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Trial registered on ANZCTR


Registration number
ACTRN12616001280493
Ethics application status
Approved
Date submitted
30/08/2016
Date registered
12/09/2016
Date last updated
12/09/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Partnering with Patients in Medication Administration: Testing the effect of a information brochure for patients on medication administration errors
Scientific title
Testing the effect of a medication information brochure for general medical patients, in the hospital setting, on medication administration errors
Secondary ID [1] 290052 0
None
Universal Trial Number (UTN)
U1111-1187-0346
Trial acronym
PPMA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Medication error 300105 0
Condition category
Condition code
Injuries and Accidents 299988 299988 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An information brochure, co-produced with consumer advisors and health professionals, to describe in lay language the checking procedure that nurses are required to follow when administering medications in the hospital setting.

Research staff will distribute the brochure by hand to all patients who meet the inclusion criteria within 24 hours of their admission to an intervention ward. The brochure will remain with the patient for the duration of their inpatient stay. Patients in the usual care wards will not receive the brochure.
Intervention code [1] 295774 0
Other interventions
Comparator / control treatment
The comparator group will not receive the brochure.
Control group
Active

Outcomes
Primary outcome [1] 299472 0
Primary outcome 1. Medication errors measuring using medication chart audits.
With a 10% medication administration error rate, a 95% CI and 80% power, to detect an anticipated 5% error reduction rate, Approximately, 600 medication orders in each arm per audit cycle will be audited.
Timepoint [1] 299472 0
Timepoint: Audits will be carried out on all four wards on a single day each month for 3-months prior, 3-months during, and 3-months post intervention.
Primary outcome [2] 299590 0
Primary outcome 2: Medication errors reported in RiskMan (risk management system).
Timepoint [2] 299590 0
Timepoint: For all four wards, monthly reports of RiskMan data will be obtained for 4-months prior, 3-months during, and 4-months post intervention.
Primary outcome [3] 299591 0
Primary outcome 3: Observations of nurses’ medication administration practices. Non-participant observation will be conducted by a member of the research team who will not interact with the nurse or patient and will remain as discrete as possible. Observation periods will be of 2-hours duration and will be conducted at typical medication administration times (e.g., 0800, 1400, 2000). A total of 200 administration episodes will be observed in each ward during each of the three phases. A structured data collection tool will be used during the observation.
Timepoint [3] 299591 0
Timepoint: For the 3-months pre, during and post intervention, observations of medication administration by nurses will be undertaken on the four wards.
Secondary outcome [1] 327284 0
Secondary outcome 1: Patient perceptions of whether they exercised the right to ask if the checking procedure had been followed. A semi-structured telephone interview will be conducted by research personnel to elicit patients’ perceptions.
Timepoint [1] 327284 0
Timepoint: Interview conducted at approximately 48 hours post discharge.
Secondary outcome [2] 327640 0
Secondary outcome 2: Focus group interviews will be conducted with registered nurses and medication endorsed enrolled nurses on each of the intervention wards to elicit their perceptions of the acceptability of the patient engagement intervention and its effect on patient behaviour. One to three focus group interviews will be conducted on each ward, dependent on the number and availability of nurses willing to participate in an interview.
Timepoint [2] 327640 0
Timepoint: The focus groups will be undertaken within the first three months following completion of the intervention.

Eligibility
Key inclusion criteria
Patients:
Admitted to a general ward where the research is being conducted
Aged 18 years or more
Ability to communicate in English
Cognitive capacity to read and understand the participant information and consent form, and provide informed consent, and complete an interview and/or survey
Received and read the patient brochure (interview patients only)

Staff:
Employed on the ward in which the research is being conducted and working during the intervention period
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Not admitted to the included wards
Less than 18 years of age
Not able to communicate clearly in English
Cognitive impairment limiting capacity to read and understand the participant information and consent form, and provide informed consent, and complete an interview and/or survey
Did not receive and read the patient brochure (interview patients only)

Staff:
Not working on the ward in which the research is being conducted during the intervention period

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)
Allocation at ward level concealed. A statistician who was not familiar with the wards that were eligible to receive the intervention was provided with a list of ward codes and used a web-based randomisation generator (http://www.randomization.com) to determine which wards would receive the intervention.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation at ward level only. Simple randomisation was undertaken using a randomisation table created by computer software - 4 subjects randomized into 2 blocks.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample size based on number of charts audited for medication error. Medication error is key dependent variable.

