An external pilot cluster randomised controlled trial of a theory-based intervention to improve appropriate polypharmacy in older people in primary care (PolyPrime)

On behalf of the PolyPrime team

doi:10.1186/s40814-022-01161-6

An external pilot cluster randomised controlled trial of a theory-based intervention to improve appropriate polypharmacy in older people in primary care (PolyPrime)

On behalf of the PolyPrime team

Surgery, Cardiac Surgery Division

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

6 Scopus citations

Abstract

Background: For older populations with multimorbidity, polypharmacy (use of multiple medications) is a standard practice. PolyPrime is a theory-based intervention developed to improve appropriate polypharmacy in older people in primary care. This pilot study aims to assess the feasibility of the PolyPrime intervention in primary care in Northern Ireland (NI) and the Republic of Ireland (ROI). Methods: This external pilot cluster randomised controlled trial (cRCT) aimed to recruit 12 general practitioner (GP) practices (six in NI; six in the ROI counties that border NI) and ten older patients receiving polypharmacy (≥ 4 medications) per GP practice (n = 120). Practices allocated to the intervention arm watched an online video and scheduled medication reviews with patients on two occasions. We assessed the feasibility of collecting GP record (medication appropriateness, health service use) and patient self-reported data [health-related quality of life (HRQoL), health service use)] at baseline, 6 and 9 months. HRQoL was measured using the EuroQol-5 dimension-5 level questionnaire (EQ-5D-5L) and medication-related burden quality-of-life (MRB-QoL) tool. An embedded process evaluation and health economics analysis were also undertaken. Pre-specified progression criteria were used to determine whether to proceed to a definitive cRCT. Results: Twelve GP practices were recruited and randomised. Three GP practices withdrew from the study due to COVID-related factors. Sixty-eight patients were recruited, with 47 (69.1%) being retained until the end of the study. GP record data were available for 47 patients for medication appropriateness analysis at 9 months. EQ-5D-5L and MRB-QoL data were available for 46 and 41 patients, respectively, at 9 months. GP record and patient self-reported health service use data were available for 47 patients at 9 months. Health service use was comparable in terms of overall cost estimated from GP record versus patient self-reported data. The intervention was successfully delivered as intended; it was acceptable to GPs, practice staff, and patients; and potential mechanisms of action have been identified. All five progression criteria were met (two ‘Go’, three ‘Amend’). Conclusion: Despite challenges faced during the COVID-19 pandemic, this study has demonstrated that it may be feasible to conduct an intervention to improve appropriate polypharmacy in older people in primary care across two healthcare jurisdictions. Trial registration: ISRCTN, ISRCTN41009897. Registered 19 November 2019. Clinicaltrials.gov, NCT04181879. Registered 02 December 2019.

Original language	English (US)
Article number	203
Journal	Pilot and Feasibility Studies
Volume	8
Issue number	1
DOIs	https://doi.org/10.1186/s40814-022-01161-6
State	Published - Dec 2022

Funding

This study is funded by the HSC R&D Division Cross-border Healthcare Intervention Trials in Ireland Network (CHITIN) programme, funded by the European Union’s INTERREG VA Programme, managed by the Special EU Programmes Body (SEUPB) project reference CHI/5431/2018. The views and opinions expressed in this paper do not necessarily reflect those of the European Commission or the Special EU Programmes Body (SEUPB). The funding body (and study sponsor) was not involved in the design of the study or in the writing of this manuscript. We would like to thank the members of the PolyPrime study team who contributed to the delivery of the cRCT (NICTU: Ms. Lynn Murphy, Mr. Gavin Kennedy, Dr. Catherine Adams, Ms. Laurie Martin, Ms. Joanne Thompson, Ms. Sorcha Toase, Ms. Carys Boyd, Ms. Rachael McQuillan; TCD: Asst. Prof. Máire O’Dwyer). We would also like to thank members of the Trial Advisory Group and Trial Steering Committee for their advice and support. And finally, we would like to thank the GPs, practice staff and patients who participated in this study during a very challenging time.

