Defining ‘usual care' in trials of complex interventions

Defining ‘usual care' in trials of complex interventions

Background Defining ‘usual care’ in studies of health services is challenging as it comprises a large variety of locally variable services. Building Blocks is trialling the Family Nurse Partnership Programme (FNP) in England. FNP is a complex intervention provided to first-time teenage mothers in the community setting. It was developed and previously trialled in the USA where support services a...

Assessing usual care in clinical trials.

Researchers designing clinical trials often specify usual care received by participants as the control condition expecting that all participants receive usual care regardless of group assignment. The assumption is that the groups in the study are affected similarly. We describe the assessment of usual care within the 16 studies in Multisite Adherence Collaboration in HIV (MACH 14), a multisite ...

Usual and unusual care: existing practice control groups in randomized controlled trials of behavioral interventions.

OBJECTIVE To evaluate the use of existing practice control groups in randomized controlled trials of behavioral interventions and the role of extrinsic health care services in the design and conduct of behavioral trials. METHOD Selective qualitative review. RESULTS Extrinsic health care services, also known as nonstudy care, have important but under-recognized effects on the design and cond...

Testing protocols in the intensive care unit: complex trials of complex interventions for complex patients.

Critical care rehabilitation trials: the importance of ‘usual care’

Denehy and colleagues conducted a novel randomized controlled trial evaluating a rehabilitation intervention starting in the ICU and continuing through the outpatient setting, with 1 year longitudinal follow-up. While the intervention did not demonstrate improved patient outcomes, this study illustrates important issues regarding 'usual care' control groups in clinical trials.