Mobile telephone contingency management to encourage adherence to supervised medication among individuals most at risk of non-adherence to opioid agonist treatment: a study protocol for a feasibility study (TIES2).
Nicola Metrebian, Carol-Ann Getty, Ewan Carr, Timothy Weaver, Stephen Pilling, Mike Kelleher, Jenny Scott, John Strang
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引用次数: 0
Abstract
Background: Supervision of opioid agonist treatment (OAT) ensures that individuals take their correct daily dose to minimise withdrawal and craving, safeguard against diversion and overdose, and receive optimal benefit from OAT. There is an urgent need to develop effective interventions to increase medication adherence and technological solutions to streamline communication between pharmacies and prescribers. The authors have developed technology to deliver contingency management (CM) remotely by mobile telephone (mCM) and alert prescribers of missed doses. In a previous feasibility study, the authors found mCM was feasible to deliver and acceptable to patients, prescribers, and pharmacists but encountered difficulty recruiting patients starting methadone treatment. Since COVID-19, supervision guidelines have changed to focus on patients at risk of/not adhering to their medication. This study aims to assess the feasibility of conducting a future confirmatory trial to assess the clinical and cost-effectiveness of mCM to encourage adherence with supervised methadone or buprenorphine. It will use broader eligibility criteria, including patients receiving buprenorphine, and target a revised group of serial re-starters.
Methods: Using a cluster randomised design, three drug services will be randomised 1:1:1 and 20 patients, attending seven pharmacies linked to each service, will be recruited (i.e. a total of N = 60). Each drug service providing supervised medication will be randomly allocated to deliver: (i) telephone-delivered text-message reinforcement with modest financial incentives; (ii) telephone-delivered text-message reminders; or (iii) no telephone text-messages. Prescribers will receive reports of patient attendance. Feasibility will be determined based on four progression criteria: the number of patients enrolled, the percentage of screened patients who are eligible, adherence to the telephone system, based on matches between sign-in at the pharmacy and pharmacy dispensing records and follow-up rates. We will also undertake qualitative assessments of clinicians' perspectives on the revised eligibility criteria undertaken.
Discussion: This study will assess the feasibility of using mCM to target a clinically important group of patients non-adhering to their supervised medication. In the future, and if effective, mCM will encourage medication adherence among patients, enabling them to achieve an optimum dose and full benefit from OAT.
Trial registration: ISRCTN33965312 (26/06/2023). This manuscript was submitted on February 27th, 2024. While recruitment was due to end on February 29th, we recruited our last patient on February 12th. The last patient/last visit took place on May 2nd, 2024.
期刊介绍：
Pilot and Feasibility Studies encompasses all aspects of the design, conduct and reporting of pilot and feasibility studies in biomedicine. The journal publishes research articles that are intended to directly influence future clinical trials or large scale observational studies, as well as protocols, commentaries and methodology articles. The journal also ensures that the results of all well-conducted, peer-reviewed, pilot and feasibility studies are published, regardless of outcome or significance of findings. Pilot and feasibility studies are increasingly conducted prior to a full randomized controlled trial. However, these studies often lack clear objectives, many remain unpublished, and there is confusion over the meanings of the words “pilot” and “feasibility”. Pilot and Feasibility Studies provides a forum for discussion around this key aspect of the scientific process, and seeks to ensure that these studies are published, so as to complete the publication thread for clinical research.
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