Clinical trial NCT01361035: Using Effective Provider-Patient Communication to Improve Cancer Screening Among Low Literacy Patients
Official title: Using Effective Provider-Patient Communication to Improve Cancer Screening Among Low Literacy Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Cancer
Breast Cancer
Colorectal Cancer
Keywords: health literacy
cancer screening
doctor-patient communication
standardized patient
continuing medical education
Lead sponsor: Tulane University
Sponsor class: OTHER
Collaborators: name: Robert Wood Johnson Foundation
First posted: 2011-05-26
Enrollment: 168
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: What's the purpose of this study? This 4-year study is designed: (1) to teach primary care physicians how to recognize low health literacy patients and effectively counsel them on cancer screening using risk communication and shared decision making and (2) to assess the impact of training on changes in physician communication behavior and changes in low health literacy patients' cancer screening behaviors. This study proposal is based on the hypothesis that physician training in cancer screening guidelines, health literacy, and communication skills will improve provider-patient interactions during encounters dealing with preventive health maintenance especially cancer screening.

How will the proposed study be implemented? Thirty-two physicians in the New Orleans metropolitan area will be recruited and randomly assigned to one of two groups. The unit of randomization will be the health care organization or clinic. The intervention group will receive training in health literacy, cancer screening, risk communication and shared decision-making. The control group will not receive communication training until the end of the study. Physicians in both groups will undergo three clinic visits with standardized patients (actors trained to portray real patients; mystery shoppers) but they will not be aware that they are conducting visits with actors. The visits will occur at study enrollment and at 6 and 12 months. At the end of each clinic visit, the standardized patients will rate the physicians' communication skills. Each physician assigned to the intervention group will receive verbal feedback on communication skills from the standardized patients and complete a web-based tutorial. Physicians in the control group will not have access to the web-based tutorial until the end of the study.

For each physician, 10-15 patients with limited health literacy will be recruited to the study. Each patient will rate his/her perceived involvement with care and global satisfaction with care at study enrollment and annually for three years. Age and gender-appropriate referral rates for breast, cervical and colorectal cancer screening and patients' receipt of such screening will be assessed annually for three years. All study physicians, regardless of group assignment, will receive performance feedback (report cards) on their cancer screening rates among low health literacy patients in their clinic.


Eligibility criteria: Inclusion Criteria:

Physician

* Physicians who practice at these clinic sites at least one half day per week are eligible to participate in this study.

Patient

* Eligible patients include men and women age 40 to 75, individuals enrolled in the clinic practice for at least one year, and individuals identified as having low or inadequate health literacy via the Rapid Estimate of Adult Literacy in Medicine.

Exclusion Criteria:

Physician

* Any provider planning to leave before the end of 12 months will be excluded.

Patient

* Patients will be excluded if they plan to change primary care provider or site of health plan, have resided in the United States for less than five years, or do not speak English

Primary outcomes:
measure: Change in cervical, breast and colorectal cancer screening rates
timeFrame: 0, 12, 24 months
Secondary outcomes:
measure: Change in standardized patient ratings of physician communication behaviors
timeFrame: 0, 6, 12 months
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Tulane Communty Health Center at Covenant House
state: Louisiana
city: New Orleans
country: United States
facility: Tulane Faculty Practice
state: Louisiana
city: New Orleans
country: United States
facility: EXCELth - Ida Hymel Community Health Center
state: Louisiana
city: New Orleans
country: United States
facility: DCSNO St Cecelia Medical Center
state: Louisiana
city: New Orleans
country: United States
facility: DCSNO Carrollton Medical Center
state: Louisiana
Study officials:
affiliation: Tulane University School of Medicine
name: Eboni Price-Haywood, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Price-Haywood EG, Roth KG, Shelby K, Cooper LA. Cancer risk communication with low health literacy patients: a continuing medical education program. J Gen Intern Med. 2010 May;25 Suppl 2(Suppl 2):S126-9. doi: 10.1007/s11606-009-1211-6.
citation: Price-Haywood EG, Harden-Barrios J, Cooper LA. Comparative effectiveness of audit-feedback versus additional physician communication training to improve cancer screening for patients with limited health literacy. J Gen Intern Med. 2014 Aug;29(8):1113-21. doi: 10.1007/s11606-014-2782-4. Epub 2014 Feb 4.