Improving Compliance With Medical Testing Guidelines

NCT02430948 — Not applicable, Completed, 218 participants, Beth Israel Medical Center

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Registry	NCT02430948
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, factorial, masking: none, screening
Enrollment	218 (Actual)
Sponsor	Beth Israel Medical Center (Other)
Conditions	Breast Cancer, Cervical Cancer, Prostate Cancer, Colon Cancer, Lung Cancer
Interventions	Color-coded materials, Academic detailing, Standard support, No academic detailing (Other)
Dates	start 2014-01-01, primary completion 2017-02-01, completion 2017-02-01, first posted 2015-04-30, last updated 2019-07-26
Locations	2 sites in United States

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Standard Support Outreach	Active comparator	Other: Standard support; Other: No academic detailing	Providers receive standard written screening recommendations and do not receive academic detailing (educational outreach)
Standard materials and academic detailing	Experimental	Other: Academic detailing; Other: Standard support	Providers receive standard written screening recommendations and receive academic detailing (educational outreach)
Color-coded materials and no academic detailing	Experimental	Other: Color-coded materials; Other: No academic detailing	Providers receive color-coded written screening recommendations and do not receive academic detailing (educational outreach)
Color-coded materials and academic detailing	Experimental	Other: Color-coded materials; Other: Academic detailing	Providers receive color-coded written screening recommendations and receive academic detailing (educational outreach)

Color-coded materials (Other): A summary of treatment recommendations for each cancer screening is color-coded to indicate the strength and direction of the recommendation
Academic detailing (Other): Educational outreach to address the rationale and data supporting recommendations for and against screening
Standard support (Other): Screening recommendations presented in standard format
No academic detailing (Other): Physician receives study orientation for not the academic detailing curriculum

+Outcome measures

Primary outcomes

Effect of educational intervention on providers' recommendations [Baseline]: Incidence of guidance compliance
Effect of educational intervention on providers' recommendations [3 months]: Incidence of guidance compliance
Effect of educational intervention on providers' recommendations [6 months]: Incidence of guidance compliance
Effect of educational intervention on providers' recommendations [12 months]: Incidence of guidance compliance

Secondary outcomes

Patients' belief in the value of screening [Baseline]: measured by survey to be determined
Patients' belief in the value of screening [3 months]: measured by survey to be determined
Patients' belief in the value of screening [6 months]: measured by survey to be determined
Patients' belief in the value of screening [12 months]: measured by survey to be determined
Patient compliance [Baseline]: measured by self- report in surveys to be determined
Patient compliance [3 months]: measured by self- report in surveys to be determined
Patient compliance [6 months]: measured by self- report in surveys to be determined
Patient compliance [12 months]: measured by self- report in surveys to be determined

+Eligibility

Sex: All, ages: 30 Years to 89 Years, accepts 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

+Locations (2)

Facility	City	Country	Status
Mount Sinai Beth Israel	New York, New York	United States
St. Luke's-Roosevelt	New York, New York	United States

+Investigators

James A Talcott, MD SM, Principal investigator, Mount Sinai Beth Israel