Keywords

Behaviour change
Complex intervention
General practice
Older people
Pilot study
Polypharmacy
Prescribing
Primary care
Process evaluation

ASJC Scopus subject areas

Medicine (miscellaneous)

Access to Document

10.1186/s40814-022-01161-6

Cite this

@article{6e51deaee062481590610dc1aaeb7d68,

title = "An external pilot cluster randomised controlled trial of a theory-based intervention to improve appropriate polypharmacy in older people in primary care (PolyPrime)",

abstract = "Background: For older populations with multimorbidity, polypharmacy (use of multiple medications) is a standard practice. PolyPrime is a theory-based intervention developed to improve appropriate polypharmacy in older people in primary care. This pilot study aims to assess the feasibility of the PolyPrime intervention in primary care in Northern Ireland (NI) and the Republic of Ireland (ROI). Methods: This external pilot cluster randomised controlled trial (cRCT) aimed to recruit 12 general practitioner (GP) practices (six in NI; six in the ROI counties that border NI) and ten older patients receiving polypharmacy (≥ 4 medications) per GP practice (n = 120). Practices allocated to the intervention arm watched an online video and scheduled medication reviews with patients on two occasions. We assessed the feasibility of collecting GP record (medication appropriateness, health service use) and patient self-reported data [health-related quality of life (HRQoL), health service use)] at baseline, 6 and 9 months. HRQoL was measured using the EuroQol-5 dimension-5 level questionnaire (EQ-5D-5L) and medication-related burden quality-of-life (MRB-QoL) tool. An embedded process evaluation and health economics analysis were also undertaken. Pre-specified progression criteria were used to determine whether to proceed to a definitive cRCT. Results: Twelve GP practices were recruited and randomised. Three GP practices withdrew from the study due to COVID-related factors. Sixty-eight patients were recruited, with 47 (69.1%) being retained until the end of the study. GP record data were available for 47 patients for medication appropriateness analysis at 9 months. EQ-5D-5L and MRB-QoL data were available for 46 and 41 patients, respectively, at 9 months. GP record and patient self-reported health service use data were available for 47 patients at 9 months. Health service use was comparable in terms of overall cost estimated from GP record versus patient self-reported data. The intervention was successfully delivered as intended; it was acceptable to GPs, practice staff, and patients; and potential mechanisms of action have been identified. All five progression criteria were met (two {\textquoteleft}Go{\textquoteright}, three {\textquoteleft}Amend{\textquoteright}). Conclusion: Despite challenges faced during the COVID-19 pandemic, this study has demonstrated that it may be feasible to conduct an intervention to improve appropriate polypharmacy in older people in primary care across two healthcare jurisdictions. Trial registration: ISRCTN, ISRCTN41009897. Registered 19 November 2019. Clinicaltrials.gov, NCT04181879. Registered 02 December 2019.",

keywords = "Behaviour change, Complex intervention, General practice, Older people, Pilot study, Polypharmacy, Prescribing, Primary care, Process evaluation",

author = "{On behalf of the PolyPrime team} and Audrey Rankin and Ashleigh Gorman and Judith Cole and Cadogan, {Cathal A.} and Barry, {Heather E.} and Ashley Agus and Danielle Logan and Cliona McDowell and Molloy, {Gerard J.} and Crist{\'i}n Ryan and Claire Leathem and Marina Maxwell and Connie Brennan and Gormley, {Gerard J.} and Alan Ferrett and Pat McCarthy and Tom Fahey and Hughes, {Carmel M.} and Lynn Murphy and Gavin Kennedy and Catherine Adams and Laurie Martin and Joanne Thompson and Sorcha Toase and Carys Boyd and Rachael McQuillan and M{\'a}ire O{\textquoteright}Dwyer",

