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Trial registered on ANZCTR


Registration number
ACTRN12618000029291
Ethics application status
Approved
Date submitted
13/12/2017
Date registered
12/01/2018
Date last updated
16/11/2018
Date data sharing statement initially provided
16/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The success of research implementation strategies on evidence informed decision making by allied health managers: a randomised controlled trial
Scientific title
The success of research implementation strategies on evidence informed decision making by allied health managers: a randomised controlled trial
Secondary ID [1] 293383 0
Nil known
Universal Trial Number (UTN)
U1111-1205-2621
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Evidence-informed decision-making 302516 0
Condition category
Condition code
Public Health 302062 302062 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Implementation strategy group 1 will involve the provision of an “evidence-based policy recommendation” document. This report contains information based on a systematic literature review and meta-analysis of the effectiveness and cost-effectiveness of weekend allied health services for improving patient health and health service outcomes on hospital wards. The document will be constructed in the 1:3:25 format developed by the Canadian Health Services Research Foundation in order to ensure that research findings were presented to policy makers in a logical and consistent manner. It allows for a one page outline of the main messages that have come from the research, a three page executive summary and 25 pages to present the findings and methodology used in a language that is clear and accessible to the non-research specialist. Specific recommendations will be made as to how allied health managers can align their weekend allied health services to the current evidence base, these recommendations will relate to how the proportion of total allied health services should be delivered during weekends in order to align with the current research evidence. This document was developed by project investigators through a consensus building approach and reviewed by a key-stakeholder review committee comprised of health professionals, managers, consumers, carer representatives, policy makers and an academic.

Implementation strategy group 2 will involve the provision of the same “evidence-based policy recommendation” document and access to a knowledge broker. One knowledge broker with a PhD level qualification, from an allied health professional background, with research experience, currently employed as a post-doctoral research fellow will be recruited as the knowledge broker for this implementation strategy. The knowledge broker will offer a 60-minute initial consultation on a 1:1 basis to perform an initial individual, organisational, and external environment (e.g. government policy) needs assessment. The personal gain through provision of ongoing professional development activities, as well as the organisational and societal impact of aligning practice to the evidence-based policy recommendation will be emphasised during this initial consultation in order to establish an imperative for change. A 12-month plan will then be developed based on a shared vision to address individual and organisational capacity for evidence-informed decision-making. One 60-minute group-based webinar session will be offered within the first 6-months of the intervention period depending on allied health manager availability. This session will serve to develop trust and networks between the knowledge broker and the allied health managers, as well as between the allied health managers. Support for organisational change and education regarding the interpretation of the evidence-based policy recommendations will be a focus of this session. Follow-up contact will be offered on a monthly basis via email or telephone (as per the managers preference) for 12-months. This activity will focus on employing effective communication strategies and providing resources to support change. Adherence to the knowledge broker implementation strategy will be monitored via the knowledge broker diary kept for the 12-month period.
Intervention code [1] 297520 0
Other interventions
Comparator / control treatment
The control implementation strategy group will involve a 12-month wait-list for provision of the evidence-based policy recommendation document at trial completion. This group will involve usual care conditions, as per each health services usual decision-making process.
Control group
Active

