Implementation Guide for the CANDOR Process

Purpose: The Toolkit Implementation Guide is a reference for organizational leaders who are committed to improving their response to unexpected patient harm events. The guide describes the CANDOR process, implementation phases, resources, and responsibilities to support successful implementation at their organization.

Who should use this guide? The individuals who are responsible for leading implementation should consult this guide. Leaders who have accepted responsibility for implementing the CANDOR process are encouraged to share this guide with all team members, including patient and family advisors.

How to use this guide: Organizations committed to the program should expect to implement a number of leading practices to improve communication and response to adverse events. The guide provides additional details and guidance on several important activities such as:

• Forming an active, multidisciplinary project team that includes clinicians, support staff, and patient and family advisors.
• Conducting training sessions on the CANDOR process for all project team members.
• Conducting ongoing communications and education with staff, patients, and families about the organization's commitment to the CANDOR process.
• Engaging staff, patients, and families in the planning, implementation, and evaluation of the CANDOR process.

Contents

Introduction
How To Use The Implementation Guide
Introduction To The CANDOR Process
CANDOR Implementation Phases
   1. Phase I: Assessments
   2. Phase II: CANDOR Process Implementation
   3. Phase III: Organizational Improvement and Sustainment
References
Appendixes
   Appendix A: Building the Business Case Worksheet
   Appendix B: Team Roles and Responsibilities
   Appendix C: Organization Team Roster
   Appendix D: Action Plan Template

Introduction

Despite the national attention that was given to patient safety in the Institute of Medicine (IOM) report, To Err Is Human: Building a Safer Health System, the problems associated with injury and harm due to processes of patient care persist.¹ Although the United States provides some of the best health care in the world, unsafe health care processes harm an alarming number of patients every year. For example, more than 1.5 million preventable infections occur annually among inpatients. This statistic represents only one type of patient harm that results during the delivery of patient care in health care delivery organizations.²

Recent research shows a significant correlation between the frequency of adverse events and malpractice claims.³ Meanwhile, information from patient satisfaction and patient experience of care surveys have been shown to predict malpractice risk.⁴ Eliminating or reducing the risks and hazards in the delivery of patient care should yield safer practices and potentially reduce medical liability claims.

The CANDOR process ^a improves patient safety through an empathetic, fair, and just approach to medical errors and promotes a culture of safety that focuses on caring for the patient, family, and caregiver; an in-depth event investigation and analysis; and resolution.

The CANDOR process is an approach that health care institutions and practitioners can use to respond in a timely, thorough, and just way to unexpected patient harm events. A CANDOR event is defined as an event that involves unexpected harm (physical, emotional, or financial) to a patient. These events trigger the CANDOR process even when a cause for the event is not yet known.

The CANDOR process toolkit provides a framework for hospitals to improve their response to unexpected patient harm events. Implementation of all elements of the framework is designed to enhance a number of short- and long-term improvements. In the short term, hospitals will develop processes to improve the reporting and monitoring of adverse events and promote better care for patients through candid, caring communication in the wake of an adverse event. In the longer term, hospitals will experience fewer medical liability claims, improved patient safety outcomes, and improved patient satisfaction scores by engaging patients and families throughout the CANDOR process.

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How To Use The Implementation Guide

The toolkit has eight different modules and contains PowerPoint slides with facilitator notes, videos, and tools to help organizations implement each phase of the CANDOR process. The toolkit modules can be customized and adapted, as needed, based on needs of the organization.

The Implementation Guide will show you how to use the modules, and it is organized according to three sections, as follows:

1. Introduction to the CANDOR Process.

This section provides a description of the CANDOR process, which consists of five components:

• Identification of a CANDOR Event.
• CANDOR System Activation.
• Response and Disclosure.
• Investigation and Analysis.
• Resolution.

2. CANDOR Implementation Phases

The CANDOR process is best implemented in three phases:

• Phase I—Assessment.
• Phase II—CANDOR Process Implementation.
• Phase III—Organizational Improvement and Sustainment.

3. Appendixes

This section provides tools to help organizations implement project components and monitor progress.

