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Trial registered on ANZCTR


Registration number
ACTRN12619000278134
Ethics application status
Approved
Date submitted
19/02/2019
Date registered
25/02/2019
Date last updated
21/07/2020
Date data sharing statement initially provided
25/02/2019
Date results information initially provided
21/07/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The HERALD study. A pragmatic pre-post implementation study on the effects of a HEalth liteRAcy sensitive modeL of Dietetic care on diet quality in nephrology outpatient clinics.
Scientific title
The HERALD study. A pragmatic pre-post implementation study on the effects of a HEalth liteRAcy sensitive modeL of Dietetic care on diet quality in nephrology outpatient clinics.
Secondary ID [1] 297455 0
nil known
Universal Trial Number (UTN)
U1111-1228-8735
Trial acronym
The HERALD study.
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic kidney disease 311638 0
Condition category
Condition code
Diet and Nutrition 310260 310260 0 0
Other diet and nutrition disorders
Renal and Urogenital 310296 310296 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention consists of an alternative model of dietetic care that has been adapted to be health literacy sensitive. Four components of care will be modified compared to usual care: patient appointment letters; use of a question prompt sheet; use of teachback; and use of health literacy adapted patient education materials.
- appointment letters in the intervention will differ from usual care by having revised wording in line with health literacy principles ie increased readability, simplified jargon, chunking of information and reduced linguistic demand.

- Dietitians employed by the local health district allocated to the nephrology clinic will deliver the intervention. The mode of delivery will be individual face to face advice delivered by dietitians. The number of times the intervention will be delivered is 2 minimum as per evidence based practice over the period of 3-6 months. If additional sessions are required these will be determined by the dietitian based on the need to modify care due to change in clinical outcomes, patient knowledge, or the need to modify the dietary prescription. The first contact will be a one hour individual face to face consultation followed by at least one review appointment of 30 minutes length as per usual standard practice. Each session will involve education and counselling by the dietitian and review of understanding with the patient using teachback. The location where the intervention occur will be the outpatient clinic in the Dept. of Renal Medicine at one of three sites in the Illawarra Shoalhaven Local Health District.

Once informed consent is received, patients will receive dietary advice from the dietitian. The dietitian may choose to use the modified patient education materials, question prompt sheet or teachback during the session with the patient. After the appointment a series of patient experience measures will be completed with the chief investigator. These tools include the EQ-5D-5L quality of life tool; the Australian hospital Patient Experience Set and the Nutrition and Dietetic Patient Outcomes Questionnaire Adult. Semi structured interview questions with patients and carers will be completed after the first appointment. Interviews with dietitians regarding the feasibility of the new model of care will occur prior to the intervention; 2 weeks after commencement and after all patients have been recruited.

All advice will be individualised as per usual routine practice except that in the intervention period, participants will receive a question prompt sheet prior to the appointment and receive health literacy modified versions of the relevant patient education materials during the session. These patient education materials will be modified prior to the intervention by the Chief Investigator using the protocols for development of patient educational materials the health district.

Intervention fidelity will be assessed by the research team by listening to audio recordings of the session to record the number of questions asked by patients, the materials used by the dietitian with the patient, and the number of rounds of teachback utilised in the session. Post intervention semi structured interviews will be conducted with dietitians to ascertain feasibility of the intervention long term.
Intervention code [1] 313709 0
Lifestyle
Comparator / control treatment
The comparator is usual care. Usual care consists of an automatically generated appointment letter sent to the patient prior to the appointment and attendance at the appointment. New patients receive 1 hour individualised assessment and counselling form the dietitian and review appointments are 30 minutes in length.
Control group
Active

