Consumer Reporting System for Patient Safety

Engaging Patients and Caregivers to Improve Health Care Safety

Eric Schneider Distinguished Chair in Health Care Quality

RAND Corporation

THIS PRESENTATION IS DERIVED FROM WORK SUPPORTED UNDER A CONTRACT WITH THE AGENCY FOR HEALTHCARE RESEARCH AND QUALITY (ACTION II Task Order #14). IT HAS NOT BEEN APPROVED BY THE AGENCY.

Seminar Outline

• Background

• Design

• Prototype

• Evaluation

Project Team

• RAND Corporation– Eric Schneider

• Principal Investigator– Denise Quigley– Lauren Hunter

• Tufts Medical Center– Saul Weingart

• Chair, TEP

• ECRI Institute– Karen Zimmer

• ECRI Project Lead

– Robert Giannini– Gregory Lee

• Brigham and Women’s Hospital

– Joel Weissman

Jim Battles (AHRQ Project Officer)

TEP members

4

NAME POSITION

Executive Vice President and Chief Medical Officer, CVS Caremark Corporation and CVS Pharmacy, Inc.Professor of Surgery, Drexel University;Clinical Director, Patient Safety and Quality Initiatives at ECRI InstitutePrincipal, Governance and Executive Leadership at Pascal Metrics; Adjunct Faculty, Harvard School of Public Health

Senior Research Fellow, Center for Survey Research at University of Massachusetts, Boston

President, National Patient Safety Foundation;

Troy Brennan

John Clarke

Jim Conway

Jack Fowler

Tejal Gandhi

Helen Haskell Founder and President, Mothers Against Medical Error

Lisa McGiffert Campaign Director, Consumer Union’s Safe Patient Project

President, World Organization of Family Doctors; Professor of Family Medicine, University of Wisconsin School of Medicine & Public Health

Richard Roberts

Patients as Vigilant Partners in Quality

• Patients can recognize errors and injuries that may not be apparent to providers

• Hospital staff have several options for reporting safety incidents

• Few systems are designed to obtain safety reports directly from patients or caregivers

• The optimal approaches for collecting patient and caregiver feedback on safety are still being defined

Do Patients Know Something Hospitals Don’t?

Survey and medical record review of 998 patients after discharge from 16 Massachusetts hospitalsSOURCE: Weissman JS, Schneider EC, Weingart SN, Epstein AM, et al. Annals of Internal Medicine, 2008;149:100-108.

Adverse event

Survey Medical Record Review

23%

11%

Patient Reporting on Safety: Mixed Options

Health Care Safety Hotline

• Objective: Design and pilot a standardized approach to collecting patient, family, and caregiver reports about safety-related issues

• Special challenges in U.S. context:

• Malpractice liability

• Decentralized organization of care delivery

Pilot Project Timeline

• Design (2011-2013)– Environmental scan– Focus groups and cognitive interviews– Expert panel review– OMB review (public comment period)

• Implementation (2013-2014)– Prototype development & testing– Community deployment

• Evaluation (2014-2016)

Desirable Features

– Patient and consumer friendly– Standardized, structured data– Engage relevant care delivery organizations– Community-based and scalable– Employs a legal framework that…

• Allows integration of provider and patient information to promote learning

• Minimizes risks to both patients and providers (privacy, confidentiality, reputation, etc.)

Pilot Project: Key Questions

• Unique contribution of patient and caregiver perspectives to safety improvement?

• Solicitation approach– active or passive?

• Handling of non-safety complaints and grievances

• Protocol for sharing details from reports?– Who (facilities, clinicians, regulators)

– How (anonymity, confidentiality, legal status)

• Coordination/integration with other external reporting systems?

– FDA medication and device reporting

Inputs to Design

• Environmental scan and prior research

• Consumer focus groups

• Consumer cognitive interviews

• Technical Expert Panel (TEP)

• Stakeholder Advisory Group

1

Safety Hotline: Topics Covered

1. Introduction (who and where)

2. Description of safety concern

3. Medical mistakes, near misses

4. Injury, harm, “negative effects”

5. Contributing factors and reporting

6. Patient and caregiver information

Health Care Safety Hotline Intake Form

Landing page• What to report• What not to report (complaints)• FAQs

Report a safety concern

Create password?

