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Emergency “Experience” Supplement

Council Presentation, February 2021

Thank you Dr. Patterson for that introduction and context, and for the opportunity to share with you all some of the lessons we have heard over the past two years as part of this emergency experience supplement. The experience supplement has been a project organized through the SIREN network to address certain questions and gaps related to topics of importance to emergency care research and NIH.

SIREN (and the NETT and ROC networks from which SIREN evolved) have always had a culture of doing research on research. In addition to our primary mission of conducting multiple simultaneous pivotal trials in the emergency space, we have always investigated how we conduct trials, especially with regard to the protection of human subjects, so these were topics we were ready and eager to help explore.

We called it the “experience” supplement because, as I will elaborate on, the goal here was really to collect and understand a lot of what has already been learned over time by a lot of people, but not necessarily individuals whose voices have been heard much.

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Overarching concept

An opportunity to contribute to NIH’s stewardship of emergency medicine research conducted under EFIC or in the pre-hospital setting.

We sought to leverage prior experiences to generate data that will contribute to shaping clinical practice in the emergency setting, and strengthen public trust in this critical arena of biomedical research.

We pursued this as a partnership of the network and an independent contract research group to facilitate rapid progress toward this opportunity; and to enhance the objectivity of the process.

As Dr. Patterson explained, the overarching concept of this project was to contribute to NIH’s stewardship of emergency medicine research conducted under exception from informed consent in the emergency department or critical care unit, or as related to trials conducted in the pre-hospital setting, by paramedics in the field.

As already described, enrollment of subjects into emergency research clinical trials provides special challenges. Over the past decade, many clinical trials and scholarly projects conducted both within the NIH emergency trials networks and by others have accumulated experience and findings related to these challenges. These experiences and findings, however, are not necessarily accessible to others in the field and may not be available to inform future research.

In this project, we sought to leverage prior experiences of paramedic and EMS researchers, investigators, ethics scholars, and regulators, and the families of emergency patients to generate data that can help shape clinical practice in the emergency setting, and strengthen public trust in this critical arena of biomedical research.

We conducted this work as a partnership with Westat, an independent research group, for data gathering and evaluation activities. This was a terrific suggestion of the NIH program staff requesting this work. This partnership facilitated rapid progress on deliverables and, importantly, also enhanced the objectivity of the process.

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Abbreviated Aims

�Assess and summarize the experience and practices of EMS paramedics in clinical trials that enroll subjects in the prehospital setting

To aggregate generalizable regulatory procedures from lessons learned from the conduct of community consultation and public disclosure in prior EFIC trials

To explore the experiences, needs, and emotional health of family members of victims of cardiac arrest and severe neurotrauma in the acute period of care

This project has three specific aims, which I have abbreviated here.

First, we wanted to learn from more than 10 years of experience with pre-hospital clinical trials, but not just from investigators. We wanted to hear from paramedics and EMS medical directors implementing these trials. Our aim was to assess and summarize the range of research practices used to involve and prepare EMS paramedics for their roles in clinical trials enrolling subjects in the prehospital setting, and to understand the experiences of EMS providers involved in these trials.

Second, we wanted to collect the scholarly work and experiences related to exception from informed consent, especially with regard to community consultation and public disclosure. The ROC and NETT networks, and others, have accumulated a lot of scholarly observations and operational expertise over the years related to implementation of EFIC, but until now there hasn’t been a systematic way to communicate and translate that into templates for good practices. So, we sought to use lessons learned, inclusive of administrative and regulatory strategies, to formulate these kind of generalizable and annotated procedures for other future emergency trialists both within or external to the network.

Finally, as our experience with patient engagement in planning clinical research has increased, and as a consequence of our empirical ethics research interviewing past emergency trial participants, it has become clear how little is known about the experience of family members of patients with critical emergency illness and injury. The impact of that experience on both patient and family member outcomes, and on emergency research participation and retention, is potentially important but poorly understood. So we explored the experiences, needs, and emotional health of family members of victims of cardiac arrest and severe neurotrauma, through interviews and a workshop.

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Project Team

Robert Silbergleit

Sharon D. Yeatts

Neal Dickert

Mike Fetters

Adrianne Haggins

Deneil Harney

Renee Kasperek-Wynn

Paula Darby Lipman

Jennifer Huang

Natalie Teixeira

Liz Jansky

Jess Kirchner

Here I just need to acknowledge the investigators and staff from both SIREN (listed on the left) and Westat (listed on the right) that made all of this happen. Sharon Yeatts and I represented the PI’s of the SIREN DCC and CCC respectively. Neal Dickert, who is presenting here with me today is a PhD ethicist and critical care cardiologist from Emory with tremendous experience with issues related to EFIC. Mike Fetters is a leader in mixed methods research and ethics, and Adrianne Haggins is an expert in socio-cultural dimensions of medical practice and research, both from the University of Michigan. Deneil Harney is the Human Subjects Protection specialist in NETT and SIREN working on all network EFIC trials. And Renee Kasperek-Wynn is the coordinator who made everything happen.

