The second phase of the project, from September 2013 to September 2015, included both implementation and refinement of the prototype and involved the following activities:
- Selecting the pilot community and health care organizations.
- Developing and implementing an outreach and marketing plan.
- Launching the hotline.
- Refining the prototype.
- Extending the outreach.
We used multiple methods for selecting the pilot community and participating health care delivery organizations; clarifying the legal framework for prototype operation; developing and carrying out an outreach and marketing plan for notifying organizational leadership, physicians, nurses, professional associations, and other community stakeholders about the prototype; developing and implementing a marketing plan for consumers; refining the prototype and protocols through testing; operating the hotline; and processing the reports that were submitted.
The evaluation was also conducted during this phase. The activities related to the evaluation are described in Chapter IV, but we discuss here the implementation of the hotline in the pilot community and ongoing efforts to refine it, as well as efforts to reach out and inform patients and caregivers about the opportunity to report patient safety problems they observe in their own care.
Selecting the Pilot Community and Health Care Organizations
To select an appropriate pilot community to test the hotline, the team sought health care organizations that had a demonstrated commitment to patient safety improvement and a representative patient population and that resided in a community of moderate size, so that an outreach effort could effectively reach the target audience. Participation in a PSO was also an important consideration because PSO protection would offer a mechanism for sharing and analyzing reports.
We identified 18 health care delivery organizations that had a history of patient safety work in a PSO context and that might have an interest in collaborating on deployment and testing of the prototype. The primary criteria for selection were (1) affiliation with ECRI Institute PSO, which simplified PSO issues; (2) geographic colocation as major health care providers in one community; (3) representativeness of the population served (adult, pediatric, mixed socioeconomic status, and race/ethnicity); and (4) enthusiasm for participation. Based on these criteria and the initial information we gathered, we reached out to 10 organizations and then convened teleconferences with the four that best fit our criteria to discuss their interest in the project. Two health care delivery organizations in one metropolitan area were selected and agreed to participate. The organizations were in the northeastern United States, which facilitated site visits, but this was not a determining factor. Other sites we considered and explored (including a large health system in a major metropolitan area) did not fit all of the criteria. Together, the two selected organizations had several favorable features. Both were integrated health care delivery organizations and members of a PSO. Both also had leaders committed to improving quality and patient safety, interest in transparency about care and in reaching out to patients and caregivers, representation of a broad population, and a history of community collaboration.
Legal and Organizational Requirements
To participate in the pilot project, the leadership of the two health care delivery organizations each signed a memorandum of understanding (MOU) and a data use agreement (DUA) with RAND, as well as a PSO agreement with ECRI Institute PSO. The purpose of the PSO agreement was to ensure privilege protection for internal analyses of patient-reported events. Each health care delivery organization designated one person from its implementation team to serve as the primary liaison with the hotline research team on all aspects of implementation, including the development of protocols for processing patient and caregiver reports and for identifying any matching adverse event reports made by staff within the organization.
The research team confirmed that the participating organizations had policies in place that would prevent retaliation against any patient or caregiver who reported safety concerns. The team also collected the organizations’ policies and training materials related to patient safety to confirm that they upheld “just culture” principles, emphasized opportunities for learning rather than blaming individuals, and recognized the role of systems in introducing or failing to mitigate patient safety risks.
Organizational Characteristics of Participating Organizations
One organization serves a specialty population and engaged one large hospital and more than 15 ambulatory practices in the pilot project. The other organization serves adult and pediatric populations and engaged two hospitals, in-hospital pharmacies, more than 20 ambulatory practices, several specialty centers, and libraries associated with it. Both organizations have a history of hospital-based adverse event and complaint reporting systems that share reported events with quality and patient-relations departments. Both encourage adverse event reporting by staff and have internal mechanisms for staff to report incidents in order to promote learning, improve service quality, and enhance risk management.
