Challenges to implementing electronic trial data collection in primary care: a qualitative study

Christie Cabral; Kathryn Curtis; Vasa Curcin; Jesús Domínguez; Vibhore Prasad; Anne Schilder; Nicholas Turner; Scott Wilkes; Jodi Taylor; Sarah Gallagher; Paul Little; Brendan Delaney; Michael Moore; Alastair D Hay; Jeremy Horwood

doi:10.1186/s12875-021-01498-6

Challenges to implementing electronic trial data collection in primary care: a qualitative study

Christie Cabral, Kathryn Curtis, Vasa Curcin, Jesús Domínguez, Vibhore Prasad, Anne Schilder, Nicholas Turner, Scott Wilkes, Jodi Taylor, Sarah Gallagher, Paul Little, Brendan Delaney, Michael Moore, Alastair D Hay, Jeremy Horwood

Research output: Contribution to journal › Article › peer-review

1 Citation (Scopus)

Abstract

BACKGROUND: Within-consultation recruitment to primary care trials is challenging. Ensuring procedures are efficient and self-explanatory is the key to optimising recruitment. Trial recruitment software that integrates with the electronic health record to support and partially automate procedures is becoming more common. If it works well, such software can support greater participation and more efficient trial designs. An innovative electronic trial recruitment and outcomes software was designed to support recruitment to the Runny Ear randomised controlled trial, comparing topical, oral and delayed antibiotic treatment for acute otitis media with discharge in children. A qualitative evaluation investigated the views and experiences of primary care staff using this trial software.

METHODS: Staff were purposively sampled in relation to site, role and whether the practice successfully recruited patients. In-depth interviews were conducted using a flexible topic guide, audio recorded and transcribed. Data were analysed thematically.

RESULTS: Sixteen staff were interviewed, including GPs, practice managers, information technology (IT) leads and research staff. GPs wanted trial software that automatically captures patient data. However, the experience of getting the software to work within the limited and complex IT infrastructure of primary care was frustrating and time consuming. Installation was reliant on practice level IT expertise, which varied between practices. Although most had external IT support, this rarely included supported for research IT. Arrangements for approving new software varied across practices and often, but not always, required authorisation from Clinical Commissioning Groups.

CONCLUSIONS: Primary care IT systems are not solely under the control of individual practices or CCGs or the National Health Service. Rather they are part of a complex system that spans all three and is influenced by semi-autonomous stakeholders operating at different levels. This led to time consuming and sometimes insurmountable barriers to installation at the practice level. These need to be addressed if software supporting efficient research in primary care is to become a reality.

Original language	English
Article number	147
Journal	BMC FAMILY PRACTICE
Volume	22
Issue number	1
DOIs	https://doi.org/10.1186/s12875-021-01498-6
Publication status	Published - 6 Jul 2021

Keywords

Electronic health records
Information technology
Primary health care

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10.1186/s12875-021-01498-6

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Cabral, C., Curtis, K., Curcin, V., Domínguez, J., Prasad, V., Schilder, A., Turner, N., Wilkes, S., Taylor, J., Gallagher, S., Little, P., Delaney, B., Moore, M., Hay, A. D., & Horwood, J. (2021). Challenges to implementing electronic trial data collection in primary care: a qualitative study. BMC FAMILY PRACTICE, 22(1), Article 147. https://doi.org/10.1186/s12875-021-01498-6

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title = "Challenges to implementing electronic trial data collection in primary care: a qualitative study",