Outcomes
Primary outcome [1] 319148 0
Change in patient experience rating will be assessed using the Australian Patient Hospital Experience Question Set
Timepoint [1] 319148 0
This will be completed at baseline and at the review appointment (1 month)
Primary outcome [2] 319200 0
Change in patient experience rating will be assessed using the Nutrition and Dieteteic Patient Outcomes Questionnaire Adult Patient tool
Timepoint [2] 319200 0
This will be completed at baseline and at the review appointment (1 month)
Primary outcome [3] 319666 0
Primary outcome will be the composite number of renal nutrition optimal care goals met. The five goals are based on the evidence based practice guidelines for management of CKD and include: protein <1/g kg (or appropriate); dietary potassium intake < 1mmol/kg (where appropriate); 2 serves of fruit per day; five serves of vegetables per day; dietary phosphate restricted to 1 serve per day of dairy per day (where appropriate).
Timepoint [3] 319666 0
baseline and at review (usually 1 month)
Secondary outcome [1] 367129 0
Change in relevant biochemistry (serum potassium phosphate, glycosylated haemoglobin or interdialytic weight gain where appropriate).
Timepoint [1] 367129 0
This will be completed at baseline and at the review appointment (1 month)
Secondary outcome [2] 367130 0
Change in quality of life will be assessed using the EQ-5D-5L tool
Timepoint [2] 367130 0
This will be completed at baseline and at the review appointment (1 month)
Secondary outcome [3] 367234 0
Assess patient and carer satisfaction with the new model of care
Timepoint [3] 367234 0
This will be completed at baseline and at the review appointment at one month using semi structured interview questions completed by the Chief Investigator or another member of the research team after the appointment. These face to face interviews will last a maximum of 30 minutes and will be audio recorded. Questions for patients and carers are adapted from work by Stow et al (Stow RE, Smith CH, et al. Care home resident and staff perceptions of the acceptability of nutrition intervention trial procedures: a qualitative study embedded within a cluster randomised feasibility trial. BMJ open. 2018;8(7):e022307.).

Secondary outcome [4] 367237 0
Assess dietitian satisfaction with the new model of care using a brief survey and semi structured interviews. The questions used to assess acceptability are guided by the theoretical framework of acceptability of healthcare interventions and Normalisation Process Theory. Responses will be provided by health professionals on a 10-point visual analogue scale.

The semi structured interview questions used to elicit details from health professionals regarding feasibility are adapted from work by Wong et al (Wong M, Soon J, et al. Development of a survey to assess the acceptability of an innovative contraception practice among rural pharmacists. Pharmacy. 2014;2(1):124-36.)
Timepoint [4] 367237 0
This will be completed prior to the intervention, 2 weeks after introduction of the intervention and after the last patients have been discharged from care.

The semi structured interview questions will be administered after the last patients have been discharged from care by the Chief Investigator or another member of the research team.

Eligibility
Key inclusion criteria
Referred by a nephrologist to the renal dietetic clinic for dietary advice
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients managed under supportive care arrangements (palliative care)

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
The study is powered based on the primary outcome of a change in the composite score of five goals. This is based on new evidence that achievement of composite and individual goals may be a better measure of effectiveness of medical nutrition therapy treatment protocols. A total sample size of 18 patients is required to detect a difference of 1 in the total goals achieved between the two study periods, assuming a standard deviation of 0.96 and at least 80% power. Power calculations were also conducted based on diet quality being considered a binary outcome. We used data from a recent review on adherence to the renal diet which indicated only 31.5% had an adequate diet. Sample size calculations using this method indicated that a sample size of 16 patients was required in both the pre and post intervention periods to provide 90% power of detecting a doubling of the proportion of participants with adequate diet quality from 31.5% to > 60%. Assuming a one third non-attendance rate at review appointments, a total of approximately 20 patients pre and post intervention are required. Two-sided hypothesis testing using a p value of p< 0.05 will be considered statistically significant.

