Effective Communication for Preventing and Responding to Oncology Adverse Events

NCT ID: NCT01871948

Last Updated: 2013-12-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2013-08-31

Brief Summary

Cancer patients often experience problems in their care, many of which are caused by communication breakdowns. Some communication breakdowns lead to adverse events and even harmful errors. Deficiencies in provider-patient communication can compound patients' distress, lower the quality of care, and disrupt patient-provider relationships. There is little research on patients' and providers' experiences of the communication breakdowns that precipitate adverse events and errors, or on effective responses to these events. Because of this, cancer providers are unsure how to communicate with patients in these difficult situations. The goal of the proposed study is to improve patient-centered communication around adverse events and errors in cancer care. Our specific aims are: 1) To describe patients' experiences with communication around adverse events and errors in cancer care, 2) To describe providers' experiences and practices with communication around adverse events and errors in cancer care, 3) To develop practical recommendations, provider training materials and patient educational materials for improving communication around adverse events and errors in cancer care, 4) To disseminate the recommendations and materials through three health plans, and 5) To conduct a preliminary evaluation of the perceived usefulness and impact of the materials. The investigators will first conduct interviews with breast and colorectal cancer patients who have experienced adverse events or errors at 3 Cancer Research Network (CRN) health plans (Atlanta, Georgia; Seattle, Washington and Worcester, Massachusetts). The interviews will focus on instances where patients believe that better communication might have prevented an adverse event or error, or mitigated the event's impact. Next the investigators will conduct focus groups to understand providers' attitudes and experiences with these communication dilemmas, and use simulations to describe providers' communication practices. Finally, the investigators will interview health plan leaders to identify the systems factors that influence communication with patients around adverse events and errors. These perspectives will be synthesized to create patient and provider educational material for improving communication. Three advisory panels: a Patient Advisory Panel, a Health Plan Advisory Panel and a Dissemination Advisory Panel (including all 14 CRN health plans) will help create and disseminate these educational interventions. Dissemination will occur at the three core clinical sites. The investigators use patient and provider surveys to evaluate the educational materials' impact. This evaluation will provide the evidence-base to refine the study products before widespread dissemination throughout the CRN and beyond. The project will have the advantage of the CRN infrastructure, the CRN Clinical Communication Research Center, and is led by nationally recognized communication researchers.

Conditions

Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Patient survey at 2 points in time

Randomly assigned patients attending cancer clinics at Washington or Georgia sites during February 2013 to August 2013 will be presented with or mailed a survey about cancer communication approximately 2 weeks later and a follow-up survey approximately 3 months later.

Group Type: NO_INTERVENTION

No interventions assigned to this group

"WeWant to Know" campaign, patient survey at 2 time points

Randomly assigned patients attending cancer clinics at Washington or Georgia sites during February 2013 to August 2013 will be presented with or mailed a survey about cancer communication approximately 2 weeks later and a follow-up survey approximately 3 months later. Additionally, this group will also receive a follow-up phone call approximately 4 weeks after baseline survey.

Group Type: EXPERIMENTAL

"We Want to Know" campaign, Patient survey at 2 time points

Intervention Type: OTHER

Randomly assigned patients attending cancer clinics at Washington or Georgia sites during February 2013 to August 2013 will be presented with or mailed a survey about cancer communication approximately 2 weeks later and a follow-up survey approximately 3 months later. Additionally, this group will also receive a follow-up phone call approximately 4 weeks after baseline survey.

Interventions

"We Want to Know" campaign, Patient survey at 2 time points

Randomly assigned patients attending cancer clinics at Washington or Georgia sites during February 2013 to August 2013 will be presented with or mailed a survey about cancer communication approximately 2 weeks later and a follow-up survey approximately 3 months later. Additionally, this group will also receive a follow-up phone call approximately 4 weeks after baseline survey.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Cancer survivors
• 21 to 80 years of age
• Able to communicate in English
• have adequate hearing
• no cognitive impairments

Exclusion Criteria

-Any non-melanoma skin cancer, Breast cancer in situ, Cervical intraepithelial neoplasia (CIN): types I, II, III, Stage I colon cancer, Stage IV cancer, Recurrent cancer or second primary

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Massachusetts, Worcester

OTHER

Sponsor Role: lead

Responsible Party

Kathleen Mazor

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kathleen M Mazor, EdD

Role: PRINCIPAL_INVESTIGATOR

University of Massachusetts, Worcester

Thomas H Gallagher, MD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

Kaiser Permanente Georgia

Atlanta, Georgia, United States

Group Health

Seattle, Washington, United States

Countries

United States

Other Identifiers

P20CA137219

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1184

Identifier Type: -

Identifier Source: org_study_id