Perspectives of community-based organizations on digital health equity interventions: a key informant interview study.

BACKGROUND: Health and healthcare are increasingly dependent on internet and digital solutions. Medically underserved communities that experience health disparities are often those who are burdened by digital disparities. While digital equity and digital health equity are national priorities, there is limited evidence about how community-based organizations (CBOs) consider and develop interventions. METHODS: We conducted key informant interviews in 2022 purposively recruiting from health and welfare organizations engaged in digital equity work. Nineteen individuals from 13 organizations serving rural and/or urban communities from the local to national level participated in semi-structured interviews via Zoom regarding their perspectives on digital health equity interventions. Directed content analysis of verbatim interview transcripts was conducted to identify themes. RESULTS: Themes emerged at individual, organizational, and societal levels. Individual level themes included potential benefits from digital health equity, internet access challenges, and the need for access to devices and digital literacy. Organizational level themes included leveraging community assets, promising organizational practices and challenges. For the societal level, the shifting complexity of the digital equity ecosystem, policy issues, and data for needs assessment and evaluation were described. Several example case studies describing these themes were provided. DISCUSSION AND CONCLUSION: Digital health equity interventions are complex, multi-level endeavors. Clear elucidation of the individual, organizational, and societal level factors that may impact digital health equity interventions are necessary to understanding if and how CBOs participate in such initiatives. This study presents unique perspectives directly from CBOs driving programs in this new arena of digital health equity.

Family and personal history of cancer in the All of Us research program for precision medicine.

The All of Us (AoU) Research Program is making available one of the largest and most diverse collections of health data in the US to researchers. Using the All of Us database, we evaluated family and personal histories of five common types of cancer in 89,453 individuals, comparing these data to 24,305 participants from the 2015 National Health Interview Survey (NHIS). Comparing datasets, we found similar family cancer history (33%) rates, but higher personal cancer history in the AoU dataset (9.2% in AoU vs. 5.11% in NHIS), Methodological (e.g. survey-versus telephone-based data collection) and demographic variability may explain these between-data differences, but more research is needed.

The ACTIVATE Digital Health Pilot Program for Diabetes and Hypertension in an Underserved and Rural Community.

BACKGROUND: Community health centers and patients in rural and agricultural communities struggle to address diabetes and hypertension in the face of health disparities and technology barriers. The stark reality of these digital health disparities were highlighted during the coronavirus disease 2019 pandemic. OBJECTIVES: The objective of the ACTIVATE (Accountability, Coordination, and Telehealth in the Valley to Achieve Transformation and Equity) project was to codesign a platform for remote patient monitoring and program for chronic illness management that would address these disparities and offer a solution that fit the needs and context of the community. METHODS: ACTIVATE was a digital health intervention implemented in three phases: community codesign, feasibility assessment, and a pilot phase. Pre- and postintervention outcomes included regularly collected hemoglobin A1c (A1c) for participants with diabetes and blood pressure for those with hypertension. RESULTS: Participants were adult patients with uncontrolled diabetes and/or hypertension (n = 50). Most were White and Hispanic or Latino (84%) with Spanish as a primary language (69%), and the mean age was 55. There was substantial adoption and use of the technology: over 10,000 glucose and blood pressure measures were transmitted using connected remote monitoring devices over a 6-month period. Participants with diabetes achieved a mean reduction in A1c of 3.28 percentage points (standard deviation [SD]: 2.81) at 3 months and 4.19 percentage points (SD: 2.69) at 6 months. The vast majority of patients achieved an A1c in the target range for control (7.0-8.0%). Participants with hypertension achieved reductions in systolic blood pressure of 14.81 mm Hg (SD: 21.40) at 3 months and 13.55 mm Hg (SD: 23.31) at 6 months, with smaller reductions in diastolic blood pressure. The majority of participants also reached target blood pressure (less than 130/80). CONCLUSION: The ACTIVATE pilot demonstrated that a codesigned solution for remote patient monitoring and chronic illness management delivered by community health centers can overcome digital divide barriers and show positive health outcomes for rural and agricultural residents.

Patient and researcher stakeholder preferences for use of electronic health record data: a qualitative study to guide the design and development of a platform to honor patient preferences.

