ABSTRACT
Interventions to implement changes into health care practice (i.e., implementation interventions) are critical to improving care but their effects are poorly understood. Two strategies to better understand intervention effects are conducting process evaluations and using theoretical approaches (i.e., theories, models, frameworks). The extent to which theoretical approaches have been used in process evaluations conducted alongside trials of implementation interventions is unclear. In this study context, we reviewed (a) the proportion of process evaluations citing theoretical approaches, (b) which theoretical approaches were cited, and (c) whether and how theories were used. Systematic review (PROSPERO: CRD42016042789). MEDLINE, PsycINFO, Embase, CINAHL, and Cochrane CENTRAL were searched up to July 31, 2017. For all studies, data extraction included names and types of theoretical approaches cited. For studies citing a theory, data extraction included study characteristics and extent of theory use (i.e., "informed by," "applied," "tested," "built/created" theory). We identified 123 process evaluations. Key findings: (a) 77 (63%) process evaluations cited a theoretical approach; (b) the most cited theory was normalization process theory; (c) 32 (26%) process evaluations used theory: 7 (22%) were informed by, 18 (56%) applied, 7 (22%) tested, and none built/created theory. Although nearly two thirds of process evaluations cited a theoretical approach, only a quarter were informed by, applied, or tested a theory-despite the potential complementarity of these strategies. When theory was used, it was primarily applied. Using theory more substantively in process evaluations may accelerate our understanding of how implementation interventions operate.
Subject(s)
Delivery of Health Care , Process Assessment, Health Care , Humans , Randomized Controlled Trials as TopicABSTRACT
BACKGROUND: In England, NHS Blood and Transplant conducts national audits of transfusion and provides feedback to hospitals to promote evidence-based practice. Audits demonstrate 20% of transfusions fall outside guidelines. The AFFINITIE programme (Development & Evaluation of Audit and Feedback INterventions to Increase evidence-based Transfusion practIcE) involves two linked, 2×2 factorial, cluster-randomised trials, each evaluating two theoretically-enhanced audit and feedback interventions to reduce unnecessary blood transfusions in UK hospitals. The first intervention concerns the content/format of feedback reports. The second aims to support hospital transfusion staff to plan their response to feedback and includes a web-based toolkit and telephone support. Interpretation of trials is enhanced by comprehensively assessing intervention fidelity. However, reviews demonstrate fidelity evaluations are often limited, typically only assessing whether interventions were delivered as intended. This protocol presents methods for assessing fidelity across five dimensions proposed by the Behaviour Change Consortium fidelity framework, including intervention designer-, provider- and recipient-levels. METHODS: (1) Design: Intervention content will be specified in intervention manuals in terms of component behaviour change techniques (BCTs). Treatment differentiation will be examined by comparing BCTs across intervention/standard practice, noting the proportion of unique/convergent BCTs. (2) Training: draft feedback reports and audio-recorded role-play telephone support scenarios will be content analysed to assess intervention providers' competence to deliver manual-specified BCTs. (3) Delivery: intervention materials (feedback reports, toolkit) and audio-recorded telephone support session transcripts will be content analysed to assess actual delivery of manual-specified BCTs during the intervention period. (4) Receipt and (5) enactment: questionnaires, semi-structured interviews based on the Theoretical Domains Framework, and objective web-analytics data (report downloads, toolkit usage patterns) will be analysed to assess hospital transfusion staff exposure to, understanding and enactment of the interventions, and to identify contextual barriers/enablers to implementation. Associations between observed fidelity and trial outcomes (% unnecessary transfusions) will be examined using mediation analyses. DISCUSSION: If the interventions have acceptable fidelity, then results of the AFFINITIE trials can be attributed to effectiveness, or lack of effectiveness, of the interventions. Hence, this comprehensive assessment of fidelity will be used to interpret trial findings. These methods may inform fidelity assessments in future trials. TRIAL REGISTRATION: ISRCTN 15490813 . Registered 11/03/2015.