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Introduction To The CANDOR Process

Each component of the CANDOR process was developed based on the collection of work conducted by previous AHRQ grantees and other experts in the field of communication and resolution programs. The CANDOR process is an approach that health care institutions and practitioners can use to respond in a timely, thorough, and just way to unexpected patient harm events. Figure 1 depicts the five components of the CANDOR process.

Figure 1: CANDOR Process

• Component 1: Identification of CANDOR Event. A CANDOR event is defined as an event that involves unexpected harm (physical, emotional, or financial) to a patient. These events trigger the CANDOR process even when a cause for the event is not yet known.

• Component 2: CANDOR System Activation. After the event is identified as a CANDOR event, CANDOR System Activation occurs and triggers the start of the next two components of the CANDOR process: Response and Disclosure (the third component) and Investigation and Analysis (the fourth component). While these two processes occur at the same time during the CANDOR process, they have been numbered for easy reference.

• Component 3: Response and Disclosure. Response and Disclosure involves the implementation of Disclosure Communication and Care for the Caregiver activities.
  • Disclosure Communication includes identification and engagement of trained Disclosure Leads and/or Disclosure Communicators who participate in disclosure communication with the patient and family after a harm event. It is important to understand that disclosure is a process and will likely be ongoing. While an initial disclosure conversation will occur within 60 minutes after the CANDOR event occurs, a full disclosure will typically not occur until after the Event Investigation and Analysis has been completed, which will take place within 30-45 days after the event occurred.
  • Care for the Caregiver activities are designed to support clinicians and support staff who may have been impacted by the adverse event.

• Component 4: Event Investigation and Analysis. This component begins with the reporting of the CANDOR event and continues until all information is gathered and analyzed, and a plan is developed to prevent the adverse event from reoccurring.

• Component 5: Resolution. After effectively implementing the first four components of the CANDOR process, organizations can begin implementing the Resolution process. During the Resolution component, the organization applies what the system has learned throughout the process to improve patient safety and prevent similar adverse events from happening in the future. During this component, the organization will also determine how best to address resolving the harm event, which might include providing compensation to the patient and/or family.

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CANDOR Implementation Phases

CANDOR process implementation occurs in three phases, and the toolkit provides eight modules to assist organizations in implementing each phase as described below:

• Phase I: Assessments:
  • Module 1: Overview of the CANDOR Process.
  • Module 2: Obtaining Organizational Buy-In and Support.
  • Module 3: Preparing for Implementation: Gap Analysis.

• Phase II: CANDOR Process Implementation:
  • Module 4: Event Investigation and Analysis.
  • Module 5: Response and Disclosure Communication.
  • Module 6: Care for the Caregiver.
  • Module 7: Resolution.

• Phase III: Organizational Improvement and Sustainment:
  • Module 8: Organizational Learning and Sustainability.

Generally, organizations can expect that it will take at least 12-18 months to implement the CANDOR process. The implementation lifecycle is highlighted in Figure 2 and described in more detail below.

Each module will also be discussed in its respective phase below.

Figure 2: CANDOR Implementation Phases

Phase I: Assessments

Phase I activities should occur during the first 3 months of CANDOR process implementation. Phase I activities have been designed to help the organization "Set the Stage" before beginning implementation of the CANDOR process. These activities include:

• Obtaining organizational buy-in and support.
• Conducting a gap analysis.
• Building project teams.
• Defining the metrics to evaluate successful implementation of the CANDOR process.

• MODULE 1: Overview of the CANDOR Process
  This module provides a general introduction to the CANDOR process that can be used to educate all staff in the organization. It also emphasizes the organization's commitment to improve the reporting and monitoring of adverse events and to promote better care for patients through candid, caring communication in the wake of an adverse event.

Tools and resources include:

• PowerPoint slides with facilitator notes.
• Introductory video titled, Introduction to Communication and Optimal Resolution (CANDOR).
• Grand Rounds video and presentation slides designed to support staff training.

• MODULE 2: Obtaining Organizational Buy-In and Support
  Obtaining senior leadership and risk management engagement is an essential first step in setting the stage for successful CANDOR process implementation. Securing organizational buy-in and support early in CANDOR process implementation will help prepare leaders, staff, and external stakeholders to promote a culture of safety. The organization should also incorporate the perspectives and input of patients and family members in each phase of CANDOR process implementation.

This module describes the characteristics of successful engagement of key leaders and stakeholders, how to enhance leadership buy-in using a business case for the CANDOR process, and how Just Culture principles support CANDOR process implementation.

Tools and resources include:

• Tools and resources provided in Module 1 above.
• Peer-to-Peer Coaching video.
• Building the Business Case Worksheet (Appendix A).

• MODULE 3: Preparing for Implementation: Gap Analysis
  This module provides additional information to help the organization prepare to implement processes designed to impact system-wide culture change.

This module includes a Gap Analysis Facilitator's Guide, which will assist you in assessing the organization's current policies, procedures, and processes related to adverse events to evaluate the organization's readiness to implement the CANDOR process.

• ACTIVITY: Building Project Teams
  
  The project teams provide the critical support necessary for successful implementation of the CANDOR process. For the change effort to be successful, designated teams must work to support and guide the process. Figure 3 provides a summary of the team structure recommended to support CANDOR process implementation.

Figure 3: CANDOR Process Implementation Team Structure

Key characteristics of team members should include:

• Authority to lead the change.
• Leadership skills.
• Credibility.
• Communications ability.
• Expertise in change management.
• Analytical skills.
• Desire to improve the system.

The CANDOR Implementation Team is responsible for the organization-wide implementation of the CANDOR process.

The CANDOR Implementation Team Leader should be a senior leader with influence and authority to make decisions and support the widespread culture change associated with the CANDOR process. He or she is responsible for ensuring that individual team members have what they need to implement the steps they own in the CANDOR process. The CANDOR Implementation Team Leader is responsible for recruiting diverse team members who will be responsible for guiding key processes during implementation of the CANDOR process.

The CANDOR Implementation Team should have three subgroups with a Team Lead for each subgroup. The Team Leads oversee the implementation of individual steps in the CANDOR process and report to the CANDOR Implementation Team Leader. The three subgroups include:

1. Communication Team. This team is responsible for overseeing the actual disclosure communication to patients and/or family and for supporting caregivers impacted by the adverse event. This team has two sub-teams:
   1. Disclosure Communication. The Disclosure Team Lead is responsible for implementing the disclosure communication process in the organization.
   2. Care for the Caregiver. The Care for the Caregiver Team Lead is responsible for implementing a Care for the Caregiver program for the organization.

2. Event Reporting, Investigation, and Analysis Team. This team is responsible for reviewing the organization's current processes and making improvements and changes to support implementation of the CANDOR process.

3. Resolution Team. This team is responsible for working with legal counsel, claims, and risk management staff to establish a resolution process for the organization.

Some organizations may choose to assign more than one role to team leaders. Backup team members should be identified for the five teams to maintain consistent delivery of all project services and continuity during turnover or staff absences. Each team should include six to eight members who may be formal or informal leaders and respected members of the health care team, including nurses, physicians, risk management champions, patient/family advisors, and other clinical and support team members. Ad hoc team members can also provide additional resources and skills, when needed.

Potential team members should be approached individually and invited to participate in this exciting project designed to improve patient safety. It is important that team members know that they have been selected to join a team based on their expertise in a particular area, their distinctive skills, and/or their recognition as a leader in the organization. Team members should be assured that management has approved their participation in the project, and that their work assignments will be covered while they attend meetings or are involved in other project activities.

Team leaders should schedule an introductory meeting with all team members to orient the team to the project. Leaders should promote the organization's commitment to this change process using existing communication vehicles such as posting flyers in public areas of the building; including information about the project in the organization's newsletter (if applicable); and announcing the opportunities to serve on teams at staff, patient, and family council meetings.

Tools and resources include:

• Team Roles and Responsibilities—Serves as a guide when forming your CANDOR teams (Appendix B).
• Organization Team Roster (Appendix C).

• ACTIVITY: Identifying Data and Outcome Measures
  The Gap Analysis can be used to help you establish a baseline from which to measure change over time. Prior to implementation, information provided in the Gap Analysis and the metrics defined in the Building the Business Case Worksheet (Appendix A) will provide you a starting point to identify the data you wish to collect to evaluate the short- and long-term success of CANDOR process implementation.

