title: Comparison communities in a cluster randomised trial innovate in response to 'being controlled'.
abstract: We conducted qualitative interviews among primary health care teams and community agencies in eight communities in Victoria, Australia which had (1) agreed to be part of a universal primary care and community development intervention to reduce post natal depression and promote maternal health; and (2) were randomised to the comparison arm. The purpose was to document their experience with and interpretation of the trial. Although 'control' in a controlled trial refers to the control of confounding of the trial result by factors other than allocation to the intervention, participants interpreted 'control' to mean restrictions on what they were allowed to do during the trial period. They had agreed not to use the Edinburgh Post Natal Depression Scale or the SF 36 in clinical practice and not to implement any of the elements of the intervention. We found that no elements of the intervention were implemented. However, the extension of the trial from three to five years made the trial agreement a strain. The imposition of trial conditions also encouraged a degree of lateral thinking and innovation in service delivery (quality improvement). This may have potentially contributed to the null trial results. The observations invite interrogation of intervention theory and consequent rethinking of the way contamination in a cluster trial is defined.
authors: Menzies Centre for Health Policy, University of Sydney, Australia; The Australian Prevention Partnership Centre, Australia. Electronic address: penny.hawe@sydney.edu.au.
authors: Penelope
authors: P
authors: Hawe
authors: Judith Lumley Centre, LaTrobe University (Now based at Centre of Excellence in Intervention and Prevention Science, Melbourne), Australia.
authors: Therese
authors: T
authors: Riley
authors: Judith Lumley Centre, Now based at School of Geography and Environmental Sciences, Monash University, Australia.
authors: Alexandra
authors: A
authors: Gartrell
authors: Centre for Health and Society, Melbourne School of Population and Global Health, University of Melbourne (Now based at Department of Anthropology, School of Social and Political Sciences, University of Melbourne, Australia.
authors: Karen
authors: K
authors: Turner
authors: O'Brien Institute of Public Health, University of Calgary, Canada.
authors: Claudia
authors: C
authors: Canales
authors: O'Brien Institute of Public Health, University of Calgary, Canada.
authors: Darlene
authors: D
authors: Omstead
mesh_terms: D001291:Attitude of Health Personnel; D001315:Australia; D019052:Depression, Postpartum / Q000628:therapy*; D005260:Female; D006801:Humans; D000068097:Maternal Health; D010348:Patient Care Team; D011320:Primary Health Care / Q000379:methods; D036301:Qualitative Research; D016032:Randomized Controlled Trials as Topic / Q000379:methods; D012107:Research Design; D012111:Residence Characteristics
keywords: Cluster-randomised trial; Comparison group; Contamination; Edinburgh post natal depression scale; Intervention theory; Qualitative research; Quality improvement