Improving Compliance With Medical Testing Guidelines

July 25, 2019 updated by: Beth Israel Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

218

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10019
        • St. Luke's-Roosevelt
      • New York, New York, United States, 10003
        • Mount Sinai Beth Israel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 89 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard Support Outreach
Providers receive standard written screening recommendations and do not receive academic detailing (educational outreach)
Other: Standard support
Screening recommendations presented in standard format
Other: No academic detailing
Physician receives study orientation for not the academic detailing curriculum
Experimental: Standard materials and academic detailing
Providers receive standard written screening recommendations and receive academic detailing (educational outreach)
Other: Standard support
Screening recommendations presented in standard format
Other: Academic detailing
Educational outreach to address the rationale and data supporting recommendations for and against screening
Experimental: Color-coded materials and no academic detailing
Providers receive color-coded written screening recommendations and do not receive academic detailing (educational outreach)
Other: No academic detailing
Physician receives study orientation for not the academic detailing curriculum
Other: Color-coded materials
A summary of treatment recommendations for each cancer screening is color-coded to indicate the strength and direction of the recommendation
Experimental: Color-coded materials and academic detailing
Providers receive color-coded written screening recommendations and receive academic detailing (educational outreach)
Other: Academic detailing
Educational outreach to address the rationale and data supporting recommendations for and against screening
Other: Color-coded materials
A summary of treatment recommendations for each cancer screening is color-coded to indicate the strength and direction of the recommendation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of educational intervention on providers' recommendations
Time Frame: Baseline
Incidence of guidance compliance
Baseline
Effect of educational intervention on providers' recommendations
Time Frame: 3 months
Incidence of guidance compliance
3 months
Effect of educational intervention on providers' recommendations
Time Frame: 6 months
Incidence of guidance compliance
6 months
Effect of educational intervention on providers' recommendations
Time Frame: 12 months
Incidence of guidance compliance
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients' belief in the value of screening
Time Frame: Baseline
measured by survey to be determined
Baseline
Patients' belief in the value of screening
Time Frame: 3 months
measured by survey to be determined
3 months
Patients' belief in the value of screening
Time Frame: 6 months
measured by survey to be determined
6 months
Patients' belief in the value of screening
Time Frame: 12 months
measured by survey to be determined
12 months
Patient compliance
Time Frame: Baseline
measured by self- report in surveys to be determined
Baseline
Patient compliance
Time Frame: 3 months
measured by self- report in surveys to be determined
3 months
Patient compliance
Time Frame: 6 months
measured by self- report in surveys to be determined
6 months
Patient compliance
Time Frame: 12 months
measured by self- report in surveys to be determined
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beth Israel Medical Center

Investigators

  • Principal Investigator: James A Talcott, MD SM, Mount Sinai Beth Israel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

September 29, 2014

First Submitted That Met QC Criteria

April 27, 2015

First Posted (Estimate)

April 30, 2015

Study Record Updates

Last Update Posted (Actual)

July 26, 2019

Last Update Submitted That Met QC Criteria

July 25, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OGARA CAN-264

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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