A Hybrid Effectiveness/Implementation Clinical Trial of Adherence to Long-Term Oxygen Therapy for Chronic Obstructive Pulmonary Disease.

Rationale: Interventions to promote adherence to long-term oxygen therapy (LTOT) in chronic obstructive pulmonary disease (COPD) are needed. Objectives: To examine the real-world effectiveness of phone-based peer coaching on LTOT adherence and other outcomes in a pragmatic trial of patients with COPD. Methods: In a hybrid effectiveness/implementation pragmatic trial, patients were randomized to receive phone-based proactive coaching (educational materials, five phone-based peer coaching sessions over 60 d), reactive coaching (educational materials, peer coaching when requested), or usual care. Study staff members collected baseline and outcome data via phone at 30, 60, and 90 days after randomization. Adherence to LTOT over 60 days, the primary effectiveness outcome, was defined as mean LTOT use ⩾17.7 h/d. LTOT use was calculated using information about home oxygen equipment use in worksheets completed by study participants. Comparisons of adherence to LTOT between each coaching group and the usual care group using multivariable logistic regression models were prespecified as the primary analyses. Secondary effectiveness outcomes included Patient Reported Outcome Management Information System measures for physical, emotional, and social health. We assessed early implementation domains in the reach, adoption, and implementation framework. Results: In 444 participants, the proportions who were adherent to LTOT at 60 days were 74% in usual care, 84% in reactive coaching, and 70% in proactive coaching groups. Although reach, adoption by stakeholder partners, and intervention fidelity were acceptable, complete LTOT adherence data were available in only 73% of participants. Reactive coaching (adjusted odds ratio, 1.77; 97.5% confidence interval, 0.80-3.90) and proactive coaching (adjusted odds ratio, 0.70; 97.5% confidence interval, 0.34-1.46) did not improve adherence to LTOT compared with usual care. However, proactive coaching significantly reduced depressive symptoms and sleep disturbance compared with usual care and reduced depressive symptoms compared with reactive coaching. Unexpectedly, LTOT adherence was significantly lower in the proactive compared with the reactive coaching group. Conclusions: The results were inconclusive about whether a phone-based peer coaching strategy changed LTOT adherence compared with usual care. Further studies are needed to confirm the potential benefits of proactive peer coaching on secondary effectiveness outcomes and differences in LTOT adherence between proactive and reactive peer coaching. Clinical trial registered with ClinicalTrials.gov (NCT02098369).

Coordinated Health Care Interventions for Childhood Asthma Gaps in Outcomes (CHICAGO) plan.

Background: Evidence-based strategies to improve outcomes in minority children with uncontrolled asthma discharged from the emergency department (ED) are needed. Objectives: This multicenter pragmatic clinical trial was designed to compare an ED-only intervention (decision support tool), an ED-only intervention and home visits by community health workers for 6 months (ED-plus-home), and enhanced usual care (UC). Methods: Children aged 5 to 11 years with uncontrolled asthma were enrolled. The change over 6 months in the Patient-Reported Outcomes Measurement Information System Asthma Impact Scale score in children and Satisfaction with Participation in Social Roles score in caregivers were the primary outcomes. The secondary outcomes included guideline-recommended ED discharge care and self-management. Results: Recruitment was significantly lower than expected (373 vs 640 expected). Of the 373 children (64% Black and 31% Latino children), only 63% completed the 6-month follow-up visit. In multivariable analyses that accounted for missing data, the adjusted odds ratios and 98% CIs for differences in Asthma Impact Scores or caregivers' Satisfaction with Participation in Social Roles scores were not significant. However, guideline-recommended ED discharge care was significantly improved in the intervention groups versus in the UC group, and self-management behaviors were significantly improved in the ED-plus-home group versus in the ED-only and UC groups. Conclusions: The ED-based interventions did not significantly improve the primary clinical outcomes, although the study was likely underpowered. Although guideline-recommended ED discharge care and self-management did improve, their effect on clinical outcomes needs further study.

