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

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

51 year–74 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Meuhedet

Tel Aviv, Israel

About this study

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:

Describe the magnitude of the problem
Map the barriers to adherence with colonoscopy recommendations among patients, physicians and geographic availability of colonoscopies facilities.
Suggest intervention models for physicians, patients and organisations according to the information provided by data collection.
Recommendation to decision makers on the implementation of national policy intervention.

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

None

Treatment and study plan

Primary outcomes

Variables related to non-completion of colonoscopy following a positive fecal occult blood test

Time frame: 18 months

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),

Sponsors and collaborators

Lead sponsor

Meuhedet. Healthcare Organization

Other

Collaborators

Bar-Ilan University, Israel

Registry information

Important dates

Study start: 2015
Primary completion: 2017
Study completion: 2017
First posted: Aug 27, 2015
Registry last updated: Aug 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed