Improving Compliance With Medical Testing Guidelines

NCT ID: NCT02430948

Last Updated: 2019-07-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 218 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2017-02-28

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.

Conditions

Breast Cancer; Cervical Cancer; Prostate Cancer; Colon Cancer; Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Standard Support Outreach

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

Group Type: ACTIVE_COMPARATOR

Standard support

Intervention Type: OTHER

Screening recommendations presented in standard format

No academic detailing

Intervention Type: OTHER

Physician receives study orientation for not the academic detailing curriculum

Standard materials and academic detailing

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

Group Type: EXPERIMENTAL

Academic detailing

Intervention Type: OTHER

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

Standard support

Intervention Type: OTHER

Screening recommendations presented in standard format

Color-coded materials and no academic detailing

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

Group Type: EXPERIMENTAL

Color-coded materials

Intervention Type: OTHER

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

No academic detailing

Intervention Type: OTHER

Physician receives study orientation for not the academic detailing curriculum

Color-coded materials and academic detailing

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

Group Type: EXPERIMENTAL

Color-coded materials

Intervention Type: OTHER

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

Academic detailing

Intervention Type: OTHER

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

Interventions

Color-coded materials

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

Intervention Type: OTHER

Academic detailing

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

Intervention Type: OTHER

Standard support

Screening recommendations presented in standard format

Intervention Type: OTHER

No academic detailing

Physician receives study orientation for not the academic detailing curriculum

Intervention Type: OTHER

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Beth Israel Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James A Talcott, MD SM

Role: PRINCIPAL_INVESTIGATOR

Mount Sinai Beth Israel

Locations

Mount Sinai Beth Israel

New York, New York, United States

St. Luke's-Roosevelt

New York, New York, United States

Countries

United States

Other Identifiers

OGARA CAN-264

Identifier Type: -

Identifier Source: org_study_id