May 30, 2013

Continuity of care initiative focuses on patients exiting clinical trials

The Vanderbilt Breast Center is piloting new measures to ensure continuity of care and timely insurance preauthorization as patients come off grant-sponsored clinical trial protocols and begin or resume standard care.

The Vanderbilt Breast Center is piloting new measures to ensure continuity of care and timely insurance preauthorization as patients come off grant-sponsored clinical trial protocols and begin or resume standard care.

The pilot is part of a planned Vanderbilt University Medical Center project to integrate clinical trials with normal clinic operations.

At Vanderbilt-Ingram Cancer Center, scores of clinical trials are in progress continually. As patients move on and off of sponsored clinical trials, not only may their treatment and medical monitoring change significantly, their patient care team may change, their clinic scheduling process may change, billing may change and so on.

“It’s good when clinical trials nurses and clinic nurses can begin speaking each other’s language. Things go much better when clinic nurses receive adequate advanced word from the clinical trials side about individual treatment plans of patients who are returning to standard of care, and about drug protocols and how they may weigh in the care of patients returning to standard of care,” said Vicki Richard, MBA, R.N., assistant administrator of the Cancer Patient Care Center.

One of the highlights of the Breast Center’s pilot is a new nurse handover process. Once the provider tells the clinical trials nurse that the patient is leaving a clinical trial:

• The clinical trials nurse asks the provider for the plan of care and passes complete nursing handover information to the clinic nurse.

• The clinical trials nurse introduces the patient to the clinic nurse in person in the clinic.

• The clinic nurse gets prompt payer preauthorization for treatment

Patients often come off clinical trials when an experimental drug they’ve been taking suddenly gains FDA approval, and in such cases the clinic nurse taking over nursing care from the clinical trials nurse may need to be brought up to speed on management of the new drug. In other cases patients may undergo a wholesale change of treatment when they leave a clinical trial.

When patients begin or resume standard care, if the Medical Center hasn’t completed insurance pre-authorization, VUMC can suddenly find itself on the hook for treatment costs.

The new handover process was designed by Breast Center clinical trials nurse Glenda Beals, R.N., and clinic nurse Andrea Whitis, R.N., with support from Sheryl Redlin-Frazier, R.N., manager of the Breast Center, and Julie Scott, R.N., clinical trials manager.

“The patient experience has been the focal point for this initiative, and Breast Center patients have greeted these changes. We’ve also seen an increase in nurse satisfaction,” said Teresa Knoop, MSN, R.N., assistant director of the VICC Clinical Trials Shared Resource.

Knoop and Richard are co-leaders of VICC’s Clinical Trials Integration Project. Beyond improved handovers and check-out processes, clinical trials integration efforts in the Breast Center include revised administrative and billing processes, new levels of pharmacy and scheduling services, and separate waiting areas for clinical trials patients (who sometimes must spend all day at the clinic).