Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001627448
Ethics application status
Approved
Date submitted
21/11/2016
Date registered
24/11/2016
Date last updated
13/11/2019
Date data sharing statement initially provided
13/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of a model of GP and pharmacist collaboration in primary care in reducing unplanned hospital readmissions: REMAIN HOME study
Scientific title
Evaluating a model of GP and pharmacist collaboration in primary care in reducing unplanned, all-cause hospital readmissions: REMAIN HOME study
Secondary ID [1] 289176 0
Nil known
Universal Trial Number (UTN)
U1111-1182-7390
Trial acronym
REMAIN HOME - REducing Medical Admissions INto Hospital through Optimising MEdication
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients prescribed five or more long-term medicines being discharged from hospital 298715 0
Patients having a hospital admission related to heart failure or COPD being discharged from hospital 299567 0
Condition category
Condition code
Public Health 298768 298768 0 0
Health service research
Respiratory 300875 300875 0 0
Chronic obstructive pulmonary disease
Cardiovascular 300876 300876 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a multi-faceted and collaborative service, involving a clinical pharmacist integrated into a medical centre to assist patients in transitioning back into primary care. The intervention is targeted at the level of the medical centre. A practice pharmacist will be co-located in each medical centre during the intervention phase for approximately 12 hours per week. The length of time a medical centre receives the intervention will depend on where they are randomised to in the stepped wedge design, from one month to seven months.

There will be four components to the intervention which will apply to each patient enrolled in the study during the intervention phase:
1. Medication management consultation with practice pharmacist
2. Consultation with GP
3. Practice pharmacist to follow-up with patient, GP, community pharmacy and other health professionals involved in the patient’s care
4. Further follow-up as required

Medication management consultation:
Participants will receive a face-face minute medication management consultation (45 - 60 minutes) with the practice pharmacist in a private room at the attended medical centre as soon as possible after discharge from hospital. During this time, the pharmacist will perform a comprehensive medication review to identify any medication-related problems, assess medication adherence, review the participant’s medication discharge letter and discuss any changes made to medication during hospital admission with the participant. The pharmacist will also review the participant’s medical records at the practice and reconcile any differences as required. The pharmacist will discuss the intended treatment plan and any problems or concerns the participant may have regarding their medication and/or medical conditions. The pharmacist may also liaise with the participant’s community pharmacy as required .

Consultation with GP:
Directly after the consultation with the pharmacist, the patient will have a consultation with their GP to and to consider any changes made by the pharmacist or hospital during the admission, discuss the recent admission from hospital and future management plans. This will take 15 - 30 minutes.

Follow up :
The pharmacist will follow up with the participant within five days either via the phone or face-to-face at the attended medical centre (10-30 minutes). Furthermore, the pharmacist will liaise with the participant’s GP, other prescribers and community pharmacist based upon clinical need.

Further follow up will be based upon clinical need.
Intervention code [1] 294702 0
Prevention
Intervention code [2] 296461 0
Treatment: Other
Comparator / control treatment
Patients will receive standard/usual care provided by the medical centre. This would usually involve the patient following up with their general practitioner after discharge.
Control group
Active

Outcomes
Primary outcome [1] 298239 0
The rate of unplanned, all-cause hospital readmissions in the intervention group compared to control/usual care. This will be assessed through review of hospital medical records.
Timepoint [1] 298239 0
12 months after discharge
Secondary outcome [1] 323628 0
The rate of unplanned, all-cause hospital readmissions in the intervention group compared to control/usual care.
This will be assessed through review of hospital medical records.
Timepoint [1] 323628 0
30 days, 3 and 6 months after discharge
Secondary outcome [2] 323632 0
The rate of ED presentations in the intervention group compared to control/usual care. This will be assessed through review of hospital medical records.
Timepoint [2] 323632 0
30 days, 3, 6 and 12 months after discharge
Secondary outcome [3] 323633 0
Number of hospital treatment plans received in the intervention group compared to control/usual care.
This will be assessed through review of medical centre medical records.
Timepoint [3] 323633 0
7 days and 30 days after discharge
Secondary outcome [4] 326425 0
Number of participants reviewed by their GP in the intervention group compared to control/usual care.
This will be assessed through review of medical centre medical records.
Timepoint [4] 326425 0
7 days after discharge
Secondary outcome [5] 327350 0
Number of visits to the enrolled medical centre in the intervention group compared to control/usual care.
This will be assessed through review of medical centre medical records.
Timepoint [5] 327350 0
12 months after discharge
Secondary outcome [6] 329397 0
Costs to the healthcare system associated with the intervention (including the costs of providing the intervention, unplanned hospital readmissions, ED presentations, and related GP visits) in the intervention group compared to control/usual care.