Outcomes
Primary outcome [1] 301494 0
(1) Practice alignment with policy recommendations:
Allied health service events (occasions of service) occurring on weekends, as a proportion of total allied health service events for the relevant hospital wards will be the metric used to determine alignment with the policy recommendation. This information will be collected for the final month of the 12 month follow-up period. Allied health service events will be defined as per the National Allied Health Data Working Group (NAHDWG) endorsed National Allied Health Best Practice Data Sets. Where data relating to allied health service events on weekends and during the week are not available, data relating to allied health staffing levels or budgetary allocations will be used. Each participant's cluster (hospital/health service) will receive a single classification as either: (1) Practice fully aligned with policy recommendation for both acute and subacute hospital wards, (2) Practice partially aligned with policy recommendation (e.g. if practice on acute wards was completely aligned within the policy recommendation but not on subacute wards and vice versa), or (3) Practice not aligned with policy recommendation.
Timepoint [1] 301494 0
One month of data will be used from the final month of the 12 month follow up
Secondary outcome [1] 332845 0
Opportunity cost to make the decision on how to provide weekend allied health services (time to make decision, resources used, and knowledge broker time attributable to each participant in implementation strategy group 2):
Participants will be asked to record the amount of time (person-hours) they took to make the resource allocation decision, and any other resources they used (e.g. librarian to conduct literature search) to make the decision. The knowledge broker will record time attributable to each participant in Implementation Strategy Group 2.
Timepoint [1] 332845 0
Data relating to the 12-month intervention period will be collected at 12-month follow up
Secondary outcome [2] 332846 0
Semi-structured interviews will be used to elicit open-ended responses from participants of their perceptions of the trustworthiness and sufficiency of the evidence base to guide clinical practice in this area of allied health service delivery,
Timepoint [2] 332846 0
12 month follow up
Secondary outcome [3] 332847 0
Semi-structured interviews will be used to elicit open-ended responses from participants to describe the sources of information that they relied upon when deciding upon the model of weekend allied health service delivery they used in acute and subacute hospital wards and why they chose to use those sources.
Timepoint [3] 332847 0
12 month follow up
Secondary outcome [4] 340623 0
Semi-structured interviews will be used to elicit open-ended responses from participants to describe what they perceived as being the most influential source of information that they encountered when deciding upon the model of weekend allied health service delivery they used in acute and subacute hospital wards and why they thought this source was the most influential.
Timepoint [4] 340623 0
12 month follow up
Secondary outcome [5] 340624 0
Semi-structured interviews will be used to elicit open-ended responses from participants to describe what they perceived as being improvements to the two interventions and how they were provided.
Timepoint [5] 340624 0
12 month follow up
Secondary outcome [6] 340625 0
Average hospital length of stay for wards identified by the allied health manager as being relevant to the present study.:
The average hospital length of stay for relevant general medical and surgical wards, and sub-acute rehabilitation wards (defined as per the evidence-based policy recommendation document) in the month preceding commencement in the trial and the same corresponding month 12-months later. Hospital length of stay will be collected as reported by the hospital electronic patient management systems.
Timepoint [6] 340625 0
Baseline and 12 month follow up
Secondary outcome [7] 341328 0
Semi-structured interviews will be used to elicit open-ended responses from participants to describe what they perceived as being the risks, barriers and facilitators encountered in adopting or not adopting the policy recommendation.
Timepoint [7] 341328 0
12 month follow-up (both intervention groups) and during knowledge broker interactions (knowledge broker group only). Control group participants will not be invited to participate in the qualitative interviews.

Eligibility
Key inclusion criteria
Allied Health manager, director or executive
Responsible for inpatient hospital weekend allied health resource allocation decisions
Australian or New Zealand public or private, acute or sub-acute hospital
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Maternity specialist hospital
Palliative specialist hospital
Paediatric specialist hospital
Cancer centre specialist hospital

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Random number sequence will be generated and held by one of the investigators (TPH) in a secure location so that investigators conducting recruitment and data collection are blinded to the allocation status of participating sites and the allocation of the next site to be recruited. Site allocation will only be revealed to the investigator providing the intervention once the site has been recruited and baseline data collected.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A random number sequence will be generated, incorporating permuted blocks of randomly selected sizes of three, six, or nine, and stratified according to metropolitan or regional status.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Clustering will occur at the level of weekend allied health decision-making.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Primary outcome 1: practice alignment with policy recommendation will be analysed with pairwise comparisons (intervention group 1 vs control, intervention group 2 vs control, and intervention group 1 vs intervention group 2) performed using the ranksum test for ordinal data amongst matched pairs. This primary analysis will be conducted at both the cluster level and ward level. Analysis will be undertaken according to ‘as randomised’ (intention-to-treat) principles. Where it is identified that participants have moved between clusters allocated to different intervention groups during the study period, we will undertake a contamination-adjusted intention-to-treat analysis.

