Recommendations to address respondent burden associated with patient-reported outcome assessment.

Patient-reported outcomes (PROs) are increasingly used in healthcare research to provide evidence of the benefits and risks of interventions from the patient perspective and to inform regulatory decisions and health policy. The use of PROs in clinical practice can facilitate symptom monitoring, tailor care to individual needs, aid clinical decision-making and inform value-based healthcare initiatives. Despite their benefits, there are concerns that the potential burden on respondents may reduce their willingness to complete PROs, with potential impact on the completeness and quality of the data for decision-making. We therefore conducted an initial literature review to generate a list of candidate recommendations aimed at reducing respondent burden. This was followed by a two-stage Delphi survey by an international multi-stakeholder group. A consensus meeting was held to finalize the recommendations. The final consensus statement includes 19 recommendations to address PRO respondent burden in healthcare research and clinical practice. If implemented, these recommendations may reduce PRO respondent burden.

Evaluating the implementation and impact of navigator-supported remote symptom monitoring and management: a protocol for a hybrid type 2 clinical trial.

BACKGROUND: Symptoms in patients with advanced cancer are often inadequately captured during encounters with the healthcare team. Emerging evidence demonstrates that weekly electronic home-based patient-reported symptom monitoring with automated alerts to clinicians reduces healthcare utilization, improves health-related quality of life, and lengthens survival. However, oncology practices have lagged in adopting remote symptom monitoring into routine practice, where specific patient populations may have unique barriers. One approach to overcoming barriers is utilizing resources from value-based payment models, such as patient navigators who are ideally positioned to assume a leadership role in remote symptom monitoring implementation. This implementation approach has not been tested in standard of care, and thus optimal implementation strategies are needed for large-scale roll-out. METHODS: This hybrid type 2 study design evaluates the implementation and effectiveness of remote symptom monitoring for all patients and for diverse populations in two Southern academic medical centers from 2021 to 2026. This study will utilize a pragmatic approach, evaluating real-world data collected during routine care for quantitative implementation and patient outcomes. The Consolidated Framework for Implementation Research (CFIR) will be used to conduct a qualitative evaluation at key time points to assess barriers and facilitators, implementation strategies, fidelity to implementation strategies, and perceived utility of these strategies. We will use a mixed-methods approach for data interpretation to finalize a formal implementation blueprint. DISCUSSION: This pragmatic evaluation of real-world implementation of remote symptom monitoring will generate a blueprint for future efforts to scale interventions across health systems with diverse patient populations within value-based healthcare models. TRIAL REGISTRATION: NCT04809740 ; date of registration 3/22/2021.

An actionable needs assessment for adolescents and young adults with cancer: the AYA Needs Assessment & Service Bridge (NA-SB).

PURPOSE: In the USA, many of the nearly 90,000 adolescents and young adults (AYAs) diagnosed with cancer each year do not receive services to address the full scope of needs they experience during and after cancer treatment. To facilitate a systematic and patient-centered approach to delivering services to address the unmet needs of AYAs with cancer, we developed the AYA Needs Assessment & Service Bridge (NA-SB). METHODS: To develop NA-SB, we leveraged user-centered design, an iterative process for intervention development based on prospective user (i.e., provider and AYA) engagement. Specifically, we conducted usability testing and concept mapping to refine an existing tool-the Cancer Needs Questionnaire-Young People-to promote its usability and usefulness in routine cancer practice. RESULTS: Our user-centered design process yielded a need assessment which assesses AYAs' physical, psychosocial, and practical needs. Importantly, needs in the assessment are grouped by services expected to address them, creating an intuitive and actionable link between needs and services. CONCLUSION: NA-SB has the potential to improve care coordination at the individual level by allowing cancer care programs to tailor service delivery and resource provision to the individual needs of AYAs they serve.

Pilot randomized trial of an electronic symptom monitoring and reporting intervention for hospitalized adults undergoing hematopoietic stem cell transplantation.

PURPOSE: Patients undergoing a hematopoietic stem cell transplantation (HCT) have varied symptoms during their hospitalization. This study examined whether daily symptom reporting (with electronic patient-reported outcomes [PROs]) in an inpatient bone marrow transplant clinic reduced symptom burden on post-transplant days +7, +10, and +14. METHODS: A prospective, single-institution 1:1 pilot randomized, two-arm study recruited HCT patients. HCT inpatients (N = 76) reported daily on 16 common symptoms using the PRO version of the Common Terminology for Adverse Events (PRO-CTCAE). Fisher's exact test was used to examine differences in the proportion of patients reporting individual symptoms. Multivariable linear regression modeling was used to examine group differences in peak symptom burden, while controlling for symptom burden at baseline, age, comorbidity, and transplantation type (autologous or allogeneic). RESULTS: HCT patients receiving the PRO intervention also experienced lower peak symptom burden (average of 16 symptoms) at days +7, +10, and +14 (10.4 vs 14.5, p = 0.03). CONCLUSIONS: Daily use of electronic symptom reporting to nurses in an inpatient bone marrow transplant clinic reduced peak symptom burden and improved individual symptoms during the 2 weeks post-transplant. A multi-site trial is warranted to demonstrate the generalizability, efficacy, and value of this intervention. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02574897.

Testing the organizational theory of innovation implementation effectiveness in a community pharmacy medication management program: a hurdle regression analysis.

BACKGROUND: Many state Medicaid programs are implementing pharmacist-led medication management programs to improve outcomes for high-risk beneficiaries. There are a limited number of studies examining implementation of these programs, making it difficult to assess why program outcomes might vary across organizations. To address this, we tested the applicability of the organizational theory of innovation implementation effectiveness to examine implementation of a community pharmacy Medicaid medication management program. METHODS: We used a hurdle regression model to examine whether organizational determinants, such as implementation climate and innovation-values fit, were associated with effective implementation. We defined effective implementation in two ways: implementation versus non-implementation and program reach (i.e., the proportion of the target population that received the intervention). Data sources included an implementation survey administered to participating community pharmacies and administrative data. RESULTS: The findings suggest that implementation climate is positively and significantly associated with implementation versus non-implementation (AME = 2.65, p < 0.001) and with program reach (AME = 5.05, p = 0.001). Similarly, the results suggest that innovation-values fit is positively and significantly associated with implementation (AME = 2.17, p = 0.037) and program reach (AME = 11.79, p < 0.001). Some structural characteristics, such as having a clinical pharmacist on staff, were significant predictors of implementation and program reach whereas other characteristics, such as pharmacy type or prescription volume, were not. CONCLUSIONS: Our study supported the use of the organizational theory of innovation implementation effectiveness to identify organizational determinants that are associated with effective implementation (e.g., implementation climate and innovation-values fit). Unlike broader environmental factors or structural characteristics (e.g., pharmacy type), implementation climate and innovation-values fit are modifiable factors and can be targeted through intervention-a finding that is important for community pharmacy practice. Additional research is needed to determine what implementation strategies can be used by community pharmacy leaders and practitioners to develop a positive implementation climate and innovation-values fit for medication management programs.