Volume 14 Supplement 1

2nd Clinical Trials Methodology Conference: Methodology Matters

Open Access

Multi-level case studies in development of complex interventions: an example of the good goals intervention

  • Niina Kolehmainen1,
  • Graeme MacLennan1,
  • Laura Ternent3,
  • Edward AS Duncan2,
  • Eilidh M Duncan1,
  • Stephen B Ryan5,
  • Lorna McKee1 and
  • Jill Francis4
Trials201314(Suppl 1):P5

https://doi.org/10.1186/1745-6215-14-S1-P5

Published: 29 November 2013

Background

Complex interventions often target factors across multiple levels of care provision (e.g. patient, clinician, service, wider context). Multi-level case studies provide a systematic method for modelling intervention processes and effects.

Methods

Prospective multi-level, mixed-methods (qual+quant) case studies were used to model an intervention (‘Good Goals') to improve shared goal-setting in occupational therapy. Cases were purposively sampled (n=3 services, n=46 clinicians within these, and n=588 of their patients). Good Goals was delivered to clinicians over 25 weeks; data were collected before, during, and after delivery using interviews, focus group, case note analysis, routine data, document analysis and researchers' observations. Results were synthesised within each case, then compared across cases.

Results

Intervention uptake was influenced by mode of delivery, competing demands on clinicians' time, and service leadership; but not by geographical or resource factors. Of hypothesised process variables, changes were observed in: clinicians' confidence, perceived social norms, and service processes. Service managers and clinicians reported positive beliefs about Good Goals' effects (e.g. it helped establish a shared rationale for clinical decisions and improved interactions with patients). Clinicians' practice changed, as observed from case notes: identifying goals, odds ratio 2.4 (95% CI 1.5-3.8); agreeing goals, 3.5 (2.4-5.1); evaluating progress, 2.0 (1.1-3.5). Patients' care episodes decreased by two months [95% CI -8 to +4] across services. Cost per clinician trained ranged from £1,003 to £1,277.

Conclusions

Multi-level case studies identified key contextual factors and process variables, and explored likely effects on outcomes, during intervention development. This facilitates cost assessment and further intervention optimisation.

Authors’ Affiliations

(1)
University of Aberdeen
(2)
University of Stirling
(3)
Newcastle University
(4)
City University London
(5)
University of Edinburgh

Copyright

© Kolehmainen et al; licensee BioMed Central Ltd. 2013

This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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