Improving Compliance With Medical Testing Guidelines

Sponsor
Beth Israel Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT02430948
Collaborator
(none)
218
2
4
37
109
2.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Color-coded materials
  • Other: Academic detailing
  • Other: Standard support
  • Other: No academic detailing
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
218 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
Improving Compliance With Medical Testing Guidelines
Study Start Date :
Jan 1, 2014
Actual Primary Completion Date :
Feb 1, 2017
Actual Study Completion Date :
Feb 1, 2017

Arms and Interventions

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: Academic detailing
Educational outreach to address the rationale and data supporting recommendations for and against screening

Other: Standard support
Screening recommendations presented in standard format

Experimental: Color-coded materials and no academic detailing

Providers receive color-coded written screening recommendations and do not receive academic detailing (educational outreach)

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

Other: No academic detailing
Physician receives study orientation for not the academic detailing curriculum

Experimental: Color-coded materials and academic detailing

Providers receive color-coded written screening recommendations and receive academic detailing (educational outreach)

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

Other: Academic detailing
Educational outreach to address the rationale and data supporting recommendations for and against screening

Outcome Measures

Primary Outcome Measures

  1. Effect of educational intervention on providers' recommendations [Baseline]

    Incidence of guidance compliance

  2. Effect of educational intervention on providers' recommendations [3 months]

    Incidence of guidance compliance

  3. Effect of educational intervention on providers' recommendations [6 months]

    Incidence of guidance compliance

  4. Effect of educational intervention on providers' recommendations [12 months]

    Incidence of guidance compliance

Secondary Outcome Measures

  1. Patients' belief in the value of screening [Baseline]

    measured by survey to be determined

  2. Patients' belief in the value of screening [3 months]

    measured by survey to be determined

  3. Patients' belief in the value of screening [6 months]

    measured by survey to be determined

  4. Patients' belief in the value of screening [12 months]

    measured by survey to be determined

  5. Patient compliance [Baseline]

    measured by self- report in surveys to be determined

  6. Patient compliance [3 months]

    measured by self- report in surveys to be determined

  7. Patient compliance [6 months]

    measured by self- report in surveys to be determined

  8. Patient compliance [12 months]

    measured by self- report in surveys to be determined

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 89 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mount Sinai Beth Israel New York New York United States 10003
2 St. Luke's-Roosevelt New York New York United States 10019

Sponsors and Collaborators

  • Beth Israel Medical Center

Investigators

  • Principal Investigator: James A Talcott, MD SM, Mount Sinai Beth Israel

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Beth Israel Medical Center
ClinicalTrials.gov Identifier:
NCT02430948
Other Study ID Numbers:
  • OGARA CAN-264
First Posted:
Apr 30, 2015
Last Update Posted:
Jul 26, 2019
Last Verified:
Jul 1, 2019
Keywords provided by Beth Israel Medical Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 26, 2019