Project Summary

This project will implement the results of PCORI research award 1406-18876: A Practical Intervention to Improve Patient-Centered Outcomes after Hip Fractures among Older Adults (REGAIN trial); PI: Mark D. Neuman.   

1. What were the results of the original PCORI-funded study? 
REGAIN randomly assigned 1,600 adults aged 50 and older undergoing hip fracture surgery at 46 hospitals in the United States and Canada to either spinal or general anesthesia. REGAIN found that recovery of walking, delirium, length of stay, location of discharge, pain and satisfaction were similar with either option. The decision about which anesthesia option to choose is therefore preference-sensitive and depends on what matters most to patients.  

2. What is the shared decision making (SDM) strategy being proposed? 
Option Grids are conversation aids or brief, tabular comparisons of options that activate patients before clinical visits and support efficient conversations during visits. They can increase SDM across diverse contexts. They promote deliberation and dialogue, while providing evidence-based information. Option Grids can be integrated into various clinical workflows and are appropriate when patients may not have had time to prepare in advance for a decision discussion, such a hip fracture requiring surgery. The project team incorporated REGAIN findings into an implementation version of an Option Grid, My Anesthesia Choice-HF, and tested it in a web-based survey of 364 adults over age 50. My Anesthesia Choice-HF increased knowledge about spinal and general anesthesia and decreased decisional conflict for a hypothetical choice of anesthesia options for hip fracture surgery. Eighty-six percent stated that the tool would help them discuss options and preferences. Approximately 76 percent would approve of their doctor using it.  

3. Why is this research finding(s) important?
This proposal addresses choices between spinal or general anesthesia for hip fracture surgery. REGAIN’s findings of similar outcomes with spinal versus general anesthesia, which have since been confirmed by meta-analyses, indicate that this choice represents a preference-sensitive decision.  

Most patients want to be involved in anesthesia care decisions, yet care teams rarely explain risks and benefits of anesthesia options such as spinal versus general anesthesia and frequently fail to elicit patient preferences. Interventions like My Anesthesia Choice-HF could fill this unmet need to increase SDM for anesthesia choices.   

4. What is the goal of this project? 
The goal of this project is to refine My Anesthesia Choice-HF, implement it and test it in diverse clinical sites. This project aims to maximize the relevance of research findings to settings in which dissemination could occur and reduce potential disparities in use. The project team will assess impact at multiple levels (e.g., patient, clinician, system).   

5. What is the project team doing? 
Aim 1: Prior to implementation, the project team will refine My Anesthesia Choice-HF and its training by conducting semistructured interviews with approximately 40 stakeholders (about 20 patients/family members and 20 anesthesia clinicians). Interviews will elicit opinions and perspectives about the intervention and training, opportunities to refine the SDM approach for clarity, and potential anticipated promoters and barriers to implementation. Suggested adaptations will be tracked, documented and reported using a standard framework. The project team will discuss these adaptations with the scientific team and patient and stakeholder advisors and refine the intervention. 

Adaptations to refine the intervention will be categorized by content (intervention components), context (how the intervention is delivered, based on the study, population, format, delivery mode, study setting, study personnel), training needs and evaluation needs and will directly inform implementation. Only adaptations that maintain fidelity to the core intervention will be used. 

Aim 2: The team will work with sites to implement the intervention by: 

  • Engaging clinical champions (e.g., clinicians, hospital leaders) 
  • Organizing and facilitating implementation team meetings 
  • Continuously re-assessing implementation sites for barriers and facilitators, providing ongoing assistance to any barriers that arise and site-specific feedback to ensure implementation success 
  • Conducting SDM trainings 
  • Providing technical assistance and consultation to facilitate ongoing maintenance of the intervention over time 

Aim 3: The project team will conduct a stepped wedge cluster randomized trial to evaluate the implementation in six sites, randomizing sites to the timing of when they will start using the intervention. Clinicians and site personnel will identify eligible patients based on operating room schedules. They will introduce the My Anesthesia Choice-HF as patients arrive, during the appointment or after the appointment depending on their preferred workflow. Clinicians will provide a paper or digital PDF copy of My Anesthesia Choice-HF to the patient at the end of the encounter, so they can review its contents with others. The team will track clinicians’ use of My Anesthesia Choice-HF and the format and timing of its use. 

6. How is the team evaluating this project? 
The project team will assess reach, effectiveness, adoption, implementation and maintenance (RE-AIM) of our strategy and will assess impact at multiple levels (e.g., patient, clinician, system).   

Reach: Percentage of eligible patients receiving the strategy (primary implementation endpoint) and representativeness of implementation sample. The project will include a broad sample to minimize selection bias and will document, track and report data about participating and nonparticipating patients at each site. The team will examine the consistency of outcomes across different subgroups (e.g., age, health literacy skills, racial and ethnic background).

Effectiveness: SDM process (primary effectiveness endpoint), CollaboRATE measure of SDM, decisional conflict, knowledge of anesthesia options, satisfaction with care, anesthesia type received, ability to walk at clinical follow-up.

Adoption and Implementation: The project team will survey stakeholders, including clinicians who did and did not use the intervention, after the study ends using validated measures and will also track the resources needed to implement it.

Maintenance: The team will continue data collection beyond the implementation phase and track sustained use.

7. How is the team involving patients and others in this project?
 A patient partner with whom the principal investigators have worked long term is a named co-investigator and will co-lead engagement efforts. Other stakeholders will be part of a Stakeholder Advisory Board, including members from organizations such as the American Academy of Orthopedic Surgeons, the Orthopedic Trauma Association, the American Society of Regional Anesthesia, the Fragility Fracture Network, the Center for Advocates for the Rights and Interests of the Elderly, and Blue Cross Blue Shield of Michigan. This team will meet regularly over the project period with the MPIs to review study progress and provide input on key decisions. They will help the project team identify potential barriers and promoters to successful strategy implementation at study sites based on disciplinary experience and understanding of larger-scale delivery-system or payment-level factors that may inform site implementation experiences. In addition, they will support outreach and dissemination of findings. 

8. How will this project help ensure future uptake and use of PCORI-funded results?
By leveraging an effective, proven approach for promoting conversation and deliberation about choices (Option Grid conversation aids), informed by immediately relevant patient-centered comparative clinical effectiveness research findings from REGAIN, this strategy will increase engagement of patients and caregivers in anesthesia decisions. It can provide further support for the contexts in which Option Grids are useful and can serve as a model for engaging patients in anesthesia choices to support other projects such as the PCORI-funded THRIVE trial when those results are available. 

Project Information

Mark Neuman, M.D., M.S.
Mary Politi, Ph.D.
University of Pennsylvania
$2,143,556 *

Key Dates

36 months *
November 2023
2023

*All proposed projects, including requested budgets and project periods, are approved subject to a programmatic and budget review by PCORI staff and the negotiation of a formal award contract.

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Last updated: January 24, 2024