Westat put together a terrific team led by Paula Lipman with extensive qualitative skills and experience. SIREN and Westat worked collaboratively on content and methodology, qualitative coding, thematic analysis, and academic publications. Westat conducted interviews, facilitated focus groups, administered surveys, performed initial synthesis and wrote the project reports. �

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Core Methods

�Partially structured stakeholder interviews

Surveys

Focus groups and a workshop

Scoping review and case study

Expert panels

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Understanding Paramedics’ Experiences, Training, And Involvement In Prehospital Clinical Trials

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Goals

Assess and summarize the experience and practices of EMS paramedics in clinical trials that enroll subjects in the prehospital setting

Domains

Organizational Factors
Learner Factors
Training Approaches
Environmental Factors

As I mentioned, there have been a number of large clinical trials conducted in the prehospital setting over the past decade or so. Most of these large trials were conducted by either NHLBI through the ROC network (such as PRIMED, ALPS, and PART), or by NINDS (like RAMPART and Fast-Mag). There are also rare industry sponsored trials like FRONTIER. Experience was accumulated in the clinical trials networks, and some lessons were passed among investigators through informal communications, but a lot of what was learned has not been recorded anywhere. Investigator experience aggregated in ROC and other trials is at particular risk of being lost since the end of that network, although we hope that some is being preserved in SIREN. But even more important are the experiences of paramedics and EMS medical directors who did a lot of the work of these trials, but often aren’t at the table when the next trial is being planned.

We talked with these stakeholders about 4 domains:

• Organizational factors affecting administration and implementation of the prehospital clinical trial is being conducted.

• Learner Factors which included paramedic characteristics, such as personal attitudes, beliefs, experiences, and skills related to conducting trials.

• Training Approaches – Different methods and strategies to encourage successful uptake of clinical trial training goals.

• Environmental Factors – what are the kinds of variables and choices that allow one trial to work well, and others not so much. What milieux and operational elements matter?

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Methods

�Paramedics with trial experience�EMS investigators and coordinators�EMS medical directors and operational chiefs

�Stakeholder Focus Groups

Key Informant Telephone Interviews

Member Checking Process

This picture is of one of the three in-person facilitated focus groups with key stakeholders held at the 2019 NAEMSP annual meeting (January, Austin TX). The stakeholders recruited were paramedics, investigators, coordinators, EMS medical directors and operational chiefs. We recruited stakeholders through prior associations with ROC and NETT trials, through the NAEMSP research committee, and through investigators from other prehospital trials, and then did snowball recruiting from identified stakeholders.

After the focus groups were analyzed, we conducted 19 subsequent semi-structured individual telephone interviews. We used the interviews to broaden and balance the pool of stakeholder experience and further refine concepts from the preliminary qualitative analysis.

After thematic analysis of the focus groups and interviews, we did member checking using a survey of the 20 leading findings among the focus group and interview participants.

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Conceptual Model

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Results

51 Stakeholder Participants

22 Paramedics
29 EMS Medical Directors, Operations Chiefs, Investigators and Coordinators

32 in Focus Groups, 19 in Interviews�33 contributed to Member Checking

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Results - Themes

Implementation Context (4 themes)

Learner Factors (6 themes)

Training Approaches: Learner (4 themes) or Institution focused (6 themes)

We found thematic saturation on 20 items, organized in 4 revised domains of: context of implementation, learner factors, learner focused training approaches, and institution focused training approaches.

Agreement on these themes was strong in the member checking survey. There was greater than 90% agreement on 15 of the 20 themes, and 80-90% agreement on 4 more.

I won’t go through all the findings. Many were perhaps unsurprising but meaningful.

With regard to implementation these included: (1) An emphasis on paramedic input on trial design, and (2) the value of buy-in from all stakeholders. Perhaps less expected themes included the potential importance of non-medical leaders from the union or city government politicians.

With regard to learner factors unsurprising themes included (1) Engaging paramedics by showing how the research may benefit patients and improve clinical care. And (2) avoiding trial procedures that are perceived to interfere with patient care, as well as (3) a favorable inclination among medics for things that are new and hands-on.

Less expected themes included an emphasis on generational cultural differences among paramedics and the impact of a rising sense of professionalism on research among younger paramedic leaders..

With regard to training approaches, themes included: (1) linking a research culture to a sense of being a high performing EMS agency (2) the importance of peer trainers and champions, and (3) integration of trial training with paramedic continued education.

A challenging finding was a consensus that In-person training is critical for paramedics engagement, that training and re-training needs to be carefully timed, and that active learning with hands on simulations and case scenarios is more effective than passive learning, and that it is important to make sure that training is tailored to the paramedics’ clinical knowledge base and is delivered in “their language”

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Results - Themes

Implementation Context

Paramedic input on trial design, or feedback on existing protocols, improves the quality of the study and ensures the protocol will be feasible to implement in the field.
Paramedics may be more willing to be engaged in research when there is evidence of buy-in from all stakeholders, and when there is a clear trial champion.
Engaging stakeholders including EMS medical directors, union leaders, and other agency leaders mitigates potential challenges in implementing prehospital clinical trials.
Informing paramedics of a possible or pending trial is more likely to engender interest and engagement.