note = "Funding Information: This study is funded by the HSC R&D Division Cross-border Healthcare Intervention Trials in Ireland Network (CHITIN) programme, funded by the European Union{\textquoteright}s INTERREG VA Programme, managed by the Special EU Programmes Body (SEUPB) project reference CHI/5431/2018. The views and opinions expressed in this paper do not necessarily reflect those of the European Commission or the Special EU Programmes Body (SEUPB). The funding body (and study sponsor) was not involved in the design of the study or in the writing of this manuscript. Funding Information: We would like to thank the members of the PolyPrime study team who contributed to the delivery of the cRCT (NICTU: Ms. Lynn Murphy, Mr. Gavin Kennedy, Dr. Catherine Adams, Ms. Laurie Martin, Ms. Joanne Thompson, Ms. Sorcha Toase, Ms. Carys Boyd, Ms. Rachael McQuillan; TCD: Asst. Prof. M{\'a}ire O{\textquoteright}Dwyer). We would also like to thank members of the Trial Advisory Group and Trial Steering Committee for their advice and support. And finally, we would like to thank the GPs, practice staff and patients who participated in this study during a very challenging time. Publisher Copyright: {\textcopyright} 2022, The Author(s).",

year = "2022",

month = dec,

doi = "10.1186/s40814-022-01161-6",

language = "English (US)",

volume = "8",

journal = "Pilot and Feasibility Studies",

issn = "2055-5784",

publisher = "BioMed Central Ltd.",

number = "1",

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TY - JOUR

T1 - An external pilot cluster randomised controlled trial of a theory-based intervention to improve appropriate polypharmacy in older people in primary care (PolyPrime)

AU - On behalf of the PolyPrime team

AU - Rankin, Audrey

AU - Gorman, Ashleigh

AU - Cole, Judith

AU - Cadogan, Cathal A.

AU - Barry, Heather E.

AU - Agus, Ashley

AU - Logan, Danielle

AU - McDowell, Cliona

AU - Molloy, Gerard J.

AU - Ryan, Cristín

AU - Leathem, Claire

AU - Maxwell, Marina

AU - Brennan, Connie

AU - Gormley, Gerard J.

AU - Ferrett, Alan

AU - McCarthy, Pat

AU - Fahey, Tom

AU - Hughes, Carmel M.

AU - Murphy, Lynn

AU - Kennedy, Gavin

AU - Adams, Catherine

AU - Martin, Laurie

AU - Thompson, Joanne

AU - Toase, Sorcha

AU - Boyd, Carys

AU - McQuillan, Rachael

AU - O’Dwyer, Máire

N1 - Funding Information: This study is funded by the HSC R&D Division Cross-border Healthcare Intervention Trials in Ireland Network (CHITIN) programme, funded by the European Union’s INTERREG VA Programme, managed by the Special EU Programmes Body (SEUPB) project reference CHI/5431/2018. The views and opinions expressed in this paper do not necessarily reflect those of the European Commission or the Special EU Programmes Body (SEUPB). The funding body (and study sponsor) was not involved in the design of the study or in the writing of this manuscript. Funding Information: We would like to thank the members of the PolyPrime study team who contributed to the delivery of the cRCT (NICTU: Ms. Lynn Murphy, Mr. Gavin Kennedy, Dr. Catherine Adams, Ms. Laurie Martin, Ms. Joanne Thompson, Ms. Sorcha Toase, Ms. Carys Boyd, Ms. Rachael McQuillan; TCD: Asst. Prof. Máire O’Dwyer). We would also like to thank members of the Trial Advisory Group and Trial Steering Committee for their advice and support. And finally, we would like to thank the GPs, practice staff and patients who participated in this study during a very challenging time. Publisher Copyright: © 2022, The Author(s).

