NCT01534923

Brief Summary

The purpose of this study is to learn more about doctor-patient communication about colon cancer screening. This study will also look to see if there are differences in those who get colon cancer screening based on the discussion the doctor had with the patient.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
76

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2012

Longer than P75 for all trials

Geographic Reach
1 country

2 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

February 7, 2012

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

February 10, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 17, 2012

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 26, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 26, 2019

Completed
Last Updated

January 2, 2020

Status Verified

December 1, 2019

Enrollment Period

7.9 years

First QC Date

February 10, 2012

Last Update Submit

December 31, 2019

Conditions

Keywords

Doctor-Patient Communicationquestionnairesurvey12-017

Outcome Measures

Primary Outcomes (1)

  • describe doctor-patient communication about CRC screening

    screening adherence through self report. Screening adherence will be assessed by contacting the patients and asking them if they received the CRC screening test their doctor ordered at the audio recorded visit.

    2 years

Secondary Outcomes (2)

  • quality of doctor-patient communication about CRC screening and low-income patients' screening outcomes.

    2 years

  • examine the association between the quality of doctor-patient communication about CRC screening and low-income patients' screening outcomes

    2 years

Study Arms (1)

Pts having colorectal cancer screening

The target sample of this study will be approximately 200 primary care physician-patient consultations who discuss CRC screening during the course of a clinical visit. Physician and patient participants will come from primary care practices associated with the New York City Research and Improvement Networking Group (NYC RING).

Behavioral: surveys

Interventions

surveysBEHAVIORAL

The intervention will be the audio-recording of the physician-patient consultation, patient and doctor surveys. These audio recordings will be coded. It will also include follow-up phone calls with patients.

Pts having colorectal cancer screening

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Five health centers of the NYC RING will participate in this project. All are located in underserved urban communities within the Bronx.

You may qualify if:

  • Physicians
  • Attending physicians or third year residents specializing in internal medicine or family medicine, as per the medical director from the clinic.
  • Clinic is based at a NYC RING-affiliated practice.
  • English speaking; Due to limited resources, we cannot have each audio recorded consultation translated therefore, the consultation needs to be in English.
  • Patients
  • Ages 50-75 years old, per the United States Preventive Services Task Force recommendations for screening. This will be determined by a pre-screening of medical records by the RSA.
  • Due for colorectal cancer screening at the time of the visit, ascertained through patient self-report (e.g., no colonoscopy within the past 10 years, no flexible sigmoidoscopy or barium enema within the past five years, and no FOBT within the past year).
  • Coming for either an annual physical exam or chronic care follow up visit, per patient self-report.
  • Planning to consult with the physician in English, per patient self-report. Due to limited resources, we cannot have each audio recorded consultation translated therefore, the consultation needs to be in English.

You may not qualify if:

  • History of colorectal cancer, per patient self-report or per EMR..
  • History of polyps being removed, per patient self-report.
  • Colonoscopy scheduled in EMR at time of screening.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Albert Einstein College of Medicine

The Bronx, New York, United States

Location

Hhc, Gun Hill and Tremont

The Bronx, New York, United States

Location

Related Links

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Jamie Ostroff, PhD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2012

First Posted

February 17, 2012

Study Start

February 7, 2012

Primary Completion

December 26, 2019

Study Completion

December 26, 2019

Last Updated

January 2, 2020

Record last verified: 2019-12

Locations