Colonoscopy Followup After Positive Fecal Occult Blood Test- Understanding Barriers to Adherence

Colorectal Cancer Clinical Trial

Official title:

Colonoscopy Followup After Positive Fecal Occult Blood Test- Understanding Barriers to Adherence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02534142
• Other study ID #: 01-20-05-15
• Status: Completed
• Start date: October 2015
• Est. completion date: December 20, 2017

Study information

• Verified date: August 2018
• Source: Meuhedet. Healthcare Organization
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Approximately 40% of members with a positive fecal occult blood result do not continue to followup colonoscopy in Meuhedet. The purpose of this study is to identify the structural, process, carer and patient related causes of undertreatment and suggest appropriate organisational interventions. Using both quantitative and qualitative methods, the investigators will identify organisational and personal barriers to completion of followup of positive FOBT.

Description:

Colorectal cancer is the second in incidence and mortality among malignant tumors. Early detection of the disease is an effective means of reducing mortality and is possible through a fecal occult blood test. In the case of a positive result colonoscopy is required. In Israel, about 30% of people with a positive occult blood test do not perform a follow-up test.

The aim of the study is to identify existing barriers to undergoing colonoscopy in a normal-risk population and improving adherence through different intervention mechanisms. At the end of the study we will describe effective intervention models at three levels: the patient, physicians and the organisation to improve early detection of colon cancer.

Innovation of the Study

• It will focus on the normal-risk population groups in Israel with a positive occult blood that didn't undergo colonoscopy.

• Will identify the barriers in diverse populations

• Will review the accessibility of diagnostic facilities forcolon cancer in Israel.

• Will propose intervention programs to improve adherence at all levels in the process.

Study Methods: A prospective study sing both both quantitative and qualitative methods in Meuhedet Health Services Target Population: Health system managers, physicians, and patients (a representative sample of 200 patients adhere colonoscopy and 600 that didn't adhere). Data collection databases from Meuhedet. The study will include questionnaires, focus groups and interviews.

Stages of the study:

1. Describe the magnitude of the problem

2. Map the barriers to adherence with colonoscopy recommendations among patients, physicians and geographic availability of colonoscopies facilities.

3. Suggest intervention models for physicians, patients and organisations according to the information provided by data collection.

4. Recommendation to decision makers on the implementation of national policy intervention.

Data processing: will use SPSS statistical analysis with the types of variables.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 774
• Est. completion date: December 20, 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 51 Years to 74 Years

Eligibility

Inclusion Criteria:

Members of MHC aged 50-74 who completed a fecal occult blood test during the study period.

Exclusion Criteria:

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Locations

Country	Name	City	State
Israel	Meuhedet	Tel Aviv

Sponsors (2)

Lead Sponsor	Collaborator
Meuhedet. Healthcare Organization	Bar-Ilan University, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Variables related to non-completion of colonoscopy following a positive fecal occult blood test	Quantitative and qualitative variables associated with non-completion of colonoscopical followup among members with a positive screening fecal occult test result: Availability and distance variables (hours, kms), Patient knowledge and awareness (questionnaire scores), Physician knowledge and awareness (qualitative data),	18 months