Abstract
BackgroundOlder patients suffering from multimorbidity are at high risk of medication nonadherence. It has been well established that self-management support is an effective strategy to enhance medication adherence for patients with chronic conditions. However, little is known about the effect of the medication self-management intervention in older patients with multimorbidity. This paper presents the protocol for a study that aims to evaluate the effectiveness of a nurse-led medication self-management intervention in improving medication adherence and health outcomes for community-dwelling older patients with multimorbidity.MethodsThe study protocol follows the recommendations of the Standard Protocol Items: Recommendations for Interventional Trials 2013 statement. This study is a multicentre, single-blind, two-arm randomised controlled trial. Older patients with multimorbidity will be recruited from three community health centres in Changsha, China. A total of 136 participants will be randomly allocated to receive usual care or usual care plus the medication self-management intervention. The intervention will be delivered by community nurses. The 6-week intervention includes three face-to-face education sessions and two weekly follow-up phone calls. Participants in the control group continue to receive all respects of usual care offered by community healthcare providers, including chronic disease management, drug prescription, referral to hospital specialists, health education and consultations regarding patients’ diseases and treatments during centre visits. The primary outcome is medication adherence as measured by the 5-item Medication Adherence Report Scale. Secondary outcomes include medication self-management capacity (medication knowledge, medication beliefs, medication social support, medication skills, and medication self-efficacy), treatment experiences (medication treatment satisfaction and treatment burden), quality of life, and utilisation of healthcare services. All outcomes will be measured at baseline, immediately post-intervention, and at 3-month post-intervention.DiscussionThis study will provide evidence about the effectiveness of a medication self-management intervention, delivered by nurses, for older patients with multimorbidity and adherence problems. It is expected that the results of the study, if proven effective in improving patients’ adherence and health outcomes, will provide evidence-based self-management support strategies for healthcare providers in routine chronic disease management in community settings.Trial registrationThe trial is registered at ChiCTR.org.cn (ChiCTR2000030011; date February 19, 2020).
Highlights
Older patients suffering from multimorbidity are at high risk of medication nonadherence
It is expected that the results of the study, if proven effective in improving patients’ adherence and health outcomes, will provide evidence-based self-management support strategies for healthcare providers in routine chronic disease management in community settings
Discussion the high prevalence and adverse consequences of medication nonadherence among older patients with multimorbidity have been well established in current research, intervention programs designed to improve medication adherence are limited in these complex patients
Summary
Trial design This is a multicentre, single-blind, two-arm randomised controlled trial with randomisation at the participant level. Based on the extended IMB model of medication adherence, this intervention is designed to offer information related to medication treatments, motivate patients to adhere, help build medication selfmanagement skills, and develop adherence improvement plans. Taking patients’ complexity into account, strategies to reduce treatment burden will be incorporated into intervention sessions, including prioritising medication and other self-management activities using shared decision making, providing communication skills with healthcare providers and encouraging patients to discuss with their physicians about burdensome regimens, exploring patients’ family and social network to support their self-care, and helping them to incorporate self-care activities into daily life. Patients will be asked to bring all medications to CHCs. After the conclusion of the last face-to-face session, education materials containing instructions and information on the name, purpose, side effects, and special tips for each usual chronic medication and medication skills will be provided to participants. Before the implementation of intervention, nurses’ acquisition of the above skills will be assessed by the principal investigator and the local nurse expert through a practicum with simulated patients to demonstrate their abilities to deliver the intervention
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