Application of the RE-AIM framework to evaluate the implementation of telehealth pulmonary rehabilitation in a randomized controlled trial among African-American and Hispanic patients with advanced stage Chronic Obstructive Pulmonary Disease.

BACKGROUND: Pulmonary rehabilitation (PR) decreases rehospitalization for people with COPD. However, less than 2% receive PR, partly due to lack of referral and sparsity of PR facilities. This disparity is particularly pronounced in African American and Hispanic persons with COPD. Telehealth-provided PR could increase access and improve health outcomes. METHODS: We applied the RE-AIM framework in a post-hoc analysis of our mixed methods RCT comparing referral to Telehealth-delivered PR (TelePR) versus standard PR (SPR) for African American and Hispanic COPD patients hospitalized for COPD exacerbation. Both arms received a referral to PR for 8 weeks, social worker follow-up, and surveys administered at baseline, 8 weeks, 6, and 12 months. PR sessions were conducted twice a week for 90 min each (16 sessions total). Quantitative data were analyzed using 2-sample t tests or nonparametric Wilcoxon tests for continuous data and χ2/Fisher exact tests for categorical data. Logistic regression-estimated odds ratios (ORs) were used for the intention-to-treat primary outcome. Qualitative interviews were conducted at the end of the study to assess adherence and satisfaction and were analyzed using inductive and deductive methods. The goal was to understand Reach (whether the target population was able to be enrolled), Effectiveness (primary outcome was a composite of 6-month COPD rehospitalization and death), Adoption (proportion of people willing to initiate the program), Implementation (whether the program was able to be executed as intended, and Maintenance (whether the program was continued). RESULTS: Two hundred nine people enrolled out of a 276-recruitment goal. Only 85 completed at least one PR session 57/111 (51%) TelePR; 28/98 (28%) SPR. Referral to TelePR compared to SPR did not decrease the composite outcome of 6-month COPD-readmission rate/death (OR1.35;95%CI 0.69,2.66). There was significant reduction in fatigue (PROMIS® scale) from baseline to 8-weeks in TelePR compared to SPR (MD-1.34; ± SD4.22; p = 0.02). Participants who received TelePR experienced improvements from baseline in several outcomes (ie, before and after 8 weeks of PR) in the following: COPD symptoms, knowledge about COPD management, fatigue, and functional capacity. Among the patients who had 1 initial visit, adherence rates were similar (TelePR arm, 59% of sessions; SPR arm, 63%). No intervention-related adverse events occurred. Barriers to PR adoption included difficulty or reluctance to complete medical clearances and beliefs about PR efficacy. Notably, only 9 participants sustained exercise after program completion. Maintenance of the program was not possible due to low insurance reimbursement and sparsity of Respiratory Therapists. CONCLUSIONS: TelePR can reach COPD patients with health disparities and can be successfully implemented. The small sample size and large confidence intervals prevent conclusion about the relative effectiveness of participating in TelePR compared to SPR. However, improved outcomes were seen for those in TelePR as well as in SPR. Increasing adoption of PR and TelePR requires consideration of comorbidity burden, and perception of PR utility, and must facilitate medical clearances. Given the sparsity of SPR locations, TelePR can overcome at least the barrier of access. However, given the challenges to the uptake and completion of PR - many of the additional barriers in PR (both in TelePR and SPR) need to be addressed. Awareness of these real-world challenges will not only inform implementation of TelePR for clinicians seeking to adopt this platform but will also inform study designers and reviewers regarding the feasibility of approaches to patient recruitment and retention.

Development of a Cystic Fibrosis Primary Palliative Care Intervention: Qualitative Analysis of Patient and Family Caregiver Preferences.

To prevent or mitigate chronic illness burden, people with cystic fibrosis (pwCF) and their family caregivers need primary (generalist-level) palliative care from the time of diagnosis forward. We used qualitative methods to explore their preferences about a screening-and-triage model ("Improving Life with CF") developed to standardize this care. We purposively sampled and interviewed 14 pwCF and caregivers from 5 Improving Life with CF study sites. Thematic analysis was guided by a priori codes using the National Consensus Project's Guidelines for Quality Palliative Care. Participants included 7 adults and 2 adolescents with CF (3 with advanced disease), 4 parents, 1 partner (7 women; 5 people of color). Few were familiar with palliative care. Illness burden was described in multiple domains, including physical (e.g., dyspnea, pain), psychological (e.g., anxiety), and social (e.g., family well-being; impact on work/school). Most preferred survey-based screening with care coordination by the CF team. Preferences for screening approaches varied. PwCF and caregivers experience illness burden and are receptive to a CF-team delivered primary palliative care screening-and-triage model with flexible processes.