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Results - Themes

Learner Factors

Paramedics generally like participating in procedures that will benefit patients and improve clinical care.
Paramedics are motivated when they understand the clinical relevance of the trial, rather than by the research process per se.
Attitudes about the value of research in general among EMS providers may impact implementation of the prehospital clinical trial.
Paramedics are less willing to complete clinical trial tasks if they think that it will interfere with patient care.
Paramedics may like clinical trials that offer opportunities to try something new, particularly if it’s “hands on.”
Some paramedics may be less inclined to participate in research due to concerns about making mistakes.

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Results - Themes

Training Approaches – Institution Focused

Leadership buy-in or a culture supportive of research helps to improve the success of training uptake.
Peer champions can be engaged to promote trainings and engagement in the research study or be trained to train others.
Trainings should be standardized across sites, include a system-wide approach, and include templates for tools that can be tailored to site specifics.
Research training should be included as part of paramedic continuing education, should piggy back on existing trainings.

Last 2 themes 13 and 18 % disagree

Consistency is important but tailoring is needed since EMS systems in the US are not uniform (NP- agree)

As with any clinical research, there will be variability in clinical practice and operations across sites which may hinder standardization. Prior to training, it is important to explore these differences. (NP-agree)

---

Depends on the EMS agency, many paramedics do not care about research and will tune this out. May be good for some interested individuals. (NP-disagree)

Paramedics should be regularly engaged with the importance of research and clinical trials in CME offerings. If the research training is part of a current trial the paramedics are involved in, regular refreshers will help reinforce important concepts and benchmarks for the trial. (NP- agree)

Key word is piggy back - separate the trial and procedural training from the research education/training Don’t exceed attention spans! (P- agree)

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Results - Themes

Training Approaches – Learner Focused

In-person training is critical for gaining buy-in and engaging paramedics.
Time lags between training and trial initiation may negatively impact paramedics’ ability to remember and implement the protocol effectively.
In-person refresher/booster training sessions can improve protocol implementation (e.g., protocol deviations, low enrolment) and motivate PM.
Training methods that support active learning (e.g., simulations, scenarios, and hands-on training) generally work better at engaging paramedics than methods relying more on passive learning.
Tailoring the content of trainings to paramedics’ clinical knowledge base and delivering the training in “their language” supports paramedic understanding and engagement.
Incentives help promote paramedic participation in training activities.

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Conclusions

Strategies for engagement

Challenges to implementation

Best practices for training

The qualitative focus groups and semi-structured interviews elucidated the breadth and depth of opinions about prehospital participation in clinical trials. Our member checking shows that most of what we heard was generalizable among the stakeholders, but that there are still some areas of discordant views.

The findings provide lessons on strategies to best engage paramedics and EMS agencies and pitfalls to avoid. It highlighted challenges to implementation and the importance of thoughtful integration into practice. The findings also provide suggestions as to likely best practices for EMS research training.

The accumulated experiences of prehospital providers can inform and help advance clinical trials conducted in the prehospital setting by anticipating recurrent errors and suggesting practices that are responsive to key stakeholder perspectives.

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Scoping review of literature on Implementation of Community Consultation and Public Disclosure for Research Using Exception from Informed Consent for Emergency Research

Model Operational Procedures for the Implementation and Review of NIH Sponsored Multicenter Clinical Trials with Exception from Informed Consent (EFIC) for Emergency Research

Moving on then to the second aim of this supplement. This part of the project was a robust review of policies, practices, training, and accumulated experiences related to EFIC. There were two main deliverables for this aim. The first is a thorough scoping review of the empirical ethics and views of investigators as reported in the literature and interpreted by panels of experts in EFIC with particular focus on community consultation and public disclosure. The second is a set of “Model Operating Procedures” based on the principles we reviewed and our accumulated experiences, vetted again by the panels of experts in EFIC. This MOP is written as both a summary of issues and practical solutions to questions arising, and as a model or template for creating plans, practices, policies, and procedures for future EFIC trials.

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SIREN Supplement- Aim 2 �Process

Teamwork Experience (NETT, ROC, and SIREN)
HSP Working Group (Ongoing)
IRB Investigator EFIC Collaborative (Ongoing)
Scoping Review and Model Procedure (Fall-Winter 2019)
EFIC Investigator Roundtable (Spring 2020)
IRB Stakeholder Roundtable (Summer 2020)
Federal Stakeholder Roundtable (Fall 2020)
Dissemination (Scholarly publication and other ongoing efforts)

The sources and processes for this part of the project are outlined here. We started with the experiences of the core teams from NETT and ROC that are now part of SIREN. We have a robust HSP working group that formed in NETT and evolved into SIREN. This is a group of trial and site investigators, coordinators, and ethics scholars that provides operational guidance for the network while also pursuing scholarly research on human subjects issues, including funded ancillary ethics studies embedded in our network trials. We also have a new group, called the IRB Investigator EFIC collaborative, where we have partnered with leaders from the Emergency Research CIRB established by Advarra IRB for SIREN and other NIH trials. This group also works on both operational issues, and educational and scholarly projects related to IRB EFIC issues. Jumping off from there we did a comprehensive review of the literature on EFIC that Neal Dickert will tell you about in more detail. We then had a series of roundtable meetings with expert stakeholders who provided written and verbal feedback on both the scoping review and the MoP, which we iteratively revised and improved after each review. The first of these was with EFIC scholars and network investigators in the Spring, the next was with local and central IRB professionals in the Summer, and then with Federal funder and regulator stakeholders in the Fall. Dissemination is planned through multiple access points and includes this talk.

