Using Effective Provider-Patient Communication to Improve Cancer Screening Among Low Literacy Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Tulane University School of Medicine.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Tulane University School of Medicine
ClinicalTrials.gov Identifier:
NCT01361035
First received: May 24, 2011
Last updated: NA
Last verified: May 2011
History: No changes posted
  Purpose

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.


Condition Intervention
Cervical Cancer
Breast Cancer
Colorectal Cancer
Other: Cancer risk communication skills training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Using Effective Provider-Patient Communication to Improve Cancer Screening Among Low Literacy Patients

Resource links provided by NLM:


Further study details as provided by Tulane University School of Medicine:

Primary Outcome Measures:
  • Change in cervical, breast and colorectal cancer screening rates [ Time Frame: 0, 12, 24 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 0, 6, 12 months ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 180
Study Start Date: June 2008
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: No communication training
Physicians enrolled in the control arm do not undergo training in health literacy, cancer screening and shared decision making
Cancer risk ommunication skills training
Physicians enrolled in the intervention arm undergo training in health literacy, cancer screening and shared decision making
Other: Cancer risk communication skills training
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.

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01361035

Contacts
Contact: Jewel Harden-Barrios 504-988-7518 jharden@tulane.edu

Locations
United States, Louisiana
Tulane Communty Health Center at Covenant House Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Arckett Yost    504-988-3000    ayost@tulane.edu   
Tulane Faculty Practice Completed
New Orleans, Louisiana, United States, 70112
DCSNO Carrollton Medical Center Completed
New Orleans, Louisiana, United States, 70118
DCSNO St Cecelia Medical Center Completed
New Orleans, Louisiana, United States, 70117
EXCELth - Ida Hymel Community Health Center Completed
New Orleans, Louisiana, United States, 70114
Sponsors and Collaborators
Tulane University School of Medicine
Investigators
Principal Investigator: Eboni Price-Haywood, MD, MPH Tulane University School of Medicine
  More Information

Publications:
Responsible Party: Eboni Price-Haywood, MD, MPH, Tulane University School of Medicine
ClinicalTrials.gov Identifier: NCT01361035     History of Changes
Other Study ID Numbers: RWJF-63523
Study First Received: May 24, 2011
Last Updated: May 24, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Tulane University School of Medicine:
health literacy
cancer screening
doctor-patient communication
standardized patient
continuing medical education

Additional relevant MeSH terms:
Breast Neoplasms
Uterine Cervical Neoplasms
Colorectal Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on April 16, 2014