A pilot study of clinical pharmacist home visits and consultant respiratory physician collaborative intervention to improve outcomes in people with chronic obstructive pulmonary disease and other health problems
| ISRCTN | ISRCTN43508703 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43508703 |
| IRAS number | 272543 |
| Secondary identifying numbers | GN18RM698; HIPS/19/27 |
- Submission date
- 28/10/2019
- Registration date
- 30/01/2020
- Last edited
- 08/08/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
People with moderate-to-severe chronic obstructive pulmonary disease (COPD) are so breathless that they need to stop for breath when walking at their own pace. At home, when breathing gets worse e.g. due to infection, hospitalisation often results. Frequent adjustment of medicines for COPD and other medical conditions improves breathing and reduces hospitalisations, but home-based check-ups for breathing and medicines are uncommon. Pharmacist home-visits, undertaken with the support of the patient’s GP and chest physician, can help ensure that patients are on the right medication and through so doing reduce the risk of a flare-up of COPD and associated hospital admission. The researchers now want to build on this work to see if pharmacist home-visits are safe and effective for patients and the NHS, but first they need a small-scale pilot study in which some patients get pharmacist home-visits and compare this with patients who do not get home-visits. If the results are promising, the researchers plan to run a trial big enough to test whether pharmacist home-visits improve patient outcomes and reduce hospital admissions for COPD.
Who can participate?
Patients aged over 18 with COPD
What does the study involve?
For all patients, there are no changes to the care they usually receive from the health service. For all participating patients, there are three monthly visits from a researcher to ask some questions and take some measures of respiratory function. None of these measures are invasive – all are routine e.g. blowing into a device that records lung function. Patients who are randomly allocated to the pharmacist intervention group receive pharmacist home visits, on average, every month for 6 months followed by two monthly visits for the following 6 months. However, some patients may receive fewer visits, and some may receive more than this. The decision to receive more or less visits depends on the patient’s preferences and clinical symptoms, through discussion with the pharmacist and consultant respiratory physician and GP. During the visits, the pharmacist assesses the patient’s respiratory symptoms, medicines and other conditions, then if agreed with the patient, the pharmacist recommends changes to the patient’s medicines, monitoring or referral to other services for further health intervention. For patients allocated to the usual care group, there are no pharmacist visits.
What are the possible benefits and risks of participating?
The benefits of taking part include receiving additional care and attention from a highly qualified pharmacist who is trained to assess and prescribe medicines independently. The pharmacist will be specialist in respiratory care. He or she will be working very closely with the patient’s existing respiratory consultant based at the patient’s usual hospital, and the patient’s GP. This collaboration will ensure that the patient receives more frequent input (from three clinicians: pharmacist, consultant and GP) than they would normally receive if not participating in the trial. The researchers cannot envisage any risks of taking part: in the usual care group (where patients do not receive more frequent input from the pharmacist), it will be care as usual from all existing care providers.
Where is the study run from?
1. NHS Greater Glasgow and Clyde (UK)
2. NHS Lothian (UK)
When is the study starting and how long is it expected to run for?
October 2019 to January 2024
Who is funding the study?
Chief Scientist Office (UK)
Who is the main contact?
Dr Richard Lowrie
Richard.Lowrie@ggc.scot.nhs.uk
Contact information
Public
Pharmacy Services
Clarkston Court
56 Busby Road
Glasgow
G76 7AT
United Kingdom
| Phone | +44 (0)7971827565 |
|---|---|
| Richard.lowrie@ggc.scot.nhs.uk |
Study information
| Study design | Pilot randomised controlled trial with parallel qualitative and economic evaluations |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Treatment |
| Participant information sheet | Not available in web format. please use contact details to request participant information sheet |
| Scientific title | Tailored Intervention at home for patients with moderate-to-severe COPD and co-morbidities by Pharmacists and Consultant Physicians (TICC PCP): a pilot randomised controlled trial |
| Study acronym | TICC PCP |
| Study objectives | This is a pilot randomised controlled trial. It seeks to determine whether we can recruit, retain, collect sufficient information, conduct randomisation as planned, and to assess whether there is enough merit in running a subsequent definitive trial. |
| Ethics approval(s) | Approved 18/09/2020, South East Scotland Research Ethics Committee 01 (Waverley Gate, 2-4 Waterloo Place, Edinburgh EH1 3EG, Edinburgh, EH1 3EG, United Kingdom; +44 7971827565; Sandra.Wylie@nhslothian.scot.nhs.uk), ref: 20/SS/0093 |
