Improving Compliance With Medical Testing Guidelines

Study Overview
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Brief Summary
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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
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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.

Official Title
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Improving Compliance With Medical Testing Guidelines

Conditions
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Breast Cancer, Cervical Cancer, Prostate Cancer, Colon Cancer, Lung Cancer

Intervention / Treatment
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* Other: Color-coded materials
* Other: Academic detailing
* Other: Standard support
* Other: No academic detailing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Support Outreach<br>Providers receive standard written screening recommendations and do not receive academic detailing (educational outreach) | Other: Standard support<br>* Screening recommendations presented in standard format<br>Other: No academic detailing<br>* Physician receives study orientation for not the academic detailing curriculum<br>|
| Experimental: Standard materials and academic detailing<br>Providers receive standard written screening recommendations and receive academic detailing (educational outreach) | Other: Academic detailing<br>* Educational outreach to address the rationale and data supporting recommendations for and against screening<br>Other: Standard support<br>* Screening recommendations presented in standard format<br>|
| Experimental: Color-coded materials and no academic detailing<br>Providers receive color-coded written screening recommendations and do not receive academic detailing (educational outreach) | Other: Color-coded materials<br>* A summary of treatment recommendations for each cancer screening is color-coded to indicate the strength and direction of the recommendation<br>Other: No academic detailing<br>* Physician receives study orientation for not the academic detailing curriculum<br>|
| Experimental: Color-coded materials and academic detailing<br>Providers receive color-coded written screening recommendations and receive academic detailing (educational outreach) | Other: Color-coded materials<br>* A summary of treatment recommendations for each cancer screening is color-coded to indicate the strength and direction of the recommendation<br>Other: Academic detailing<br>* Educational outreach to address the rationale and data supporting recommendations for and against screening<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Screening, Shared Decision Making