Recording medical visits for people with breast cancer

Institution: University of California, San Francisco
Investigator(s): Jeffrey  Belkora , Ph.D. - Sara  O'Donnell ,  -
Award Cycle: 2010 (Cycle 16) Grant #: 16BB-1400 Award: $637,500
Award Type: CRC Full Research Award
Research Priorities
Community Impact of Breast Cancer>Sociocultural, Behavioral, and Psychological Issues: the human side

Initial Award Abstract (2010)

People diagnosed with breast cancer often struggle to ask questions and absorb, understand, and act upon the information they get from doctors. This is a significant problem because patients have a legal and ethical right to be as informed and involved as they want to be in their treatment decisions. Fortunately, researchers have identified strategies that increase question-asking and improve patient recall of information. These strategies include helping patients develop a list of questions prior to major medical visits, and providing audio-recordings and/or plain language summaries of consultations. Patient support organizations, including the Cancer Resource Centers of Mendocino County, have begun to provide assistance with question-listing, audio-recording, and note-taking. As a result, patients are indeed asking more questions and recalling more of the answers they get from doctors. However, our study team recently discovered that patients, doctors, and resource center staff sometimes share question-lists, notes, and audio-recordings with other parties, usually to coordinate care or support. The problem is that current regulations are not clear about how to treat documents created, like these, by employees of support organizations that are not legally considered “covered entities.” This policy gap creates barriers to adoption of these interventions due to concerns about potential legal conflict, loss of privacy, errors and omissions, and other risks. We propose to develop community-endorsed policies, procedures, and guidelines for the safe, legal, private, and effective storing and sharing of question-lists, audio-recordings, and notes.


To answer the study questions, we will review 432 resource center records and interview 30-50 community members, including survivors, doctors, and resource center employees. In this way we will identify positive and negative incidents associated with doctors, patients, and others storing and sharing question-lists, audio-recordings, and notes. From these incidents we will form an understanding of the risks and benefits of various storing and sharing practices. Then we will design and test community-supported policies, procedures and guidelines to maximize the positive effects and minimize the negative. We expect our guidelines to use legal and organizational best practices such as business associate agreements, certificates of confidentiality, de-identification, and license agreements, among others.

The US Agency for Healthcare Research and Quality, the Mayo Clinic, and others have recognized our team’s work as innovatively patient-centered. This project will add to our track record of innovation by addressing policy issues that need to be resolved for broader adoption of question-listing, audio-recording, and note-taking. Broader adoption of these interventions will allow more patients and doctors to exchange information more effectively.

Our community consists of individuals and organizations in Mendocino County with an interest in helping people with breast cancer be informed and involved in their care as they make treatment decisions. Our team has conducted three prior studies addressing our community’s desire to facilitate information exchange between patients and doctors. Our study questions respond to issues that were brought up during a pilot award in which we interviewed 34 community members. We will continue to engage community members in every aspect of this research, from refining the questions and study procedures, to collecting and analyzing data, and disseminating our findings.

We are actively working with two non-profit agencies, the Cancer Support Community and Avon Foundation for Women, to disseminate our research on question-listing, audio-recording, and note-taking to resource centers around the country. We also plan to study the financial costs and benefits of this type of support, and involve insurers and other payers in testing reimbursements for these services.

Final Report (2015)

Our study partner, the Cancer Resource Centers of Mendocino County (CRCMC), provides assistance with question-listing, audio-recording and note-taking for clients’ medical appointments. Health care providers wish to refer patients to the CRCMC for these services before the first office visit, so patients can benefit from CRCMC support before and during the doctor-patient discussion. CRCMC is not a HIPAA covered entity and is not covered by the Privacy Rule. There are no clear policies guiding referrals from health care providers to CRCMC. To address this gap, our study developed community-endorsed policies to guide patients, health care providers, and non-medical organizations wishing to collaborate across organizational boundaries. Our study used a participatory approach with both academic and community partners providing input during each phase of the research process. We now report our results for each of the study aims:

AIM 1: Form and evaluate mechanisms for community participation in and dissemination of our research Between September 2010 and July 2014, we created and maintained a project communications infrastructure including 168 phone meetings with project team members consisting of community and scientific partners. These meetings included 9 phone meetings with our participatory consultant and 17 phone meetings with our legal consultant. Additionally, our team met on 11 occasions for in-person meetings and held 5 community participation meetings. We monitored the participatory aspect of our research on 3 occasions, by administering questionnaires to 29 meeting participants. Overall, we interpreted our qualitative and quantitative results as indicating that 25 respondents [community representatives] felt we were generally meeting accepted standards for participatory research, with 2 feeling we were not inclusive enough overall; and 2 feeling we could be more participatory on technical aspects of the science, including research methods, data collection, and analysis.

AIM 2: Learn the risks and benefits of current patient support arrangements, by reviewing patient, doctor, and resource center staff experiences
We analyzed program data over a five year period to determine the effect of the resource center’s patient support services, finding significant pre/post improvements in patient self-efficacy and anxiety. Based on further input from community partners, we concluded that patients need access to these services immediately after diagnosis, before the first treatment decisions are made. However, patients faced a barrier to referring themselves for these services: many did not know the resource center existed. We concluded that patients would benefit from direct referrals between providers and the resource center. This would allow the resource center to contact patients to offer services. However, providers faced a barrier to making direct referrals: their staff worried about violating privacy laws and regulations. We found no other significant barriers to patient, provider, and resource center cooperation, collaboration and coordination. We did find an opportunity for improvement in the resource center’s internal effectiveness. We implemented and evaluated a web-based program database to replace the existing combination of paper records, desktop databases, and spreadsheets that the resource center had been using to track services and outcomes.

AIM 3: Design, implement, and evaluate policies, procedures, and guidelines that promote patient-centered care across organizational boundaries
To address the concerns about making direct referrals, we reviewed state and federal regulations related to sharing patient health information. During this process, we produced 4 reports on laws applicable to sharing patient information between health care providers and entities not covered by health care privacy laws. We concluded that providers making verbal referrals to the resource center were implicitly invoking the “treatment purposes” exception to the privacy laws. This exception allows providers to refer patients to non-medical providers whose services are needed to implement an overall treatment plan. In this case, providers in Mendocino County were referring patients to the resource center for psychosocial support as part of overall treatment for cancer. We facilitated a consultative process through which providers and resource center leaders agreed to formalize the referral process by signing Business Associate Agreements (BAAs) under which the resource center would voluntarily act as if it were an entity covered by health care privacy laws. To assist the resource center in creating and complying with these BAAs, we identified relevant templates and created a checklist. On July 1, 2014, the resource center signed a BAA with the largest local provider system. We compared referral volume during the 6 quarters prior to the agreement to the volume during the 4 quarters after. Direct referrals from this provider system increased from under 5 per quarter to over 10 per quarter. Key stakeholders attributed this increase to the business associate agreement. We leave the resource center with the capacity to expand this agreement to other providers and share the lessons learned with other community-based organizations.