Recruitment
Recruitment status
Not yet 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

Funding & Sponsors
Funding source category [1] 294424 0
Other
Name [1] 294424 0
Nurses Board of Victoria Legacy Limited
Address [1] 294424 0
NBVLL Secretariat
PO Box 327
Wendouree VIC 3355
Country [1] 294424 0
Australia
Primary sponsor type
Individual
Name
Alison Hutchinson
Address
School of Nursing and Midwifery
Deakin University
221 Burwood Highway
Burwood VIC 3125
Country
Australia
Secondary sponsor category [1] 293369 0
University
Name [1] 293369 0
Deakin University
Address [1] 293369 0
75 Pigdons Rd, Waurn Ponds VIC 3216
Country [1] 293369 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295849 0
Monash Health HREC
Ethics committee address [1] 295849 0
Monash Medical Centre
246 Clayton Rd, Clayton VIC 3168
Ethics committee country [1] 295849 0
Australia
Date submitted for ethics approval [1] 295849 0
Approval date [1] 295849 0
15/03/2016
Ethics approval number [1] 295849 0
16091A
Ethics committee name [2] 295850 0
Deakin University HREC
Ethics committee address [2] 295850 0
Deakin University
75 Pigdons Rd, Waurn Ponds VIC 3216
Ethics committee country [2] 295850 0
Australia
Date submitted for ethics approval [2] 295850 0
Approval date [2] 295850 0
12/04/2016
Ethics approval number [2] 295850 0
2016-115

Summary
Brief summary
Primary objectives
To determine (1) the feasibility of the KT patient engagement intervention and study design, and (2) the effect of the patient engagement intervention on medication administration error rates.

Secondary objectives
To determine (1) patients’ and nurses’ perceptions of the acceptability of the KT patient engagement intervention, and (2) the effect of the intervention on nurses’ and patients’ behaviour.

The intervention
The basis of this knowledge translation (KT) patient engagement intervention will be a patient brochure containing information about the required medication administration checking procedures, developed in consultation with consumer representatives and clinical nurse representatives. Four general wards across two hospitals will be included: two intervention wards (i.e., brochure) and two control wards (i.e., usual practice/no brochure). Research staff will distribute the brochure to patients within 24 hours of their admission to the intervention wards. Their attention will be drawn to the content of the brochure and their right to ask the nurse if the checking procedure has been adhered to. The brochure will remain with the patient for the duration of their inpatient stay.

Outcome data
Data on medication administration errors will be obtained from three different sources:
Medication chart audits: Carried out on all four wards on a single day each month for 3-months prior, 3-months during, and 3-months post intervention.
RiskMan medication error data: For all four wards, monthly reports of RiskMan data will be obtained for 4-months prior, 3-months during, and 4-months post intervention.
Random observations of nurses’ medication administration practices: For the 3-months pre, during and post intervention, observations of medication administration by nurses will be undertaken on the four wards.

Process evaluation data
Patient interview: Approximately 48-hours following discharge from intervention wards (consent will be obtained prior to discharge), a telephone interview will be conducted to elicit patients’ perceptions of the brochure and whether it had any effect on their behaviour.
Patient survey: Patients discharged from all four wards during the 3-month intervention phase will be invited to complete a survey, primarily focused on their confidence to manage their health and their involvement and engagement in their own care.
Staff focus group interview: Registered nurses and medication endorsed enrolled nurses on intervention wards will be invited to participate in a focus group interview to determine their perceptions of the intervention.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 68690 0
Prof Alison Hutchinson
Address 68690 0
School of Nursing and Midwifery
Deakin University - Burwood
221 Burwood Highway
Burwood, Victoria, 3125
Country 68690 0
Australia
Phone 68690 0
+61 3 9244 6446
Fax 68690 0
Email 68690 0
alison.hutchinson@deakin.edu.au
Contact person for public queries
Name 68691 0
Prof Alison Hutchinson
Address 68691 0
School of Nursing and Midwifery
Deakin University - Burwood
221 Burwood Highway
Burwood, Victoria, 3125
Country 68691 0
Australia
Phone 68691 0
+61 3 9244 6446
Fax 68691 0
Email 68691 0
alison.hutchinson@deakin.edu.au
Contact person for scientific queries
Name 68692 0
Prof Alison Hutchinson
Address 68692 0
School of Nursing and Midwifery
Deakin University - Burwood
221 Burwood Highway
Burwood, Victoria, 3125
Country 68692 0
Australia
Phone 68692 0
+61 3 9244 6446
Fax 68692 0
Email 68692 0
alison.hutchinson@deakin.edu.au

No information has been provided regarding IPD availability
Summary results
No Results