Pragmatic Clinical Trial to Improve Patient Experience Among Adults During Transitions from Hospital to Home: the PArTNER study.

INTRODUCTION: Minority-serving hospitals (MSHs) need evidence-based strategies tailored to the populations they serve to improve patient-centered outcomes after hospitalization. METHODS: We conducted a pragmatic randomized clinical trial (RCT) from October 2014 to January 2017 at a MSH comparing the effectiveness of a stakeholder-supported Navigator intervention vs. Usual care on post-hospital patient experience, outcomes, and healthcare utilization. Community health workers and peer coaches delivered the intervention which included (1) in-hospital visits to assess barriers to health/healthcare and to develop a personalized Discharge Patient Education Tool (DPET); (2) a home visit to review the DPET; and (3) telephone-based peer coaching. The co-primary outcomes were between-group comparisons of 30-day changes in Patient-Reported Outcomes Measurement Information System (PROMIS) measures of anxiety and informational support (minimum important difference is 2 to 5 units change); a p-value <0.025 was considered significant using intention-to-treat analysis. Secondary outcomes included death, ED visits, or readmissions and measures of emotional, social, and physical health at 30 and 60 days. RESULTS: We enrolled 1029 adults hospitalized with heart failure (28%), pneumonia (22%), MI (10%), COPD (11%), or sickle cell disease (29%). Over 80% were non-Hispanic Black. Overall, there were no significant between-group differences in the 30-day change in anxiety (adjusted difference: -1.6, 97.5% CI -3.3 to 0.1, p=0.03), informational support (adjusted difference: -0.01, 97.5% CI -2.0 to 1.9, p=0.99), or any secondary outcomes. Exploratory analyses suggested the Navigator intervention improved anxiety among participants with COPD, a primary care provider, a hospitalization in the past 12 months, or higher baseline anxiety; among participants without health insurance, the intervention improved informational support (all p-values <0.05). CONCLUSIONS: In this pragmatic RCT at a MSH, the Navigator intervention did not improve post-hospital anxiety, informational support, or other outcomes compared to Usual care. Benefits observed in participant subgroups should be confirmed in future studies. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT02114515.

Design of the patient navigator to Reduce Readmissions (PArTNER) study: A pragmatic clinical effectiveness trial.

Previous work indicates the potential for community health workers and peer coaches serving as patient navigators to improve processes of care and health outcomes during care transitions, but have not been sufficiently tested to determine if such programs improve measures of patient experience in minority serving institutions. The objectives of the Patient Navigator to Reduce Readmissions (PArTNER) study was to: 1) conduct a pragmatic clinical effectiveness trial comparing a multi-faceted, stakeholder-supported Navigator intervention (in-person CHW visits in the hospital and after hospital discharge, plus telephone-based peer coaching) versus usual care on the experience of hospital-to-home care transitions in patients hospitalized with heart failure, pneumonia, chronic obstructive pulmonary disease, myocardial infarction, or sickle cell disease; 2) examine the effectiveness of the Navigator intervention in patient subgroups; and 3) understand the barriers and facilitators of successfully implementing the Navigator intervention across patient populations. The co-primary outcomes are the 30-day changes in: 1) Patient Reported Outcomes Measurement Information System (PROMIS) emotional distress-anxiety, and 2) PROMIS informational support. Secondary outcomes at 30 and 60 days include other PROMIS health measures and hospital readmissions. Innovative features of the PArTNER study include early and continuous engagement of patients, their caregivers, clinicians, health system administrators, and other stakeholders to inform the design and implementation of the Navigator intervention. In this report, we describe the design of the PArTNER study.

Design of a pragmatic trial in minority children presenting to the emergency department with uncontrolled asthma: The CHICAGO Plan.

