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

NCT ID: NCT02534142

Last Updated: 2018-08-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 774 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2017-12-20

Brief 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.

Detailed 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.

Conditions

Colorectal Cancer

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Completed followup

All members aged 50-74 who completed a fecal occult blood test between 1/1/2014 and 1/1/2015, who had a positive result and had a colonoscopy following the result.

No interventions assigned to this group

Did not complete followup

All members aged 50-74 who completed a fecal occult blood test between 1/1/2014 and 1/1/2015, who had a positive result and did not have a colonoscopy following the result.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

None

• Minimum Eligible Age: 51 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bar-Ilan University, Israel

OTHER

Sponsor Role: collaborator

Meuhedet. Healthcare Organization

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Revital Azulay, MSC

Role: PRINCIPAL_INVESTIGATOR

Meuhedet Health Care

Locations

Meuhedet

Tel Aviv, , Israel

Countries

Israel

References

Azulay R, Valinsky L, Hershkowitz F, Magnezi R. Is the patient activation measure associated with adherence to colonoscopy after a positive fecal occult blood test result? Isr J Health Policy Res. 2018 Dec 21;7(1):74. doi: 10.1186/s13584-018-0270-8.

Reference Type: DERIVED

PMID: 30577883 (View on PubMed)

Other Identifiers

01-20-05-15

Identifier Type: -

Identifier Source: org_study_id