Patient Navigation in the Safety Net:CONNECTeDD

Sponsor

Boston Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT00613275

Collaborator

(none)

4,038

Enrollment

Location

Duration (Months)

54.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The Boston University Medical Center, funded by the National Cancer Institutes will train health workers at six of its affiliated Community Health Centers to guide patients through the cancer care system. The project will help to teach patients how to communicate more effectively with their health care team in order to understand the treatment options available to them. Although not widely available, it is believed patient navigation programs are beneficial.

This research study will evaluate how well this tool works, especially among those who experience disparities in health care. The goal is to determine if having a trained navigator shortens the time between an abnormal test result and a definitive diagnosis and between a definitive diagnosis and completion of treatment for breast and Cervical cancer patients. The project also will evaluate whether navigation improves the ability to communicate with the doctor, satisfaction with patient's care and quality of life.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Cervical Cancer	Other: patient Navigation	Phase 4

Detailed Description

Racial and ethnic minority groups and low-income persons experience significantly higher cancer mortality rates than other Americans. These disparities are due to at least two factors: (1) delays in follow-up of abnormal cancer screening results and (2) suboptimal management of diagnosed cancer. Patient navigation represents a promising means for addressing disparities by improving cancer related management for minority and other underserved populations. However, patient navigation for cancer has yet to be evaluated through a well-designed randomized controlled trial. Furthermore, patient navigation is likely to prove most effective and sustainable when it is integrated into primary care and helps patients be more active in their care. This combination of patient empowerment and engagement is referred to as "activation." The aim of this project is to evaluate the effectiveness and costs of such a program in a rigorous manner so that the results can be generalized and the program can be widely disseminated and implemented. We will develop, implement, and evaluate a primary care-based, patient navigation-activation program using specially-trained patient Navigators who work within one of the six affiliated Community Health Centers. We propose to investigate the effect of this intervention on timing and quality of cancer-related care. Secondary aims examine the impact of navigation on disparities in care, improvement in patient activation, and total costs. Project findings will inform national policy regarding patient navigation for cancer.

Study Design

Study Type:

Interventional

Actual Enrollment :

4038 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

Patient Navigation in the Safety Net:CONNECTeDD

Study Start Date :

Jul 1, 2005

Actual Primary Completion Date :

Jun 1, 2010

Actual Study Completion Date :

Sep 1, 2011

Outcome Measures

Primary Outcome Measures

Develop,implement and evaluate a primary care-based,patient navigation program using patient navigators in the Community Health Centers. We will investigate the effect of this intervention on timing and quality of cancer-related care [4 years]

Secondary Outcome Measures

Secondary aims examine the impact of navigation on disparities in care, improvement in patient activation and total costs [4 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Receive care at one of the 6 participating community Health centers
Have received a positive breast or colorectal cancer screening test requiring follow-up on a different day
Have been newly diagnosed with breast or colorectal cancer
Have received notification by the provider of an abnormal breast or colorectal screening result

Exclusion Criteria:

Cognitively impaired
Institutionalized (nursing home, incarcerated)
Children <18
Actively involved in cancer treatment at time of presentation
Currently or previously navigated with (a) navigation documented in the medical record or (b) patient can articulate that they are in a navigation program or case management program for cancer