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A pilot randomised controlled trial of a Telehealth intervention in patients with chronic obstructive pulmonary disease: challenges of clinician-led data collection
Bentley, C.L. Mountain, Gail Thompson, J. Fitzsimmons, D.A. Lowrie, K. Parker, S.G. Hawley, M.S.
Bentley, C.L.
Mountain, Gail
Thompson, J.
Fitzsimmons, D.A.
Lowrie, K.
Parker, S.G.
Hawley, M.S.
Publication Date
2014-08-06
End of Embargo
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Rights
© 2014 The Authors. This is an Open Access article distributed under the Creative Commons CC-BY license
(https://creativecommons.org/licenses/by/4.0)
Peer-Reviewed
Yes
Open Access status
openAccess
Accepted for publication
2014-07-18
Institution
Department
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Abstract
The increasing prevalence and associated cost of treating chronic obstructive pulmonary disease
(COPD) is unsustainable, and focus is needed on self-management and prevention of hospital admissions.
Telehealth monitoring of patients’ vital signs allows clinicians to prioritise their workload and enables patients to
take more responsibility for their health. This paper reports the results of a pilot randomised controlled trial (RCT) of
Telehealth-supported care within a community-based COPD supported-discharge service.
Methods: A two-arm pragmatic pilot RCT was conducted comparing the standard service with a
Telehealth-supported service and assessed the potential for progressing into a full RCT. The co-primary outcome
measures were the proportion of COPD patients readmitted to hospital and changes in patients’ self-reported
quality of life. The objectives were to assess the suitability of the methodology, produce a sample size calculation
for a full RCT, and to give an indication of cost-effectiveness for both pathways.
Results: Sixty three participants were recruited (n = 31 Standard; n = 32 Telehealth); 15 participants were excluded
from analysis due to inadequate data completion or withdrawal from the Telehealth arm. Recruitment was slow
with significant gaps in data collection, due predominantly to an unanticipated 60% reduction of staff capacity
within the clinical team. The sample size calculation was guided by estimates of clinically important effects and
COPD readmission rates derived from the literature. Descriptive analyses showed that the standard service group
had a lower proportion of patients with hospital readmissions and a greater increase in self-reported quality of life
compared to the Telehealth-supported group. Telehealth was cost-effective only if hospital admissions data were
excluded.
Conclusions: Slow recruitment rates and service reconfigurations prevented progression to a full RCT. Although
there are advantages to conducting an RCT with data collection conducted by a frontline clinical team, in this case,
challenges arose when resources within the team were reduced by external events. Gaps in data collection were
resolved by recruiting a research nurse. This study reinforces previous findings regarding the difficulty of undertaking
evaluation of complex interventions, and provides recommendations for the introduction and evaluation of complex
interventions within clinical settings, such as prioritisation of research within the clinical remit.
Version
Published version
Citation
Bentley CL, Mountain GA, Thompson J et al (2014) A pilot randomised controlled trial of
a Telehealth intervention in patients with chronic obstructive pulmonary disease: challenges of
clinician-led data collection. Trials. 15(1): 313.
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Article