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Scoping review of literature on Implementation of Community Consultation and Public Disclosure for Research Using Exception from Informed Consent for Emergency Research

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BACKGROUND

Exception from Informed Consent (EFIC) regulations are the only federal regulations to require formal community engagement activities

Community Consultation- Two-way exchange prior to approval
Public Disclosure- One-way exchange prior to study conduct and after it is finished

Heterogenous practices have emerged for both CC and PD
Both CC and PD remain unfamiliar to many investigators and IRBs
Important to clarify lessons learned, areas of consensus, and lingering gaps
Especially important in the move toward central IRB review

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SCOPING REVIEW METHODS

Diverse literature

Conceptual and empirical
Multiple domains

Structured search with an informationist

EMBASE, HEIN Online, PubMed, and Web of Science
1127 individual records 84 with focus on CC/PD

Synthesis focused on identifying areas of convergence and residual challenges

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CONCEPTUAL �AND �POLICY THEMES

Value and Purpose of Community Consultation

Clarify impact on subjects, potential refinement
Promote trust, provide transparency and education, and demonstrate respect
Not a referendum or vote
Questions about impact

Community Consultation Methods

Depth versus breadth
Relevance of general public vs those with connection

Challenges related to Community Consultation

Defining relevant community
Interpreting acceptance data

Public Disclosure

Discrete one-way function
Less endorsement of value

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COMMUNITY CONSULTATION�

Methods:

Open forum/town hall meetings (11)
Meetings with existing groups (10)
Focus groups (9)
Random-digit dialing (7)
Surveys in hospital or community settings (6)
Interviews (4)

Population:

General public (19)
Current/former patients (8) with the condition under study
Neighborhood/geographic groups (7)
Patients in emergency departments (6)
Support group members (2)

Strategies and resources

No consistent reporting of resource requirements
$1500- >$80,000 per site
Town halls/open forum low yield

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COMMUNITY CONSULTATION�ACCEPTANCE�

Personal EFIC Enrollment

Range 51-93%
Heavily clustered in 70-80%
Variation in question phrasing (e.g. personal acceptance of enrollment vs support for the study)

No consistent predictors of acceptance

Increased when more interactive CC methods used
Demographic predictors vary
Variable relationship with connection to condition

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PUBLIC DISCLOSURE

Method	Described Advantages	Described Limitations
Print Media (Newspapers, press releases)	-Can reach large audiences -Can approximate reach	-Expensive -Passive, unfocused
Broadcast Media (Radio, TV, PSA)	-Can reach large audiences -Can approximate reach	-Expensive -Often not targeted to specific communities
Social Media ads	-Geographic targeting (Facebook ads) –Cheap, can increase website traffic	-Only certain demographics (younger) -Little engagement (time spent on websites)
Websites	-Can measure hit rates -Can facilitate opt-outs -Provide detail, multi-media options	-Often short interactions -Have to drive traffic to sites -Limited to individuals with internet access
Individual communication (letters, emails, phone)	-Can target specific communities/leaders -Better opportunities to opt out	-Calls and postage are resource intensive - Smaller scale
In-Hospital materials – posters, brochures	-Can target specific communities -Reaches people in the healthcare system	-Passive method -People often don’t notice posters/brochures
Meetings (e.g. hospital staff)	-Inform staff members likely to be involved	-Personnel time and cost

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PUBLIC DISCLOSURE

Population

Often geographically-defined
Attempts at focus

Impact

Penetration difficult to assess- often rough estimates
Awareness where reported has been low
Opt out rates have been very low

Metrics

No consistent reporting in terms of reach, representation, or resources
No settled understanding of adequacy

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SUMMARY- COMMUNITY CONSULTATION

Areas of Consensus

Community consultation should be a two-way process
Move away from town-halls/open fora and common to use a combination of methods

Areas of Debate

Depth versus breadth
Focus on those with connection to condition vs ”representation” of geographic community
How best to assess acceptance

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SUMMARY- PUBLIC DISCLOSURE

Areas of Consensus

Functional consensus that what is need is a ”good faith effort”

Areas of Debate

Less a focus in the literature so core goals are less clear
Disclosure and consultation function sometimes gets blurred
No clear standards or benchmarks to indicate what a “good faith effort” is

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ADDITIONAL IMPLICATIONS AND QUESTIONS

Role/proper use of social media platforms
Importance of inclusion of geographic community on its own
Role of Central IRBs

Manuscript currently under review

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Model Operational Procedures for the Implementation and Review of NIH Sponsored Multicenter Clinical Trials with Exception from Informed Consent (EFIC) for Emergency Research

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Model Operational Procedures for the Implementation and Review of NIH Sponsored Multicenter Clinical Trials with Exception from Informed Consent (EFIC) for Emergency Research

Next I just want to walk you through some high points of the model operating procedure tools that we created. These were built on our evolving network processes and were strongly informed by the lessons in the scoping review, and by our extensive vetting and input from stakeholders.

