Improving Compliance With Medical Testing Guidelines

Breast Cancer Clinical Trial

Official title:

Improving Compliance With Medical Testing Guidelines

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02430948
• Other study ID #: OGARA CAN-264
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: February 2017

Study information

• Verified date: July 2019
• Source: Beth Israel Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 218
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Cervical Cancer
• Colon Cancer
• Lung Cancer
• Prostate Cancer
• Uterine Cervical Neoplasms

Intervention

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
• Academic detailing
Educational outreach to address the rationale and data supporting recommendations for and against screening
• Standard support
Screening recommendations presented in standard format
• No academic detailing
Physician receives study orientation for not the academic detailing curriculum

Locations

Country	Name	City	State
United States	Mount Sinai Beth Israel	New York	New York
United States	St. Luke's-Roosevelt	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of educational intervention on providers' recommendations	Incidence of guidance compliance	Baseline
Primary	Effect of educational intervention on providers' recommendations	Incidence of guidance compliance	3 months
Primary	Effect of educational intervention on providers' recommendations	Incidence of guidance compliance	6 months
Primary	Effect of educational intervention on providers' recommendations	Incidence of guidance compliance	12 months
Secondary	Patients' belief in the value of screening	measured by survey to be determined	Baseline
Secondary	Patients' belief in the value of screening	measured by survey to be determined	3 months
Secondary	Patients' belief in the value of screening	measured by survey to be determined	6 months
Secondary	Patients' belief in the value of screening	measured by survey to be determined	12 months
Secondary	Patient compliance	measured by self- report in surveys to be determined	Baseline
Secondary	Patient compliance	measured by self- report in surveys to be determined	3 months
Secondary	Patient compliance	measured by self- report in surveys to be determined	6 months
Secondary	Patient compliance	measured by self- report in surveys to be determined	12 months