This will be assessed through review of hospital and medical centre medical records. The primary source of hospital cost estimates (i.e. cost of a particular readmission) will be derived from the National Efficient Cost (NEC) and National Efficient Price (NEP) data that are collected and published annually by Australia’s Independent Hospital Pricing Authority (IHPA).
Timepoint [6] 329397 0
30 days, 3, 6 and 12 months after discharge
Secondary outcome [7] 329398 0
Description of views of the intervention from GPs, practice pharmacists and participants involved in the study.
This will be assessed through self-report questionnaires.
Timepoint [7] 329398 0
9 months after commencement of trial (i.e. end of study intervention)

Eligibility
Key inclusion criteria
*Prescribed 5 or more long-term prescribed medicines on discharge OR reason for admission was related to heart failure or Chronic Obstructive Pulmonary Disease (COPD)
*Have nominated a GP working in an enrolled medical centre in their hospital records which they see majority of the time.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded if they are:
*Receiving active radiation therapy or chemotherapy for malignant conditions
*Admission was for planned dialysis
*In palliative care as reflected by the treatment regimen (e.g. cessation of preventative medicines)
*Unable to attend a medication review and the follow up within the time frame

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patient recruitment will occur by research assistants who will screen patients daily being discharged for eligibility to enter the trial and recruit those that do. Once the patient has been enrolled, the research assistant will notify the project coordinator who will be able to determine whether the medical centre that the participant is attending is in the control or intervention phase. If the medical centre is in the intervention phase (or lead in phase), the project coordinator will pass the participant details onto the practice pharmacist performing the intervention. The project coordinator will collect data from all participant’s hospital and medical centre records around the hospital admission and current medical history.
The medical centre randomisation list will be kept centrally by the project coordinator, and research assistants recruiting participants into the study will be blinded to the medical centre randomisation schedule throughout the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The unit of randomisation is the study medical centre, not the recruited patient. Medical centres will be randomised to intervention or control phase using a stepped wedge design.
Stratified randomisation will be used to achieve a balance between medical centres in Brisbane North and South PHNs, while maintaining randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
This is a stepped-wedge cluster design trial which has a unidirectional crossover design where all clusters begin in the control phase and cross over to the intervention at different time points. The intervention will be delivered at the level of the medical centre and cluster randomisation will be used to allow for randomisation to occur at the level of the cluster (medical centre) instead of the participant.
Blinding of the intervention to staff at the medical centre and to participating patients is not possible as the presence of the pharmacist in the medical centre will indicate they are in the intervention phase. Research assistants will remain blinded to the randomisation schedule throughout the study.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size was calculated for the primary outcome, the rate of all-cause unplanned readmissions at 12 months from date of hospital discharge, using a method that takes into account the: intracluster correlation coefficient (ICC), expected baseline number of readmissions, effect of the intervention and power of the study. We followed methods described by others to determine the sample size needed, assuming a random effect for cluster (medical centre) and a fixed effect for each step to account for time. We have been conservative in our estimate of the ICC as we have limited a priori data to inform this value and also because the ICC is a process outcome, which usually have larger ICCs.

Whilst the analysis will be a Poisson regression of rate of re-admission, the study has been powered on a binary proportion outcome. This is because there is no data on which to estimate current rate of readmission and sample size methodology for stepped wedge studies does not currently exist for rate outcomes. This is a limitation of the sample size calculation, but the estimate of power will be conservative because the analysis will make full use of the number of readmissions. Literature from Australian studies suggests that 45% of patients discharged from medical inpatient units and 61% from Geriatrics Evaluation and Management units have an unplanned readmission within one year. A meta-analysis on pharmacist-led medication reconciliation at hospital transition found a reduction in all-cause readmissions of 19% by the intervention. A hospital discharge program involving medication reconciliation and telephone follow up reduced readmissions (combined with ED visits) by 30% in general medicine patients.

We expect only minimal variation in cluster sizes and so have not allowed for varying cluster sizes. With 14 clusters, and 20 patients recruited per cluster per month (except during the transition phase), gives an expected total sample size of 2,240 participants. Using these estimates and expected loss to follow up of approximately 20%, the design will have in the region of 80 – 90% power to detect a change in proportions of unplanned readmissions from 0.3 to 0.2 for a range of ICCs (from 0.05 to 0.15).

An intention-to-treat analysis will be conducted. All participants will be included in the analysis. Each medical centre will be classified as being in the intervention or the control phase based on their pre-specified randomised crossover time, regardless of whether crossover is achieved at that time.

In the primary analysis, differences in readmissions will be modelled using a mixed effects Poisson regression model with an offset to incorporate the number of days of follow up, a random effect for cluster and a fixed effect for each step to account for any temporal trend. Temporal trends may include seasonal variation in readmissions or changes in practice. We also intend to allow for both levels of clustering at the analysis stage - clustering by hospital and medical centre. We will do this by including both a random effect for medical centres and hospitals. If this model does not converge, we will include a fixed effect for hospital (as there will not be many hospitals) and a random effect for medical centre. Follow up time for each person will be the number of days from discharge for index admission to the earlier of 12 months post discharge; death or loss to follow up for example because of moving out of the region.

