IDEAS home Printed from https://ideas.repec.org/a/eee/socmed/v133y2015icp102-110.html
   My bibliography  Save this article

Comparison communities in a cluster randomised trial innovate in response to ‘being controlled’

Author

Listed:
  • Hawe, Penelope
  • Riley, Therese
  • Gartrell, Alexandra
  • Turner, Karen
  • Canales, Claudia
  • Omstead, Darlene

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.

Suggested Citation

  • Hawe, Penelope & Riley, Therese & Gartrell, Alexandra & Turner, Karen & Canales, Claudia & Omstead, Darlene, 2015. "Comparison communities in a cluster randomised trial innovate in response to ‘being controlled’," Social Science & Medicine, Elsevier, vol. 133(C), pages 102-110.
    • Handle: RePEc:eee:socmed:v:133:y:2015:i:c:p:102-110
    DOI: 10.1016/j.socscimed.2015.03.033
    as

    Download full text from publisher

    File URL: http://www.sciencedirect.com/science/article/pii/S027795361500177X
    Download Restriction: Full text for ScienceDirect subscribers only
    File URL: https://libkey.io/10.1016/j.socscimed.2015.03.033?utm_source=ideas
    LibKey link: if access is restricted and if your library uses this service, LibKey will redirect you to where you can use your library subscription to access this item
    ---><---

    As the access to this document is restricted, you may want to search for a different version of it.

    References listed on IDEAS

    as
    1. Bower, Peter & King, Michael & Nazareth, Irwin & Lampe, Fiona & Sibbald, Bonnie, 2005. "Patient preferences in randomised controlled trials: Conceptual framework and implications for research," Social Science & Medicine, Elsevier, vol. 61(3), pages 685-695, August.
    2. May, Carl, 2013. "Agency and implementation: Understanding the embedding of healthcare innovations in practice," Social Science & Medicine, Elsevier, vol. 78(C), pages 26-33.
    3. Bonell, Chris & Fletcher, Adam & Morton, Matthew & Lorenc, Theo & Moore, Laurence, 2012. "Realist randomised controlled trials: A new approach to evaluating complex public health interventions," Social Science & Medicine, Elsevier, vol. 75(12), pages 2299-2306.
    Full references (including those not matched with items on IDEAS)

