Page 3 Effect of telehealth on quality of life and psychological out comes over 12 months
P. 3
BMJ 2013;346:f653 doi: 10.1136/bmj.f653 (Published 26 February 2013) Page 3 of 20
RESEARCH
telemonitoring on any outcome examined. These results Cluster level recruitment and randomisation
highlight the need for rigorous, large scale, high quality Allocation was conducted at the cluster (general practice) level.
independent studies to evaluate healthcare interventions before All 365 general practices in the four primary care trusts were
wide scale adoption. 54 55 invited to participate. To maximise participation, the evaluation
adopted a pragmatic approach: each practice provided
WSD evaluation intervention participants for one technology (telehealth or
Part of the UK government’s response to this need for robust telecare) in one trial and control participants for the other
18
evidence was to fund the WSD Evaluation to investigate the technology (telecare or telehealth) in the other trial, ensuring
effects of two broad classes of technologies (telehealth and equity of access to advanced assistive technology at the level
18
telecare) on a comprehensive range of outcomes in regions of of the practice population. Consenting practices were allocated
England that had undergone the Whole Systems Redesign (web to the intervention and control groups by the trial statistician
appendix 1). The design, protocol, and objectives of the WSD (HD), using a centrally administered minimisation algorithm
18
Evaluation have been reported in detail elsewhere. Briefly, the that ensured comparability across trial arms in terms of practice
evaluation comprises a pragmatic, cluster randomised controlled size; deprivation; proportion of patients from non-white ethnic
trial of telehealth for service users with long term conditions groups; prevalence of diabetes, chronic obstructive pulmonary
(chronic obstructive pulmonary disease, diabetes, heart failure; disease, and heart failure; and WSD site.
known as the WSD telehealth trial) and an equivalent trial of There was no blinding for practices, participants, or assessors,
telecare for service users with social care needs (the WSD although most measures in the WSD telehealth and telecare
telecare trial). questionnaires studies were self reported. Participants allocated
These cluster randomised controlled trials evaluate a to the control arm were informed that they would be offered the
comprehensive range of healthcare utilisation outcomes and appropriate technology at the end of the 12 month trial period,
mortality. The evaluation was designed to avoid some of the subject to a further needs assessment.
shortcomings of previous research by conducting large,
methodologically rigorous, multicentre trials across three regions Participant level recruitment
of England. Each trial included a nested questionnaire study In participating practices, patients with chronic obstructive
(the WSD telehealth questionnaire study and WSD telecare pulmonary disease, diabetes, or heart failure were deemed
questionnaire study) to assess outcomes reported by patients eligible on the basis of one of the following:
and carers (for example, health related QoL, anxiety, depressive
symptoms, functional ability, self care behaviour), and cost • Inclusion on the relevant Quality Outcomes Framework
register in primary care
effectiveness based on quality adjusted life years.
Additional qualitative studies of purposive subsamples explored • A confirmed medical diagnosis in primary or secondary
the experiences of patients, carers, healthcare professionals, and care medical records, as indicated by general practice Read
healthcare organisations. Collectively, the WSD Evaluation is codes or ICD-10 (international classification of diseases,
the largest and most comprehensive investigation of telehealth 10th revision) codes
and telecare so far. In the present study, we focus on the WSD • Confirmation of disease status by a local clinician (such
telehealth questionnaire study and report on the effect of as general practitioner or community matron) or hospital
telehealth on health related QoL and two psychological consultant.
outcomes (anxiety and depressive symptoms). For this part of Patients were not excluded on the basis of additional physical
the WSD Evaluation, we assessed the hypothesis that comorbidities. However, participants were required to have a
introduction of a broad class of home based telehealth improves telephone landline for broadband internet connection (at all
quality of life, anxiety, and depressive symptoms over a 12 WSD sites), and a digital television (in Newham). Other
month period for patients with chronic obstructive pulmonary financial costs (including phone calls and data transmission to
disease, diabetes, or heart failure, compared with usual care the monitoring centres) were paid for by the local WSD project
only. teams. Since the telehealth system used in the trial required
participants to read and respond to textual information presented
Methods via a base unit or television screen, sufficient English language
Design and setting literacy was required, as determined by the local WSD project
team. Cognitive impairment was not an exclusion criterion for
The WSD telehealth trial is a pragmatic, cluster randomised the WSD telehealth trial, provided that an informal carer was
controlled trial of telehealth (n=3230). This paper reports on available to assist with use of the telehealth system. However,
the nested WSD telehealth questionnaire study, which was cognitive impairment was an exclusion criterion for the
designed to include 1650 participants. Between May 2008 to questionnaire study because we aimed to collect self reported
December 2009, we recruited participants for the WSD data without third party influence. Participants with physical
telehealth trial, across three sociodemographically distinct impairments could receive practical assistance with completing
regions in England (rural Cornwall, rural and urban Kent, and the questionnaire battery from an independent trained researcher.
urban Newham in London) comprising four primary care trusts. All 15 171 potentially eligible patients in participating practices
Participants were also invited to take part in the WSD telehealth were contacted about the study. To meet ethical obligations,
questionnaire study, a supplementary investigation of patient these patients were initially sent and asked to complete a data
reported outcomes. We assessed participants at four and 12 sharing consent form if they were interested in the study and
months after recruitment (the last 12 month assessment occurred willing to allow their medical and social care data to be shared
in December 2010). Figure 1⇓ shows a CONSORT diagram of with the WSD research team. Follow-up letters and telephone
general practice and participant flow into the parent trial and calls encouraged responses.
