Capnography-Assisted Learned, Monitored (CALM) breathing therapy for dysfunctional breathing in COPD: A bridge to pulmonary rehabilitation.

BACKGROUND: Although dyspnea is a primary symptom of chronic obstructive pulmonary disease (COPD), its treatment is suboptimal. In both COPD and acute anxiety, breathing patterns become dysregulated, contributing to abnormal CO2, dyspnea, and inefficient recovery from breathing challenges. While pulmonary rehabilitation (PR) improves dyspnea, only 1-2% of patients access it. Individuals with anxiety who use PR have worse outcomes. METHODS: We present the protocol of a randomized controlled trial designed to determine the feasibility and acceptability of a new, four-week mind-body intervention that we developed, called "Capnography-Assisted Learned, Monitored (CALM) Breathing," as an adjunct to PR. Eligible participants are randomized in a 1:1 ratio to either CALM Breathing program or Usual Care. CALM Breathing consists of 10 core, slow breathing exercises combined with real time biofeedback (of end-tidal CO2, respiratory rate, and airflow) and motivational interviewing. CALM Breathing promotes self-regulated breathing, linking CO2 changes to dyspnea and anxiety symptoms and targeting breathing efficiency and self-efficacy in COPD. Participants are randomized to CALM Breathing or a Usual Care control group. RESULTS: Primary outcomes include feasibility and acceptability metrics of recruitment efficiency, participant retention, intervention adherence and fidelity, PR facilitation, patient satisfaction, and favorable themes from interviews. Secondary outcomes include breathing biomarkers, symptoms, health-related quality of life, six-minute walk distance, lung function, mood, physical activity, and PR utilization and engagement. CONCLUSION: By disrupting the cycle of dyspnea and anxiety, and providing a needed bridge to PR, CALM Breathing may address a substantive gap in healthcare and optimize treatment for patients with COPD.

Applying User-Centered Design and Implementation Science to the Early-Stage Development of a Telehealth-Enhanced Hybrid Cardiac Rehabilitation Program: Quality Improvement Study.

BACKGROUND: Cardiac rehabilitation (CR) is an evidence-based intervention that improves event-free survival in patients with cardiac conditions, yet <27% of all eligible patients use CR in the United States. CR is traditionally delivered in clinic-based settings where implementation barriers abound. Innovative nontraditional program designs and strategies are needed to support widespread CR uptake. OBJECTIVE: This study aimed to demonstrate how user-centered design (UCD) and implementation science (IS) principles and methods can be integrated into the early-stage development of nontraditional CR interventions. METHODS: As part of a NewYork-Presbyterian Hospital (NYPH) quality improvement initiative (March 2020-February 2022), we combined UCD and IS principles and methods to design a novel home- and clinic-based telehealth-enhanced hybrid CR (THCR) program. We co-designed this program with multilevel stakeholders using an iterative 3-step UCD process to identify user and contextual barriers and facilitators to CR uptake (using semistructured interviews and contextual inquiry [step 1]), design an intervention prototype that targets contextual and user factors and emulates the evidence-based practice (through design workshops and journey mapping [step 2]), and review and refine the prototype (according to real-world usability testing and feedback [step 3]). The UCD process was informed by the Theoretical Domains Framework and Consolidated Framework for Implementation Research. RESULTS: At step 1, we conducted semistructured interviews with 9 provider- and system-level stakeholders (female: n=6, 67%) at 3 geographically diverse academic medical centers, which revealed behavioral (eg, self-efficacy and knowledge) and contextual (eg, social distancing guidelines, physical space, staffing, and reimbursement) barriers to uptake; hybrid delivery was a key facilitator. Step 2 involved conducting 20 design workshops and 3 journey-mapping sessions with multidisciplinary NYPH stakeholders (eg, digital health team, CR clinicians, and creative director) where we identified key design elements (eg, mix of clinic- and home-based CR and synchronous remote patient monitoring), yielding an initial THCR prototype that leveraged NYPH's telehealth infrastructure. At step 3, we conducted usability testing with 2 CR clinicians (both female) administering home-based sessions to 3 CR patients (female: n=1, 33%), which revealed usability themes (eg, ease of using remote patient monitoring devices or a telehealth platform, technology disruptions, and confidence in using the telehealth platform to safely monitor patients) and design solutions (eg, onboarding sessions, safety surveys, and fully supervised remote sessions) to be included in the final THCR prototype. CONCLUSIONS: Combining UCD and IS methods while engaging multidisciplinary stakeholders in an iterative process yielded a theory-informed THCR program targeting user and contextual barriers to real-world CR implementation. We provide a detailed summary of the process and guidance for incorporating UCD and IS principles and methods into the early-stage development of a nontraditional CR intervention. The feasibility, acceptability, appropriateness, and usability of the final THCR prototype is being evaluated in an ongoing study.

User-centered design of a telehealth-enhanced hybrid cardiac rehabilitation program as hospital quality improvement.

Background Innovative program designs and strategies are needed to support the widespread uptake of cardiac rehabilitation (CR) programs in the post-COVID19 era. We combined user-centered design (UCD) and implementation science (ImS) principles to design a novel telehealth-enhanced hybrid (home and clinic-based) CR (THCR) program. Methods As part of a New York Presbyterian Hospital (NYPH) quality improvement initiative (March 2020-February 2022), we designed a THCR program using an iterative 3 step UCD process informed by the Theoretical Domains Framework and Consolidated Framework for Implementation Research to: 1) identify user and contextual barriers to CR uptake (stakeholder interviews), 2) design an intervention prototype (design workshops and journey mapping), and 3) refine the prototype (usability testing). The process was optimized for usability and implementation outcomes. Results Step 1: Semi-structured interviews with stakeholders (n = 9) at 3 geographically diverse academic medical centers revealed behavioral (e.g., self-efficacy, knowledge) and contextual (e.g., social distancing guidelines, physical space, staffing, reimbursement) barriers to uptake. Step 2: Design workshops (n = 20) and journey-mapping sessions (n = 3) with multi-disciplinary NYPH stakeholders (e.g., digital health team, CR clinicians, creative director) yielded a THCR prototype that leveraged NYPH's investment in their remote patient monitoring (RPM) platform to optimize feasibility of home-based CR sessions. Step 3: Usability testing with CR clinicians (n = 2) administering and CR patients (n = 3) participating in home-based sessions revealed usability challenges (e.g., RPM devices/exercise equipment usability; Wi-Fi/Bluetooth connectivity/syncing; patient safety/knowledge and protocol flexibility). Design workshops (n = 24) and journey-mapping sessions (n = 3) yielded design solutions (e.g., onboarding sessions, safety surveys, fully supervised remote sessions) and a refined THCR prototype. Conclusion Combining UCD and ImS methods while engaging multi-disciplinary stakeholders in an iterative process yielded a theory-informed telehealth-enhanced hybrid CR program targeting user and contextual barriers to real-world CR implementation. We provide a detailed summary of the process, and guidance for incorporating UCD and ImS methods in early-stage intervention development. THCR may shrink the evidence-to-practice gap in CR implementation. A future hybrid type I effectiveness-implementation trial will determine its feasibility, acceptability, and effectiveness.