Clinical trial NCT01871948: Effective Communication for Preventing and Responding to Oncology Adverse Events
Official title: Effective Communication for Preventing and Responding to Oncology Adverse Events
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2013-06-07
Enrollment: 500
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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

Primary outcomes:
measure: Calculate differences in satisfaction with cancer care communication, using a summary score from patient surveys, between intervention and control groups.
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Kaiser Permanente Georgia
state: Georgia
city: Seattle
country: United States
facility: Group Health
state: Washington
Study officials:
affiliation: University of Massachusetts, Worcester
name: Kathleen M Mazor, EdD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: Thomas H Gallagher, MD
role: PRINCIPAL_INVESTIGATOR
References: