Improving Compliance With Medical Testing Guidelines

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: Cervical Cancer; Breast Cancer; Lung Cancer; Prostate Cancer; Colon Cancer
• Intervention / Treatment: Other: Standard support; Other: No academic detailing; Other: Academic detailing; Other: Color-coded materials

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

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

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

How is the study designed?

Design Details

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

Number of Arms

4

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	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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Beth Israel Medical Center
• Investigators: Principal Investigator: James A Talcott, MD SM, Mount Sinai Beth Israel

Study record dates

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: Screening; Shared Decision Making
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Uterine Cervical Neoplasms; Colonic Neoplasms
• Other Study ID Numbers: OGARA CAN-264