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Improving Compliance With Medical Testing Guidelines

Primary Purpose

Breast Cancer, Cervical Cancer, Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Color-coded materials
Academic detailing
Standard support
No academic detailing
Sponsored by
Beth Israel Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Breast Cancer focused on measuring Screening, Shared Decision Making

Eligibility Criteria

30 Years - 89 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Sites / Locations

  • Mount Sinai Beth Israel
  • St. Luke's-Roosevelt

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

Standard Support Outreach

Standard materials and academic detailing

Color-coded materials and no academic detailing

Color-coded materials and academic detailing

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Effect of educational intervention on providers' recommendations
Incidence of guidance compliance
Effect of educational intervention on providers' recommendations
Incidence of guidance compliance
Effect of educational intervention on providers' recommendations
Incidence of guidance compliance
Effect of educational intervention on providers' recommendations
Incidence of guidance compliance

Secondary Outcome Measures

Patients' belief in the value of screening
measured by survey to be determined
Patients' belief in the value of screening
measured by survey to be determined
Patients' belief in the value of screening
measured by survey to be determined
Patients' belief in the value of screening
measured by survey to be determined
Patient compliance
measured by self- report in surveys to be determined
Patient compliance
measured by self- report in surveys to be determined
Patient compliance
measured by self- report in surveys to be determined
Patient compliance
measured by self- report in surveys to be determined

Full Information

First Posted
September 29, 2014
Last Updated
July 25, 2019
Sponsor
Beth Israel Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02430948
Brief Title
Improving Compliance With Medical Testing Guidelines
Official Title
Improving Compliance With Medical Testing Guidelines
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beth Israel Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
This study is a cluster randomized trial that compares the immediate post-encounter impressions of 12 physicians and 18 of their patients about the discussion of screening for breast, cervical, colorectal, lung and prostate cancer as well as their beliefs about screening efficacy and patient reports of the screening experience. The interventions are educational materials and academic detailing (educational outreach) for providers. The investigators are particularly interested in contrasting the patient and provider recollections, the differential impact on underuse and overuse compliance and whether patient behaviors are consistent with their stated screening plans.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Cervical Cancer, Prostate Cancer, Colon Cancer, Lung Cancer
Keywords
Screening, Shared Decision Making

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
218 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Support Outreach
Arm Type
Active Comparator
Arm Description
Providers receive standard written screening recommendations and do not receive academic detailing (educational outreach)
Arm Title
Standard materials and academic detailing
Arm Type
Experimental
Arm Description
Providers receive standard written screening recommendations and receive academic detailing (educational outreach)
Arm Title
Color-coded materials and no academic detailing
Arm Type
Experimental
Arm Description
Providers receive color-coded written screening recommendations and do not receive academic detailing (educational outreach)
Arm Title
Color-coded materials and academic detailing
Arm Type
Experimental
Arm Description
Providers receive color-coded written screening recommendations and receive academic detailing (educational outreach)
Intervention Type
Other
Intervention Name(s)
Color-coded materials
Intervention Description
A summary of treatment recommendations for each cancer screening is color-coded to indicate the strength and direction of the recommendation
Intervention Type
Other
Intervention Name(s)
Academic detailing
Intervention Description
Educational outreach to address the rationale and data supporting recommendations for and against screening
Intervention Type
Other
Intervention Name(s)
Standard support
Intervention Description
Screening recommendations presented in standard format
Intervention Type
Other
Intervention Name(s)
No academic detailing
Intervention Description
Physician receives study orientation for not the academic detailing curriculum
Primary Outcome Measure Information:
Title
Effect of educational intervention on providers' recommendations
Description
Incidence of guidance compliance
Time Frame
Baseline
Title
Effect of educational intervention on providers' recommendations
Description
Incidence of guidance compliance
Time Frame
3 months
Title
Effect of educational intervention on providers' recommendations
Description
Incidence of guidance compliance
Time Frame
6 months
Title
Effect of educational intervention on providers' recommendations
Description
Incidence of guidance compliance
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Patients' belief in the value of screening
Description
measured by survey to be determined
Time Frame
Baseline
Title
Patients' belief in the value of screening
Description
measured by survey to be determined
Time Frame
3 months
Title
Patients' belief in the value of screening
Description
measured by survey to be determined
Time Frame
6 months
Title
Patients' belief in the value of screening
Description
measured by survey to be determined
Time Frame
12 months
Title
Patient compliance
Description
measured by self- report in surveys to be determined
Time Frame
Baseline
Title
Patient compliance
Description
measured by self- report in surveys to be determined
Time Frame
3 months
Title
Patient compliance
Description
measured by self- report in surveys to be determined
Time Frame
6 months
Title
Patient compliance
Description
measured by self- report in surveys to be determined
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Patient life expectancy of less than 1 year in primary care provider's judgment Inability to read and understand English Transgender status
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James A Talcott, MD SM
Organizational Affiliation
Mount Sinai Beth Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Beth Israel
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
St. Luke's-Roosevelt
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States

12. IPD Sharing Statement

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Improving Compliance With Medical Testing Guidelines

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