Clinical trial NCT02430948: Improving Compliance With Medical Testing Guidelines
Official title: Improving Compliance With Medical Testing Guidelines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Cervical Cancer
Prostate Cancer
Colon Cancer
Lung Cancer
Keywords: Screening
Shared Decision Making
Lead sponsor: Beth Israel Medical Center
Sponsor class: OTHER
First posted: 2015-04-30
Enrollment: 218
Sex: ALL
Minimum age (years): 30
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SCREENING

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.

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

Primary outcomes:
measure: Effect of educational intervention on providers' recommendations
timeFrame: Baseline
measure: Effect of educational intervention on providers' recommendations
timeFrame: 3 months
measure: Effect of educational intervention on providers' recommendations
timeFrame: 6 months
measure: Effect of educational intervention on providers' recommendations
timeFrame: 12 months
Secondary outcomes:
measure: Patients' belief in the value of screening
timeFrame: Baseline
measure: Patients' belief in the value of screening
timeFrame: 3 months
measure: Patients' belief in the value of screening
timeFrame: 6 months
measure: Patients' belief in the value of screening
timeFrame: 12 months
measure: Patient compliance
timeFrame: Baseline
measure: Patient compliance
timeFrame: 3 months
measure: Patient compliance
timeFrame: 6 months
measure: Patient compliance
timeFrame: 12 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Beth Israel
state: New York
city: New York
country: United States
facility: St. Luke's-Roosevelt
state: New York
Study officials:
affiliation: Mount Sinai Beth Israel
name: James A Talcott, MD SM
role: PRINCIPAL_INVESTIGATOR
References: