None listed
Conditions
Brief summary
There is urgency to address rural access to timely and safe diagnostic services for Maori with input from communities. Point of Care Testing (PoCT) combined with appropriate care pathways may potentially improve timely access to test results and treatment and ultimately reduce morbidity and mortality associated with these infections. We will explore the impact of PoCT on the clinical care pathways: Group A Streptococcus (GAS), respiratory infections including Influenza and Respiratory Syncytial Virus and sexually transmitted infections (STIs) (Chlamydia trachomatis, Neisseria gonorrhoeae). Point of Care diagnostic testing means that a swab taken from a patient (e.g. throat swab) can be tested on site in the clinic, processed on a small machine by a trained nurse or health worker and a result obtained in 30 -90 minutes depending on the infection being tested for. We hypothesise that utilising PoCT to improve timely access to care in rural Aotearoa New Zealand will reduce morbidity and mortality.
Interventions
Point of care testing (PoCT) for Group A Streptococcus (GAS), respiratory infections, and sexually transmitted infections (STIs) for rural communities at eight primary care sites in Aotearoa New Zealand
-Provision of PoCT diagnostic machines to two sites, one site has their own PoCT machines
-Training of nursing and health work staff in the set-up, running, preparing samples, interpreting results, quality assurance procedures, clinical update training
-This involves face-to-face hands on traini
Point of care testing (PoCT) for Group A Streptococcus (GAS), respiratory infections, and sexually transmitted infections (STIs) for rural communities at eight primary care sites in Aotearoa New Zealand -Provision of PoCT diagnostic machines to two sites, one site has their own PoCT machines -Training of nursing and health work staff in the set-up, running, preparing samples, interpreting results, quality assurance procedures, clinical update training -This involves face-to-face hands on training at the research sites 2-3 nurses and or health workers are trained at each site -Training is provided by molecular scientist on the research team and online training from the PoCT manufacturer and a certificate is provided once training is complete. -Training is a 2-4 hour session the week prior to recruitment starting, follow up one hour sessions in person or zoom 3 monthly at each site - includes regular site visits for quality and update purposes - PoCT testing will be undertake ONLY by clinic staff who have undergone training from the molecular scientist on research team and from the PoCT manufacturers official online training - Patients will be consented face to face by the clinic staff as part of their usual clinic appointment - Clinical staff will decide if the patient requires a test depending on presentation and history - Clinical management is not changed from usual standard care, only the diagnostic test is different from usual lab pathway - Patients can have multiple tests within the study recruitment period if clinically indicated - Rural primary care clinics - Patient adherence and fidelity is not indicated in this study as it is clinical staff who make the decision to test -PoCT machines used are Cepheid Gene Xperts at two sites, Roche Liats at one site - PoCT machines are set up in a suitable and appropriate space within the clinic with appropriate biohazard disposal, clean bench space, storage facilities for supplies and access to a fridge, -testing cartridges are provided by the study - technological support provided by research team scientist and PoCT manufacturers as needed. - test running time is from 30-90 minutes depending on infection being tested for - e.g. GAS - 30mins, Chlamydia/NG 90 minutes
Sponsors
Victoria University of Wellington
Study design
Allocation
Non-randomised trial
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Healthy volunteers
No
Inclusion criteria
Patients and whanau who require investigation and testing for respiratory infections including Influenza, RSA, GAS or Chlamydia and Gonorrhoea. Children under 16 years of age can take part and tested for respiratory or GAS infections as long as their guardian gives consent, and the child gives their assent to take part.
Exclusion criteria
Exclusion criteria include anyone who does not or is unable to give consent to take part and any person who the clinician decides where a laboratory test is preferable. The only exemption to this is where someone has undiagnosed respiratory distress and who is too sick to give written consent. Consent will be waived if the attending clinician judges it to be of clinical benefit to the patient to have the PoCT test on site.
Outcome results
None listed