NCT01361035

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
168

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

May 24, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 26, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

March 10, 2017

Status Verified

March 1, 2017

Enrollment Period

4 years

First QC Date

May 24, 2011

Last Update Submit

March 9, 2017

Conditions

Keywords

health literacycancer screeningdoctor-patient communicationstandardized patientcontinuing medical education

Outcome Measures

Primary Outcomes (1)

  • 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

    0, 12, 24 months

Secondary Outcomes (1)

  • Change in standardized patient ratings of physician communication behaviors

    0, 6, 12 months

Study Arms (2)

No communication training

NO INTERVENTION

Physicians enrolled in the control arm do not undergo training in health literacy, cancer screening and shared decision making

Cancer risk ommunication skills training

OTHER

Physicians enrolled in the intervention arm undergo training in health literacy, cancer screening and shared decision making

Other: Cancer risk communication skills training

Interventions

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.

Cancer risk ommunication skills training

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Tulane Communty Health Center at Covenant House

New Orleans, Louisiana, 70112, United States

Location

Tulane Faculty Practice

New Orleans, Louisiana, 70112, United States

Location

EXCELth - Ida Hymel Community Health Center

New Orleans, Louisiana, 70114, United States

Location

DCSNO St Cecelia Medical Center

New Orleans, Louisiana, 70117, United States

Location

DCSNO Carrollton Medical Center

New Orleans, Louisiana, 70118, United States

Location

Related Publications (3)

  • 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.

    PMID: 20352506BACKGROUND
  • 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.

  • Riganti P, Ruiz Yanzi MV, Escobar Liquitay CM, Sgarbossa NJ, Alarcon-Ruiz CA, Kopitowski KS, Franco JV. Shared decision-making for supporting women's decisions about breast cancer screening. Cochrane Database Syst Rev. 2024 May 10;5(5):CD013822. doi: 10.1002/14651858.CD013822.pub2.

MeSH Terms

Conditions

Uterine Cervical NeoplasmsBreast NeoplasmsColorectal Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Eboni Price-Haywood, MD, MPH

    Tulane University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Adjunct Associate Professor of Clinical Medicine

Study Record Dates

First Submitted

May 24, 2011

First Posted

May 26, 2011

Study Start

June 1, 2008

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

March 10, 2017

Record last verified: 2017-03

Locations