Poor medication adherence is associated with poor clinical outcomes, an increase in hospitalisations and increased mortality. This is a multicentre randomised study that evaluates the effectiveness of using a manual pill organiser (MPO) and a custom-developed pill reminder app (PRA) on medication adherence, morbidity, as well as health economic outcomes among Indian elderly individuals taking multiple medications.

The primary objective of this study is to evaluate the impact of MPO and PRA alone or in combination in improving medication adherence among elderly individuals on multiple medications. The secondary objectives include the impact of interventions on the morbidity profile and health-related quality of life. The study also plans to assess the cost-effectiveness and cost-utility of improving medication adherence.

This is a community-based, open-label, factorial-design randomised controlled trial to be conducted across rural and urban populations at two geographically distinct sites in India. The study will enrol 752 elderly individuals aged 60–80 years, receiving three or more medications for at least 6 months and having access to smartphones. The participants will be randomised to receive one of the following interventions for 12 months: control group, PRA, MPO and MPO+PRA. All study groups would receive patient education about the importance of medication adherence. The study outcomes include the proportion of improvement in medication adherence (using Medication Adherence Rating System-5, 7-day point prevalence of medication non-adherence and pill count); adverse clinical outcomes; healthcare utilisation; health-related quality of life; cost-effectiveness and cost-utility outcomes.

The study protocol has been approved by institutional ethics committees at all three institutes. The study results for primary and secondary outcomes will be published in peer-reviewed journals.

CTRI/2024/01/061975 (Registered on: 29 January 2024).

Intraoperative anaesthesia handoffs represent a risk point in the care of surgical patients. Although often necessary to prevent fatigue, improve vigilance and optimise operational efficiency, critical information can be lost, potentially leading to postoperative complications. Structured handoffs can increase the transfer of knowledge during intraoperative anaesthesia handoffs, improving their quality. We therefore propose to test the primary hypothesis that a semi-structured intraoperative anaesthesia handoff cognitive aid reduces the number of serious 30-day complications in surgical patients.

We will enrol adults having non-cardiac surgery who are scheduled to have an intraoperative anaesthesia handoff for operational reasons. We plan a cluster randomised trial (enrolling over 18 months, anticipated sample size approximately 4500 patients) that will compare the Epic Electronic Health Record intraoperative anaesthesia handoff cognitive aid to routine handoffs. Our primary outcome will be the number of serious postoperative complications within 30 days. Our secondary outcomes will be: (1) the number of minor complications; and (2) the duration of postoperative hospitalisation. Bayesian analysis with generalised linear multilevel modelling will be used to estimate the effect of structured handoffs on the primary and secondary outcomes.

This study has been approved by the local institutional review board with a waiver of informed consent. Results will be disseminated in the medical literature with de-identified data available on request.

NCT06533111.