Trial registered on ANZCTR


Trial ID
ACTRN12613001361796
Ethics application status
Approved
Date submitted
22/11/2013
Date registered
12/12/2013
Date last updated
30/10/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of a stakeholder-driven model of weekend allied health services
Scientific title
Does a new stakeholder-driven model of weekend allied health services improve efficiency and safety of patient care for acute medical / surgical patients compared to weekday only
services?
Secondary ID [1] 283584 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
adults who are acute medical and surgical inpatients 290488 0
Condition category
Condition code
Public Health 290880 290880 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
New allied health weekend service developed following focus group interviews with health professionals (medical, nursing and allied health) on each ward to identify the most appropriate distribution of funds to different allied health professions. Services will include physiotherapy, occupational therapy, social work, nutrition and speech pathology weekend allied health service delivery. Services delivered are the same as those done on weekdays, although the intensity of weekend services is lower (fewer hours per ward) than weekday services. Services may include mobilization, chest physiotherapy, discharge planning, assessment and prescription of aids and equipment, swallowing assessment, dietary analysis and prescription, and counselling.
The duration of this intervention is 6 months: the new model of
weekend allied health service delivery will be rolled-out across 6 acute medical and surgical units one-by-one on a monthly basis.
Intervention code [1] 288271 0
Other interventions
Comparator / control treatment
No weekend allied health service delivery. The duration of this
intervention is 7 months, as it includes one month with no weekend services in any of the 6 trial wards, plus the 6 months of gradual roll-out of new services.
Control group
Active

Outcomes
Primary outcome [1] 290872 0
Length of hospital stay. This will be analysed as mean length of stay and the proportion of patients who stay longer than their Australian Refined Diagnosis Related Group average “inlier” length of stay according to data published from the previous year.
Timepoint [1] 290872 0
on patient discharge from acute hospital ward.
Primary outcome [2] 290873 0
Number of unplanned hospital readmissions
Timepoint [2] 290873 0
at 28 days post patient discharge from hospital.
Primary outcome [3] 290874 0
Rate of adverse events: In-hospital falls, Code Blue / Medical Emergency Team calls, pulmonary embolus, DVT, unexpected death and hospital acquired pressure area, or ICU admission from the ward. These will be analysed as any adverse event and also adverse events within each subcategory. Falls will be analysed as total falls, falls resulting in any injury, and falls resulting in fracture, brain injury, or death.
Timepoint [3] 290874 0
at point of patient discharge or transfer from the study ward.
Secondary outcome [1] 305516 0
Number of complaints emanating from targeted wards (total and allied health specific) as captured through the hospital RiskMan database
Timepoint [1] 305516 0
monthly data extraction over the 7 month trial period
Secondary outcome [2] 305517 0
Number of compliments emanating from targeted wards (total and allied health specific) are captured through the hospital RiskMan database
Timepoint [2] 305517 0
monthly data extraction over the 7 month trial period
Secondary outcome [3] 305518 0
Patient discharge destination
Timepoint [3] 305518 0
at patient discharge from the study ward
Secondary outcome [4] 305519 0
Patient satisfaction using Victorian Patient Satisfaction Survey - Overall satisfaction domain (on a randomly selected subset of participants)
Timepoint [4] 305519 0
on day of patient discharge from the study ward
Secondary outcome [5] 305520 0
Patient functional independence using Modified Barthel Index (on a
randomly selected subset of participants)
Timepoint [5] 305520 0
on day of patient discharge from the study ward
Secondary outcome [6] 305521 0
Staff absenteeism (medical, nursing, allied health)
Timepoint [6] 305521 0
monthly data extraction over 7 month trial period
Secondary outcome [7] 309762 0
Patient health related quality of life using EQ-5D-5L (on a randomly selected subset of participants)
Timepoint [7] 309762 0
on day of patient discharge from the study ward

Eligibility
Key inclusion criteria
Patients admitted to participating acute medical / surgical wards at Dandenong Hospital, Western Hospital or Royal Melbourne Hospital during trial period
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Data from patients who are exposed to both control and intervention conditions will be excluded from the analyses.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
As this is a stepped-wedge cluster RCT, patients will not be individually randomised. Extensive consultation with the managers and clinicians at participating sites has resulted in a list of wards agreeing to participate in this trial. Placement of each ward into the ward number location will be determined at random by an investigator blinded to ward identity.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
One investigator will develop pseudonyms for each ward involved in the study. Another investigator, blinded to the true identity of each pseudonym, will use a random number generator in Microsoft Excel to allocate ward number locations to each pseudonym. The first investigator will then be able to reveal which pseudonym represented which ward.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
The design of this trial is a roll-out stepped wedge cluster randomised trial.

