Effect of Physical Activity Coaching on Acute Care and Survival Among Patients With Chronic Obstructive Pulmonary Disease: A Pragmatic Randomized Clinical Trial.

Importance: While observational studies show that physical inactivity is associated with worse outcomes in chronic obstructive pulmonary disease (COPD), there are no population-based trials to date testing the effectiveness of physical activity (PA) interventions to reduce acute care use or improve survival. Objective: To evaluate the long-term effectiveness of a community-based PA coaching intervention in patients with COPD. Design, Setting, and Participants: Pragmatic randomized clinical trial with preconsent randomization to the 12-month Walk On! (WO) intervention or standard care (SC). Enrollment occurred from July 1, 2015, to July 31, 2017; follow-up ended in July 2018. The setting was Kaiser Permanente Southern California sites. Participants were patients 40 years or older who had any COPD-related acute care use in the previous 12 months; only patients assigned to WO were approached for consent to participate in intervention activities. Interventions: The WO intervention included collaborative monitoring of PA step counts, semiautomated step goal recommendations, individualized reinforcement, and peer/family support. Standard COPD care could include referrals to pulmonary rehabilitation. Main Outcomes and Measures: The primary outcome was a composite binary measure of all-cause hospitalizations, observation stays, emergency department visits, and death using adjusted logistic regression in the 12 months after randomization. Secondary outcomes included self-reported PA, COPD-related acute care use, symptoms, quality of life, and cardiometabolic markers. Results: All 2707 eligible patients (baseline mean [SD] age, 72 [10] years; 53.7% female; 74.3% of white race/ethnicity; and baseline mean [SD] percent forced expiratory volume in the first second of expiration predicted, 61.0 [22.5]) were randomly assigned to WO (n = 1358) or SC (n = 1349). The intent-to-treat analysis showed no differences between WO and SC on the primary all-cause composite outcome (odds ratio [OR], 1.09; 95% CI, 0.92-1.28; P = .33) or in the individual outcomes. Prespecified, as-treated analyses compared outcomes between all SC and 321 WO patients who participated in any intervention activities (23.6% [321 of 1358] uptake). The as-treated, propensity score-weighted model showed nonsignificant positive estimates in favor of WO participants compared with SC on all-cause hospitalizations (OR, 0.84; 95% CI, 0.65-1.10; P = .21) and death (OR, 0.62; 95% CI, 0.35-1.11; P = .11). More WO participants reported engaging in PA compared with SC (47.4% [152 of 321] vs 30.7% [414 of 1349]; P < .001) and had improvements in the Patient-Reported Outcomes Measurement Information System 10 physical health domain at 6 months. There were no group differences in other secondary outcomes. Conclusions and Relevance: Participation in a PA coaching program by patients with a history of COPD exacerbations was insufficient to effect improvements in acute care use or survival in the primary analysis. Trial Registration: ClinicalTrials.gov identifier: NCT02478359.

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.

Exercise in patients with pulmonary arterial hypertension.

Pulmonary arterial hypertension is a group of disorders defined by a progressive elevation of pulmonary vascular resistance in the small pulmonary arteries and arterioles. In its untreated form, the disease causes progressive dyspnea and severe activity limitation resulting in premature death due to right ventricular failure. However, the advent of multiple-targeted medical therapies has significantly altered the prognosis of this disorder, allowing patients to live longer with increased functional ability. Given the trend in prognosis and functionality, this review revisits the possible role for exercise training in patients with pulmonary arterial hypertension. The evidence suggesting that exercise may be safe in these patients is summarized and a potential exercise prescription is suggested.