Among children with asthma, black children are two to four times as likely to have an emergency department (ED) visit and die from asthma, respectively, compared to white children in the United States. Despite the availability of evidence-based asthma management guidelines, minority children are less likely than white children to receive or use effective options for asthma care. The CHICAGO Plan is a three-arm multi-center randomized pragmatic trial of children 5 to 11years old presenting to the ED with uncontrolled asthma that compares: [1] an ED-focused intervention to improve the quality of care on discharge to home, [2] the same ED-focused intervention together with a home-based community health worker (CHW)-led intervention, and [3] enhanced usual care. All children receive spacers for the metered dose inhaler and teaching about its use. The Patient-Reported Outcomes Measurement Information System (PROMIS) Asthma Impact Scale and Satisfaction with Participation in Social Roles at 6months are the primary outcomes in children and in caregivers, respectively. Other patient-reported outcomes and indicators of healthcare utilization are assessed as secondary outcomes. Innovative features of the CHICAGO Plan include early and continuous engagement of children, caregivers, the Chicago Department of Public Health, and other stakeholders to inform the design and implementation of the study and a shared research infrastructure to coordinate study activities. The objective of this report is to describe the development of the CHICAGO Plan, including the methods and rationale for engaging stakeholders, the shared research infrastructure, and other features of the pragmatic clinical trial design.

Evaluation and Documentation of Supplemental Oxygen Requirements is Rarely Performed in Patients Hospitalized With COPD.

Rationale: Patients hospitalized with chronic obstructive pulmonary disease (COPD) who require supplemental oxygen (O2) are at increased risk of hospital readmissions. There is a paucity of information regarding quality of evaluation and documentation regarding the need for supplemental O2 in this population.  Objective: To determine the extent to which evaluation and documentation regarding the need for supplemental O2 occurs prior to hospital discharge in patients with COPD.  Methods: We conducted a two-center retrospective cohort study of hospitalized adults with a physician diagnosis of COPD.  We reviewed electronic health records to ascertain whether patients underwent evaluation beyond rest oximetry documenting hypoxemia and if there was adequate documentation of supplemental O2 requirements prior to discharge. Results:  Of 526 patients hospitalized with a primary or secondary discharge diagnosis of COPD, 335 patients (mean age 69 years, 78% with diagnosis of COPD exacerbation) met eligibility criteria. Overall, 1 in 5 (22%, 73/335) hospitalized patients with COPD had an evaluation beyond rest oximetry for supplemental O2 requirements during admission.  Adequate documentation of supplemental O2 requirements occurred in even fewer patients (16%, 54/335). Both evaluation (26% versus 5%, p=0.002) and documentation (19% versus 4%, p=0.001) of supplemental O2 requirements were more common in patients hospitalized for a COPD exacerbation compared to those hospitalized with COPD but without an exacerbation. Conclusions: Evaluation and documentation of supplemental O2 requirements beyond rest oximetry occur infrequently in patients hospitalized with COPD.

Can Commercially Available Pedometers Be Used For Physical Activity Monitoring In Patients With COPD Following Exacerbations?

BACKGROUND: Commercially available pedometers have been used as tools to measure endpoints in studies evaluating physical activity promotion programs. However, their accuracy in patients recovering from COPD exacerbations is unknown. The objectives of this study were to 1) assess the relative accuracy of different commercially available pedometers in healthy volunteers and 2) evaluate the accuracy of the top-performing commercially available pedometer in patients recovering from COPD exacerbations following hospital discharge. METHODS: Twelve healthy volunteers wore 2 pedometers, 2 smartphones with pedometer apps and an accelerometer for 15 minutes of indoor activity. The top-performing device in healthy volunteers was evaluated in 4 patients recovering from COPD exacerbations following hospital discharge during 6 minutes of walking performed at home. Bland-Altman plots were employed to evaluate accuracy of each device compared with direct observation (the reference standard). RESULTS: In healthy volunteers, the mean percent error compared to direct observation of the various devices ranged from -49% to +1%. The mean percent error [95% confidence interval (CI)] of the top-performing device in healthy volunteers, the Fitbit Zip®, was +1% [-33 to +35%], significantly lower than that of the accelerometer (-13% [-56 to +29%], p=0.01). The mean percent error [95% CI] for the Fitbit Zip® in patients recovering from COPD exacerbations was -3% [-7 to +12%]. CONCLUSIONS: The accuracy of commercially available pedometers in healthy volunteers is highly variable. The top-performing pedometer in our study, the Fitbit Zip,® accurately measures step counts in both healthy volunteers and patients recovering from COPD exacerbations.

Nurses' knowledge of inhaler technique in the inpatient hospital setting.

PURPOSE/OBJECTIVES: High rates of inhaler misuse in patients with chronic obstructive pulmonary disease and asthma contribute to hospital readmissions and increased healthcare cost. The purpose of this study was to examine inpatient staff nurses' self-perception of their knowledge of proper inhaler technique compared with demonstrated technique and frequency of providing patients with inhaler technique teaching during hospitalization and at discharge. DESIGN: A prospective, descriptive study. SETTING: A 495-bed urban academic medical center in the Midwest United States. SAMPLE: A convenience sample of 100 nurses working on inpatient medical units. METHODS: Participants completed a 5-item, 4-point Likert-scale survey evaluating self-perception of inhaler technique knowledge, frequency of providing patient education, and responsibility for providing education. Participants demonstrated inhaler technique to the investigators using both a metered dose inhaler (MDI) and Diskus device inhaler, and performance was measured via a validated checklist. FINDINGS: Overall misuse rates were high for both MDI and Diskus devices. There was poor correlation between perceived ability and investigator-measured performance of inhaler technique. Frequency of education during hospitalization and at discharge was related to measured level of performance for the Diskus device but not for the MDI. CONCLUSIONS: Nurses are a key component of patient education in the hospital; however, nursing staff lack adequate knowledge of inhaler technique. IMPLICATIONS: Identifying gaps in nursing knowledge regarding proper inhaler technique and patient education about proper inhaler technique is important to design interventions that may positively impact patient outcomes. Interventions could include one-on-one education, Web-based education, unit-based education, or hospital-wide competency-based education. All should include return demonstration of appropriate technique.

Interventions to reduce rehospitalizations after chronic obstructive pulmonary disease exacerbations. A systematic review.

RATIONALE: Approximately 20% of patients hospitalized for COPD exacerbations in the United States will be readmitted within 30 days. The Centers for Medicare and Medicaid Services has recently proposed to revise the Hospital Readmissions Reduction Program to financially penalize hospitals with high all-cause 30-day rehospitalization rates after a hospitalization for COPD exacerbation on or after October 1, 2014. OBJECTIVES: To report the results of a systematic review of randomized clinical trials evaluating interventions to reduce the rehospitalizations after COPD exacerbations. METHODS: Multiple electronic databases were systematically searched to identify relevant studies published between January 1966 and June 2013. Titles, abstracts, and, subsequently, full-text articles were assessed for eligibility. Each study was appraised using predefined criteria. MEASUREMENTS AND MAIN RESULTS: Among 913 titles and abstracts screened, 5 studies (1,393 participants) met eligibility criteria. All studies had a primary outcome of rehospitalization at 6 or 12 months. No study examined 30-day rehospitalization as the primary outcome. Each study tested a different set of interventions. Two studies (one conducted in Canada and one conducted in Spain and Belgium) showed a decrease in all-cause rehospitalization over 12 months in the intervention group versus comparator group (mean number of hospitalizations per patient, 1.0 vs. 1.8; P = 0.01; percent hospitalized, 45 vs. 67%; P = 0.028; respectively). The only study conducted in the United States found a greater than twofold higher risk of mortality in the intervention group (17 vs. 7%, P = 0.003) but no significant difference in rehospitalizations. It was unclear which set of interventions was effective or harmful. CONCLUSIONS: The evidence base is inadequate to recommend specific interventions to reduce rehospitalizations in this population and does not justify penalizing hospitals for high 30-day rehospitalization rates after COPD exacerbations.