US and Dutch Perspectives on the Use of COVID-19 Clinical Prediction Models: Findings from a Qualitative Analysis.

INTRODUCTION: Clinical prediction models (CPMs) for coronavirus disease 2019 (COVID-19) may support clinical decision making, treatment, and communication. However, attitudes about using CPMs for COVID-19 decision making are unknown. METHODS: Online focus groups and interviews were conducted among health care providers, survivors of COVID-19, and surrogates (i.e., loved ones/surrogate decision makers) in the United States and the Netherlands. Semistructured questions explored experiences about clinical decision making in COVID-19 care and facilitators and barriers for implementing CPMs. RESULTS: In the United States, we conducted 4 online focus groups with 1) providers and 2) surrogates and survivors of COVID-19 between January 2021 and July 2021. In the Netherlands, we conducted 3 focus groups and 4 individual interviews with 1) providers and 2) surrogates and survivors of COVID-19 between May 2021 and July 2021. Providers expressed concern about CPM validity and the belief that patients may interpret CPM predictions as absolute. They described CPMs as potentially useful for resource allocation, triaging, education, and research. Several surrogates and people who had COVID-19 were not given prognostic estimates but believed this information would have supported and influenced their decision making. A limited number of participants felt the data would not have applied to them and that they or their loved ones may not have survived, as poor prognosis may have suggested withdrawal of treatment. CONCLUSIONS: Many providers had reservations about using CPMs for people with COVID-19 due to concerns about CPM validity and patient-level interpretation of the outcome predictions. However, several people who survived COVID-19 and their surrogates indicated that they would have found this information useful for decision making. Therefore, information provision may be needed to improve provider-level comfort and patient and surrogate understanding of CPMs. HIGHLIGHTS: While clinical prediction models (CPMs) may provide an objective means of assessing COVID-19 prognosis, provider concerns about CPM validity and the interpretation of CPM predictions may limit their clinical use.Providers felt that CPMs may be most useful for resource allocation, triage, research, or educational purposes for COVID-19.Several survivors of COVID-19 and their surrogates felt that CPMs would have been informative and may have aided them in making COVID-19 treatment decisions, while others felt the data would not have applied to them.

Prognostic models for COVID-19 needed updating to warrant transportability over time and space.

BACKGROUND: Supporting decisions for patients who present to the emergency department (ED) with COVID-19 requires accurate prognostication. We aimed to evaluate prognostic models for predicting outcomes in hospitalized patients with COVID-19, in different locations and across time. METHODS: We included patients who presented to the ED with suspected COVID-19 and were admitted to 12 hospitals in the New York City (NYC) area and 4 large Dutch hospitals. We used second-wave patients who presented between September and December 2020 (2137 and 3252 in NYC and the Netherlands, respectively) to evaluate models that were developed on first-wave patients who presented between March and August 2020 (12,163 and 5831). We evaluated two prognostic models for in-hospital death: The Northwell COVID-19 Survival (NOCOS) model was developed on NYC data and the COVID Outcome Prediction in the Emergency Department (COPE) model was developed on Dutch data. These models were validated on subsequent second-wave data at the same site (temporal validation) and at the other site (geographic validation). We assessed model performance by the Area Under the receiver operating characteristic Curve (AUC), by the E-statistic, and by net benefit. RESULTS: Twenty-eight-day mortality was considerably higher in the NYC first-wave data (21.0%), compared to the second-wave (10.1%) and the Dutch data (first wave 10.8%; second wave 10.0%). COPE discriminated well at temporal validation (AUC 0.82), with excellent calibration (E-statistic 0.8%). At geographic validation, discrimination was satisfactory (AUC 0.78), but with moderate over-prediction of mortality risk, particularly in higher-risk patients (E-statistic 2.9%). While discrimination was adequate when NOCOS was tested on second-wave NYC data (AUC 0.77), NOCOS systematically overestimated the mortality risk (E-statistic 5.1%). Discrimination in the Dutch data was good (AUC 0.81), but with over-prediction of risk, particularly in lower-risk patients (E-statistic 4.0%). Recalibration of COPE and NOCOS led to limited net benefit improvement in Dutch data, but to substantial net benefit improvement in NYC data. CONCLUSIONS: NOCOS performed moderately worse than COPE, probably reflecting unique aspects of the early pandemic in NYC. Frequent updating of prognostic models is likely to be required for transportability over time and space during a dynamic pandemic.