Qualitative outcomes:
A small, cross-disciplinary group of health professionals (4-6 per ward) will be sought to describe the impact that changing
the model of weekend allied health service has had on staff workload and patient care during the trial. This information will be collected at group-interviews. interviews will be conducted with staff members from each ward prior to the trial, and again at the post-trial timepoint. The aim is to explore their satisfaction with and experiences of the different weekend allied health service delivery models. We will also explore differing workplace pressures both during the weekend and on working days experienced under the different models, and also
workers' perspectives on and response to being involved in a research program undertaken with a disinvestment focus.
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Stepped-wedge cluster RCT: Linear mixed model analyses will be used to construct the 95% confidence intervals that compare effectiveness and safety outcomes between groups. These models will nest patients within wards, treating both as random factors, to account for the clustered nature of this data. “Weekend allied health service delivery model provided” will be treated as a fixed factor. Data distributions will be examined (+/- transformations as indicated) as a part of model building. Data from patients who are exposed to both control and intervention conditions within each phase will be excluded from the analyses. Superiority analyses will be conducted. Interim analyses will be conducted as monthly outcome data becomes available. Data will be analysed at a site-specific level (relevant to this specific trial registration) and in a pre-planned meta-analysis across 6 studies (including this one) being conducted as a part of this research program.
The economic analysis will be a cost-effectiveness analysis from the hospital perspective that examines the incremental cost per patient treated. These costs will include the “total cost” of patients during their admission plus additional costs from an unplanned admission within 28 days. The primary analysis will examine data from all patients, while a secondary analysis will focus on patients present on a weekend. Data from patients who are transferred between wards in different study periods (ie. one without access to allied health services, one with access to allied health services) will be excluded from the analyses as will data
from patients who remain within the same ward over two or more weekends if they are allowed to access weekend allied health services during one weekend, and not allowed to access allied health services on another.

A framework approach will be used for the analysis of qualitative data collected as a part of this study.

The sample size in this study is governed by the patient through-put of the participating wards over the trial period. Current data from study wards indicates there will be approximately 7308 patients in total.

We used the approach for conducting power analyses for stepped
wedge trials advocated by Hussey and Hughes based upon the Wald statistic. Using this approach, this trial has 96% power, given a 0.03 absolute increase (10% relative increase) non-inferiority margin from 0.30 (40%) for the proportion of patients who exceed their diagnosis specific “inlier” average length of stay.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Current
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 1708 0
Dandenong Hospital - Dandenong
Recruitment hospital [2] 2000 0
Western Hospital - Footscray
Recruitment hospital [3] 2001 0
Royal Melbourne Hospital - City campus - Parkville

Funding & Sponsors
Funding source category [1] 288264 0
Government body
Name [1] 288264 0
National Health and Medical Research Council - Partnership Project Grant
Address [1] 288264 0
GPO Box 1421
Canberra ACT 2601
Country [1] 288264 0
Australia
Primary sponsor type
Government body
Name
Department of Health, Victoria
Address
GPO Box 4057
Level 16, 50 Lonsdale Street
Melbourne VIC 3000
Country
Australia
Secondary sponsor category [1] 286981 0
None
Name [1] 286981 0
Address [1] 286981 0
Country [1] 286981 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290163 0
Monash Health Human Research Ethics Committee B
Ethics committee address [1] 290163 0
Research Directorate
Monash Health
Monash Medical Centre
246 Clayton Road
CLAYTON VIC 3168
Ethics committee country [1] 290163 0
Australia
Date submitted for ethics approval [1] 290163 0
30/08/2013
Approval date [1] 290163 0
28/11/2013
Ethics approval number [1] 290163 0
EC00383

Summary
Brief summary
Provision of allied health services over 7 days per week as opposed to 5 days per week for medical and surgical hospital inpatients is a practice inconsistently applied across health services in Australia. Presently, no evidence from randomised trials is available to guide service delivery for this population. These services have developed incrementally and in an ad hoc process at Monash, Western and Melbourne Health, in a similar experience to other health services around the state. It is possible that this is wasting resources that could be used for other purposes within these organisations. This study aims to examine whether removal and provision of weekend allied health services on general medical and surgical wards has an impact on length of stay on those wards, other indicators of quality and safety of service provision, and staff satisfaction. A novel research methodology will be applied using a stepped wedge cluster randomised controlled trial design to both incrementally remove existing services, then reintroduce services in a structured, stakeholder driven process (the 1st phase has been registered as a separate trial ID: ACTRN12613001231730). At Monash, Western and Melbourne Health, new, stakeholder driven weekend allied health services will be incrementally rolled out across 6 wards over a 7 month period. Outcomes will be collected predominantly through existing data collection processes, although additional data will be collected through staff group and key informant interviews, and random sampling of patients.
Trial website
Trial related presentations / publications
Haines, T, O'Brien, L, McDermott, F, Markham, D, Mitchell, D, Watterson, D, and Skinner, E (2013) A novel research design can aid disinvestment/reallocation from existing health technologies with uncertain effectiveness, cost-effectiveness and/or safety. Journal of Clinical Epidemiology (in press)
Public notes

Contacts
Principal investigator
Name 44282 0
A/Prof Terry Haines
Address 44282 0
Allied Health Research Unit
Monash Health
Kingston Centre
400 Warrigal Road
Cheltenham VIC 3195
Country 44282 0
Australia
Phone 44282 0
+61392651822
Fax 44282 0
Email 44282 0
terrence.haines@monash.edu
Contact person for public queries
Name 44283 0
A/Prof Terry Haines
Address 44283 0
Allied Health Research Unit
Monash Health
Kingston Centre
400 Warrigal Road
Cheltenham VIC 3195
Country 44283 0
Australia
Phone 44283 0
+61392651822
Fax 44283 0
Email 44283 0
terrence.haines@monash.edu
Contact person for scientific queries
Name 44284 0
A/Prof Terry Haines
Address 44284 0
Allied Health Research Unit
Monash Health
Kingston Centre
400 Warrigal Road
Cheltenham VIC 3195
Country 44284 0
Australia
Phone 44284 0
+61392651822
Fax 44284 0
Email 44284 0
terrence.haines@monash.edu