Using Effective Provider-Patient Communication to Improve Cancer Screening Among Low Literacy Patients
Primary Purpose
Cervical Cancer, Breast Cancer, Colorectal Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cancer risk communication skills training
Sponsored by
About this trial
This is an interventional health services research trial for Cervical Cancer focused on measuring health literacy, cancer screening, doctor-patient communication, standardized patient, continuing medical education
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
Sites / Locations
- Tulane Communty Health Center at Covenant House
- Tulane Faculty Practice
- EXCELth - Ida Hymel Community Health Center
- DCSNO St Cecelia Medical Center
- DCSNO Carrollton Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Other
Arm Label
No communication training
Cancer risk ommunication skills training
Arm Description
Physicians enrolled in the control arm do not undergo training in health literacy, cancer screening and shared decision making
Physicians enrolled in the intervention arm undergo training in health literacy, cancer screening and shared decision making
Outcomes
Primary Outcome Measures
Change in cervical, breast and colorectal cancer screening rates
Cervical/Breast/Colorectal cancer screening rates will be measured at baseline and annually for 2 years to assess whether screening rates improve over time
Secondary Outcome Measures
Change in standardized patient ratings of physician communication behaviors
The mystery shoppers (standardized patients) will rate the physicians' shared decision making and counseling about cancer screening prior to the intervention at baseline and then again at 6-month and 12-month follow up evaluations to assess whether communication behaviors improve over time
Full Information
NCT ID
NCT01361035
First Posted
May 24, 2011
Last Updated
March 9, 2017
Sponsor
Tulane University School of Medicine
Collaborators
Robert Wood Johnson Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01361035
Brief Title
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
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tulane University School of Medicine
Collaborators
Robert Wood Johnson Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer, Breast Cancer, Colorectal Cancer
Keywords
health literacy, cancer screening, doctor-patient communication, standardized patient, continuing medical education
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
168 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No communication training
Arm Type
No Intervention
Arm Description
Physicians enrolled in the control arm do not undergo training in health literacy, cancer screening and shared decision making
Arm Title
Cancer risk ommunication skills training
Arm Type
Other
Arm Description
Physicians enrolled in the intervention arm undergo training in health literacy, cancer screening and shared decision making
Intervention Type
Other
Intervention Name(s)
Cancer risk communication skills training
Intervention Description
Intervention physicians receive training in cancer risk communication and shared decision making (SDM). At the end of each visit with intervention physicians, standardized patients (SPs) reveal themselves as actors and give structured verbal feedback. After baseline SP visits, each intervention physician undergoes academic detailing with a communication expert. Intervention physicians are directed to a web-based communication skills tutorial where SP ratings are hyperlinked to key references for supplemental reading. Both study groups will receive annual reports detailing their patients' cancer screening status and aggregate ratings of their communication style.
Primary Outcome Measure Information:
Title
Change in cervical, breast and colorectal cancer screening rates
Description
Cervical/Breast/Colorectal cancer screening rates will be measured at baseline and annually for 2 years to assess whether screening rates improve over time
Time Frame
0, 12, 24 months
Secondary Outcome Measure Information:
Title
Change in standardized patient ratings of physician communication behaviors
Description
The mystery shoppers (standardized patients) will rate the physicians' shared decision making and counseling about cancer screening prior to the intervention at baseline and then again at 6-month and 12-month follow up evaluations to assess whether communication behaviors improve over time
Time Frame
0, 6, 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eboni Price-Haywood, MD, MPH
Organizational Affiliation
Tulane University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tulane Communty Health Center at Covenant House
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Tulane Faculty Practice
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
EXCELth - Ida Hymel Community Health Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70114
Country
United States
Facility Name
DCSNO St Cecelia Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70117
Country
United States
Facility Name
DCSNO Carrollton Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70118
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20352506
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.
Results Reference
background
PubMed Identifier
24590734
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.
Results Reference
result
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Using Effective Provider-Patient Communication to Improve Cancer Screening Among Low Literacy Patients
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