Humanizing the ICU Patient: A Qualitative Exploration of Behaviors Experienced by Patients, Caregivers, and ICU Staff.

OBJECTIVES: To understand how patients and family members experience dehumanizing or humanizing treatment when in the ICU. DESIGN: Qualitative study included web-based focus groups and open-ended surveys posted to ICU patient/family social media boards. Focus groups were audio recorded and transcribed. Social media responses were collected and organized by stakeholder group. Data underwent qualitative analysis. SETTING: Remote focus groups and online surveys. PATIENTS: ICU patient survivors, family members, and ICU teams. INTERVENTIONS: Not available. MEASUREMENTS AND MAIN RESULTS: Semi-structured questions and open-ended survey responses. We enrolled 40 patients/family members and 31 ICU team members. Focus groups and surveys revealed three primary themes orienting humanizing/dehumanizing ICU experiences: 1) communication, 2) outcomes, and 3) causes of dehumanization. Dehumanization occurred during "communication" exchanges when ICU team members talked "over" patients, made distressing remarks when patients were present, or failed to inform patients about ICU-related care. "Outcomes" of dehumanization were associated with patient loss of trust in the medical team, loss of motivation to participate in ICU recovery, feeling of distress, guilt, depression, and anxiety. Humanizing behaviors were associated with improved recovery, well-being, and trust. "Perceived causes" of dehumanizing behaviors were linked to patient, ICU team, and healthcare system factors. CONCLUSIONS: Behaviors of ICU clinicians may cause patients and families to feel dehumanized when in the ICU. Negative behaviors are noticed by patients and families, possibly contributing to poor outcomes including mental health, recovery, and lack of trust in ICU teams. Supporting ICU clinicians may enable a more empathic environment and in turn more humanizing clinician-patient encounters.

Models of Palliative Care Delivery for Individuals with Cystic Fibrosis: Cystic Fibrosis Foundation Evidence-Informed Consensus Guidelines.

Cystic fibrosis (CF) affects more than 70,000 individuals and their families worldwide. Although outcomes for individuals with CF continue to improve, it remains a life-limiting condition with no cure. Individuals with CF manage extensive symptom and treatment burdens and face complex medical decisions throughout the illness course. Although palliative care has been shown to reduce suffering by alleviating illness-related burdens for people with serious illness and their families, little is known regarding the components and structure of various delivery models of palliative care needed to improve outcomes for people affected by CF. The Cystic Fibrosis Foundation (CFF) assembled an expert panel of clinicians, researchers, individuals with CF, and family caregivers, to develop consensus recommendations for models of best practices for palliative care in CF. Eleven statements were developed based on a systematic literature review and expert opinion, and address primary palliative care, specialty palliative care, and screening for palliative needs. These recommendations are intended to comprehensively address palliative care needs and improve quality of life for individuals with CF at all stages of illness and development, and their caregivers.

Other Ways of Knowing.

BACKGROUND: Patients with advanced-stage chronic obstructive pulmonary disease (COPD) may suffer severe respiratory exacerbations and need to decide between accepting life-sustaining treatments versus foregoing these treatments (choosing comfort care only). We designed the InformedTogether decision aid to inform this decision and describe results of a pilot study to assess usability focusing on participants' trust in the content of the decision aid, acceptability, recommendations for improvement, and emotional reactions to this emotionally laden decision. METHODS: Study participants ( N = 26) comprising clinicians, patients, and surrogates viewed the decision aid, completed usability tasks, and participated in interviews and focus groups assessing comprehension, trust, perception of bias, and perceived acceptability of InformedTogether. Mixed methods were used to analyze results. RESULTS: Almost all participants understood the gist (general meaning) of InformedTogether. However, many lower literacy participants had difficulty answering the more detailed questions related to comprehension, especially when interpreting icon arrays, and many were not aware that they had misunderstood the information. Qualitative analysis showed a range of emotional reactions to the information. Participants with low verbatim comprehension frequently referenced lived experiences when answering knowledge questions, which we termed "alternative knowledge." CONCLUSIONS: We found a range of emotional reactions to the information and frequent use of alternative knowledge frameworks for deriving meaning from the data. These observations led to insights into the impact of lived experiences on the uptake of biomedical information presented in decision aids. Communicating prognostic information could potentially be improved by eliciting alternative knowledge as a starting point to build communication, in particular for low literacy patients. Decision aids designed to facilitate shared decision making should elicit this knowledge and help clinicians tailor information accordingly.