abstract = "BACKGROUND: Within-consultation recruitment to primary care trials is challenging. Ensuring procedures are efficient and self-explanatory is the key to optimising recruitment. Trial recruitment software that integrates with the electronic health record to support and partially automate procedures is becoming more common. If it works well, such software can support greater participation and more efficient trial designs. An innovative electronic trial recruitment and outcomes software was designed to support recruitment to the Runny Ear randomised controlled trial, comparing topical, oral and delayed antibiotic treatment for acute otitis media with discharge in children. A qualitative evaluation investigated the views and experiences of primary care staff using this trial software.METHODS: Staff were purposively sampled in relation to site, role and whether the practice successfully recruited patients. In-depth interviews were conducted using a flexible topic guide, audio recorded and transcribed. Data were analysed thematically.RESULTS: Sixteen staff were interviewed, including GPs, practice managers, information technology (IT) leads and research staff. GPs wanted trial software that automatically captures patient data. However, the experience of getting the software to work within the limited and complex IT infrastructure of primary care was frustrating and time consuming. Installation was reliant on practice level IT expertise, which varied between practices. Although most had external IT support, this rarely included supported for research IT. Arrangements for approving new software varied across practices and often, but not always, required authorisation from Clinical Commissioning Groups.CONCLUSIONS: Primary care IT systems are not solely under the control of individual practices or CCGs or the National Health Service. Rather they are part of a complex system that spans all three and is influenced by semi-autonomous stakeholders operating at different levels. This led to time consuming and sometimes insurmountable barriers to installation at the practice level. These need to be addressed if software supporting efficient research in primary care is to become a reality.",

keywords = "Electronic health records, Information technology, Primary health care",

author = "Christie Cabral and Kathryn Curtis and Vasa Curcin and Jes{\'u}s Dom{\'i}nguez and Vibhore Prasad and Anne Schilder and Nicholas Turner and Scott Wilkes and Jodi Taylor and Sarah Gallagher and Paul Little and Brendan Delaney and Michael Moore and Hay, {Alastair D} and Jeremy Horwood",

note = "Funding Information: This research is funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme (funder ref.: 16/85/01). The views expressed in this publication are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care. The TRANSFoRm trial platform was developed as part of the EU FP7 TRANSFoRm Project 247787 ( www.transformproject.eu ). Dr Prasad received salary funding as part of the National Institute for Health Research (NIHR) academic clinical lecturer scheme, hosted by King{\textquoteright}s College London. Other than the financial support provided, the funding body had no role in the design of the study and collection, analysis, and interpretation of data and in writing the manuscript. Funding Information: This study was designed and delivered in collaboration with the Bristol Randomised Trials Collaboration (BRTC), part of the Bristol Trials Centre, a UKCRC registered clinical trials unit, which is in receipt of National Institute for Health Research CTU support funding. The University of Bristol is acting as sponsor for this study and is responsible for overall oversight of the trial; the NHS Bristol, North Somerset and South Gloucestershire Group (CCG) host the REST trial. The authors would like to thank all of the participants, parents, GPS and practice staff at each of the REST study sites for their involvement. The authors would like to thank all 15 UK CRNs for their role in the study. The authors would also like to thank members of their TSC and DMC. Publisher Copyright: {\textcopyright} 2021, The Author(s). Copyright: Copyright 2021 Elsevier B.V., All rights reserved.",

year = "2021",

month = jul,

day = "6",

doi = "10.1186/s12875-021-01498-6",

language = "English",

volume = "22",

journal = "BMC FAMILY PRACTICE",

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TY - JOUR

T1 - Challenges to implementing electronic trial data collection in primary care

T2 - a qualitative study

AU - Cabral, Christie

AU - Curtis, Kathryn

AU - Curcin, Vasa

AU - Domínguez, Jesús

AU - Prasad, Vibhore

AU - Schilder, Anne

AU - Turner, Nicholas

AU - Wilkes, Scott

AU - Taylor, Jodi

AU - Gallagher, Sarah

AU - Little, Paul

AU - Delaney, Brendan

AU - Moore, Michael

AU - Hay, Alastair D

AU - Horwood, Jeremy

N1 - Funding Information: This research is funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme (funder ref.: 16/85/01). The views expressed in this publication are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care. The TRANSFoRm trial platform was developed as part of the EU FP7 TRANSFoRm Project 247787 ( www.transformproject.eu ). Dr Prasad received salary funding as part of the National Institute for Health Research (NIHR) academic clinical lecturer scheme, hosted by King’s College London. Other than the financial support provided, the funding body had no role in the design of the study and collection, analysis, and interpretation of data and in writing the manuscript. Funding Information: This study was designed and delivered in collaboration with the Bristol Randomised Trials Collaboration (BRTC), part of the Bristol Trials Centre, a UKCRC registered clinical trials unit, which is in receipt of National Institute for Health Research CTU support funding. The University of Bristol is acting as sponsor for this study and is responsible for overall oversight of the trial; the NHS Bristol, North Somerset and South Gloucestershire Group (CCG) host the REST trial. The authors would like to thank all of the participants, parents, GPS and practice staff at each of the REST study sites for their involvement. The authors would like to thank all 15 UK CRNs for their role in the study. The authors would also like to thank members of their TSC and DMC. Publisher Copyright: © 2021, The Author(s). Copyright: Copyright 2021 Elsevier B.V., All rights reserved.

PY - 2021/7/6

Y1 - 2021/7/6

N2 - BACKGROUND: Within-consultation recruitment to primary care trials is challenging. Ensuring procedures are efficient and self-explanatory is the key to optimising recruitment. Trial recruitment software that integrates with the electronic health record to support and partially automate procedures is becoming more common. If it works well, such software can support greater participation and more efficient trial designs. An innovative electronic trial recruitment and outcomes software was designed to support recruitment to the Runny Ear randomised controlled trial, comparing topical, oral and delayed antibiotic treatment for acute otitis media with discharge in children. A qualitative evaluation investigated the views and experiences of primary care staff using this trial software.METHODS: Staff were purposively sampled in relation to site, role and whether the practice successfully recruited patients. In-depth interviews were conducted using a flexible topic guide, audio recorded and transcribed. Data were analysed thematically.RESULTS: Sixteen staff were interviewed, including GPs, practice managers, information technology (IT) leads and research staff. GPs wanted trial software that automatically captures patient data. However, the experience of getting the software to work within the limited and complex IT infrastructure of primary care was frustrating and time consuming. Installation was reliant on practice level IT expertise, which varied between practices. Although most had external IT support, this rarely included supported for research IT. Arrangements for approving new software varied across practices and often, but not always, required authorisation from Clinical Commissioning Groups.CONCLUSIONS: Primary care IT systems are not solely under the control of individual practices or CCGs or the National Health Service. Rather they are part of a complex system that spans all three and is influenced by semi-autonomous stakeholders operating at different levels. This led to time consuming and sometimes insurmountable barriers to installation at the practice level. These need to be addressed if software supporting efficient research in primary care is to become a reality.

AB - BACKGROUND: Within-consultation recruitment to primary care trials is challenging. Ensuring procedures are efficient and self-explanatory is the key to optimising recruitment. Trial recruitment software that integrates with the electronic health record to support and partially automate procedures is becoming more common. If it works well, such software can support greater participation and more efficient trial designs. An innovative electronic trial recruitment and outcomes software was designed to support recruitment to the Runny Ear randomised controlled trial, comparing topical, oral and delayed antibiotic treatment for acute otitis media with discharge in children. A qualitative evaluation investigated the views and experiences of primary care staff using this trial software.METHODS: Staff were purposively sampled in relation to site, role and whether the practice successfully recruited patients. In-depth interviews were conducted using a flexible topic guide, audio recorded and transcribed. Data were analysed thematically.RESULTS: Sixteen staff were interviewed, including GPs, practice managers, information technology (IT) leads and research staff. GPs wanted trial software that automatically captures patient data. However, the experience of getting the software to work within the limited and complex IT infrastructure of primary care was frustrating and time consuming. Installation was reliant on practice level IT expertise, which varied between practices. Although most had external IT support, this rarely included supported for research IT. Arrangements for approving new software varied across practices and often, but not always, required authorisation from Clinical Commissioning Groups.CONCLUSIONS: Primary care IT systems are not solely under the control of individual practices or CCGs or the National Health Service. Rather they are part of a complex system that spans all three and is influenced by semi-autonomous stakeholders operating at different levels. This led to time consuming and sometimes insurmountable barriers to installation at the practice level. These need to be addressed if software supporting efficient research in primary care is to become a reality.

KW - Electronic health records

KW - Information technology

KW - Primary health care

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U2 - 10.1186/s12875-021-01498-6

DO - 10.1186/s12875-021-01498-6

M3 - Article

C2 - 34229624

AN - SCOPUS:85109617166

SN - 1471-2296

VL - 22

JO - BMC FAMILY PRACTICE

JF - BMC FAMILY PRACTICE

IS - 1

M1 - 147

ER -

Challenges to implementing electronic trial data collection in primary care: a qualitative study

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