Hybrid experimental design: A suitable design to tackle contamination of control groups

• Background: Randomized controlled trials (RCTs) are considered to be the “gold standard” to assess the effectiveness of interventions. Because nursing interventions are most likely complex, multicomponent interventions, RCTs are often not suitable due to the risk of contamination of the control group. Such contamination can lead to a lower point estimate of the intervention’s effect and to underestimate the difference between both groups. Objective: To describe an innovative study design aiming to verify the contamination in the control group when testing the effectiveness of a person-centered transition program for adolescents with congenital heart disease (ConHD). Design: A hybrid experimental design is developed, in which a longitudinal, observational study is embedded in a RCT, resulting in a 3-arms design. The study will be conducted in 4 ConHD-centers in Sweden. Two centers will perform the RCT, by randomly assigning patients to either the experimental group (60 patients) or the comparison group (60 patients). This latter group may be subject of contamination. Two other centers are “intervention-naïve” and therefore comprise a contamination-free control group (120 patients). The occurrence of contamination will be investigated by comparing the comparison group and control group. Participants and setting: Participants are literate, Swedish-speaking adolescents with ConHD, aged 16 years and their parents. Discussion: This hybrid experimental design will give us the opportunity to investigate potential contamination of the comparison group, by studying differences with the control group from intervention-naïve centers. If this design is successful, it can be employed in the evaluation of complex nursing interventions.

Ämnesord

MEDICIN OCH HÄLSOVETENSKAP  -- Hälsovetenskap -- Omvårdnad (hsv//swe)

MEDICAL AND HEALTH SCIENCES  -- Health Sciences -- Nursing (hsv//eng)

MEDICIN OCH HÄLSOVETENSKAP  -- Hälsovetenskap (hsv//swe)

MEDICAL AND HEALTH SCIENCES  -- Health Sciences (hsv//eng)

Nyckelord

study design

randomized controlled trial

transition to adult care

Publikations- och innehållstyp

ref (ämneskategori)

kon (ämneskategori)