A sample size of 25 hospitals/health services (clusters) per group will provide greater than 80% power under the assumption that 50% of participants in an intervention group and 10% in the control group are completely consistent with the policy recommendation, We will aim to recruit 27 hospitals/health services per group to allow for some loss to follow-up.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 8746 0
New Zealand
State/province [1] 8746 0

Funding & Sponsors
Funding source category [1] 295934 0
Government body
Name [1] 295934 0
National Health and Medical Research Council (NHMRC)
Address [1] 295934 0
16 Marcus Clarke Street, Canberra ACT 2601
Country [1] 295934 0
Australia
Funding source category [2] 298011 0
Government body
Name [2] 298011 0
Department of Health and Human Services
Address [2] 298011 0
50 Lonsdale Street, Melbourne, 3000, Victoria, Australia
Country [2] 298011 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Moorooduc Hwy, Frankston, Victoria 3199
Country
Australia
Secondary sponsor category [1] 297077 0
None
Name [1] 297077 0
Address [1] 297077 0
Country [1] 297077 0
Other collaborator category [1] 279815 0
University
Name [1] 279815 0
La Trobe University
Address [1] 279815 0
Plenty Rd & Kingsbury Drive, Bundoora VIC 3086
Country [1] 279815 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297214 0
Monash Health Human Research Ethics Low Risk Review Panel
Ethics committee address [1] 297214 0
246 Clayton Road, Clayton, Victoria 3168
Ethics committee country [1] 297214 0
Australia
Date submitted for ethics approval [1] 297214 0
03/02/2017
Approval date [1] 297214 0
03/05/2017
Ethics approval number [1] 297214 0
HREC/17/MonH/44

Summary
Brief summary
This study aims to improve the translation of research evidence into healthcare practice. We will achieve this aim by comparing two different strategies to help allied health managers make resource allocation decisions in the hospital setting. One group will be provided with an "evidence-based policy recommendation" document; the other group will be provided with the same document with the addition of an expert knowledge broker to assist in the decision-making process; A third "control" group will not be provided with either of the interventions during the study period. The success of these research implementation strategies will be measured by comparing between group changes in practice to align with the policy recommendations. We will also explore the (1) opportunity cost to make decision (time to make decision, resources used, and knowledge broker time attributable to each participant in implementation strategy group 2); (2) participant perceptions of the research evidence related to this issue; (3) sources of evidence relied upon during decision-making; (4) domains of decision making that were most influential upon the decision to adopt the policy or not; (5) average hospital length of stay at baseline and 12-months; and (6) suggested improvements, perception of risk, and barriers and facilitators encountered in adopting or not adopting the policy recommendation.
Trial website
http://www.med.monash.edu.au/spahc/evitah/
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 73358 0
Prof Terry P Haines
Address 73358 0
Monash University, Level 3, Building G, Peninsula Campus, McMahons Rd, Frankston Victoria 3199, Australia
Country 73358 0
Australia
Phone 73358 0
+61 (0) 433 596 526
Fax 73358 0
Email 73358 0
terrence.haines@monash.edu
Contact person for public queries
Name 73359 0
Dr Jennifer White
Address 73359 0
Monash University,
Monash Health Allied Health Research Unit 400 Warrigal Rd, Cheltenham VIC 3192
Country 73359 0
Australia
Phone 73359 0
+61 (0) 447 492 943
Fax 73359 0
Email 73359 0
jenni.white@monash.edu
Contact person for scientific queries
Name 73360 0
Mr Mitchell N Sarkies
Address 73360 0
Monash University,
Monash Health Allied Health Research Unit 400 Warrigal Rd, Cheltenham VIC 3192
Country 73360 0
Australia
Phone 73360 0
+61 (0) 433 337 491
Fax 73360 0
Email 73360 0
mitchell.sarkies@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Information relating to the participation in the trial will not be available to any persons outside the study team. De-identified results data can be made available upon request to study investigators.
When will data be available (start and end dates)?
After publication of study results. No end date determined.
Available to whom?
Upon request to study investigators reviewed on a case by case basis.
Available for what types of analyses?
To achieve the aims in the approved proposal, meta-analyses of study results, or other purposes reviewed on a case by case basis.
By what mechanism will data be made available?
Electronic
What supporting documents are/will be available?
Study protocol
Attachments/websites
Type [1] 269 0
Study protocol
URL/details/comments [1] 269 0
https://implementationscience.biomedcentral.com/articles/10.1186/s13012-018-0752-7
Summary results
Not applicable