OBJECTIVE: This qualitative study aimed to understand patient and researcher perspectives regarding consent and data-sharing preferences for research and a patient-centered system to manage consent and data-sharing preferences. MATERIALS AND METHODS: We conducted focus groups with patient and researcher participants recruited from three academic health centers via snowball sampling. Discussions focused on perspectives on the use of electronic health record (EHR) data for research. Themes were identified through consensus coding, starting from an exploratory framework. RESULTS: We held two focus groups with patients (n = 12 patients) and two with researchers (n = 8 researchers). We identified two patient themes (1-2), one theme common to patients and researchers (3), and two researcher themes (4-5). Themes included (1) motivations for sharing EHR data, (2) perspectives on the importance of data-sharing transparency, (3) individual control of personal EHR data sharing, (4) how EHR data benefits research, and (5) challenges researchers face using EHR data. DISCUSSION: Patients expressed a tension between the benefits of their data being used in studies to benefit themselves/others and avoiding risk by limiting data access. Patients resolved this tension by acknowledging they would often share their data but wanted greater transparency on its use. Researchers expressed concern about incorporating bias into datasets if patients opted out. CONCLUSIONS: A research consent and data-sharing platform must consider two competing goals: empowering patients to have more control over their data and maintaining the integrity of secondary data sources. Health systems and researchers should increase trust-building efforts with patients to engender trust in data access and use.

A Structured Review and Evaluation of Android Mobile Applications for Yoga Support.

Although there are hundreds of mobile yoga apps in the app market space, the quality and usefulness of these apps have not been systematically tested. We conducted a structured quality evaluation of apps from the Google Play store, applying the validated Mobile Application Rating Scale (MARS) by two independent raters. 18 out of 250 apps were identified for evaluation after applying inclusion/exclusion criteria. The mean MARS score is 4.11 (out of 5) with SD = 0.38. There was high interrater reliability (ICC = .88; 95% CI 0.85-0.91). Apps performed well on functionality and aesthetics. However, there is much room for improvement in information and engagement. Designers and researchers should focus on improving user engagement and building the evidence base for informational content provided in apps.

Trust and shared decision-making among individuals with multiple myeloma: A qualitative study.

BACKGROUND: Multiple myeloma (MM) is an incurable cancer with complex treatment options. Trusting patient-clinician relationships are essential to promote effective shared decision-making that aligns best clinical practices with patient values and preferences. This study sought to shed light on the development of trust between MM patients and clinicians. METHODS: Nineteen individual semi-structured interviews were conducted with MM patients within 2 years of initial diagnosis or relapse for this qualitative study. Interviews were recorded and transcripts were coded thematically. RESULTS: We identified three main themes: (1) externally validated trust describes patients' predisposition to trust or distrust clinicians based on factors outside of patient-clinician interactions; (2) internally validated trust describes how patients develop trust based on interactions with specific clinicians. Internally validated trust is driven primarily by clinician communication practices that demonstrate competence, responsiveness, listening, honesty, and empathy; and (3) trust in relation to shared decision-making describes how patients relate the feeling of trust, or lack thereof, to the process of shared decision-making. CONCLUSION: Many factors contribute to the development of trust between MM patients and clinicians. While some are outside of clinicians' control, others derive from clinician behaviors and interpersonal communication skills. These findings suggest the possibility that trust can be enhanced through communication training or shared decision-making tools that emphasize relational communication. Given the important role trust plays in shared decision-making, clinicians working with MM patients should prioritize establishing positive, trusting relationships.

Infliximab versus second intravenous immunoglobulin for treatment of resistant Kawasaki disease in the USA (KIDCARE): a randomised, multicentre comparative effectiveness trial.