Developing and Implementing an Outreach and Marketing Plan
To communicate the availability of the hotline to patients and caregivers, the research team, AHRQ, and the pilot organizations developed clear descriptions of the hotline that could be featured in materials selected by the organizations, including 4-by-9-inch cards/brochures, folded business cards, and posters. The descriptions were developed in both English and Spanish. The materials contained the ECRI Institute and RAND logos, referenced the two participating health care delivery organizations, indicated that the project was funded by AHRQ, and referred to the hotline as a “research project.”
The research team and the health care organizations discussed additional options for communicating hotline information to patients and caregivers, such as “piggybacking” on patient experience survey mailings and adding links to Web portals. In collaboration with the partner health care delivery organizations, the research team determined that these options would require additional time to implement because of existing vendor contracts and work flows and thus were not realistic for the remaining time period of the project.
Clinicians and staff of the participating health care organizations who had not participated in the initial planning and roll-out of the hotline received a letter from the leadership of their own organization that discussed the purpose of the hotline, the plan for communicating information about it to patients and caregivers, how the patient and caregiver reports would be used, and how clinicians and staff could help.
As part of the announcement of the launch of the pilot project and to gain buy-in from provider organizations, we also drafted and sent letters from RAND and the two health care organizations to other relevant entities, such as State-level professional associations and State regulatory agencies.
Although media outreach was not in the initial marketing plan (the team had decided not to consider active outreach to the media until the hotline had been operating for several months), the team and the health care organizations developed a plan for responding to media inquiries, including designated points of contact and sample frequently asked questions (FAQs). We did not receive any media inquiries.
In February 2014, after the research team and organizations had adequately tested the Web site, the notification letters and other communication materials (e.g., posters, business cards) were circulated publicly and throughout the two health care delivery organizations. Outreach materials were distributed to hospitals (posters and brochures for hallways and lobbies/registration desks, and business cards placed in admission packets), outpatient practices (posters, brochures, and business cards), pharmacies (brochures and business cards), and other facilities affiliated with the organizations (posters, brochures, and business cards). At this time, the Web site went live and started accepting reports.
Refining the Prototype
During this period, the research team, the TEP, AHRQ, and the participating health care organizations (including their PFACs) continued to identify opportunities to improve the “look and feel” of the Web site platform and content and to better engage consumers.
During the first year of the implementation phase (2013–2104), changes in the patient event reporting form included revisions to formatting, clarification, and more consistent use of the terms “grievance” and “complaint” throughout the introductory Web site pages and FAQ pages. We also added a request for permission to share the name of the patient in the case of reports submitted by caregivers who agree to have it shared with the relevant clinician or delivery organization. We also increased the character limit of free text boxes to allow for longer narratives. These and other changes were incorporated as the need arose and were batched for quarterly implementation.
In June 2014, the research team convened the second in-person meeting of the TEP, which was attended by the AHRQ Project Officer, TEP members, and implementation leaders at the two health care delivery organizations.
Technical Expert Panel Feedback
The research team used feedback from the TEP as formative evaluation data, drawing from the TEP’s recommendations and those of the PFACs (described below) to make midcourse corrections. The TEP members focused their comments on how to improve outreach and marketing, not on changing the data collection strategy. Key recommendations from the TEP for the reporting form and Web site included:
- Be clearer on the Web site and in outreach materials about the type of safety concerns that are of interest and what the benefits to patients might be.
- Terms like “safety” and “error” may suggest that the hotline is interested only in serious adverse events, whereas terms like “concern” may suggest that it is interested in a broader set of issues.
Key recommendations for outreach included:
- Add information about the hotline to discharge packets, since patients are reflecting on their care at that time.
- Reach out to patients who are known to have experienced safety concerns.
- Share information about the hotline with the broader community.
- Raise the project’s profile in the media.
- Include a reference to the hotline in CAHPS, Press Ganey, or other patient experience surveys.
- Engage patient advisors in discussions about how to improve and promote the hotline.
Patient and Family Council Feedback
In September 2014, the research team met with the PFACs to obtain input on the prototype. The meeting started with a presentation that included a short demonstration of the prototype. After the demonstration, members of each PFAC were asked to address two main questions:
- Given what you heard here about our current dissemination and outreach strategies, how would you suggest that we focus or improve our approach to providing patients and families with an opportunity to report? How would you suggest that we go about raising awareness among patients and families?