| Health condition(s) or problem(s) studied | Chronic obstructive pulmonary disease, and other morbidities |
| Intervention | Method of randomisation: Interactive Voice Response system operated by the Robertson Centre for Biostatistics, Glasgow University. Intervention arm: Pharmacist home visits every month for 6 months then every two months for 6 months. Pharmacist will assess respiratory and other health problems, then, based on patient’s presenting condition, recommend any changes to medicines or monitoring or onward referral that are likely to lead to improved respiratory health, and improved outcomes from other conditions. Recommendations will be discussed with consultant physician, GP and others. The pharmacist will implement the changes, as an autonomous Independent prescriber. Usual care arm: No pharmacist visits. Both arms: researcher home visits every three months to collect objective measures and health-related quality of life and patient experience of treatment, resource use. The intervention will be tailored to patients’ needs, meaning some patients may not require visits every month for 6 months and then 2 monthly for the following 6 months: some will require more, others less. Follow-up 24-30 months. |
| Intervention type | Other |
| Primary outcome measure | Current primary outcome measure as of 07/08/2024: The primary outcome for this pilot study, was whether to progress to a definitive RCT based on achievement of four progression criteria: 1. Recruitment of at least 70% invited participants within four months; 2. At least 70% of intervention arm participants receiving TICC PCP as planned (at least monthly for 6 months then every two months) from the date of allocation to intervention arm; 3. At least 80% of participants (excluding those who died or developed incapacity before the end of the study) remaining in the study until 21-month data collection; 4. At least 90% of in-person data collected at each study time point (baseline and every three months for up to 21 months). Researchers did not take blood samples during assessments and so the availability of blood results, depended on whether the participant had bloods collected recently as part of their routine care. Therefore, blood results were excluded from the calculation of missing data. A modified version of the Patient Experience with Treatment and Self-management (PETS: a patient-reported measure of treatment burden) was used, which had not been validated, therefore PETS responses were not included in data collection calculations. The percentage of missing data was calculated as the: number of missing data points divided by the total number of possible data points. _____ Previous primary outcome measure: Whether the researchers should proceed to a definitive trial, based on: 1. Eligibility 2. Recruitment 3. Retention 4. Implementation of study procedures (extent of collection of information every three months and time taken; randomisation, intervention delivery (completeness and fidelity between sites)) 5. Range of outcomes and optimal duration of follow up 6. Sample size 7. Completeness of efficacy outcome measures and estimates of variability collected from patients, clinical records, and through ISD Scotland record linkage ≥70% of invited patients agreeing to participate ≥70% of patients in the intervention group receiving the intervention as planned ≥80% of patients remaining in the study until the end (excluding those who die between consenting and follow up) ≥90% of data collected as planned Agreement of the independent TSC on the merits of progressing to a randomised controlled trial Qualitative - semi-structured interviews with 15-20 patients, and 7-10 health professionals |
| Secondary outcome measures | Current secondary outcome measures as of 07/08/2024: The following secondary outcomes and resource use will be measured by independent researchers extracting data from primary and secondary care health records at 3, 6, 9, 12, 15, 18, and 21 months whilst the participant remains in the study: 1. the number of, and the number of people with: Primary care contacts (GP, nurse, healthcare assistant, pharmacist or other), in person or by phone; 2. the number of prescribed medicines for respiratory conditions; 3. the number of prescribed medicines for: bone health; gastrointestinal problems; pain; skin conditions; cardiovascular disorders; depression; anxiety; anaemia; and vitamin or other dietary insufficiency; 4. the total number of prescribed medicines; 5. the total number of, the number of people with, and time to first: ED attendances (without admission) for respiratory reasons; 6. the total number of, the number of people with, and time to first: ED attendances (without admission) for non-respiratory reasons; 7. the total number of, the number of people with, and time to first: hospitalisation for respiratory reasons; 8. the total number of, the number of people with, and time to first: hospitalisation for non-respiratory reasons; 9. the duration of hospitalisation for respiratory reasons; 10. the duration of hospitalisations for non-respiratory reasons; 11. the number of out-patient attendances and out-patient non-attendance for respiratory and other reasons; 12. the