The Care Home Independent Prescribing Pharmacist Study (CHIPPS)-a non-randomised feasibility study of independent pharmacist prescribing in care homes.


Journal

Pilot and feasibility studies
ISSN: 2055-5784
Titre abrégé: Pilot Feasibility Stud
Pays: England
ID NLM: 101676536

Informations de publication

Date de publication:
2019
Historique:
received: 11 01 2019
accepted: 06 06 2019
entrez: 25 7 2019
pubmed: 25 7 2019
medline: 25 7 2019
Statut: epublish

Résumé

Residents in care homes are often very frail, have complex medicine regimens and are at high risk of adverse drug events. It has been recommended that one healthcare professional should assume responsibility for their medicines management. We propose that this could be a pharmacist independent prescriber (PIP). This feasibility study aimed to test and refine the service specification and proposed study processes to inform the design and outcome measures of a definitive randomised controlled trial to examine the clinical and cost effectiveness of PIPs working in care homes compared to usual care. Specific objectives included testing processes for participant identification, recruitment and consent and assessing retention rates; determining suitability of outcome measures and data collection processes from care homes and GP practices to inform selection of a primary outcome measure; assessing service and research acceptability; and testing and refining the service specification. Mixed methods (routine data, questionnaires and focus groups/interviews) were used in this non-randomised open feasibility study of a 3-month PIP intervention in care homes for older people. Data were collected at baseline and 3 months. One PIP, trained in service delivery, one GP practice and up to three care homes were recruited at each of four UK locations. For ten eligible residents (≥ 65 years, on at least one regular medication) in each home, the PIP undertook management of medicines, repeat prescription authorisation, referral to other healthcare professionals and staff training. Outcomes (falls, medications, resident's quality of life and activities of daily living, mental state and adverse events) were described at baseline and follow-up and assessed for inclusion in the main study. Participants' views post-intervention were captured in audio-recorded focus groups and semi-structured interviews. Transcripts were thematically analysed. Across the four locations, 44 GP practices and 16 PIPs expressed interest in taking part; all care homes invited agreed to take part. Two thirds of residents approached consented to participate (53/86). Forty residents were recruited (mean age 84 years; 61% (24) were female), and 38 participants remained at 3 months (two died). All GP practices, PIPs and care homes were retained. The number of falls per participating resident was selected as the primary outcome, following assessment of the different outcome measures against predetermined criteria. The chosen secondary outcomes/outcome measures include total falls, drug burden index (DBI), hospitalisations, mortality, activities of daily living (Barthel (proxy)) and quality of life (ED-5Q-5 L (face-to-face and proxy)) and selected items from the STOPP/START guidance that could be assessed without need for clinical judgement. No adverse drug events were reported. The PIP service was generally well received by the majority of stakeholders (care home staff, GPS, residents, relatives and other health care professionals). PIPs reported feeling more confident implementing change following the training but reported challenges accommodating the new service within their existing workload. Implementing a PIP service in care homes is feasible and acceptable to care home residents, staff and clinicians. Findings have informed refinements to the service specification, PIP training, recruitment to the future RCT and the choice of outcomes and outcome measures. The full RCT with internal pilot started in February 2016 and results are expected to be available in mid late 2020.

Sections du résumé

BACKGROUND BACKGROUND
Residents in care homes are often very frail, have complex medicine regimens and are at high risk of adverse drug events. It has been recommended that one healthcare professional should assume responsibility for their medicines management. We propose that this could be a pharmacist independent prescriber (PIP). This feasibility study aimed to test and refine the service specification and proposed study processes to inform the design and outcome measures of a definitive randomised controlled trial to examine the clinical and cost effectiveness of PIPs working in care homes compared to usual care. Specific objectives included testing processes for participant identification, recruitment and consent and assessing retention rates; determining suitability of outcome measures and data collection processes from care homes and GP practices to inform selection of a primary outcome measure; assessing service and research acceptability; and testing and refining the service specification.
METHODS METHODS
Mixed methods (routine data, questionnaires and focus groups/interviews) were used in this non-randomised open feasibility study of a 3-month PIP intervention in care homes for older people. Data were collected at baseline and 3 months. One PIP, trained in service delivery, one GP practice and up to three care homes were recruited at each of four UK locations. For ten eligible residents (≥ 65 years, on at least one regular medication) in each home, the PIP undertook management of medicines, repeat prescription authorisation, referral to other healthcare professionals and staff training. Outcomes (falls, medications, resident's quality of life and activities of daily living, mental state and adverse events) were described at baseline and follow-up and assessed for inclusion in the main study. Participants' views post-intervention were captured in audio-recorded focus groups and semi-structured interviews. Transcripts were thematically analysed.
RESULTS RESULTS
Across the four locations, 44 GP practices and 16 PIPs expressed interest in taking part; all care homes invited agreed to take part. Two thirds of residents approached consented to participate (53/86). Forty residents were recruited (mean age 84 years; 61% (24) were female), and 38 participants remained at 3 months (two died). All GP practices, PIPs and care homes were retained. The number of falls per participating resident was selected as the primary outcome, following assessment of the different outcome measures against predetermined criteria. The chosen secondary outcomes/outcome measures include total falls, drug burden index (DBI), hospitalisations, mortality, activities of daily living (Barthel (proxy)) and quality of life (ED-5Q-5 L (face-to-face and proxy)) and selected items from the STOPP/START guidance that could be assessed without need for clinical judgement. No adverse drug events were reported. The PIP service was generally well received by the majority of stakeholders (care home staff, GPS, residents, relatives and other health care professionals). PIPs reported feeling more confident implementing change following the training but reported challenges accommodating the new service within their existing workload.
CONCLUSION CONCLUSIONS
Implementing a PIP service in care homes is feasible and acceptable to care home residents, staff and clinicians. Findings have informed refinements to the service specification, PIP training, recruitment to the future RCT and the choice of outcomes and outcome measures. The full RCT with internal pilot started in February 2016 and results are expected to be available in mid late 2020.

Identifiants

pubmed: 31338204
doi: 10.1186/s40814-019-0465-y
pii: 465
pmc: PMC6625047
doi:

Types de publication

Journal Article

Langues

eng

Pagination

89

Subventions

Organisme : Department of Health
ID : RP-PG-0613-20007
Pays : United Kingdom

Déclaration de conflit d'intérêts

Competing interestsDW is in receipt of unrestricted education grants from Rosemont Pharmaceuticals, manufacturers of generic liquid medicines, and undertakes occasional consultancy work on their behalf. All other authors declare that they have no competing interests.

Références

Md State Med J. 1965 Feb;14:61-5
pubmed: 14258950
Health Econ. 2018 Jan;27(1):7-22
pubmed: 28833869
Arch Intern Med. 2007 Apr 23;167(8):781-7
pubmed: 17452540
Trials. 2017 Apr 12;18(1):175
pubmed: 28403876
BMJ Open. 2013 Jul 08;3(7):
pubmed: 23836761
J Eval Clin Pract. 2004 May;10(2):307-12
pubmed: 15189396
J Am Geriatr Soc. 2014 Sep;62(9):1658-65
pubmed: 25243680
Cochrane Database Syst Rev. 2016 Feb 12;2:CD009095
pubmed: 26866421
Qual Saf Health Care. 2009 Oct;18(5):341-6
pubmed: 19812095
Expert Rev Clin Pharmacol. 2012 Mar;5(2):187-97
pubmed: 22390561
BMJ. 2008 Sep 29;337:a1655
pubmed: 18824488
Eur J Clin Pharmacol. 2015 Dec;71(12):1429-40
pubmed: 26407688
BMJ. 2016 Oct 24;355:i5239
pubmed: 27777223
Age Ageing. 2006 Nov;35(6):586-91
pubmed: 16905764
Int J Geriatr Psychiatry. 2011 Jul;26(7):711-22
pubmed: 20845397
BMJ Open. 2013 Apr 05;3(4):
pubmed: 23562814
Eur J Hosp Pharm. 2017 Jan;24(1):30-33
pubmed: 31156894

Auteurs

Jacqueline Inch (J)

1Primary Care, Institute of Applied Health Sciences, School of Medicine, Medical Sciences & Nutrition, University of Aberdeen, Foresterhill, Aberdeen, AB25 2ZD Scotland.

Frances Notman (F)

1Primary Care, Institute of Applied Health Sciences, School of Medicine, Medical Sciences & Nutrition, University of Aberdeen, Foresterhill, Aberdeen, AB25 2ZD Scotland.

Christine M Bond (CM)

1Primary Care, Institute of Applied Health Sciences, School of Medicine, Medical Sciences & Nutrition, University of Aberdeen, Foresterhill, Aberdeen, AB25 2ZD Scotland.

David P Alldred (DP)

2School of Healthcare, Baines Wing, University of Leeds, Leeds, UK.

Antony Arthur (A)

3School of Health Sciences, Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, UK.

Annie Blyth (A)

4Norwich Medical School, University of East Anglia, Norwich, UK.

Amrit Daffu-O'Reilly (A)

2School of Healthcare, Baines Wing, University of Leeds, Leeds, UK.

Joanna Ford (J)

5Older Peoples Medicine, Norfolk and Norwich University Hospitals NHS Foundation Trust, Norwich, UK.

Carmel M Hughes (CM)

6School of Pharmacy, Queen's University Belfast, Belfast, UK.

Vivienne Maskrey (V)

4Norwich Medical School, University of East Anglia, Norwich, UK.

Anna Millar (A)

6School of Pharmacy, Queen's University Belfast, Belfast, UK.

Phyo K Myint (PK)

1Primary Care, Institute of Applied Health Sciences, School of Medicine, Medical Sciences & Nutrition, University of Aberdeen, Foresterhill, Aberdeen, AB25 2ZD Scotland.

Fiona M Poland (FM)

7School of Health Sciences, University of East Anglia, Norwich, UK.

Lee Shepstone (L)

4Norwich Medical School, University of East Anglia, Norwich, UK.

Arnold Zermansky (A)

8School of Healthcare, University of Leeds, Leeds, UK.

Richard Holland (R)

9Leicester Medical School, University of Leicester, Leicester, UK.

David Wright (D)

10School of Pharmacy, University of East Anglia, Norwich, UK.

Classifications MeSH