- Do you have any suggestions for different or preferred dissemination and outreach strategies involving the community?
Those discussions brought forward another set of recommendations for the reporting form and Web site, including:
- Focus less on research and more on the opportunity for learning.
- Remove the term “investigator,” which might suggest a “government investigator” to some people.
- Emphasize that the hotline aims to use the reported data to try to prevent future patient safety events.
- Emphasize the options of reporting anonymously and confidentially.
- Make clearer that family members and other caregivers can submit reports.
- Reference the names of the participating health care delivery organizations on the home page.
- Emphasize that patients will not be retaliated against and that making a report will not result in providers getting into trouble.
Key recommendations for further outreach efforts included:
- Move information about the hotline from admissions packets (which patients and caregivers rarely have the time or energy to review) to discharge packets (which patients and caregivers sometimes review when they get home).
- Include information about the hotline in followup calls completed a few days after a hospitalization.
- Post information about the hotline in hallways, family resource rooms, elevators, emergency departments, and surgery areas.
- Spend more time educating health system staff—including social workers and case managers—about the hotline.
- Publicize the hotline to the larger community.
- Add a reference to the hotline to Press Ganey or other patient experience surveys.
While we considered all of the recommendations carefully, some were clearly outside the scope of both the contract and the agreements we had made with the partner organizations testing the prototype. Some recommendations would have required changes to procedures or additional staffing by the health care systems themselves (e.g., actively recruiting patients known to have been injured, conducting discharge followup calls using the event reporting form), and others would have required the cooperation of vendors (e.g., Press Ganey or CAHPS surveys).
During 2015, additional changes were made to improve the functionality of the Web site, including text revisions to the introductory pages of the reporting form and the addition of the participating organizations’ logos. We updated the FAQs and the resources page hyperlinks to provide additional resources for assistance and reporting to other organizations/agencies. Further refinements to the consent process for sharing reports with the health care delivery organizations were also made. The team completed a total of five iterations of refinements.
Extending the Outreach
The research team, in collaboration with one of the health care delivery organizations, decided to extend the “human touch” outreach to consumers, with the following efforts:
- Case managers, nurses, and social workers began to hand out a brochure describing the hotline on day 2 of the hospital stay rather than at admission (when it might get overlooked among the admission paperwork).
- Nurses began to include the hotline information in discharge discussions.
- Case managers began to remind patients of the hotline during post-discharge and post-emergency-department outreach calls.
- Outreach materials were provided to Spanish-language interpreters to share with patients during translation encounters.
The same health care delivery organization also discussed other options for outreach, including prompting patients by portal-generated email notifications; identifying additional locations for distribution of outreach brochures (e.g., emergency departments, chemotherapy infusion, obstetrics departments, ambulatory surgery centers); inviting PFAC volunteers to learn about the hotline and share its availability with friends and colleagues; and inviting community organizations (senior centers, barbershops, faith-based organizations) to distribute the outreach materials.
Building a consumer-oriented patient safety reporting system using a Web portal and a toll-free phone number is feasible and relatively easy to implement. However, building one does not mean that consumers will use it. A passive strategy for bringing consumers to the Web site did not produce a high volume of reports. It is unclear whether consumers were having trouble finding the hotline, suggesting that our outreach and marketing strategy did not work, or that they were having trouble with the Web page or event reporting form once they found it.
We do not have evidence that more outreach is necessarily better, although it is plausible that different consumers might attend to and respond to different types of outreach modalities. There is also a fundamental problem of presenting individuals with the opportunity to report at a time when they have something to say.
Many ideas were generated about possible ways to increase the visibility of the hotline, but data to inform a choice among the myriad of recommendations are scarce. We appreciated the ideas generated by the PFACs, the TEP, and others, but not all were necessarily practical, and the failure to implement some of them was both logistical and resource-related.