At-risk registers integrated into primary care to stop asthma crises in the UK (ARRISA-UK)

study protocol for a pragmatic, cluster randomised trial with nested health economic and process evaluations

Jane R Smith, Stanley Musgrave, Estelle Payerne, Michael Noble, Erika J Sims, Allan B Clark, Garry Barton, Hilary Pinnock, Aziz Sheikh, Andrew M Wilson, ARRISA-UK Group

Research output: Contribution to journalArticle

4 Downloads (Pure)

Abstract

BACKGROUND: Despite effective treatments and long-standing management guidelines, there are approximately 1400 hospital admissions for asthma weekly in the United Kingdom (UK), many of which could be avoided. In our previous research, a secondary analysis of the intervention (ARRISA) suggested an improvement in the management of at-risk asthma patients in primary care. ARRISA involved identifying individuals at risk of adverse asthma events, flagging their electronic health records, training practice staff to develop and implement practice-wide processes of care when alerted by the flag, plus motivational reminders. We now seek to determine the effectiveness and cost-effectiveness of ARRISA in reducing asthma-related crisis events.

METHODS: We are undertaking a pragmatic, two-arm, multicentre, cluster randomised controlled trial, plus health economic and process evaluation. We will randomise 270 primary care practices from throughout the UK covering over 10,000 registered patients with 'at-risk asthma' identified according to a validated algorithm. Staff in practices randomised to the intervention will complete two 45-min eLearning modules (an individually completed module giving background to ARRISA and a group-completed module to develop practice-wide pathways of care) plus a 30-min webinar with other practices. On completion of training at-risk patients' records will be coded so that a flag appears whenever their record is accessed. Practices will receive a phone call at 4 weeks and a reminder video at 6 weeks and 6 months. Control practices will continue to provide usual care. We will extract anonymised routine patient data from primary care records (with linkage to secondary care data) to determine the percentage of at-risk patients with an asthma-related crisis event (accident and emergency attendances, hospitalisations and deaths) after 12 months (primary outcome). We will also capture the time to crisis event, all-cause hospitalisations, asthma control and any changes in practice asthma management for at-risk and all patients with asthma. Cost-effectiveness analysis and mixed-methods process evaluations will also be conducted.

DISCUSSION: This study is novel in terms of using a practice-wide intervention to target and engage with patients at risk from their asthma and is innovative in the use of routinely captured data with record linkage to obtain trial outcomes.

TRIAL REGISTRATION: ISRCTN95472706 . Registered on 5 December 2014.

Original languageEnglish
Article number466
JournalTrials
Volume19
DOIs
Publication statusPublished - 29 Aug 2018

Fingerprint

Cost-Benefit Analysis
Primary Health Care
Asthma
Health
Hospitalization
United Kingdom
Secondary Care
Electronic Health Records
Practice Management
Risk Management
Accidents
Emergencies
Randomized Controlled Trials
Guidelines
Research

Keywords

  • At-risk asthma
  • general practice
  • pathway of care
  • register
  • elearning
  • hospitalisation

Cite this

At-risk registers integrated into primary care to stop asthma crises in the UK (ARRISA-UK) : study protocol for a pragmatic, cluster randomised trial with nested health economic and process evaluations. / Smith, Jane R; Musgrave, Stanley; Payerne, Estelle; Noble, Michael; Sims, Erika J; Clark, Allan B; Barton, Garry; Pinnock, Hilary; Sheikh, Aziz; Wilson, Andrew M; ARRISA-UK Group.

In: Trials, Vol. 19, 466, 29.08.2018.