    Most related items

    These are the items that most often cite the same works as this one and are cited by the same works as this one.
    1. Dimittri Delevry & Quang A. Le, 2019. "Effect of Treatment Preference in Randomized Controlled Trials: Systematic Review of the Literature and Meta-Analysis," The Patient: Patient-Centered Outcomes Research, Springer;International Academy of Health Preference Research, vol. 12(6), pages 593-609, December.
    2. Mulhall, Peter & Taggart, Laurence & Coates, Vivien & McAloon, Toni & Hassiotis, Angela, 2018. "A systematic review of the methodological and practical challenges of undertaking randomised-controlled trials with cognitive disability populations," Social Science & Medicine, Elsevier, vol. 200(C), pages 114-128.
    3. Humphreys, David K. & Eisner, Manuel P., 2014. "Do flexible alcohol trading hours reduce violence? A theory-based natural experiment in alcohol policy," Social Science & Medicine, Elsevier, vol. 102(C), pages 1-9.
    4. Busse, Heide & Campbell, Rona & Kipping, Ruth, 2018. "Examining the wider context of formal youth mentoring programme development, delivery and maintenance: A qualitative study with mentoring managers and experts in the United Kingdom," Children and Youth Services Review, Elsevier, vol. 95(C), pages 95-108.
    5. Mauldin, Laura, 2019. "Don't look at it as a miracle cure: Contested notions of success and failure in family narratives of pediatric cochlear implantation," Social Science & Medicine, Elsevier, vol. 228(C), pages 117-125.
    6. Hatcher, Abigail M & McBride, Ruari-Santiago & Rebombo, Dumisani & Munshi, Shehnaz & Khumalo, Mzwakhe & Christofides, Nicola, 2020. "Process evaluation of a community mobilization intervention for preventing men’s partner violence use in peri-urban South Africa," Evaluation and Program Planning, Elsevier, vol. 78(C).
    7. Rhodes, Tim & Lancaster, Kari, 2019. "Evidence-making interventions in health: A conceptual framing," Social Science & Medicine, Elsevier, vol. 238(C), pages 1-1.
    8. Davina Allen & Carl May, 2017. "Organizing Practice and Practicing Organization: An Outline of Translational Mobilization Theory," SAGE Open, , vol. 7(2), pages 21582440177, June.
    9. Barbara Sianesi, 2016. "‘Randomisation bias’ in the medical literature: a review," IFS Working Papers W16/23, Institute for Fiscal Studies.
    10. Dan Bristow & Lauren Carter & Steve Martin, 2015. "Using evidence to improve policy and practice: the UK What Works Centres," Contemporary Social Science, Taylor & Francis Journals, vol. 10(2), pages 126-137, June.
    11. Maniatopoulos, Gregory & Procter, Rob & Llewellyn, Sue & Harvey, Gill & Boyd, Alan, 2015. "Moving beyond local practice: Reconfiguring the adoption of a breast cancer diagnostic technology," Social Science & Medicine, Elsevier, vol. 131(C), pages 98-106.
    12. Margaret Dalziel, 2018. "Why are there (almost) no randomised controlled trial-based evaluations of business support programmes?," Palgrave Communications, Palgrave Macmillan, vol. 4(1), pages 1-9, December.
    13. Melendez-Torres, G.J. & Warren, Emily & Viner, Russell & Allen, Elizabeth & Bonell, Chris, 2021. "Moderated mediation analyses to assess intervention mechanisms for impacts on victimisation, psycho-social problems and mental wellbeing: Evidence from the INCLUSIVE realist randomized trial," Social Science & Medicine, Elsevier, vol. 279(C).
    14. Gyeongcheol Cho & Younyoung Choi & Ji-Hyun Kim, 2020. "Investigating the Unintended Consequences of the High School Equalization Policy on the Housing Market," Sustainability, MDPI, vol. 12(20), pages 1-9, October.
    15. Massazza, Alessandro & May, Carl R. & Roberts, Bayard & Tol, Wietse A. & Bogdanov, Sergiy & Nadkarni, Abhijit & Fuhr, Daniela C., 2022. "Process evaluations of mental health and psychosocial support interventions for populations affected by humanitarian crises," Social Science & Medicine, Elsevier, vol. 303(C).
    16. Wade, Julia & Donovan, Jenny L. & Athene Lane, J. & Neal, David E. & Hamdy, Freddie C., 2009. "It's not just what you say, it's also how you say it: Opening the 'black box' of informed consent appointments in randomised controlled trials," Social Science & Medicine, Elsevier, vol. 68(11), pages 2018-2028, June.
    17. Wolfgang A. Markham & Alan Dolan & Graham F. Moore, 2021. "A Sociological Framework to Reduce Aberrant Behaviour of School Students Through Increasing School Connectedness," SAGE Open, , vol. 11(3), pages 21582440211, July.
    18. Macabasag, Romeo Luis A. & Mallari, Eunice U. & Pascual, Patrick Joshua C. & Fernandez-Marcelo, Portia Grace H., 2022. "Normalisation of electronic medical records in routine healthcare work amidst ongoing digitalisation of the Philippine health system," Social Science & Medicine, Elsevier, vol. 307(C).
    19. Mark Jeffries & Richard N Keers & Denham L Phipps & Richard Williams & Benjamin Brown & Anthony J Avery & Niels Peek & Darren M Ashcroft, 2018. "Developing a learning health system: Insights from a qualitative process evaluation of a pharmacist-led electronic audit and feedback intervention to improve medication safety in primary care," PLOS ONE, Public Library of Science, vol. 13(10), pages 1-16, October.
    20. Andreassen, Hege K. & Kjekshus, Lars Erik & Tjora, Aksel, 2015. "Survival of the project: A case study of ICT innovation in health care," Social Science & Medicine, Elsevier, vol. 132(C), pages 62-69.

    Corrections

    All material on this site has been provided by the respective publishers and authors. You can help correct errors and omissions. When requesting a correction, please mention this item's handle: RePEc:eee:socmed:v:133:y:2015:i:c:p:102-110. See general information about how to correct material in RePEc.

    If you have authored this item and are not yet registered with RePEc, we encourage you to do it here. This allows to link your profile to this item. It also allows you to accept potential citations to this item that we are uncertain about.

    If CitEc recognized a bibliographic reference but did not link an item in RePEc to it, you can help with this form .

    If you know of missing items citing this one, you can help us creating those links by adding the relevant references in the same way as above, for each refering item. If you are a registered author of this item, you may also want to check the "citations" tab in your RePEc Author Service profile, as there may be some citations waiting for confirmation.

    For technical questions regarding this item, or to correct its authors, title, abstract, bibliographic or download information, contact: Catherine Liu (email available below). General contact details of provider: http://www.elsevier.com/wps/find/journaldescription.cws_home/315/description#description .

    Please note that corrections may take a couple of weeks to filter through the various RePEc services.

    IDEAS is a RePEc service. RePEc uses bibliographic data supplied by the respective publishers.