Skip to content

Avoiding the “triple whammy”: Protocol for a randomized feasibility trial to test the effect of an information package for patients at increased risk of renal damage.

Avoiding the “triple whammy”: Protocol for a randomized feasibility trial to test the effect of an information package for patients at increased risk of renal damage who are already being prescribed angiotensin-converting enzyme inhibitors (ACEi) or angiotensin II receptor blockers plus a diuretic.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621000574842
Enrollment
20
Registered
2021-05-17
Start date
2021-04-12
Completion date
2021-04-19
Last updated
2021-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Non-steroidal anti-inflammatory drugs (NSAIDs) are a common cause of renal damage. The risk of renal injury dramatically increases when NSAIDs are taken together with angiotensin-converting enzyme inhibitors (ACEi) or angiotensin II receptor blockers (ARBs) plus a diuretic– this is known as the “triple whammy” combination. Co-prescribing of these medications is still common in New Zealand, and patients can easily buy NSAIDs independently of their doctor. Providing information directly to patients may help address some of those issues. We have developed patient educational material including a printable information sheet, a webpage and an online learning activity with collaborative input from patients, GPs, pharmacists, and a patient education provider. These resources aim to inform patients about their elevated risk of harm from NSAIDs, and discourage them from using over-the-counter NSAIDs. A randomised controlled trial was proposed to examine the effect of giving patients at-risk harm from the “triple whammy” (because of the combination of long-term medications they are prescribed) this information directly, without needing their health care practitioners to provide it. To ensure best use of resources and enhance the likelihood of success of a RCT, we intend to conduct this feasibility study to determine if the methods proposed are suitable.

Interventions

Intervention group patients will be emailed a link to a webpage containing a downloadable PDF and a fully accessible online interactive learning activity. Both the PDF and interactive learning activity have been designed specifically for this project. The single A4 page PDF provides background information about the potential drug interactions and effect on the kidneys, as well as advice about avoiding non-steroidal anti-inflammatory medication. Participants can download and print this information if they would like. The interactive learning activity provides more detailed information about the potential harms associated with non-steroidal anti-inflammatory medication, and potential drug interactions. There are several self-marking quizzes to reinforce learning for each short module. The online task takes about 10-15 minutes. Participants can access the online learning activity as many times as they like during the two week study period. Administration of the intervention will occur by automatic email at time of randomisation. Web portal analytics will be used to evaluate use of the online activity and corroborate self-reported use. The intervention group will also receive usual general practice care from their own primary care team. Usual general practice care means patients can contact their general practice as often as they like during normal business hours to speak with a healthcare provider, have a clinical appointment, receive advice or any clinical treatment deemed necessary, or be referred on for secondary care if required.

Sponsors

Sharon Leitch
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used) (Investigator)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Must be prescribed an angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers, PLUS a diuretic in the past 3 months 2. Attend a general practice in the Northland region of New Zealand 3. Have signed up to receive emails from Conporto Health Ltd

Exclusion criteria

1. Do not take the prerequisite medication 2. Do not complete the consent process

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026