Growing pains: Institution merges two very different CR centers

Staff morale was major obstacle

Research institutions often have more than one clinical research office or departments in which each handles its own CR duties, creating some duplication and inefficiencies along the way.

So what happens when an institution decides to merge two or more CR offices in hopes of creating a more efficient research organization?

The University of Kentucky in Lexington, KY, discovered the answer to this recently as it implemented major changes by merging two physically and philosophically different clinical research operations.

"We've undergone some growing pains in merging two, long-standing units with different focuses," says Linda Rice, RN, clinical operations director at the University of Kentucky Clinical Research Development and Operations Center (CR-DOC).

"We're in the process of looking at how we could create our center for clinical and translational science, and our leadership pulled together the two research groups and said, 'How could we look at an economy of scale to make ourselves efficient?'" Rice explains. "'Do we have duplicates of effort in these two groups? What if we brought the units together as one?' And that's where the journey begins."

The two units were put into the CR-DOC, a centralized unit, where there are inpatient and outpatient units, Rice adds.

There were two major obstacles to the merger: the first involved funding since each CR unit had very different budgeting structures; the second involved staffing and personnel needs, says Marietta Barton-Baxter, CCRC, administrative director at the University of Kentucky CR-DOC.

"The two units were so vastly different, and my biggest challenge was in figuring out how to manage that," Barton-Baxter says. "We had to look at our staffing needs and then figure out how we would merge the two to get economies of scale."

The unit Barton-Baxter managed operated under a service center model in which pharmaceutical companies and other sponsors funded trials. The second unit, which Rice managed, was a grant-funded model, Barton-Baxter explains.

"We ran into problems because we couldn't cross-cover one another, and that's what we needed," she adds. "So we had to look for other ways to accomplish that, and so we reallocated our positions in a way that will allow us to accomplish it."

When an institution merges two separate research units, the first question typically is whether it should start from scratch or reorganize existing staff, Rice notes.

"We decided to keep everyone we had and restructure from within," Rice says. "I'm glad we did it the way we did — it was less traumatizing to staff."

There remained morale and staffing problems because even the best-handled sort of change is difficult for people who have been at their jobs for a number of years, she adds.

"It was painful at times for me as a manager because I didn't always have buy-in," Rice says. "Change takes time for people to deal with, and this was a much longer process than if we'd shut down both units and started over with new employees."

Workers typically want stability in their jobs, Barton-Baxter notes.

"We were merging units and moving staff, and although we tried the best we could to manage the change, it was difficult for everyone," she explains. "Overall, we came up really well, but the challenge of change is tough."

Another major issue was that employees in the two units had never worked together, and so when they first were merged there was tension, Rice says.

"When we did any kind of event together, one group sat on one side of the room, and another sat on the other side," Rice says.

Research staff also had a lot of anxiety over their jobs, recalls Roxane Poskin, BA, manager of participant recruitment and marketing at the University of Kentucky CR-DOC.

Research employees feared losing their positions or their current job duties, she adds.

"We had a little bit of anxiety over whether we were keeping our jobs or not," Poskin says. "But they did find a way to pull us all together, and it's great now."

Clinical research employees also were concerned about changes in their work duties, says Poskin, who is a 10-year employee.

"They were trying to define everyone's roles," Poskin says.

As it turned out, Poskin's job duties did change, but in a positive way, she says.

"I'm back to doing quite a bit more graphics — I have a graphics artist background," she says. "I design posters, fliers, and Web sites, and I use all of these toward recruiting research participants."

Before the merger, Poskin was spending more of her work time talking to pharmaceutical companies about placing studies at the university.

Rice, Barton-Baxter, and Poskin describe some of the lessons learned during the CR units' merger:

Identify the units' differences and commonalities: "We had to find our commonalities," Rice says. "What was it that both groups did that was duplicated? How could we consolidate functions?"

As they looked for tasks and roles that overlapped, they found these differences:

- The units' staff had different knowledge and expertise and in different areas, Rice says;

- Nurses from the grant-funded unit predominantly were involved in data collection and nursing activities, while nurses from the private sponsor-funded unit were accustomed to being research coordinators, Rice explains;

- The sponsor-funded unit was a service unit that charged for services and recouped its costs, including infrastructure costs, and its employees were not as busy, Rice says;

- The grant-funded area had a busier study caseload, she adds.

"There wasn't a lot of staff we could use on both sides," Barton-Baxter notes.

"Until we started changing the model, the only positions we could utilize on both sides were those that were fully subsidized -- positions that were set in the service center, but weren't 100% reliant on the recharge [to grants]," she explains. "These were jobs that were subsidized by the university, including my position."

For example, Barton-Baxter works on specific studies only in the capacity of overseeing staff. But other employees, such as regulatory specialists, were assigned to specific studies, and their salaries had to be paid through grant recharges.

"If a principal investigator has a study contract with us to provide regulatory support, then our regulatory person works on his study and tracks her time to the quarter of an hour," Barton-Baxter says. "We charge that time directly to the grant."

Divide positions into tasks and duties: "I did some homework, checking with local clinical research organizations (CROs) to see what kind of services they offered," Rice says. "They broke down the coordinators position and found a cheaper way to manage studies."

For example, nurses were given tasks that had to be performed by someone at the nursing level, Rice says.

Then data managers would handle the paperwork, scheduling, and transcriptions, she adds.

"The CROs had a document and quality assurance manager who made sure data were in good shape," Rice says. "My supervisor liked the idea of a staffing model where you no longer had a nurse coordinator who ran everything and was managing the study by herself."

Since one of the goals of the merger was to reduce costs, they opted to adopt the staffing model approach, she adds.

"This created major duress," Rice says. "This created a lack of a sense of identity for some nurses who felt very tied to being a coordinator and controlling their environment and studies."

But it did save the organization money because it moved lower-skills tasks to lower-paid disciplines, rather than having high salary nurses drawing blood, scheduling patients, and transcribing information, Rice explains.

"The nurse is one of the highest-paid positions on our team, so if we can save nurses' time and let them do more nursing tasks while utilizing other people who can do the duties that do not require nursing skills, then it saves money," she adds.

The staffing change also made it possible for the merged unit to take on additional research projects without having to add more staff, Barton-Baxter says.

"That was a bonus for us, and that was the primary way in which we were able to achieve some economy of scale," Barton-Baxter adds.