This document starts with an introduction and background. It emphasizes that this is a jumping off point for learning and developing best practices. It is explicitly not a turn-key solution because there are so many aspects of EFIC trials that vary from trial to trial, so that every trial still has to be tailored to its particulars. But it is an attempt to constantly do better, by not making everyone start over from scratch for every trial..

We also emphasize that this is a peer-to-peer guidance document. By which I mean that it provides guidance with a small ‘g’ and not a big “G”. Despite them having provided review, input and advice, this is not an regulatory guidance from FDA or OHRP. Although NIH provided review, input and funding, it is also not any kind of policy or requirement of NIH.

We mean it to be a thoroughly useful, but thoroughly unofficial tool, a collection of shared suggestions and practices.

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Front material

Introduction

Background

Peer to Peer Tool - NOT Guidance

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Organization

Investigator’s EFIC Implementation Plan
Standard Operating Procedure for Trial Applications involving Exception from Informed Consent (EFIC) to a S/CIRB
Guidelines for Centralized Review of Community Consultation and Public Disclosure
Supplemental: Sample Site EFIC Activity Reports for IRB Submission

The overall organization of the document has 4 major sections.

The investigators EFIC implementation plan. This is the bulk of the document. It is the plan that investigators use to describe why EFIC is applicable for the trial, how each regulatory requirement will be met, how community consultation and public disclosure will be performed, and how it will all be reported. This is the plan that investigators submit to FDA and the IRB for approval at the outset.

The next part is a standard operating procedure describing in detail a sequence of the administrative, regulatory, and logistical steps needed to bring up an EFIC trial. It is formatted for easy adoption as an SOP by both a clinical trial network or trial coordinating center and the CIRB.

The third part is a guideline for IRB panels themselves with suggestions on how to conduct reviews of community consultation and public disclosure. This was something that the specifically requested by some IRB panels..

Finally, the last part provides examples of a standardized site report of community consultation and public disclosure results for IRB review and posting to the FDA public docket.

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Investigator’s EFIC Implementation Plan

Introduction

Overview

Regulatory Criteria for Use of EFIC

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Investigator’s EFIC Implementation Plan

Community Consultation Principles

We think that it is also important to start with “why”. The regulations don’t provide any ethics-based regulatory intent, so we lay out and explain a set of principles for Community Consultation and public disclosure from which everything else can be derived.

In an abbreviated format, for community consultation, these are to:

● To show respect for persons by informing the community about the study in advance;

● To provide a way for affected communities to provide meaningful input to the IRB before approval or disapproval of the trial

● To show respect for the community by allowing representatives of the community to share community-level concerns; and

● To show respect for autonomy by including in community consultation activities individuals who may have, or be at risk for, the condition under study .

Later in the document we similarly discuss how the underlying principles of public disclosure is transparency and trustworthiness.

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Investigator’s EFIC Implementation Plan

Community Consultation Menu

The plan then goes on to describe the menu of community consultation event types from which each site will select, to create a balanced local schedule of events. For each type of event, the advantages and limitations are discussed, as well practical strategies and best practices for leveraging that kind of event. Guidance is also provided for the kind of groups and individuals that might be approached, and importance of reaching a broad and diverse set of voices from the community.

Later in the plan a similar menu for public disclosure is provided, again with descriptions of possible events and best practices.

The plan then concludes with some other specific policies and best practices for EFIC trials. These include notifying and communicating with legally authorized representatives and families after EFIC enrollment. There is an important section on centralized tracking and reporting related to EFIC implementation. Finally the plan gives examples of the kind of resources a plan should provide to support sites such as focus group guides, surveys, press releases, slide sets, and ad copy.

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Investigator’s EFIC Implementation Plan

Public Disclosure Principles

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Investigator’s EFIC Implementation Plan

Public Disclosure Menu

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Investigator’s EFIC Implementation Plan

Contacting an LAR

Description of opt-out

Examples of resources

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Standard Operating Procedure for Trial Applications involving Exception from Informed Consent (EFIC) to a Single/Central Institutional Review Board

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Process Guideline for Central IRB Review of Site Applications for EFIC Trials: How to Review Local Community Consultation and Public Disclosure Findings

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Supplemental Material: Site EFIC Activity Reports for IRB Submission

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Emphasis

Shared Platform

Evolving Tool

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Experience of Family Members of Victims of Cardiac Arrest and Severe Neurotrauma: Workshop

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Background

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Workshop Co-chairs

Susanne Muehlschlegel

Sarah �Perman

Jonathan

Elmer

Adrianne Haggins

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A sequential, qualitative mixed methods approach with data collection occurring in two stages was used to capture information related to the following key research questions:

• What are family members’ needs in the first 48 hours after the patient’s hospitalization?