BACKGROUND: Although intravenous immunoglobulin (IVIG) is effective therapy for Kawasaki disease, 10-20% of patients have recrudescent fever as a sign of persistent inflammation and require additional treatment. We aimed to compare infliximab with a second infusion of IVIG for treatment of resistant Kawasaki disease. METHODS: In this multicentre comparative effectiveness trial, patients (aged 4 weeks to 17 years) with IVIG resistant Kawasaki disease and fever at least 36 h after completion of their first IVIG infusion were recruited from 30 hospitals across the USA. Patients were randomly assigned (1:1) to second IVIG (2 g/kg over 8-12 h) or intravenous infliximab (10 mg/kg over 2 h without premedication), by using a randomly permuted block randomisation design with block size of two or four. Patients with fever 24 h to 7 days following completion of first study treatment crossed over to receive the other study treatment. The primary outcome measure was resolution of fever at 24 h after initiation of study treatment with no recurrence of fever attributed to Kawasaki disease within 7 days post-discharge. Secondary outcome measures included duration of fever from enrolment, duration of hospitalisation after randomisation, and changes in markers of inflammation and coronary artery Z score. Efficacy was analysed in participants who received treatment and had available outcome values. Safety was analysed in all randomised patients who did not withdraw consent. This clinical trial is registered with ClinicalTrials.gov, NCT03065244. FINDINGS: Between March 1, 2017, and Aug 31, 2020, 105 patients were randomly assigned to treatment and 103 were included in the intention-to-treat population (54 in the infliximab group, 49 in the second IVIG group). Two patients randomised to infliximab did not receive allocated treatment. The primary outcome was met by 40 (77%) of 52 patients in the infliximab group and 25 (51%) of 49 patients in the second IVIG infusion group (odds ratio 0·31, 95% CI 0·13-0·73, p=0·0076). 31 patients with fever beyond 24 h received crossover treatment: nine (17%) in the infliximab group received second IVIG and 22 (45%) in second IVIG group received infliximab (p=0·0024). Three patients randomly assigned to infliximab and two to second IVIG with fever beyond 24h did not receive crossover treatment. Mean fever days from enrolment was 1·5 (SD 1·4) for the infliximab group and 2·5 (2·5) for the second IVIG group (p=0·014). Mean hospital stay was 3·2 days (2·1) for the infliximab group and 4·5 days (2·5) for the second IVIG group (p<0·001). There was no difference between treatment groups for markers of inflammation or coronary artery outcome. 24 (44%) of 54 patients in the infliximab group and 33 (67%) of 49 in the second IVIG group had at least one adverse event. A drop in haemoglobin concentration of at least 2g/dL was seen in 19 (33%) of 58 patients who received IVIG as either their first or second study treatment (three of whom required transfusion) and in three (7%) of 43 who received only infliximab (none required transfusion; p=0·0028). Haemolytic anaemia was the only serious adverse events deemed definitely or probably related to study treatment, and was reported in nine (15%) of 58 patients who received IVIG as either their first or second study treatment and none who received infliximab only. INTERPRETATION: Infliximab is a safe, well tolerated, and effective treatment for patients with IVIG resistant Kawasaki disease, and results in shorter duration of fever, reduced need for additional therapy, less severe anaemia, and shorter hospitalisation compared with second IVIG infusion. FUNDING: Patient Centered Outcomes Research Institute.

Informatics-enabled citizen science to advance health equity.

The COVID-19 pandemic has once again highlighted the ubiquity and persistence of health inequities along with our inability to respond to them in a timely and effective manner. There is an opportunity to address the limitations of our current approaches through new models of informatics-enabled research and clinical practice that shift the norm from small- to large-scale patient engagement. We propose augmenting our approach to address health inequities through informatics-enabled citizen science, challenging the types of questions being asked, prioritized, and acted upon. We envision this democratization of informatics that builds upon the inclusive tradition of community-based participatory research (CBPR) as a logical and transformative step toward improving individual, community, and population health in a way that deeply reflects the needs of historically marginalized populations.

Privacy-protecting, reliable response data discovery using COVID-19 patient observations.

OBJECTIVE: To utilize, in an individual and institutional privacy-preserving manner, electronic health record (EHR) data from 202 hospitals by analyzing answers to COVID-19-related questions and posting these answers online. MATERIALS AND METHODS: We developed a distributed, federated network of 12 health systems that harmonized their EHRs and submitted aggregate answers to consortia questions posted at https://www.covid19questions.org. Our consortium developed processes and implemented distributed algorithms to produce answers to a variety of questions. We were able to generate counts, descriptive statistics, and build a multivariate, iterative regression model without centralizing individual-level data. RESULTS: Our public website contains answers to various clinical questions, a web form for users to ask questions in natural language, and a list of items that are currently pending responses. The results show, for example, that patients who were taking angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers, within the year before admission, had lower unadjusted in-hospital mortality rates. We also showed that, when adjusted for, age, sex, and ethnicity were not significantly associated with mortality. We demonstrated that it is possible to answer questions about COVID-19 using EHR data from systems that have different policies and must follow various regulations, without moving data out of their health systems. DISCUSSION AND CONCLUSIONS: We present an alternative or a complement to centralized COVID-19 registries of EHR data. We can use multivariate distributed logistic regression on observations recorded in the process of care to generate results without transferring individual-level data outside the health systems.

