NCT02430948

Brief Summary

The study hypothesis is that clearer visual presentation of guideline recommendations and educational outreach, or academic detailing, can improve guideline compliance. However, it will investigate other aspects of screening-related decision-making, such as provider and patient beliefs about screening, provider-patient communication and patient's willingness to forgo expected testing. The research question is whether educational interventions can decrease non-compliance with screening guidelines for 5 common cancers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
218

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Jan 2014

Typical duration for not_applicable breast-cancer

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

January 1, 2014

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2014

Completed
7 months until next milestone

First Posted

Study publicly available on registry

April 30, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

July 26, 2019

Status Verified

July 1, 2019

Enrollment Period

3.1 years

First QC Date

September 29, 2014

Last Update Submit

July 25, 2019

Conditions

Breast CancerCervical CancerProstate CancerColon CancerLung Cancer

Keywords

ScreeningShared Decision Making

Outcome Measures

Primary Outcomes (4)

  • Effect of educational intervention on providers' recommendations

    Incidence of guidance compliance

    Baseline

  • Effect of educational intervention on providers' recommendations

    Incidence of guidance compliance

    3 months

  • Effect of educational intervention on providers' recommendations

    Incidence of guidance compliance

    6 months

  • Effect of educational intervention on providers' recommendations

    Incidence of guidance compliance

    12 months

Secondary Outcomes (8)

  • Patients' belief in the value of screening

    Baseline

  • Patients' belief in the value of screening

    3 months

  • Patients' belief in the value of screening

    6 months

  • Patients' belief in the value of screening

    12 months

  • Patient compliance

    Baseline

  • +3 more secondary outcomes

Study Arms (4)

Standard Support Outreach

ACTIVE COMPARATOR

Providers receive standard written screening recommendations and do not receive academic detailing (educational outreach)

Other: Standard supportOther: No academic detailing

Standard materials and academic detailing

EXPERIMENTAL

Providers receive standard written screening recommendations and receive academic detailing (educational outreach)

Other: Academic detailingOther: Standard support

Color-coded materials and no academic detailing

EXPERIMENTAL

Providers receive color-coded written screening recommendations and do not receive academic detailing (educational outreach)

Other: Color-coded materialsOther: No academic detailing

Color-coded materials and academic detailing

EXPERIMENTAL

Providers receive color-coded written screening recommendations and receive academic detailing (educational outreach)

Other: Color-coded materialsOther: Academic detailing

Interventions

Color-coded materialsOTHER

A summary of treatment recommendations for each cancer screening is color-coded to indicate the strength and direction of the recommendation

Color-coded materials and academic detailingColor-coded materials and no academic detailing
Academic detailingOTHER

Educational outreach to address the rationale and data supporting recommendations for and against screening

Color-coded materials and academic detailingStandard materials and academic detailing
Standard supportOTHER

Screening recommendations presented in standard format

Standard Support OutreachStandard materials and academic detailing
No academic detailingOTHER

Physician receives study orientation for not the academic detailing curriculum

Color-coded materials and no academic detailingStandard Support Outreach

Eligibility Criteria

Age30 Years - 89 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients: healthy men and women ages 30-89 seeing their primary care provider for routine visit
  • Providers: non-pediatric primary care physicians from Mount Sinai Beth Israel or St. Luke's-Roosevelt associated practices

You may not qualify if:

  • Patient life expectancy of less than 1 year in primary care provider's judgment
  • Inability to read and understand English
  • Transgender status

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mount Sinai Beth Israel

New York, New York, 10003, United States

Location

St. Luke's-Roosevelt

New York, New York, 10019, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsUterine Cervical NeoplasmsProstatic NeoplasmsColonic NeoplasmsLung Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGenital Neoplasms, MaleGenital Diseases, MaleProstatic DiseasesMale Urogenital DiseasesColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • James A Talcott, MD SM

    Mount Sinai Beth Israel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2014

First Posted

April 30, 2015

Study Start

January 1, 2014

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

July 26, 2019

Record last verified: 2019-07

Locations

US(2)