• How are these needs addressed by hospital staff and institutions (i.e., EDs and ICUs)?

• How can hospital staff and the institution better address family members’ needs?

The first stage was a single-site case study to generate formative research findings from interviews with both family members and health care professionals, and the second stage was a virtual workshop on November 19, 2020 that relied on facilitated discussions among a diverse sample of family members and health care professionals. Information collected from all data sources was analyzed and themes were organized according to an analytic framework based on an ecological model, which grouped family members’ needs into five domains – information, communication, emotional, physical, and sociocultural.

In the first stage of the project, seven family members and twelve health care professionals were interviewed. Seventeen family members and 12 health care professionals participated in the virtual workshop. Family members discussed a variety of needs, including information needs (e.g., information about their loved one’s care and status, what to expect in the immediate timeframe and post-discharge); communication needs (e.g., consistent and coordinated information from the care team, assistance with processing information); emotional needs (e.g., sensitivity and compassion from care team, support from family and friends); sociocultural needs (e.g., religious support services, equitable treatment); and physical needs (e.g., comfortable spaces while waiting, private meeting rooms for sensitive conversations).

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Case Study - Interviews

Strategy - Health Professionals interviewed, suggested and contacted candidate family members

7 Family Member Stakeholders

3 Spouse, 4 Parent
3 Cardiac Arrest, 4 Neurotrauma
4 Survivors, 3 Nonsurvivors

The first stage of the project was a single site case study. An academic hospital in a culturally and economically diverse region of the United States was selected for the case site because of its diverse patient population and the large volume of critical care provided to victims of cardiac arrest and severe neurotrauma. Data were collected via interviews with family member and hospital stakeholders. The qualitative case study methodology is described in more detail below.

Recruitment

Recruitment for interviews occurred via two distinct sequential nonprobability approaches. First, health care professionals affiliated with the case study site, who communicate with family members during the first 48 hours following a loved one’s severe neurotrauma or cardiac arrest, were identified and recruited. To obtain a breadth of perspectives, the research team intentionally sought a cohort of health care professionals with diverse roles to reflect the range of care team members who interact with family members. A workshop co-chair whose primary affiliation is with the case study site conducted outreach to the identified health care professionals in July 2020 to request their participation in an interview. Health care professionals who expressed interest in participating received follow-up contact from Westat via email to identify a time for the interview.

Single site case study Interviews family member 7

Relationship Parent 4, Spouse 3

Gender Female 3, Male 2, Dyad 2

Experience TBI 4 (survivor 2, nonsurvivor 2)

Cardiac Arrest 3 (survivor 2, nonsurvivor 1)

To identify family members whose loved ones received care at the case study site following severe neurotrauma or cardiac arrest, the research team engaged participating health care professionals in recruiting family members with whom they had existing relationships in a snowball sampling approach. Health care professionals were asked to contact 2-3 candidate family members to assess their interest in being interviewed. The research team aimed to speak with family members of diverse backgrounds with loved ones having a range of outcomes. If the family member expressed interest in sharing their experiences, they were informed that Westat would be in contact with more details. Westat contacted the referred family members by email in August-September 2020 to provide more information and to schedule the interviews.

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Workshop Participants

Family Members, recruited for:

Cardiac Arrest v. Neurotrauma
Survival of Loved One
Race and Ethnicity
Geography Across the US

Professionals, recruited for:

Profession and discipline
Geography Across the US

17 Family Members

8 Parents, 9 Spouses
8 Cardiac Arrest, 9 Neurotrauma
Geographically diverse
14 Survivors, 3 Non-survivors
2 Black, 15 White
3 Male, 14 Female
14 College educated

The second stage of the project was a workshop, conducted virtually on November 19, 2020. The goal of the workshop was to assess the transferability of findings from Stage 1, capture any missing themes related to family members’ needs, and dive deeper into a subset of topics.

Recruitment

To understand if findings from Stage 1 were transferable, the research team aimed to recruit approximately 30 participants from across the United States , including family members with diverse racial-ethnic and socioeconomic backgrounds and health care professionals in a variety of roles that intersect with family members during the first 48 hours. The workshop co-chairs leveraged their networks to identify workshop invitees from across the United States who could bring valuable perspective or expertise to the workshop, including a subset of the case study interview participants. In total, 18 family members and 12 health care professionals were invited to the workshop.

Comment on diversity present and diversity missing.

Workshop Family Member 17

Relationship Parent 8, Spouse 9

Gender Female 14, Male 3

Experience Traumatic Brain Injury 9 (Survivor 7, Non-Survivor 2)

Cardiac Arrest 8 (Survivor 7, Non-Survivor 1)

Race/Ethnicity Non-Hispanic White 15, Black or African American 2

Education More than 4-year college graduate 9

4-year college graduate 5

Less than 4-year college graduate 3

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I won’t elaborate on the rigorous qualitative methodology of the workshop, other than to say that over the months preceding the meeting we used case study and interviews of family members and providers to inform the scope and organization of the meeting agenda, and the kinds of discussions to seed..

