause readmission. Regular physical activity was routinely assessed at the time of all outpatient visits and expressed as the total minutes of moderate or vigorous physical activity (MVPA) per week. MEASUREMENTS AND MAIN RESULTS: The sample included a total of 4,596 patients (5,862 index admissions) with a mean age of 72.3 ± 11 years. The 30-day readmission rate was 18%, with 59% of readmissions occurring in the first 15 days. Multivariate adjusted analyses showed that patients reporting any level of MPVA had a significantly lower risk of 30-day readmission compared with inactive patients (1-149 min/wk of MVPA: relative risk, 0.67; 95% confidence interval, 0.55-0.81; ≥150 min/wk of MVPA: relative risk, 0.66; 95% confidence interval, 0.51-0.87). Other significant independent predictors of increased readmission included anemia, prior hospitalizations, longer lengths of stay, more comorbidities, receipt of a new oxygen prescription at discharge, use of the emergency department or observational stay before the readmission (all, P < 0.05), and being unpartnered (P = 0.08). CONCLUSIONS: Our findings further support the importance of physical activity in the management of COPD across the care continuum. Although it is possible that lower physical activity is a reflection of worse disease, promoting and supporting physical activity is a promising strategy to reduce the risk of readmission.