Clinical trial NCT02534142: Colonoscopy Followup After Positive Fecal Occult Blood Test- Understanding Barriers to Adherence
Official title: Colonoscopy Followup After Positive Fecal Occult Blood Test- Understanding Barriers to Adherence
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Lead sponsor: Meuhedet. Healthcare Organization
Sponsor class: OTHER
Collaborators: name: Bar-Ilan University, Israel
First posted: 2015-08-27
Enrollment: 774
Sex: ALL
Minimum age (years): 51
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: a representative sample of Meuhedet members who adhered / did not adhere to followup of a positive fecal occult blood test using colonoscopy

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

None

Primary outcomes:
measure: Variables related to non-completion of colonoscopy following a positive fecal occult blood test
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Meuhedet
Study officials:
affiliation: Meuhedet Health Care
name: Revital Azulay, MSC
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.