Research output: Contribution to journalArticle

Smith, Jane R ; Musgrave, Stanley ; Payerne, Estelle ; Noble, Michael ; Sims, Erika J ; Clark, Allan B ; Barton, Garry ; Pinnock, Hilary ; Sheikh, Aziz ; Wilson, Andrew M ; ARRISA-UK Group. / At-risk registers integrated into primary care to stop asthma crises in the UK (ARRISA-UK) : study protocol for a pragmatic, cluster randomised trial with nested health economic and process evaluations. In: Trials. 2018 ; Vol. 19.
@article{b16e324375d9426783138266f970504d,
title = "At-risk registers integrated into primary care to stop asthma crises in the UK (ARRISA-UK): study protocol for a pragmatic, cluster randomised trial with nested health economic and process evaluations",
abstract = "BACKGROUND: Despite effective treatments and long-standing management guidelines, there are approximately 1400 hospital admissions for asthma weekly in the United Kingdom (UK), many of which could be avoided. In our previous research, a secondary analysis of the intervention (ARRISA) suggested an improvement in the management of at-risk asthma patients in primary care. ARRISA involved identifying individuals at risk of adverse asthma events, flagging their electronic health records, training practice staff to develop and implement practice-wide processes of care when alerted by the flag, plus motivational reminders. We now seek to determine the effectiveness and cost-effectiveness of ARRISA in reducing asthma-related crisis events.METHODS: We are undertaking a pragmatic, two-arm, multicentre, cluster randomised controlled trial, plus health economic and process evaluation. We will randomise 270 primary care practices from throughout the UK covering over 10,000 registered patients with 'at-risk asthma' identified according to a validated algorithm. Staff in practices randomised to the intervention will complete two 45-min eLearning modules (an individually completed module giving background to ARRISA and a group-completed module to develop practice-wide pathways of care) plus a 30-min webinar with other practices. On completion of training at-risk patients' records will be coded so that a flag appears whenever their record is accessed. Practices will receive a phone call at 4 weeks and a reminder video at 6 weeks and 6 months. Control practices will continue to provide usual care. We will extract anonymised routine patient data from primary care records (with linkage to secondary care data) to determine the percentage of at-risk patients with an asthma-related crisis event (accident and emergency attendances, hospitalisations and deaths) after 12 months (primary outcome). We will also capture the time to crisis event, all-cause hospitalisations, asthma control and any changes in practice asthma management for at-risk and all patients with asthma. Cost-effectiveness analysis and mixed-methods process evaluations will also be conducted.DISCUSSION: This study is novel in terms of using a practice-wide intervention to target and engage with patients at risk from their asthma and is innovative in the use of routinely captured data with record linkage to obtain trial outcomes.TRIAL REGISTRATION: ISRCTN95472706 . Registered on 5 December 2014.",
keywords = "At-risk asthma, general practice, pathway of care, register, elearning, hospitalisation",
author = "Smith, {Jane R} and Stanley Musgrave and Estelle Payerne and Michael Noble and Sims, {Erika J} and Clark, {Allan B} and Garry Barton and Hilary Pinnock and Aziz Sheikh and Wilson, {Andrew M} and Price, {David B} and {ARRISA-UK Group}",
note = "The ARRISA-UK trial is fully funded by the NIHR Health Technology Assessment (HTA), Grant number 13/34/70. This protocol presents independent research commissioned by the NIHR. The views and opinions expressed by authors in this publication are those of the authors and do not necessarily reflect those of the NHS, the NIHR, the NIHR Evaluation, Trials and Studies Coordinating Centre, the HTA programme or the Department of Health. Availability of data and materials After completion of the trial the database will be retained on the servers of UEA for 15 years for on-going secondary analysis. The datasets generated and/or analysed during the current study will be available from the corresponding author on reasonable request, provided appropriate credit is attributed to the original authors and the data source.",
year = "2018",
month = "8",
day = "29",
doi = "10.1186/s13063-018-2816-z",
language = "English",
volume = "19",
journal = "Trials",
issn = "1745-6215",
publisher = "BioMed Central",

}

TY - JOUR

T1 - At-risk registers integrated into primary care to stop asthma crises in the UK (ARRISA-UK)

T2 - study protocol for a pragmatic, cluster randomised trial with nested health economic and process evaluations

AU - Smith, Jane R

AU - Musgrave, Stanley

AU - Payerne, Estelle

AU - Noble, Michael

AU - Sims, Erika J

AU - Clark, Allan B

AU - Barton, Garry

AU - Pinnock, Hilary

AU - Sheikh, Aziz

AU - Wilson, Andrew M

AU - Price, David B

AU - ARRISA-UK Group

N1 - The ARRISA-UK trial is fully funded by the NIHR Health Technology Assessment (HTA), Grant number 13/34/70. This protocol presents independent research commissioned by the NIHR. The views and opinions expressed by authors in this publication are those of the authors and do not necessarily reflect those of the NHS, the NIHR, the NIHR Evaluation, Trials and Studies Coordinating Centre, the HTA programme or the Department of Health. Availability of data and materials After completion of the trial the database will be retained on the servers of UEA for 15 years for on-going secondary analysis. The datasets generated and/or analysed during the current study will be available from the corresponding author on reasonable request, provided appropriate credit is attributed to the original authors and the data source.