Psychometric Properties of the Preparedness Assessment for the Transition Home After Stroke Instrument.

PURPOSE: The aim of this study was to evaluate psychometric properties of the Preparedness Assessment for the Transition Home After Stroke (PATH-s), a novel instrument to assess stroke caregiver commitment and capacity. The PATH-s instrument can be obtained at www.rehabnurse.org/pathtool. DESIGN: The design of this study is cross-sectional. METHODS: The PATH-s, the Preparedness for Caregiving Scale (PCS), the Patient Health Questionnaire, the Perceived Stress Scale, and the Global Health Scale were self-reported from a convenience sample of caregiver-stroke survivor dyads (n = 183) during inpatient rehabilitation. RESULTS: Exploratory factor analysis revealed eight factors underlying the PATH-s structure. The PATH-s Cronbach's alpha of .90 demonstrated criterion-related validity with the PCS (r = .79, p < .01). Both the PATH-s and the PCS were negatively correlated with the Patient Health Questionnaire (r = -.26 and -.27, respectively; p < .01) and the Perceived Stress Scale (r = -.12 and -.15, respectively; p > .05) and positively correlated with the Global Health Scale (r = -.46 and .46, respectively; p < .01), indicating convergent validity. CONCLUSIONS: The PATH-s demonstrates excellent internal consistency and satisfactory criterion-related and convergent validity. CLINICAL RELEVANCE: The PATH-s may be used to assess the risk/needs of caregivers over time.

Nurse-Led Telephonic Symptom Support for Patients Receiving Chemotherapy.

PROBLEM STATEMENT: The use of evidence-informed symptom guides has not been widely adopted in telephonic support. DESIGN: This is a descriptive study of nurse-led support using evidence-based symptom guides during telephone outreach. DATA SOURCES: Documentation quantified telephone encounters by frequency, length, and type of patient-reported symptoms. Nurse interviews examined perceptions of their role and the use of symptom guides. ANALYSIS: Quantitative data were summarized using univariate descriptive statistics, and interviews were analyzed using directed descriptive content analysis. FINDINGS: Symptom guides were viewed as trusted evidence-based resources, suitable to address common treatment-related symptoms. A threshold effect was a reported barrier of the guides, such that the benefit diminished over time for managing recurring symptoms. IMPLICATIONS FOR PRACTICE: Telephone outreach using evidence-based symptom guides can contribute to early symptom identification while engaging patients in decision making. Understanding nurse activities aids in developing an economical and high-quality model for symptom support, as well as in encouraging nurses to practice at the highest level of preparation.

Privacy-Protecting, Reliable Response Data Discovery Using COVID-19 Patient Observations.

There is an urgent need to answer questions related to COVID-19's clinical course and associations with underlying conditions and health outcomes. Multi-center data are necessary to generate reliable answers, but centralizing data in a single repository is not always possible. Using a privacy-protecting strategy, we launched a public Questions & Answers web portal (https://covid19questions.org) with analyses of comorbidities, medications and laboratory tests using data from 202 hospitals (59,074 COVID-19 patients) in the USA and Germany. We find, for example, that 8.6% of hospitalizations in which the patient was not admitted to the ICU resulted in the patient returning to the hospital within seven days from discharge and that, when adjusted for age, mortality for hospitalized patients was not significantly different by gender or ethnicity.

Citizen science to further precision medicine: from vision to implementation.

The active involvement of citizen scientists in setting research agendas, partnering with academic investigators to conduct research, analyzing and disseminating results, and implementing learnings from research can improve both processes and outcomes. Adopting a citizen science approach to the practice of precision medicine in clinical care and research will require healthcare providers, researchers, and institutions to address a number of technical, organizational, and citizen scientist collaboration issues. Some changes can be made with relative ease, while others will necessitate cultural shifts, redistribution of power, recommitment to shared goals, and improved communication. This perspective, based on a workshop held at the 2018 AMIA Annual Symposium, identifies current barriers and needed changes to facilitate broad adoption of a citizen science-based approach in healthcare.

Feasibility, Acceptability, and Influence of mHealth-Supported N-of-1 Trials for Enhanced Cognitive and Emotional Well-Being in US Volunteers.

