Assessment of depressive symptoms during post-transplant follow-up care performed via telehealth.

Telehealth provides a successful medium for the treatment of depression and other mental health illnesses. Often, inadequate treatment for this condition is found in patients with chronic co-morbid conditions such as those presented by the transplant recipient, a population at risk for depression. One concern of healthcare providers is the inability to adequately screen for symptoms of depression. This secondary analysis describes depression screening of 138 transplant recipients receiving follow-up care via telehealth (TH) and standard care (SC) as part of a larger National Institute of Nursing Research-funded randomized clinical trial. Of subjects who consented, 70 (51%) were randomized to the TH portion of the study. Depressive symptoms were measured by the Center for Epidemiologic Studies-Depression (CES-D) survey at study entry and at 6 and 12 months postconsent into the study. Univariate and subgroup analyses using SAS found no differences between the TH (n = 70) and SC (n = 68) group for demographic and social characteristics. No differences in CES-D scores were found between TH and SC groups. The concern in adding distance in the care of this medically fragile population was not substantiated in this study.

Infection, rejection, and hospitalizations in transplant recipients using telehealth.

CONTEXT: Telehealth technology serves individuals who live in geographical areas that prohibit easy access to specialized health care and can provide transplant recipients with access to transplant center personnel for adjunctive follow-up care. OBJECTIVE: To compare infection, rejection, and hospitalization events in subjects randomized to telehealth or to standard posttransplant care. STUDY DESIGN, STUDY PARTICIPANTS, SETTING AND RESEARCH PROCEDURE: This longitudinal prospective study compared transplant outcomes (infections, rejections, and hospitalizations) of 106 subjects who were randomized to either the telehealth (n = 53) or standard care (n = 53) group and met the 6-month study end point. Sex, race, and transplant type were evenly distributed within the 2 groups. Subjects received primary follow-up care from nurse practitioners. The telehealth visits were conducted via live interactive sessions with digitized equipment used to perform physical examinations. MAIN OUTCOMES: Infections, rejections, and hospitalizations were summarized for each of the groups. Subgroup analyses were performed by sex, transplant type, and time since transplant. RESULTS: No differences were found between the telehealth and standard care groups for infections, rejections, or hospitalizations at the 6-month data end point. Overall, females had twice as many infections as males (P = .01). In this analysis, group assignment did not affect study outcomes. CONCLUSIONS: The rates of infection, rejection, and hospitalization in a sample of primarily long-term transplant patients did not differ between patients who received telehealth follow-up and patients who received standard care, indicating that this delivery system can be used to provide follow-up care after transplant.

Implementing randomized assignment in a nursing clinical randomized control trial.

During the design phase of any research, an investigator addresses internal and external threats to validity and develops mechanisms to minimize these threats. Controlling for threats to study validity enhances the meaningfulness and generalizability of study outcomes. Representativeness of the study sample is one key design feature undertaken to ensure study validity; however, during clinical trials the investigator must stay attuned to ongoing situations that can alter sample representativeness. In the context of an ongoing nursing-led randomized control trial, threats to sample representativeness are discussed. These threats can occur in any study and may require modification of the study design to maintain validity of research outcomes. This article provides insight regarding threats to study validity encountered by one research team and the modifications undertaken to address them.