Partnership for Healthy Seniors

NCT00379743 | Completed

• 1 other identifier: IRB00000063
• Study Type: interventional
• Target: 2,593
• Locations: 1 country
• Sites: 1

Brief Summary

The Centers for Medicare and Medicaid Services (CMS) has awarded cooperative agreements to 6 sites from across the country (Salt Lake City, UT, Molokai, HI, Houston, TX, Newark, NJ, Detroit, MI, and Baltimore City) to participate in a national 4-year demonstration (September 15, 2006 to September 30, 2010). One goal of the demonstration is to reduce disparities in cancer screening among seniors from U.S. racial and ethnic minority populations. Each site will focus on a specific racial/ethnic minority group, and collaborate with CMS in project implementation. A Core questionnaire, the Cancer Screening Assessment (CSA) will be administered at baseline to all participants in the demonstration. Participant identification, randomization, and intervention implementation will be standardized across sites. Goal: The proposal developed by the Johns Hopkins Bloomberg School of Public Health in collaboration with the Baltimore City Community Health Coalition is designed to address persistent disparities in screening for breast, cervix, colon/rectum and prostate cancer among Baltimore City's seniors. Primary Objective: Conduct a randomized controlled trial (target N = 2,874) within a project, to compare the efficacy of 2 interventions that differ in intensity to improve continuity and outcomes of care among African Americans seniors. Among African American seniors, compared to a less intensive intervention (general information and educational materials), does the addition of facilitation services delivered by a health coordinator result in a greater improvement in adherence to cancer screening recommendations among those who are not known to have cancer? Study Population: We will recruit African American residents of Baltimore, age 65 years or older, and currently enrolled in Medicare Parts A and B. (Baltimore City's 82,202 seniors represent 13% of its population, and account for 68% of the City's cancer deaths. Among these seniors, 96% have Medicare Parts A and B, 54.5% have income levels at less than 250% of the federal poverty guideline, and 55.6% are African American.) Eligible participants will respond to a baseline questionnaire, Cancer Screening Assessment (CSA). They will then be randomized to receive a less intensive or more intensive intervention. The less intensive group will receive general information about cancer and Medicare covered services, and instructions to discuss the information with their primary care doctor. The more intensive group will receive the same information as the less intensive group receives, plus tailored facilitation services delivered by a nurse-supervised community health worker. The primary outcome variable will be the difference between randomized groups in adherence to screening for breast, cervix, colon/rectum and prostate cancer. A community advisory committee will guide all aspects of the study and will include important stake holders (both public and private sectors), representatives from the Baltimore City Community Health Coalition, the Baltimore City Department of Health, the Maryland Department of Health and Mental Hygiene, community leaders, consumers, health care providers (physicians, oncologists, nurse practitioners, physician assistants, nurses, social workers, pathologists) and academicians.

Conditions

Breast Cancer; Colon Cancer; Rectum Cancer; Cervix Cancer; Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Difference between the two intervention groups in the proportion of participants who complete at least one of the recommended screenings.

  Number of days from date of randomization to date of completion of participation in the study

Secondary Outcomes (7)

• Adherence to maintenance screening.

  Number of days beyond extended window for completion of a specific screening test

• Timely notification of abnormal screening results.

  Number of days between detection of an abnormal screening result and participant notification about the results

• Timely follow up with specialist following abnormal screening result.

  From date of detection of an abnormal screening result to date of visit with specialist

• Timely diagnosis following abnormal result.

  From date of detection of an abnormal screening result to date of diagnosis

• Timely treatment start-up.

  Number of days from the date of diagnosis to date of initiation of therapy

Study Arms (1)

2

ACTIVE COMPARATOR

Individuals randomized to this arm receive the following interventions: 1) educational materials on recommended cancer-preventive services, plus 2) a health coordinator (patient navigator) who helps the participant schedule and keep appointments for cancer screening and/or treatment.

Behavioral: Health coordinator (or patient navigator); Behavioral: Educational materials only

Interventions

Health coordinator (or patient navigator) BEHAVIORAL

Individuals randomized to receive the less intensive intervention receive educational materials only. Those randomized to the more intensive intervention are assigned a health coordinator (patient navigator) who delivers an enhanced, tailored educational intervention after review of the participant's screening history and knowledge gaps about cancer. The health coordinator also facilitate adherence to cancer screening and/or treatment services, by assisting in scheduling and keeping of appointments for cancer-related screening and/or treatment services.

2

Educational materials only BEHAVIORAL

A brochure is provided to the participant with information about preventive services covered by Medicare, and the frequency with which those services should be obtained.

2

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Age 65 or older;
• Residence in Baltimore;
• Enrolled in Medicare Part A;
• Enrolled in Medicare Part B of Title XVIII of the Social Security Act;
• Provided informed consent;
• Must be free from cancer or in remission for 5 years or more

You may not qualify if:

• Age less than 65;
• Residence outside of Baltimore;
• Enrollment in Medicare managed care (Part C);
• Residence in a chronic care facility or otherwise institutionalized;
• Planning to move within the next year;
• Unable or unwilling to give informed consent;
• Diagnosed with cancer within 5 years or less;
• Diagnosed with cancer more than 5 years ago, but cancer in remission for less than 5 years

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• Centers for Medicare and Medicaid Services: collaborator

Study Sites (1)

Bloomberg School of Public Health

Baltimore, Maryland, 21205, United States

Location

Related Publications (1)

• Martinez KA, Pollack CE, Phelan DF, Markakis D, Bone L, Shapiro G, Wenzel J, Howerton M, Johnson L, Garza MA, Ford JG. Gender differences in correlates of colorectal cancer screening among Black Medicare beneficiaries in Baltimore. Cancer Epidemiol Biomarkers Prev. 2013 Jun;22(6):1037-42. doi: 10.1158/1055-9965.EPI-12-1215. Epub 2013 Apr 29.

  PMID: 23629519 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Colonic Neoplasms; Rectal Neoplasms; Uterine Cervical Neoplasms; Prostatic Neoplasms

Interventions

Patient Navigation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Patient-Centered Care; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Adrian Dobs, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2006
• First Posted: September 22, 2006
• Study Start: October 1, 2006
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: April 26, 2018

Record last verified: 2018-04

Locations

US (1)