Phase II: CANDOR Process Implementation

Phase II is the implementation of the CANDOR process, which operationalizes a timely, thorough and just response to unexpected patient harm events. To effectively implement the process, the organization must provide sufficient training and education to staff involved in each implementation task. All activities that comprise the CANDOR process should include the patient and family, whenever possible.

During Phase II, the organization should begin to collect data on process and outcome measures. Data collection during this phase includes collection of CANDOR process measures related to patient safety.

As you begin implementation of the CANDOR process, an Action Plan Template (Appendix D) will help you track the progress of each implementation activity.

Detailed information, resources, and tools concerning the five components of the CANDOR process are included in the toolkit modules as follows:

• MODULE 4: Event Investigation and Analysis
  This module provides specific training in the key elements of a timely and comprehensive event reporting system, event investigation, and event analysis.

Tools and resources include:

• CANDOR Event Checklist.
• System-Focused Event Investigation and Analysis Guide.

• MODULE 5: Response and Disclosure Communication
  This module defines the response and disclosure component of the CANDOR process and provides additional information concerning the knowledge, skills, and attitudes needed for individuals who may support disclosure communication.

Tools and resources include:

• Disclosure Checklist.
• Communication Assessment Guide.
• Case Scenarios: Handling Challenging Communications.
• Videos: Appropriate Disclosure to a Patient and Inappropriate Disclosure to a Patient.

• MODULE 6: Care for the Caregiver
  This module identifies the steps for developing a Care for the Caregiver program, provides additional information concerning the second-victim phenomenon, and describes challenges and interventions for peer support.

Tools and resources include:

• Care for the Caregiver Program Implementation Guide.
• Videos: Peer Support Interaction (Physician) and Peer Support Interaction (Nurse).

• MODULE 7: Resolution
  This module defines the CANDOR process resolution component, the steps of the resolution process, and the roles of the resolution team and other stakeholders.

Tools and resources include videos, which include vignettes that demonstrate how the resolution process might occur following an adverse event (see Adverse Event (Reasonable Care) and Adverse Event (Unreasonable Care)).

Phase III: Organizational Improvement and Sustainment

Phase III focuses on ensuring that the improvement processes that have been implemented will continue without interruption. In this phase, the organization will begin to track when the CANDOR process is in control or when control is lost. It is important that the organization continue to train and educate staff and to evaluate success through data collection and outcome measures. Sustaining the improvements and continuing to learn from the process is an important feature of the final implementation phase. Common elements that support sustaining organizational improvement include:

• The organization ensures that its mission, vision, and values support the CANDOR process.
• The CANDOR process will support and enhance the organization's quality improvement and patient safety initiatives.
• Trust between the organization, its clinicians, and patients is established and sustained.

Resources to educate the organization about sustaining the CANDOR process are included in the toolkit modules as follows:

• MODULE 8: Organizational Learning and Sustainability
  This module defines the concepts of organizational learning and sustainability and provides additional information to guide an organization as it sustains the CANDOR process.
  
  The Action Plan Template (Appendix D) can also be used to track project activities and tasks, as well as challenges and solutions to assure ongoing improvement and sustainment.

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References

1. Institute of Medicine (IOM). To Err is Human: Building a Safer Health System. In: Kohn LT, Corrigan JM, Donaldson MS, editors. Washington, DC: National Academy Press; 2000. PMID: 25077248.
2. Studdert OM, Mello MM, Brennan TA. Medical Malpractice. N Engl J Med 2004; 350(4): 283-92. PMID: 14724310.
3. Greenberg MD, Haviland AM, Ashwood JS, Main R. Is better patient safety associated with less malpractice activity? Evidence from California. Santa Monica: RAND Institute for Civil Justice; 2010.
4. Fullam F, Garman AN, Johnson TJ, Hedberg EC. The use of patient satisfaction surveys and alternative coding procedures to predict malpractice risk. Med Care 2009; 47(5): 553-9. PMID: 19365294.

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^a. The Communication and Optimal Resolution Process is one of the main outgrowths of the Patient Safety and Medical Liability Reform Initiative funded in 2010. This $25 million initiative funded several projects that tested models and approaches to improving patient safety and understanding the relationship between patient safety and medical liability.

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