Methods
deaths, COPD, diabetes
DISEASES, RECRUITMENT, RECRUITMENT, COPD, SECONDARY, DIABETES
The protocol for the study (known as the FreeMeds study) and the recruitment process are published elsewhere [This was a two-group parallel prospective randomised controlled trial. People living in areas of high socio-economic deprivation (NZDep 7–10) were eligible if they self-reported that they took medicines for diabetes, or anti-psychotic medication, or had COPD. NZDep is an area-level measure of deprivation, derived from census data such as income levels, damp and mouldy housing, internet access, and rental housing. NZDep 7–10 refers to the most deprived 40% of areas in NZ [The study was carried out in several geographic areas of New Zealand, including small cities, towns and rural areas in both the North and South Island. No major metropolitan areas were included because a major supermarket chain offers free prescriptions at its in-store pharmacies in major cities.Potential participants were informed about the study by pharmacy staff, Facebook, media stories, mail-drops, through general practices and community organisations. Participants were enrolled in person or on the phone, to provide a range of options and ensure that people who were disengaged from health services could also enroll.At recruitment, participants provided demographic data and were randomized into intervention or control. Participants were randomly allocated 1:1 to either intervention or control group. There was no blocking on geographical location, and the allocation sequence was concealed from the recruiter. Those participants who enrolled in person were asked to tap an icon on a tablet computer which randomly turned red or green indicating that they were in the intervention or control group (“Randomizer – random generator” on android devices or “Coin Flipper” on PCs). Staff did this for those who enrolled on the phone and informed participants of their allocation. Blinding participants was not possible or desirable (they knew whether they paid for their prescriptions or not, and the security of knowing that they could access medicines without charge was an important aspect of the intervention). Similarly, community pharmacies could not be blinded. However, the researchers involved in the analysis of outcome data were blinded to participant allocation status.The intervention was designed to mimic what might happen if the government decided to exempt this group from $5 prescription co-payments for all medicines they received (not just those for the conditions listed in the eligibility criteria), while the control group experienced usual practice for the study year (and were sent a $100 grocery voucher after the study period to thank them for their participation). There was no centralised system for indicating to pharmacies that participants were in the intervention group. Community pharmacies were given a list of all participants in the intervention group in their region, so that they could exempt participants from all $5 prescription co-payments for any medicines and instead invoice the study for these. Participants in the intervention group were also given a study ID card with their name, photo and NHI number, so they could visit any pharmacy and be exempted from the $5 charge. Participants continued to pay any additional charges, such as for blister packing. Participants in the control group continued with usual care, i.e. being charged $5 per prescription item until they reached the 20 item annual payment ceiling. Some may have accessed one-off support from charities etc. There were no pharmacies waiving the $5 co-payment in the study areas at the time of the study, but it is possible that some participants occasionally took advantage of these if they or others were travelling to other areas.Recruitment had to occur in a narrow timeframe (October – February) because of the design of the copayment system in New Zealand. On 1 February each year co-payments commence, and after an individual or family is dispensed 20 items, copayments are waived. The intervention needed to start for all participants on or near 1 Feb to ensure that they got free prescriptions for a full year. If, for example, if it started in September many people in both intervention and control groups would have already reached the 20 item limit and so the intervention would have had no effect for several months. Recruitment therefore had to cease in early February. It was very difficult to recruit before the end of October because prescription charges were not a salient issue for many people at that time of the year and the intervention seemed too far in the future.The primary outcome was length of stay (measured by hospital bed-days) within the year of the study (1 Feb 2020 to 31 Jan 2021). Secondary outcomes included: deaths (regardless of cause), ED visits (whether people visited ED during the year, and number of visits) and hospital admissions (whether people were hospitalised, number of hospitalisations and length of stay for diabetes, mental health and COPD).NHI numbers for participants were determined on enrolment or soon after, and data on all of the outcomes presented here were accessed, with participants’ consent, from routinely collected data held by the Ministry of Health. Data on medicines dispensed are from the Pharms dataset. Data on hospitalisation outcomes, including diagnosis information and length of stay, were obtained from the National Minimum Dataset (NMDS) [The secondary cause-specific hospitalisation outcomes were identified using the International Statistical Classification of Diseases and Related Health Problems, Tenth Revision, Australian Modification (ICD-10-AM) diagnosis codes recorded in the NMDS and NNPAC. The specific approach used for each of the hospitalisation outcomes, as well as the ICD-10-AM codes used, are described in The only change made to trial outcomes after the study commenced was the addition of hospitalisations for COPD (because we expanded eligibility to those with COPD).We planned to recruit 2000 participants in order to achieve a power of 80% to detect a 10% reduction in the primary outcome in the intervention group. Because enrolment was slower than anticipated we enrolled 1061 people.No interim analyses were performed and no guidelines for stopping the trial were developed, because it seemed unlikely that the intervention, which aimed to ensure people could access medicines prescribed for them, would cause harm (although we acknowledge that harm can be inadvertently caused by access to participants’ data).