the questionnaire study (n=1573). Table 1⇓ compares sample
characteristics at baseline across the parent trial and the nested Once data sharing consent was received eligibility was
questionnaire study. confirmed by the local WSD project team and eligible patients
No commercial reuse: See rights and reprints http://www.bmj.com/permissions Subscribe: http://www.bmj.com/subscribe
RESEARCH
telemonitoring on any outcome examined. These results Cluster level recruitment and randomisation
highlight the need for rigorous, large scale, high quality Allocation was conducted at the cluster (general practice) level.
independent studies to evaluate healthcare interventions before All 365 general practices in the four primary care trusts were
wide scale adoption. 54 55 invited to participate. To maximise participation, the evaluation
adopted a pragmatic approach: each practice provided
WSD evaluation intervention participants for one technology (telehealth or
Part of the UK government’s response to this need for robust telecare) in one trial and control participants for the other
18
evidence was to fund the WSD Evaluation to investigate the technology (telecare or telehealth) in the other trial, ensuring
effects of two broad classes of technologies (telehealth and equity of access to advanced assistive technology at the level
18
telecare) on a comprehensive range of outcomes in regions of of the practice population. Consenting practices were allocated
England that had undergone the Whole Systems Redesign (web to the intervention and control groups by the trial statistician
appendix 1). The design, protocol, and objectives of the WSD (HD), using a centrally administered minimisation algorithm
18
Evaluation have been reported in detail elsewhere. Briefly, the that ensured comparability across trial arms in terms of practice
evaluation comprises a pragmatic, cluster randomised controlled size; deprivation; proportion of patients from non-white ethnic
trial of telehealth for service users with long term conditions groups; prevalence of diabetes, chronic obstructive pulmonary
(chronic obstructive pulmonary disease, diabetes, heart failure; disease, and heart failure; and WSD site.
known as the WSD telehealth trial) and an equivalent trial of There was no blinding for practices, participants, or assessors,
telecare for service users with social care needs (the WSD although most measures in the WSD telehealth and telecare
telecare trial). questionnaires studies were self reported. Participants allocated
These cluster randomised controlled trials evaluate a to the control arm were informed that they would be offered the
comprehensive range of healthcare utilisation outcomes and appropriate technology at the end of the 12 month trial period,
mortality. The evaluation was designed to avoid some of the subject to a further needs assessment.
shortcomings of previous research by conducting large,
methodologically rigorous, multicentre trials across three regions Participant level recruitment
of England. Each trial included a nested questionnaire study In participating practices, patients with chronic obstructive
(the WSD telehealth questionnaire study and WSD telecare pulmonary disease, diabetes, or heart failure were deemed
questionnaire study) to assess outcomes reported by patients eligible on the basis of one of the following:
and carers (for example, health related QoL, anxiety, depressive
symptoms, functional ability, self care behaviour), and cost • Inclusion on the relevant Quality Outcomes Framework
register in primary care
effectiveness based on quality adjusted life years.
Additional qualitative studies of purposive subsamples explored • A confirmed medical diagnosis in primary or secondary
the experiences of patients, carers, healthcare professionals, and care medical records, as indicated by general practice Read
healthcare organisations. Collectively, the WSD Evaluation is codes or ICD-10 (international classification of diseases,
the largest and most comprehensive investigation of telehealth 10th revision) codes
and telecare so far. In the present study, we focus on the WSD • Confirmation of disease status by a local clinician (such
telehealth questionnaire study and report on the effect of as general practitioner or community matron) or hospital
telehealth on health related QoL and two psychological consultant.
outcomes (anxiety and depressive symptoms). For this part of Patients were not excluded on the basis of additional physical
the WSD Evaluation, we assessed the hypothesis that comorbidities. However, participants were required to have a
introduction of a broad class of home based telehealth improves telephone landline for broadband internet connection (at all
quality of life, anxiety, and depressive symptoms over a 12 WSD sites), and a digital television (in Newham). Other
month period for patients with chronic obstructive pulmonary financial costs (including phone calls and data transmission to
disease, diabetes, or heart failure, compared with usual care the monitoring centres) were paid for by the local WSD project
only. teams. Since the telehealth system used in the trial required
participants to read and respond to textual information presented
Methods via a base unit or television screen, sufficient English language
Design and setting literacy was required, as determined by the local WSD project
team. Cognitive impairment was not an exclusion criterion for
The WSD telehealth trial is a pragmatic, cluster randomised the WSD telehealth trial, provided that an informal carer was
controlled trial of telehealth (n=3230). This paper reports on available to assist with use of the telehealth system. However,
the nested WSD telehealth questionnaire study, which was cognitive impairment was an exclusion criterion for the
designed to include 1650 participants. Between May 2008 to questionnaire study because we aimed to collect self reported
December 2009, we recruited participants for the WSD data without third party influence. Participants with physical
telehealth trial, across three sociodemographically distinct impairments could receive practical assistance with completing
regions in England (rural Cornwall, rural and urban Kent, and the questionnaire battery from an independent trained researcher.
urban Newham in London) comprising four primary care trusts. All 15 171 potentially eligible patients in participating practices
Participants were also invited to take part in the WSD telehealth were contacted about the study. To meet ethical obligations,
questionnaire study, a supplementary investigation of patient these patients were initially sent and asked to complete a data
reported outcomes. We assessed participants at four and 12 sharing consent form if they were interested in the study and
months after recruitment (the last 12 month assessment occurred willing to allow their medical and social care data to be shared
in December 2010). Figure 1⇓ shows a CONSORT diagram of with the WSD research team. Follow-up letters and telephone
general practice and participant flow into the parent trial and calls encouraged responses.
the questionnaire study (n=1573). Table 1⇓ compares sample
characteristics at baseline across the parent trial and the nested Once data sharing consent was received eligibility was
questionnaire study. confirmed by the local WSD project team and eligible patients
No commercial reuse: See rights and reprints http://www.bmj.com/permissions Subscribe: http://www.bmj.com/subscribe
