Accepted for/Published in: JMIR Formative Research
Date Submitted: Aug 15, 2018
Open Peer Review Period: Aug 15, 2018 - Oct 4, 2018
Date Accepted: Dec 9, 2018
(closed for review but you can still tweet)
Using exploratory trials to identify relevant contexts and mechanisms in complex eHealth interventions: evaluating the electronic Patient Reported Outcome tool.
ABSTRACT
Background:
Designing appropriate studies for evaluating complex interventions, like eHealth solutions to support integrated care, remains a methodological challenge. With the many moving parts of complex interventions, it is not always clear how program activities are connected to anticipated and unanticipated outcomes. Exploratory trials can be used to uncover determinants (or mechanisms) to inform content theory that underpins complex interventions prior to designing a full evaluation plan.
Objective:
A multi-method exploratory trial of the electronic Patient Reported Outcome (ePRO) tool was conducted to uncover contexts, processes, and outcomes variables, and the mechanisms that link these variables prior to full-scale evaluation. ePRO is a mobile application and portal designed to support goal-oriented care in inter-disciplinary primary health care practices (clinical level integration). This paper offers methodological insight on how to use exploratory trial data to identify relevant context, process and outcome variables, as well as central (necessary to achieving outcomes) vs. peripheral (less critical and potentially context dependent) mechanisms at play.
Methods:
The four month trial was conducted in two primary health care practices in Toronto, Canada. Patients were randomized into control and intervention groups and compared pre and post on quality of life and activation outcome measures. Semi-structured interviews were conducted with providers and patients in the intervention group. Narrative analysis was used to uncover dominant mechanisms of the intervention to inform the interventions content theory (how context and process variables are linked to outcomes).
Results:
Seven providers, one administrator, and 16 patients (7-control, 9-intervention) participated in the study. Our study uncovered many complex and nuanced context, process and outcome variables at play in the intervention. Narrative analysis of patient and provider interviews revealed dominant story lines that help to tease apart central and peripheral mechanisms driving the intervention. Provider and patient storylines centered-around fitting the new intervention into everyday work and life of patients and providers, and meaningfulness of the intervention. These themes were moderated by patient-provider relationships going into and throughout the intervention, their comfort with technology, and the research process.
Conclusions:
Identifying dominant storylines using narrative analysis helps to identify the most relevant context and process variables likely to influence on study outcomes. Normalization Process Theory emerges as a useful theory to uncover underlying mechanisms due to its emphasis on the social production and normalization of technological, processual, and social aspects of work; all found to be critical to our intervention. The number of complex, overlapping influencing variables suggests that complex interventions like ePRO require us to pay careful attention to central vs. peripheral mechanisms underlying the intervention. The narrative methods presented here is shown to be a useful tool to help uncover these mechanisms, helping to guide subsequent larger evaluation studies.
Citation

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Copyright
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