Redefining Clinical Science: A Researcher Challenges Perceptions About a Community in Need

VOLUME 10, NUMBER 4

JORDAN J. COHEN, M.D., PRESIDENT

JANUARY 2001

Redefining Clinical Science: A Researcher Challenges Perceptions About a Community in Need

By Barbara A. Gabriel

Dr. Martha Hill's clinical trials bring home care to East Baltimore's residents.

In 1992, Martha Hill, Ph.D., R.N., set out to prove the clinical research community wrong. She knew that young, urban black men suffered disproportionately high rates of undetected, untreated, and uncontrolled high blood pressure. She also knew that conventional wisdom among clinical researchers and other health care professionals held that this particular population was virtually impossible to identify, follow, and retain in both high blood pressure treatment protocols and clinical trials.

So Dr. Hill, director of the Center for Nursing Research at Johns Hopkins University, did something few other clinical researchers do. She left her office and went to where her potential subjects lived: the poor, urban, predominantly African-American community of East Baltimore.

"I started by asking myself, 'What would it take to conduct a successful clinical trial of young, hypertensive black men?'" says Dr. Hill. "And then I went out into the community and asked my potential subjects the same question. Through street interviews and focus groups, the men told us what they would require to participate in an ongoing clinical trial."

Dr. Hill next organized a staff committed to establishing meaningful relationships with her target population and who understood their specific needs. Often, that meant hiring workers from the community she wished to study. Today, Dr. Hill's staff of seven and investigative team of 20 includes high school students from East Baltimore who work as research assistants and often continue working for her into their college years.

Dr. Hill's first study, which spanned 1992-1995, enrolled 204 participants who received access to support, reinforcement, and education about high blood pressure. Determined to dispel the myth that her target group could not be tracked in a clinical trial, Dr. Hill built into the study lessons learned from the social and behavioral sciences, involving the men in decisions about their high blood pressure care and control and eliciting the help of their family and friends to maintain contact with them. Her efforts resulted in a retention rate after one year of 86 percent, proving her ability to identify, recruit, and follow a population previously believed to be extremely difficult, if not impossible, to retain in clinical studies.

Despite a high retention rate, Dr. Hill was unable to show a significant decline in blood pressure in the group that received special interventions. She explains that because the study focused solely on support and reinforcement and did not include funding for medical care, the interventions were insufficient to make a statistically significant difference. However, in 1996, Dr. Hill was able to procure funding from the NIH and two corporate sponsors for a larger study in which 309 men currently receive free medications and clinical care, and a randomly selected subgroup also receives interventions provided by special nurse practitioner-community health worker-physician (NP-CHW-MD) teams.

Dr. Hill explains that this unique approach treats men within a socioeconomic context that takes into account the formidable barriers to controlling their high blood pressure. "When asked, 'What do you lie awake at night worrying about?' the men's most common answer is getting and keeping a job. Controlling their high blood pressure is often at the bottom of their priority lists," she notes. "This population is dealing with a high rate of substance abuse, over half have a history of incarceration, half are unemployed, and there are almost no jobs available in their vicinity. To make their health more of a concern, these other priorities must first be addressed."

Mary Roary, who began working with Dr. Hill in 1992 and has since risen to the post of project director, explains how the NP-CHW-MD care model works: "The nurse and doctor tend to the man's health care needs, while the community health worker helps him find a job and housing, and can even help him get into rehab programs for drug and alcohol abuse," she explains. "The community health worker ties the medical and community model together so that the men have a well-rounded, caring system in place. The teams hold weekly meetings to review individual cases and make sure the men are following through with their medication and treatment regimens."

Dr. Hill also takes pains to ensure that each interaction the men in her study have with health care workers is characterized by courtesy and respect. "One time I asked a young man with high blood pressure if he had seen a doctor, and he replied, 'I don't do doctors. They talk down to you. They're not interested in guys like me.' It occurred to me that if these men were treated with more compassion and respect, the result would trickle down to improved health outcomes."

Both the study's special intervention group and the control group have shown significant lowering from their baseline blood pressures, with the special intervention group benefiting more. The study, for which funding has been procured through 2002, also has produced data sets pertaining to basic and clinical science, genetics, community health, and the effects of psychosocial factors and variables on health.

"To be able to do all of that in a single study lends it a breadth that is just thrilling," Dr. Hill says. "This study is a marvelous vehicle for cross-disciplinary education and training, and it can be a wonderful contribution to other researchers struggling with the practicalities of studying hard-to-reach populations."

Information: Mary Roary, (410) 614-1449