Although group-level evidence supports the use of behavioral interventions to enhance cognitive and emotional well-being, different interventions may be more acceptable or effective for different people. N-of-1 trials are single-patient crossover trials designed to estimate treatment effectiveness in a single patient. We designed a mobile health (mHealth) supported N-of-1 trial platform permitting US adult volunteers to conduct their own 30-day self-experiments testing a behavioral intervention of their choice (deep breathing/meditation, gratitude journaling, physical activity, or helpful acts) on daily measurements of stress, focus, and happiness. We assessed uptake of the study, perceived usability of the N-of-1 trial system, and influence of results (both reported and perceived) on enthusiasm for the chosen intervention (defined as perceived helpfulness of the chosen intervention and intent to continue performing the intervention in the future). Following a social media and public radio campaign, 447 adults enrolled in the study and 259 completed the post-study survey. Most were highly educated. Perceived system usability was high (mean scale score 4.35/5.0, SD 0.57). Enthusiasm for the chosen intervention was greater among those with higher pre-study expectations that the activity would be beneficial for them (p < 0.001), those who obtained more positive N-of-1 results (as directly reported to participants) (p < 0.001), and those who interpreted their N-of-1 study results more positively (p < 0.001). However, reported results did not significantly influence enthusiasm after controlling for participants' interpretations. The interaction between pre-study expectation of benefit and N-of-1 results interpretation was significant (p < 0.001), such that those with the lowest starting pre-study expectations reported greater intervention enthusiasm when provided with results they interpreted as positive. We conclude that N-of-1 behavioral trials can be appealing to a broad albeit highly educated and mostly female audience, that usability was acceptable, and that N-of-1 behavioral trials may have the greatest utility among those most skeptical of the intervention to begin with.

The Personal Health Network Mobile App for Chemotherapy Care Coordination: Qualitative Evaluation of a Randomized Clinical Trial.

BACKGROUND: Cancer care coordination addresses the fragmented and inefficient care of individuals with complex care needs. The complexity of care coordination can be aided by innovative technology. Few examples of information technology-enabled care coordination exist beyond the conventional telephone follow-up. For this study, we implemented a custom-designed app, the Personal Health Network (PHN)-a Health Insurance Portability and Accountability Act-compliant social network built around a patient to enable patient-centered health and health care activities in collaboration with clinicians, care team members, caregivers, and others designated by the patient. The app facilitates a care coordination intervention for patients undergoing chemotherapy. OBJECTIVE: This study aimed to understand patient experiences with PHN technology and assess their perspectives on the usability and usefulness of PHNs with care coordination during chemotherapy. METHODS: A two-arm randomized clinical trial was conducted to compare the PHN and care coordination with care coordination alone over a 6-month period beginning with the initiation of chemotherapy. A semistructured interview guide was constructed based on a theoretical framework of technology acceptance addressing usefulness, usability, and the context of use of the technology within the participant's life and health care setting. All participants in the intervention arm were interviewed on completion of the study. Interviews were recorded and transcribed verbatim. A summative thematic analysis was completed for the transcribed interviews. Features of the app were also evaluated. RESULTS: A total of 27 interviews were completed. The resulting themes included the care coordinator as a partner in care, learning while sick, comparison of other technology to make sense of the PHN, communication, learning, usability, and usefulness. Users expressed that the nurse care coordinators were beneficial to them because they helped them stay connected to the care team and answered their questions. They shared that the mobile app gave them access to the health information they were seeking. Users expressed that the mobile app would be more useful if it was fully integrated with the electronic health record. CONCLUSIONS: The findings highlight the value of care coordination from the perspectives of cancer patients undergoing chemotherapy and the important role of technology, such as the PHN, in enhancing this process by facilitating better communication and access to information regarding their illness.

Development of an individualized asynchronous sensor-based telerehabilitation program for patients undergoing total knee replacement: Participatory design.

Telerehabilitation programs can be employed to establish communication between patients and healthcare professionals and empower patients performing their training remotely. This study aimed to identify patients' requirements after a total knee replacement following a self-training rehabilitation program, leading to the design and development of a telerehabilitation program that can meet the stakeholders' actual needs. System design, development, and testing were conducted in five iterations based on a participatory design approach. Data collection was performed using interviews, observations, prototyping, and questionnaires. It was found that the main barriers facing the existing rehabilitation program were a lack of clear communication, lack of relevant information, and healthcare professional's feedback. The participants emphasized the main themes of communication, information, training, and motivation in the process of design and development. In using the telerehabilitation program, the patients reported a high level of user-friendliness, flexibility, and a sense of security. This study has identified obstacles in the current rehabilitation program and revealed the potential effectiveness of using asynchronous communication and sensor-based technologies by employing participatory design and development. A higher level of portability and flexibility were observed. However, future studies and development are required to investigate the overall usability and reliability of the telerehabilitation program.