total number of, time to, and causes of death. The following secondary outcomes will be collected from participants during home visits by independent researchers at the same time points noted above whilst the participant remains in the study: 1. the number of COPD exacerbations (confirmed by patient report on use of rescue pack (steroids and/or antibiotics); 2. HRQoL using the EQ-5D-5L instrument score and individual domain scores; 3. modified Medical Research Council Dyspnoea scale (mMRC) score; 4. COPD Assessment Test (CAT) score; 5. the total number of, the number of people with, and time to first fall; 6. the total number of, the number of people with, and time to first fracture; 7. Treatment burden scores (PETS questionnaire) collected at 3, 6, 12, and 21 months); and 8. Patient Health Questionnaire-4 Item (PHQ-4) depression and anxiety score and sub scores (anxiety and depression). _____ Previous secondary outcome measures: Measured at follow up (i.e. 24-30 months or earlier): 1. Number of exacerbations (data linkage showing community pharmacy dispensing dates of short course (5-14 day) antibiotic and/or short course prednisolone at 24 -30 months follow up (this will vary for each patient) 2. Medication changes (prescribed and used) from community pharmacy dispensing records (data linkage) 3. Number of A&E /medical admissions unit visits due to respiratory causes from data linkage 4. Number of emergency admissions due to COPD from ISD data linkage 5. Number of GP emergency visits and GEMS/Lothian Unscheduled Care visits due to COPD/respiratory causes from clinical systems in Glasgow and Lothian, respectively 6. Number and duration of hospitalisations (for respiratory) from ISD data linkage 7. Lung function (FEV1) from researchers’ records 8. Patient-reported measures (EQ-5D-5L, PETS both measured by researchers during three monthly visits) 9. Intervention acceptability from analysis of semi-structured interviews |
| Overall study start date | 29/10/2019 |
| Completion date | 05/01/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 100 |
| Total final enrolment | 110 |
| Key inclusion criteria | 1. Adults (>18 years) 2. With COPD and FEV1< 80% predicted 3. FEV1/FVC ratio<0.7; mMRC ≥215 4. Living at home 5. On a hospital respiratory outpatient clinic list |
| Key exclusion criteria | Lung or suspected other malignancy |
| Date of first enrolment | 07/07/2021 |
| Date of final enrolment | 04/01/2022 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centres
56 Busby Road
Glasgow
G76 7AT
United Kingdom
United Kingdom
Sponsor information
Hospital/treatment centre
Pharmacy Services
Clarkston Court
56 Busby Road
Glasgow
G76 7AT
Scotland
United Kingdom
| Phone | +44 (0)7971827565 |
|---|---|
| Richard.lowrie@ggc.scot.nhs.uk |
Funders
Funder type
Government
Government organisation / Local government
- Alternative name(s)
- CSO
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/11/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The protocol, including the statistical analysis plan, will be available. Results to be published in November 2022. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Richard Lowrie (Richard.Lowrie@ggc.scot.nhs.uk). Type of data: summary data tables of quantitative data including economic evaluation, and qualitative data. Available after completion of the trial in November 2022 for one year. Data will be shared by asking through email for any analyses. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other files | Baseline data collection form | 08/08/2024 | No | No | |
| Other files | Distribution of Healthcare Costs | 08/08/2024 | No | No | |
| Other files | Healthcare resource use unit costs | 08/08/2024 | No | No | |
| Other files | Participant flow | 08/08/2024 | No | No | |
| Other files | Reference list | 08/08/2024 | No | No | |
| Other files | Supplementary Appendix 1 Systematic literature search | 08/08/2024 | No | No | |
| Other files | description of intervention using the TiDier Framework | 08/08/2024 | No | No |
Additional files
- ISRCTN43508703 Participant flow.pdf
- Participant flow
- ISRCTN43508703 Figure 2. Distribution of Healthcare Costs.pdf
- Distribution of Healthcare Costs
- ISRCTN43508703 Reference list.pdf
- Reference list
- ISRCTN43508703 Supplementary Appendix 1 Systematic literature search.pdf
- Supplementary Appendix 1 Systematic literature search
- ISRCTN43508703 Baseline data collection form.pdf
- Baseline data collection form
- ISRCTN43508703 description of intervention using the TiDier Framework.pdf
- description of intervention using the TiDier Framework
- ISRCTN43508703 Healthcare resource use unit costs.pdf
- Healthcare resource use unit costs
Editorial Notes
08/08/2024: Additional files were uploaded.
07/08/2024: The following changes were made to the trial record:
1. The IRAS number was added.
2. The ethics approval was added.
3. The overall end date was changed from 01/11/2022 to 05/01/2024.
4. The primary outcome measure was changed.
5. The secondary outcome measures were changed.
6. The total final enrolment was added.
7. The recruitment start date was changed from 01/06/2020 to 07/07/2021.
8. The recruitment end date was changed from 01/12/2020 to 04/01/2022.
20/09/2021: Internal review.
05/11/2019: Trial's existence confirmed by funder.