Y N

HSPC consent?

Exit18+ years?

Module 1: Intro• Who, where?

Y

N

Module 3: Mistake• Type of mistake (several

questions)• Mistake location

• Would you like to share provider’s name/address?

• Provider’s name/address

Y

N

Share your report with the provider?

Module 2: Description of Safety Concern

• Free text description• Patient name

Log in

Was there a negative effect?

Was a mistake made?

Y N/DKModule 4: Negative Effect

• Type of negative effect (several questions)

• Negative effect location**

Module 6: Patient/Caregiver Info

• May we contact you with follow-up questions?

• Contact information

Would you like to share the provider’s name and

address?**

Share your report with the provider?**

Module 5: Contributing Factors and Reporting

• Could something have been done differently to prevent?

• Contributing factors• Did the patient change

providers after?• Reporting (several

questions)

[If agreed to share report]• When we share your report,

can we include name and contact information?

• Patient demographics• How did you learn about the

Hotline?

Submit safety concern to HCSH

Y ExitN

Was there a negative effect?

Y

• When did the mistake happen?

• How did you find out?• Did the mistake affect the

patient financially?

**Respondent only asked this question if she did not complete Module 3

• When did the negative effect happen?**

• Did the patient get additional testing or treatment?

• How did the patient find out?• Did providers make a special

effort to help the patient handle the negative effect?

• Did the negative effect cause the patient to miss regular activities?

• Did the negative effect affect the patient financially?**

Y

N

NY

N

Y

N/DK

Home Page

Modular Construction

1. Introduction2. Description of Safety Concern3. Mistake4. Negative Effect5. Contributing Factors & Reporting6. Clinician / Facility & Patient

Information

Module #1 – Introduction

Module #2 – Description of Safety Concern

Module #3 – Mistake

Module #4 – Negative Effect

Module #5 – Contributing Factors…

Safety Information Sharing is Complex

Safety Hotline

Patient and Caregiver Reports

Health Care Delivery Organizationor Provider

PSES, PSWP

PSOAdverse Event Reports

Sharing with Consent

Protected under PSO Authority

Patient or Caregiver Descriptions

Protected under AHRQ Research Authority

Public InformationDiscussions

Independent of the Project

Sharing Safety Information with Providers

Patient or caregiver answers questions

about safety concern

Hotline team asks patient or caregiver

follow-up questions

Hotline team uploads

information to provider’s

secure website

Hotline team contacts

provider with questions

about what was done with the

information

Hotline team produces de-

identified aggregate

reports

24‐72 hours

45 days (due to 30‐day CMS grievance follow‐up

period)

Pilot

• Participating providers

• Outreach to clinicians and managers

• Outreach to patients, caregivers

Outreach

Safety Information Sharing is Complex

Safety Hotline

Patient and Caregiver Reports

Health Care Delivery Organizationor Provider

PSES, PSWP

PSOAdverse Event Reports

Sharing with Consent

Protected under PSO Authority

Patient or Caregiver Descriptions

Protected under AHRQ Research Authority

Public InformationDiscussions

Independent of the Project

Evaluation Phase 1: Barriers and Facilitators to Implementation

• Adoption and planning for implementation– Primary motivators for undertaking the pilot– Acceptance/participation by front-line staff– Role of and value to marketing dept

• Operation and maintenance– Complementarity with existing reporting systems– Costs (financial; organizational)

• Perceived utility of data from system– Will managers and clinicians find the summary information

relevant?– Will the system help facilitate the investigation and

remediation of individual safety problems?

Evaluation Phase 2: Feasibility and Value of the Reporting System

• Participation– Were patients and caregivers willing to report?– Volume of reports?– Do consumers prefer anonymous or identified reporting?– Can patients identify relevant settings and clinicians?

• Validity of reports– Can consumer-reported events be matched to events in PSO

or facility databases?

• Utility of data from the Hotline– Will managers and clinicians find the summary information

relevant?– Can the system facilitate the investigation and remediation of

individual safety problems?

Conclusion: Lessons to Date

• Health Care Safety Hotline prototype is feasible and can be deployed in partnership with willing organizations

• Several political and legal hurdles

• Outreach to patients, caregivers, and public benefits from local customization

• Optimal deployment of an “independent” hotline is under study