Secondary analysis will be conducted using similar techniques, but using different link functions as appropriate. Descriptive statistics will used to report the level of agreement with survey statements used to elicit the views of the intervention from GPs, practice pharmacists and participants involved in the study.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/01/2017
Actual
22/05/2017
Date of last participant enrolment
Anticipated
15/03/2018
Actual
14/03/2018
Date of last data collection
Anticipated
29/09/2018
Actual
14/04/2019
Sample size
Target
2240
Accrual to date
Final
353
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 5782 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [2] 5783 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [3] 5784 0
Logan Hospital - Meadowbrook
Recruitment hospital [4] 6231 0
Caboolture Hospital - Caboolture
Recruitment hospital [5] 6232 0
Redcliffe Hospital - Redcliffe
Recruitment hospital [6] 6398 0
Queen Elizabeth II Jubilee Hospital - Coopers Plains
Recruitment hospital [7] 6399 0
The Prince Charles Hospital - Chermside

Funding & Sponsors
Funding source category [1] 293606 0
Charities/Societies/Foundations
Name [1] 293606 0
HCF Research Foundation
Country [1] 293606 0
Australia
Funding source category [2] 293607 0
Government body
Name [2] 293607 0
Brisbane South PHN
Country [2] 293607 0
Australia
Funding source category [3] 294106 0
Government body
Name [3] 294106 0
Brisbane North PHN
Country [3] 294106 0
Australia
Primary sponsor type
Individual
Name
Christopher Freeman
Address
Pharmacy Australia Centre of Excellence (PACE)
Level 4
20 Cornwall St
Woolloongabba
Brisbane
Queensland 4102
Country
Australia
Secondary sponsor category [1] 292943 0
None
Name [1] 292943 0
Address [1] 292943 0
Country [1] 292943 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295046 0
Royal Brisbane & Women's hospital Human Ethics Research committee
Ethics committee address [1] 295046 0
Ethics committee country [1] 295046 0
Australia
Date submitted for ethics approval [1] 295046 0
26/08/2016
Approval date [1] 295046 0
18/11/2016
Ethics approval number [1] 295046 0
HREC/16/QRBW/410
Ethics committee name [2] 295047 0
The University of Queensland Medical Research Ethics Committee
Ethics committee address [2] 295047 0
Ethics committee country [2] 295047 0
Australia
Date submitted for ethics approval [2] 295047 0
Approval date [2] 295047 0
Ethics approval number [2] 295047 0
Ethics committee name [3] 295648 0
UnitingCare Queensland Human Research Ethics Committee
Ethics committee address [3] 295648 0
Ethics committee country [3] 295648 0
Australia
Date submitted for ethics approval [3] 295648 0
Approval date [3] 295648 0
Ethics approval number [3] 295648 0
Ethics committee name [4] 295649 0
Greenslopes Research and Ethics Committee
Ethics committee address [4] 295649 0
Ethics committee country [4] 295649 0
Australia
Date submitted for ethics approval [4] 295649 0
Approval date [4] 295649 0
Ethics approval number [4] 295649 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 65702 0
Dr Christopher Freeman
Address 65702 0
Pharmacy Australia Centre of Excellence (PACE)
Level 4, 20 Cornwall st
Woolloongabba, Brisbane
Queensland 4102
Country 65702 0
Australia
Phone 65702 0
+61 7 33461727
Fax 65702 0
Email 65702 0
c.freeman4@uq.edu.au
Contact person for public queries
Name 65703 0
Holly Foot
Address 65703 0
Pharmacy Australia Centre of Excellence (PACE)
Level 4, 20 Cornwall st
Woolloongabba, Brisbane
Queensland 4102
Country 65703 0
Australia
Phone 65703 0
+ 61 7 3346 1900
Fax 65703 0
Email 65703 0
h.ross1@uq.edu.au
Contact person for scientific queries
Name 65704 0
Holly Foot
Address 65704 0
Pharmacy Australia Centre of Excellence (PACE)
Level 4, 20 Cornwall st
Woolloongabba, Brisbane
Queensland 4102
Country 65704 0
Australia
Phone 65704 0
+ 61 7 3346 1900
Fax 65704 0
Email 65704 0
h.ross1@uq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ethics approval does not allow sharing of information


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5661Study protocolFoot H, Freeman C, Hemming K, et alReducing Medical Admissions into Hospital through Optimising Medicines (REMAIN HOME) Study: protocol for a stepped-wedge, cluster-randomised trialBMJ Open 2017;7:e015301. doi: 10.1136/bmjopen-2016-015301   
5662Informed consent form  c.freeman4@uq.edu.au
5663Ethical approval  c.freeman4@uq.edu.au



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseReducing Medical Admissions and Presentations Into Hospital through Optimising Medicines (REMAIN HOME): a stepped wedge, cluster randomised controlled trial.2021https://dx.doi.org/10.5694/mja2.50942
N.B. These documents automatically identified may not have been verified by the study sponsor.