The workshop had to be converted from an in-person to a virtual format, which frankly worried me given the sensitivity of the topic, but it ended up working very well.

A key constraint was the need to maintain a small, sufficiently intimate group, to allow everyone to speak and share, while striving for diversity of participants on a whole bunch of experiences. In the end 17 Family Members participated from all around the US,

9 were Spouses, 8 were Parents,

8 of their family members had Cardiac Arrest, and 9 had had Neurotrauma

14 of their family members had survived, and 3 had not

For race only 2 were Black, 15 White

Only 3 were Male, 14 were Female

And perhaps the biggest skew is that 14 were College educated, a parameter we had not thought to diversify on ahead of time.

12 professional members included nurses, social workers, chaplains, and doctors.

The agenda was organized into facilitated large group and small group discussions. Some small groups were just for family participants, and some were mixed groups of family members and professionals.

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Workshop Agenda

Welcome, Objectives, Introductions (30 minutes)

Overviews (95 minutes)

Presentations, Q&A,
Reflection Session - Small Groups (2 family, 2 professionals)

Breakout Sessions (120 minutes)

Family needs - Small Groups (2 family, 2 professionals)
Uncertainty and Information Processing - Small Groups (4 mixed)

Takeaways, Synthesis, and Next Steps (60 minutes)

Presentations and Reflection Session. After reviewing the objectives and outlining “ground rules” for participation, two co-chairs delivered presentations. The first presentation provided an overview of the field, and the second presentation focused on findings from the case study interviews. After a brief “question and answers” session, attendees broke into four homogeneous groups (two groups consisted of family members, the other two groups consisted of health care professionals). Each reflection session was led by a trained Westat facilitator with backup support from a workshop co-chair. A few workshop observers joined each group, but did not participate in the discussion.

The purpose of the reflection session was to determine the transferability of findings from the case study interviews. A discussion guide was developed to standardize and guide participant reflections in each group (Appendix G). Discussion questions sought to understand whether or not the case study interview findings resonated with participants and learn about any needs that were not captured in the case study interviews. During the reflection session, Padlet, a web-based collaborative discussion board, was used as a tool to collect input from participants.

Breakout Sessions. To probe further into selected interview findings, two rounds of breakout sessions were conducted. The first breakout session included four homogeneous groups, similar to the reflection session (i.e., two groups of family members and two groups of health care professionals), and focused on family member logistical needs in the first 24 hours (for the family member groups) and provider training and care team approach (for the health care professional groups). The second round of breakout groups included four groups of mixed composition, and discussion topics focused on communicating and handling uncertainty in the first 48 hours.

Discussion topics were selected as they emerged during the case study interviews as meaningful gaps that necessitated further elaboration and aligned with key research questions. It is important to note, however, that if a theme was generated during the interviews but not discussed during the workshop, this is not an indication of lower importance to the participants, but due to the limitations in scope to the workshop’s agenda.

Similar to the reflection session, each breakout session was facilitated by a Westat researcher with backup support from a workshop co-chair, and observers in attendance refrained from participating in the discussion. Discussion guides were developed for both breakout sessions (Appendix H).

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Themes

58 Themes across 5 Domains

5

Physical Needs - 7

4

Sociocultural Needs - 9

3

Emotional Needs - 13

Communication Needs-13

2

1

Information Needs - 16

We heard a lot. After qualitative coding and synthesis we report on 58 themes across 5 domains.

The domains are clearly overlapping and interdependent rather than distinct, but are conceptually useful. The domains are

Informational

Communication

Emotional

And Sociocultural and Physical Needs

For many of the themes we heard a remarkable amount of commonality of experience and a lot of agreement among participants. For some other themes experiences and opinions were more varied and there was less consensus.

I obviously can’t go through all the ideas we heard, but I’ll just give some examples of experiences and observations.

A lot of what we heard was not surprising, but actual stories make even expected issues feel more immediate and important. And then there were other things that I wouldn’t actually have expected..

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Information

“I do remember feeling like frustrated or a little just – like the fear of the unknown. Like first they were talking about like on day one they were talking about like being in a coma, ... – I mean, I could see that she wasn’t awake, but I don’t know, just to hear those words was hard, and then the next day they’re talking about a TBI. … but like nobody ever said to me she has a traumatic brain injury. And I’ll tell you, that hit me the hardest.”

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Communication

“We did not have a social worker greet us. We did not have a single point of contact…never met the neurologist, and I hope I don’t offend anybody by saying this, but I felt like they were on two different planets, the cardiologist and the neurologist.”

Communication

family members emphasized the need for health care professionals to be clear, consistent and compassionate in their communication. In particular, family members said they were often overcome with emotion and distracted, and appreciated when health care professionals communicated in ways that made information processing easier. These strategies included repeating information, pausing for family members to ask questions, and avoiding using medical jargon.

There was a lot of dissatisfaction with inconsistent communication, and fragmentation of health care.