All continuous data will be assessed for normality using the Shapiro Wilk test. Data will be reported as mean and standard deviation or median and interquartile range. Categorical data will be reported as counts and percentages. Analysis of the primary outcome of change in the proportion with adequate diet quality will be evaluated by using the Independent samples t tests or Wilcoxon rank sum test will be used. Effect sizes will be calculated for the primary outcome of change in diet quality, and for secondary outcomes such as the patient centerdness ratio and change in quality of life score. Subgroup analysis will be performed in the primary outcome of change in proportion with adequate diet quality and change in total diet score according to gender and age ( = 65 years old vs < 65 years). Binary logistic regression will be used to determine characteristics of individuals who achieve adequate diet quality. A p value of less than 0.05 will be considered statistically significant.

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
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 13200 0
Wollongong Hospital - Wollongong
Recruitment hospital [2] 13201 0
Shellharbour Hospital - Mount Warrigal
Recruitment hospital [3] 13202 0
Shoalhaven Hospital - Nowra
Recruitment postcode(s) [1] 25755 0
2500 - Wollongong
Recruitment postcode(s) [2] 25756 0
2528 - Mount Warrigal
Recruitment postcode(s) [3] 25757 0
2541 - Nowra

Funding & Sponsors
Funding source category [1] 302026 0
Government body
Name [1] 302026 0
National Health and Medical Research Council
Address [1] 302026 0
Research Committee Secretariat NHMRC GPO Box 1421 Canberra ACT 2601
Country [1] 302026 0
Australia
Primary sponsor type
Government body
Name
Illawarra Shoalhaven Local Health District
Address
Wollongong Hospital, PO Box 1798 Crown St, Wollongong, NSW 2500
Country
Australia
Secondary sponsor category [1] 301822 0
None
Name [1] 301822 0
none
Address [1] 301822 0
none
Country [1] 301822 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302704 0
Joint University of Wollongong and Illawarra Shoalhaven Local Health District Human Research Ethics Committee
Ethics committee address [1] 302704 0
University of Wollongong, Northfields Ave, Wollongong, NSW 2522
Ethics committee country [1] 302704 0
Australia
Date submitted for ethics approval [1] 302704 0
09/11/2018
Approval date [1] 302704 0
04/12/2018
Ethics approval number [1] 302704 0
2018/515.

Summary
Brief summary
The Illawarra Shoalhaven Local Health District has twice the national prevalence of chronic kidney disease. Dietary modification plays a key part in preventing progression of kidney disease and managing the complications of end stage kidney disease. Recent research has indicated that inadequate health literacy is common in patients with kidney disease and
they have particular problems understanding health information. Local research using a health literacy sensitive question prompt sheet has also found a significant improvement in clinic participation and patient centredness of the consultation. However little is known if this translates into improved patient reported and clinical outcomes.

Thus the objectives of this project are to:
1. Evaluate the impact on clinical outcomes of a redesigned health literacy sensitive model of care in the renal
dietetic clinics
2. Evaluate the impact of the new model of care on patient reported outcomes
3. Evaluate patient and dietitian satisfaction with the new model of care
4. Make recommendations for ongoing practice
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91114 0
Dr Kelly Lambert
Address 91114 0
University of Wollongong , Northfields Ave, building 41.319C, Northfields ave, Wollongong, NSW 2522
Country 91114 0
Australia
Phone 91114 0
+61 242215251
Fax 91114 0
Email 91114 0
klambert@uow.edu.au
Contact person for public queries
Name 91115 0
Dr Kelly Lambert
Address 91115 0
University of Wollongong , Northfields Ave, building 41.319C, Northfields ave, Wollongong, NSW 2522
Country 91115 0
Australia
Phone 91115 0
+61 242215251
Fax 91115 0
Email 91115 0
klambert@uow.edu.au
Contact person for scientific queries
Name 91116 0
Dr Kelly Lambert
Address 91116 0
University of Wollongong , Northfields Ave, building 41.319C, Northfields ave, Wollongong, NSW 2522
Country 91116 0
Australia
Phone 91116 0
+61 242215251
Fax 91116 0
Email 91116 0
klambert@uow.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
not requested in ethics approval
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary