A study evaluating the feasibility of trial processes and delivery of an intervention for doctors and pharmacists working in older people’s medicine wards in hospitals in England, to facilitate the review and stopping of medicines no longer needed or where the risk of harm outweighs the benefit.
| ISRCTN | ISRCTN11899506 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11899506 |
| IRAS number | 312494 |
| Secondary identifying numbers | IRAS 312494, CPMS 52420 |
- Submission date
- 21/02/2022
- Registration date
- 12/05/2022
- Last edited
- 11/10/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English summary of protocol
Background and study aims
As we get older, our bodies are less able to handle some medicines. Medicines that were once effective and safe may not have as much benefit and may have an increased chance of causing harm. Research shows that almost half of older people in hospital are prescribed a medication with a risk of harm, but these medicines are rarely stopped.
In our previous research we asked older people and their carers about their thoughts on stopping these medicines. They told us that they would like these medicines reviewed by doctors in hospital during their stay and for those no longer needed or that could cause harm to be stopped. This is called ‘proactive deprescribing’ and is different to stopping a medicine after harm has occurred.
To make this happen we need to change doctor and pharmacist behaviour so that the idea of stopping medicines is more likely to be discussed with patients.
The CHARMER (CompreHensive geriAtRician led MEdication Review) Programme has been funded by the NIHR and will develop and test a way to support geriatricians (doctors working on older people’s medicine wards) and hospital pharmacists to proactively deprescribe for older people whilst they are in hospital.
We have already explored the reasons why geriatricians and hospital pharmacists do not proactively deprescribe for older people, working with doctors, pharmacists and patients/carers. We have used this work to develop an intervention to support and encourage proactive deprescribing and will test this in a feasibility study.
Who can participate?
Geriatricians or pharmacists working in older adult medicine wards in four hospitals in England will take part.
What does the study involve?
Geriatricians and pharmacists at 3 hospitals will receive the intervention and those at the 4th will not, they will be the control hospital. We will test the intervention for 4 weeks in the hospitals. The findings from this will be used to design a larger, definitive study.
What are the possible benefits and risks of participating?
None
Where is the study run from?
University of Leicester (UK)
When is the study starting and how long is it expected to run for?
February 2022 to September 2025
Who is funding the study?
National Institute for Health Research (NIHR) (UK).
Who is the main contact?
Prof. Debi Bhattacharya, d.bhattacharya@leicester.ac.uk
Contact information
Principal Investigator
School of Allied Health Professions
University of Leicester
University Road
Leicester
LE1 7RH
United Kingdom
| Phone | +44 7801 535715 |
|---|---|
| d.bhattacharya@leicester.ac.uk |
Study information
| Study design | Two arm open purposive allocation feasibility study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Two arm, open, purposive allocation feasibility study of a deprescribing behaviour change intervention for use by physicians and pharmacists with acute patients admitted to secondary care geriatric wards |
| Study acronym | CHARMER |
| Study objectives | The aim of this feasibility study is to inform the development of the definitive trial protocol for CHARMER by testing on a small-scale, the feasibility and acceptability of delivering and evaluating the CHARMER intervention. |
| Ethics approval(s) |
Approved 07/04/2022, Wales REC 1 (Health and Care Research Wales Support and Delivery Centre, Castlebridge 4, 15-19 Cowbridge Road East, Cardiff, CF11 9AB, United Kingdom; +44 (0)1792 606334; Wales.REC1@wales.nhs.uk), ref: 22/WA/0087 |
| Health condition(s) or problem(s) studied | Evaluation of a deprescribing intervention for geriatricians and pharmacists in older adult medicine setting in acute hospitals in England |
| Intervention | Current interventions as of 22/05/2023: A theory and evidence-based intervention have been developed to address the barriers and enablers to geriatricians and pharmacists proactively deprescribing medicines in hospitals. The deprescribing intervention developed and refined in earlier CHARMER studies will be compared to usual care in older people's medicine wards at four hospital sites in England. The aim of this feasibility study is to inform the development of a definitive trial protocol to evaluate the intervention, by testing the feasibility and acceptability of delivering the intervention and trial. During months 1 and 2, intervention sites will undertake the setup and implementation of the intervention and clinician recruitment. Once clinicians have received the intervention they may begin to make use of the training received as part of their daily clinical practice. NB The intervention does not direct clinical decision-making regarding whether to proactively deprescribe. This will remain a clinical decision based on a partnership between the patient, prescriber, and (if appropriate) the consultee. The decision will be based on both the clinical picture and individual preference. Evaluation of the intervention on clinical behaviour and patient outcomes will begin in month 3 and be monitored for 4 weeks. Three-month follow-up data from NHS Digital is expected in August/September 2023. _____ Previous interventions: A theory and evidence-based intervention have been developed to address the barriers and enablers to geriatricians and pharmacists proactively deprescribing medicines in hospitals. The deprescribing intervention developed and refined in earlier CHARMER studies will be compared to usual care in older people's medicine wards at four hospital sites in England. The aim of this feasibility study is to inform the development of a definitive trial protocol to evaluate the intervention, by testing the feasibility and acceptability of delivering the intervention and trial. During months 1 and 2, intervention sites will undertake the setup and implementation of the intervention and clinician recruitment. Once clinicians have received the intervention they may begin to make use of the training received as part of their daily clinical practice. NB The intervention does not direct clinical decision-making regarding whether to proactively deprescribe. This will remain a clinical decision based on a partnership between the patient, prescriber, and (if appropriate) the consultee. The decision will be based on both the clinical picture and individual preference. Evaluation of the intervention on clinical behaviour and patient outcomes will begin in month 3 and the active study window at sites will last 4 weeks. Data collection at follow-up will last 3 months following the end of the active study window. |
| Intervention type | Behavioural |
| Primary outcome measure | Current primary outcome measures as of 22/05/2023: 1. Recruitment rate recorded as number of participants who consent to take part in the study by end of active study window. 2. Attrition rate recorded as the number of participants who consent to participate that remain in the study until the end of follow up. Previous primary outcome measures: 1. Recruitment rate recorded as number of participants who consent to take part in the study by end of active study window. 2. Attrition rate recorded as the number of participants who consent to participate that remain in the study until the end of follow up at 3 months. |
| Secondary outcome measures | 1. Hospital readmission rate measured using HES Admitted patient care data set at 3 months 2. Mortality rate measured using ONS death report data at 3 months 3. Quality of Life measured using EQ5D-5L and SF36 at baseline and at 3 months |
| Overall study start date | 21/02/2022 |
| Completion date | 30/09/2025 |
Eligibility
| Participant type(s) | Patient, Health professional, Mixed |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 4 sites, 3 intervention sites recruiting up to 6 staff members each. 3 intervention and 1 control site recruiting up to 100 patients each. Total participants circa 400 |
| Key inclusion criteria | Clinicians: 1. Geriatrician or pharmacists working in older adult medicine wards in hospitals in England Patients: 2. Patients receiving care from a participating clinician during the study window |
| Key exclusion criteria | Clinicians: 1. Less than 0.3 FTE ward time |
| Date of first enrolment | 29/06/2022 |
| Date of final enrolment | 11/11/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Watford Road
Harrow
HA1 3UJ
United Kingdom
Colney
Norwich
NR4 7UY
United Kingdom
Eccles
Salford
M6 8HD
United Kingdom
Wigan
WN1 2NN
United Kingdom
Sponsor information
University/education
University Road
Leicester
LE1 7RH
England
United Kingdom
| Phone | +44 1163736508 |
|---|---|
| rgosponsor@leicester.ac.uk | |
| Website | http://www.le.ac.uk/ |
"ROR" |
https://ror.org/04h699437 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/02/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to data sharing restrictions as part of section 251 approval and NHS Digital governance requirements |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Protocol article | 04/08/2023 | 07/08/2023 | Yes | No |
Editorial Notes
11/10/2024: The participant information sheet field was updated and patient, and health professionals were added as participant types.
06/10/2023: The following changes were made to the trial record:
1. The overall end date was changed from 26/09/2023 to 30/09/2025.
2. The intention to publish date was changed from 01/02/2024 to 01/02/2026.
07/08/2023: Publication reference added.
22/05/2023: The following changes have been made:
1. The overall end date was changed from 25/09/2023 to 26/09/2023.
2. The interventions have been changed.
3. The primary outcome measures have been changed.
4. The recruitment start date has been changed from 20/06/2022 to 29/06/2022.
5. The recruitment end date has been changed from 31/10/2022 to 11/11/2022.
18/05/2023: The overall end date was changed from 31/07/2023 to 25/09/2023 and the plain English summary was updated accordingly.
21/02/2023: The overall end date was changed from 28/02/2023 to 31/07/2023 and the plain English summary was updated accordingly.
06/10/2022: The recruitment end date was changed from 30/09/2022 to 31/10/2022.
16/06/2022: The following changes have been made:
1. The recruitment start date has been changed from 01/06/2022 to 20/06/2022.
2. The recruitment end date has been changed from 30/06/2022 to 30/09/2022.
3. The trial website has been added.
17/03/2022: Trial's existence confirmed by the National Institute for Health Research (NIHR) (UK).
