Condition category
Respiratory
Date applied
28/10/2019
Date assigned
30/01/2020
Last edited
30/01/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

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 November 2022

Who is funding the study?
Chief Scientist Office (UK)

Who is the main contact?
Dr Richard Lowrie
Richard.Lowrie@ggc.scot.nhs.uk

Trial website

Contact information

Type

Public

Primary contact

Dr Richard Lowrie

ORCID ID

Contact details

Pharmacy Services
Clarkston Court
56 Busby Road
Glasgow
G76 7AT
United Kingdom
+44 (0)7971827565
Richard.lowrie@ggc.scot.nhs.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

GN18RM698; HIPS/19/27

Study information

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

Acronym

TICC PCP

Study hypothesis

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

Not provided at time of registration

Study design

Pilot randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Treatment

Patient information sheet

Not available in web format. please use contact details to request participant information sheet

Condition

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

Phase

Drug names

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

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 trial start date

29/10/2019

Overall trial end date

01/11/2022

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant exclusion criteria

Lung or suspected other malignancy

Recruitment start date

01/06/2020

Recruitment end date

01/12/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

NHS Greater Glasgow and Clyde (South sector)
Clarkston Court 56 Busby Road
Glasgow
G76 7AT
United Kingdom

Trial participating centre

NHS Lothian
EH4 2XU
United Kingdom

Sponsor information

Organisation

NHS Greater Glasgow and Clyde

Sponsor details

Pharmacy Services
Clarkston Court
56 Busby Road
Glasgow
G76 7AT
United Kingdom
+44 (0)7971827565
Richard.lowrie@ggc.scot.nhs.uk

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Chief Scientist Office

Alternative name(s)

CSO

Funding Body Type

government organisation

Funding Body Subtype

Local government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The protocol, including the statistical analysis plan, will be available. Results to be published in November 2022.

IPD sharing statement
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.

Intention to publish date

01/11/2022

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

05/11/2019: Trial's existence confirmed by funder.