A very common experience was family members searching out a consistent guide to help them through the process. Someone, “an insider”, that they could go to with any question. It didn’t even seem to matter who it was, or whether that person had answers, but it was invariably someone who could help them figure out how to get answers. These were social workers, or clergy, or a particular nurse or doctor, or just a family friend who worked at the hospital. It seemed to be an important part of not feeling alone in a crowd of care-providers.

There were a few other things I hadn’t heard of before, like handing out business cards at family meetings. And the desired role of technology was surprising to me. I also thought of these situations as being very private and in-person, more human. But a lot of family members discussed wanting to be able to use text messages with the care teams. They wanted help communicating with extended family and friends using social media. They wanted to conference in more members to family meetings.

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Emotional

“It's vitally important for survivors, family members and the care team to reunite months later. Our hospital facilitated a reunion tour at our request. It was amazing for all... and very healing.”

Family members experienced a range of feelings, including shock, distress, confusion, and despair, as they attempted to cope with their loved one’s critical illness or injury. The unexpected life-threatening event, uncertainty regarding their loved one’s condition or outcome, and reliance on the health care team for compassionate updates contributed to the emotional response of members of the family.

As one would expect, a lot of the successes and failures in helping family members with their emotional needs related to expressions of empathy and compassion. Uncertainty frequently drives anxiety. Managing expectations was a challenge for professionals who want to both provide hope and prepare families for bad news. We heard that it is important that teams not appear to be “giving up on patients”.

We heard about some things that may not have been expected, like the importance of having closure with the ICU care team by coming back and visiting the ED or ICU sometime after recovery..

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Sociocultural and Physical

“..., where would I sleep? Where can I get food? Where can I get a change of clothes, toothbrush, etc.? What the appropriate/effective ways to get medical updates on my wife? ... I felt like I figured this out on my own--I asked a lot of questions.” (FM, WS – Survey)

Family members and professionals emphasized the need for equitable treatment and socio-culturally appropriate behavior to ensure that medical providers and other hospital staff treat everyone with respect, regardless of one’s personal characteristics, including gender, age, religion, race or ethnicity, cultural affiliation, geographic location, or family structure.

This included huge issues that shouldn’t be surprising, including disrespect for patients and families rooted in implicit or systemic racism. It was emphasized that language interpretation services not only improves communication, but lessens the burden on family members having to struggle to translate unfamiliar ideas on their own.

Support for diverse religious beliefs and prayer were discussed..

What we heard about physical needs included things we’d also heard in information needs. Family members spoke of the need for a physical space where they could still be close to the patient and the care teams, they spoke of struggling to figure out where they would sleep, eat, park. They were often from far away and hadn’t packed anything when they ran to the hospital so they needed a toothbrush or a razor or socks.

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Conclusion

I want to wrap this up with another observation that I heard, that made a big impact on me. I never thought much about this and it is something that we don’t facilitate well in the hospital. In the report this was categorized as an emotional need, but I think it is also a real physical need. It is the power of touch. Many family members have a need to be with their loved ones, not just in the room, but through physical contact. All of our medical tools, tubes and lines, and bedside machines discourage family members from getting close, for fear of breaking something or maybe just breaking a rule. A mother told the story of how she asked to help clean her son as it became likely he was approaching the end of his life. She said to her astonishment that the nurse said yes, and that the nurse encouraged her and got her supplies and helped her to wash his hair and his body. She told us how much she still cherishes that hour of caring for him intimately one last time.

I couldn’t help think of the number of lost opportunities for experiences like that I had witnessed over the years, because we never thought to invite it or encourage it. Holding hands, encouraging a kiss, maybe even letting someone lay down with a spouse are all ways of maybe breaking this bubble of isolation we create just a little bit. I never thought much about before, because I hadn’t asked before, and I hadn’t listened.

But in this workshop we started to listen just a little bit, to a group that hasn’t been much heard.

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Wrap up

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Through the emergency experience supplement NIH has created the opportunity to listen and hear perspectives relevant to the conduct of emergency care research.

We have been able to consolidate lessons relevant to the engagement and training of paramedics involved in clinical trials, building on this special and critical interface between researchers and the public.

We have synthesized the knowledge and experience with EFIC, and especially with the unique aspects of community consultation and public disclosure into tools that we hope will promote more consistent best practices.

We have broadened our vision of patient engagement in the emergency care and early critical care space by listening to and better considering the variety of needs and experiences of families of patients with life-threatening emergencies.

I think we’ve shown overall, that you can learn a lot when we make the effort to really listen.

We’d like to hear your thoughts and questions.

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siren.network

Through the emergency experience supplement NIH has created the opportunity to listen and hear perspectives relevant to the conduct of emergency care research.

We have been able to consolidate lessons relevant to the engagement and training of paramedics involved in clinical trials, building on this special and critical interface between researchers and the public.

We have synthesized the knowledge and experience with EFIC, and especially with the unique aspects of community consultation and public disclosure into tools that we hope will promote more consistent best practices.

We have broadened our vision of patient engagement in the emergency care and early critical care space by listening to and better considering the variety of needs and experiences of families of patients with life-threatening emergencies.

I think we’ve shown overall, that you can learn a lot when we make the effort to really listen.

We’d like to hear your thoughts and questions.