PY - 2018/8/29

Y1 - 2018/8/29

N2 - BACKGROUND: Despite effective treatments and long-standing management guidelines, there are approximately 1400 hospital admissions for asthma weekly in the United Kingdom (UK), many of which could be avoided. In our previous research, a secondary analysis of the intervention (ARRISA) suggested an improvement in the management of at-risk asthma patients in primary care. ARRISA involved identifying individuals at risk of adverse asthma events, flagging their electronic health records, training practice staff to develop and implement practice-wide processes of care when alerted by the flag, plus motivational reminders. We now seek to determine the effectiveness and cost-effectiveness of ARRISA in reducing asthma-related crisis events.METHODS: We are undertaking a pragmatic, two-arm, multicentre, cluster randomised controlled trial, plus health economic and process evaluation. We will randomise 270 primary care practices from throughout the UK covering over 10,000 registered patients with 'at-risk asthma' identified according to a validated algorithm. Staff in practices randomised to the intervention will complete two 45-min eLearning modules (an individually completed module giving background to ARRISA and a group-completed module to develop practice-wide pathways of care) plus a 30-min webinar with other practices. On completion of training at-risk patients' records will be coded so that a flag appears whenever their record is accessed. Practices will receive a phone call at 4 weeks and a reminder video at 6 weeks and 6 months. Control practices will continue to provide usual care. We will extract anonymised routine patient data from primary care records (with linkage to secondary care data) to determine the percentage of at-risk patients with an asthma-related crisis event (accident and emergency attendances, hospitalisations and deaths) after 12 months (primary outcome). We will also capture the time to crisis event, all-cause hospitalisations, asthma control and any changes in practice asthma management for at-risk and all patients with asthma. Cost-effectiveness analysis and mixed-methods process evaluations will also be conducted.DISCUSSION: This study is novel in terms of using a practice-wide intervention to target and engage with patients at risk from their asthma and is innovative in the use of routinely captured data with record linkage to obtain trial outcomes.TRIAL REGISTRATION: ISRCTN95472706 . Registered on 5 December 2014.

AB - BACKGROUND: Despite effective treatments and long-standing management guidelines, there are approximately 1400 hospital admissions for asthma weekly in the United Kingdom (UK), many of which could be avoided. In our previous research, a secondary analysis of the intervention (ARRISA) suggested an improvement in the management of at-risk asthma patients in primary care. ARRISA involved identifying individuals at risk of adverse asthma events, flagging their electronic health records, training practice staff to develop and implement practice-wide processes of care when alerted by the flag, plus motivational reminders. We now seek to determine the effectiveness and cost-effectiveness of ARRISA in reducing asthma-related crisis events.METHODS: We are undertaking a pragmatic, two-arm, multicentre, cluster randomised controlled trial, plus health economic and process evaluation. We will randomise 270 primary care practices from throughout the UK covering over 10,000 registered patients with 'at-risk asthma' identified according to a validated algorithm. Staff in practices randomised to the intervention will complete two 45-min eLearning modules (an individually completed module giving background to ARRISA and a group-completed module to develop practice-wide pathways of care) plus a 30-min webinar with other practices. On completion of training at-risk patients' records will be coded so that a flag appears whenever their record is accessed. Practices will receive a phone call at 4 weeks and a reminder video at 6 weeks and 6 months. Control practices will continue to provide usual care. We will extract anonymised routine patient data from primary care records (with linkage to secondary care data) to determine the percentage of at-risk patients with an asthma-related crisis event (accident and emergency attendances, hospitalisations and deaths) after 12 months (primary outcome). We will also capture the time to crisis event, all-cause hospitalisations, asthma control and any changes in practice asthma management for at-risk and all patients with asthma. Cost-effectiveness analysis and mixed-methods process evaluations will also be conducted.DISCUSSION: This study is novel in terms of using a practice-wide intervention to target and engage with patients at risk from their asthma and is innovative in the use of routinely captured data with record linkage to obtain trial outcomes.TRIAL REGISTRATION: ISRCTN95472706 . Registered on 5 December 2014.

KW - At-risk asthma

KW - general practice

KW - pathway of care

KW - register

KW - elearning

KW - hospitalisation

U2 - 10.1186/s13063-018-2816-z

DO - 10.1186/s13063-018-2816-z

M3 - Article

VL - 19

JO - Trials

JF - Trials

SN - 1745-6215

M1 - 466

ER -