Conceptual Framework to Guide Intervention Research Across the Trajectory of Dementia Caregiving.

This article presents a comprehensive conceptual framework designed to foster research in the changing needs of caregivers and persons with dementia as they move through their illness trajectory. It builds on prior theoretical models and intervention literature in the field, while at the same time addressing notable gaps including inadequate attention to cultural issues; lack of longitudinal research; focus on primary caregivers, almost to the exclusion of the person with dementia and other family members; limited outcome measures; and lack of attention to how the culture of health care systems affects caregivers' quality of life. The framework emphasizes the intersectionality of caregiving, sociocultural factors, health care systems' factors, and dementia care needs as they change across time. It provides a template to encourage longitudinal research on reciprocal relationships between caregiver and care recipient because significant changes in the physical and/or mental health status of one member of the dyad will probably affect the physical and/or mental health of the partner. This article offers illustrative research projects employing this framework and concludes with a call to action and invitation to researchers to test components, share feedback, and participate in continued refinement to more quickly advance evidence-based knowledge and practice in the trajectory of dementia caregiving.

Technology and Caregiving: Emerging Interventions and Directions for Research.

An array of technology-based interventions has increasingly become available to support family caregivers, primarily focusing on health and well-being, social isolation, financial, and psychological support. More recently the emergence of new technologies such as mobile and cloud, robotics, connected sensors, virtual/augmented/mixed reality, voice, and the evermore ubiquitous tools supported by advanced data analytics, coupled with the integration of multiple technologies through platform solutions, have opened a new era of technology-enabled interventions that can empower and support family caregivers. This paper proposes a conceptual framework for identifying and addressing the challenges that may need to be overcome to effectively apply technology-enabled solutions for family caregivers. The paper identifies a number of challenges that either moderate or mediate the full use of technologies for the benefit of caregivers. The challenges include issues related to equity, inclusion, and access; ethical concerns related to privacy and security; political and regulatory factors affecting interoperability and lack of standards; inclusive/human-centric design and issues; and inherent economic and distribution channel difficulties. The paper concludes with a summary of research questions and issues that form a framework for global research priorities.

Assessing the Quality of Electronic Data for 'Fit-for-Purpose' by Utilizing Data Profiling Techniques Prior to Conducting a Survival Analysis for Adults with Acute Lymphoblastic Leukemia.

Acute lymphoblastic leukemia affects both children and adults. Rising costs of cancer care and patient burden contribute to the need to study factors influencing outcomes. This study explored the quality of datasets generated from a clinical research institution. The 'fit-for-use' of data prior to examining survival/complications was determined through a systematic approach guided by the Weiskopf et al. 3x3 Data Quality Assessment Framework. Constructs of completeness, correctness, and currency were explored for the data dimensions of patient, variables, and time. There were 11 types of data retrieved. Sufficient data points were found for patient and variable data in each dataset (≥70% of its cells filled with patient level data). Although there was concordance between variables, we found the distribution of lab values and death data to be incorrect. There were missing values for labs ordered and death dates. Our study showed that datasets retrieved can vary, even from the same institution.

Development of an Instrument to Assess Stroke Caregivers' Readiness for the Transition Home.

PURPOSE: The study purpose was to develop a measure to assess stroke caregivers' commitment and capacity to assume the caregiving role prior to discharge. DESIGN: Participants were caregivers of stroke survivors in an inpatient rehabilitation facility. METHODS: A sequential, multimethod approach, which included item generation from qualitative data, review of items by expert clinicians, cognitive interviews to determine response format (n = 22), and item clarity (n = 20), and an analysis of pilot data were utilized. FINDINGS: Cognitive interviewing provided information to improve item clarity. CONCLUSION: This instrument development approach resulted in the Preparedness Assessment for the Transition Home After Stroke (PATH-s), a 26-item self-report instrument. The PATH-s represents the domains of the Model of Caregiver Readiness, upon which the instrument was developed. CLINICAL RELEVANCE: The PATH-s, once further validated, may guide healthcare providers in the development of tailored care plans to address identified gaps and better prepare caregivers for the transition home.