PY - 2022/12

Y1 - 2022/12

N2 - Background: For older populations with multimorbidity, polypharmacy (use of multiple medications) is a standard practice. PolyPrime is a theory-based intervention developed to improve appropriate polypharmacy in older people in primary care. This pilot study aims to assess the feasibility of the PolyPrime intervention in primary care in Northern Ireland (NI) and the Republic of Ireland (ROI). Methods: This external pilot cluster randomised controlled trial (cRCT) aimed to recruit 12 general practitioner (GP) practices (six in NI; six in the ROI counties that border NI) and ten older patients receiving polypharmacy (≥ 4 medications) per GP practice (n = 120). Practices allocated to the intervention arm watched an online video and scheduled medication reviews with patients on two occasions. We assessed the feasibility of collecting GP record (medication appropriateness, health service use) and patient self-reported data [health-related quality of life (HRQoL), health service use)] at baseline, 6 and 9 months. HRQoL was measured using the EuroQol-5 dimension-5 level questionnaire (EQ-5D-5L) and medication-related burden quality-of-life (MRB-QoL) tool. An embedded process evaluation and health economics analysis were also undertaken. Pre-specified progression criteria were used to determine whether to proceed to a definitive cRCT. Results: Twelve GP practices were recruited and randomised. Three GP practices withdrew from the study due to COVID-related factors. Sixty-eight patients were recruited, with 47 (69.1%) being retained until the end of the study. GP record data were available for 47 patients for medication appropriateness analysis at 9 months. EQ-5D-5L and MRB-QoL data were available for 46 and 41 patients, respectively, at 9 months. GP record and patient self-reported health service use data were available for 47 patients at 9 months. Health service use was comparable in terms of overall cost estimated from GP record versus patient self-reported data. The intervention was successfully delivered as intended; it was acceptable to GPs, practice staff, and patients; and potential mechanisms of action have been identified. All five progression criteria were met (two ‘Go’, three ‘Amend’). Conclusion: Despite challenges faced during the COVID-19 pandemic, this study has demonstrated that it may be feasible to conduct an intervention to improve appropriate polypharmacy in older people in primary care across two healthcare jurisdictions. Trial registration: ISRCTN, ISRCTN41009897. Registered 19 November 2019. Clinicaltrials.gov, NCT04181879. Registered 02 December 2019.

AB - Background: For older populations with multimorbidity, polypharmacy (use of multiple medications) is a standard practice. PolyPrime is a theory-based intervention developed to improve appropriate polypharmacy in older people in primary care. This pilot study aims to assess the feasibility of the PolyPrime intervention in primary care in Northern Ireland (NI) and the Republic of Ireland (ROI). Methods: This external pilot cluster randomised controlled trial (cRCT) aimed to recruit 12 general practitioner (GP) practices (six in NI; six in the ROI counties that border NI) and ten older patients receiving polypharmacy (≥ 4 medications) per GP practice (n = 120). Practices allocated to the intervention arm watched an online video and scheduled medication reviews with patients on two occasions. We assessed the feasibility of collecting GP record (medication appropriateness, health service use) and patient self-reported data [health-related quality of life (HRQoL), health service use)] at baseline, 6 and 9 months. HRQoL was measured using the EuroQol-5 dimension-5 level questionnaire (EQ-5D-5L) and medication-related burden quality-of-life (MRB-QoL) tool. An embedded process evaluation and health economics analysis were also undertaken. Pre-specified progression criteria were used to determine whether to proceed to a definitive cRCT. Results: Twelve GP practices were recruited and randomised. Three GP practices withdrew from the study due to COVID-related factors. Sixty-eight patients were recruited, with 47 (69.1%) being retained until the end of the study. GP record data were available for 47 patients for medication appropriateness analysis at 9 months. EQ-5D-5L and MRB-QoL data were available for 46 and 41 patients, respectively, at 9 months. GP record and patient self-reported health service use data were available for 47 patients at 9 months. Health service use was comparable in terms of overall cost estimated from GP record versus patient self-reported data. The intervention was successfully delivered as intended; it was acceptable to GPs, practice staff, and patients; and potential mechanisms of action have been identified. All five progression criteria were met (two ‘Go’, three ‘Amend’). Conclusion: Despite challenges faced during the COVID-19 pandemic, this study has demonstrated that it may be feasible to conduct an intervention to improve appropriate polypharmacy in older people in primary care across two healthcare jurisdictions. Trial registration: ISRCTN, ISRCTN41009897. Registered 19 November 2019. Clinicaltrials.gov, NCT04181879. Registered 02 December 2019.

KW - Behaviour change

KW - Complex intervention

KW - General practice

KW - Older people

KW - Pilot study

KW - Polypharmacy

KW - Prescribing

KW - Primary care

KW - Process evaluation

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ER -

An external pilot cluster randomised controlled trial of a theory-based intervention to improve appropriate polypharmacy in older people in primary care (PolyPrime)

Abstract

Funding

Keywords

ASJC Scopus subject areas

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