Interprofessional Medication Adherence Program for Patients With Diabetic Kidney Disease: Protocol for a Randomized Controlled and Qualitative Study (PANDIA-IRIS)

Bandiera, Carole; Dotta-Celio, Jennifer; Locatelli, Isabella; Nobre, Dina; Wuerzner, Grégoire; Pruijm, Menno; Lamine, Faïza; Burnier, Michel; Zanchi, Anne; Schneider, Marie‐Paule

doi:10.2196/25966

Cited by 6 publications

(14 citation statements)

References 27 publications

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“…We showed on this data that adherence pattern was significantly worse among men. Several clinical trials have been conducted in the past to assess the impact of an intervention on medication intake 15,16 and others are planned for the future 17,18 . The method we have proposed will allow evaluation (estimate and test) of the effect of the intervention on the adherence trends, by introducing the intervention variable into the (weighted corrected) longitudinal adherence model.…”

Section: Discussionmentioning

confidence: 99%

Estimation of adherence to medication treatment in presence of censoring

Pasquier

Schneider

Locatelli

2022

Brit J Clinical Pharma

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The purpose of this study is to provide a theoretical framework for the analysis of medication adherence based on longitudinal data from electronic medication monitors and to suggest methods for unbiased estimation of the effect of time and covariates on adherence.Methods: After defining the statistical summaries involved in adherence analyses and the assumptions necessary for their estimation, we address the issue of bias encountered when adherence is estimated on censored data. We suggest 2 unbiased methods to estimate adherence: (i) indirect combining implementation and persistence; and (ii) based on weights, allowing estimation of the effect of time and covariates on adherence via generalized estimating equations models. Results:We applied the proposed methods to investigate the effect of sex on adherence in a sample of 43 oncology patients followed 1 year. Implementation was higher for men than for women at baseline (98.8 vs. 97.5%, odds ratio [OR] 2.08, 95% confidence interval [CI]: 1.00-4.35), whereas the relationship was reversed at 1 year (94.5 vs. 96.4%, OR 0.65, 95%CI: 0.28-1.52). Adherence declined faster in men, with yearend values of 46.3% for men and 92.2% for women (OR 0.07, 95%CI: 0.02-0.26).Conclusion: Estimation of adherence is a complex statistical issue with longitudinal and duration data, possibly censored, interleaving. This study provides a theoretical framework and suggests methods for unbiased estimation of adherence as a function of time and covariates. This allows the effect of an intervention to be estimated in clinical trials, and helps healthcare providers reframe adherence programmes to address covariates such as sex.

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Section: Discussionmentioning

confidence: 99%

Estimation of adherence to medication treatment in presence of censoring

Pasquier

Schneider

Locatelli

2022

Brit J Clinical Pharma

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“…Enrolled patients were adults diagnosed with diabetes and renal impairment (estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m 2 ). The included patients were randomized into two arms, each lasting for 24 months—participants in the first arm received IMAP intervention for 6 months vs 12 months in the second arm [ 12 ]. During the intervention phase, the patient and pharmacist together explore patients’ medication management habits and skills, patients’ beliefs, preferences and motivation to take the treatment, and patient needs for information regarding the treatment and medication adherence; they investigate the presence of side effects and their management, and they set stepped goals, if necessary, from one interview to the next.…”

Section: Methodsmentioning

confidence: 99%

“…After the intervention phase (i.e., the follow-up phase), medication adherence was monitored electronically in a blinded manner, without any motivational interviews or feedback. The aim of the PANDIA-IRIS study was to compare medication adherence in both groups to determine the impact of IMAP duration on 24-month medication adherence [ 12 ].…”

Section: Methodsmentioning

confidence: 99%

“…The program consists of regular motivational face-to-face interviews between the patient and pharmacist to explore patients’ medication management monitored by electronic monitors (EMs) (MEMS and MEMS AS, AARDEX Group, Sion, Switzerland) that capture each date and time the EM is opened by the patient. The protocol has been previously described [ 12 ]. This study approached 275 eligible DKD patients, but 73% of the patients declined to participate.…”

Section: Introductionmentioning

confidence: 99%

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Understanding reasons and factors for participation and non-participation to a medication adherence program for patients with diabetic kidney disease in Switzerland: a mixed methods study

Bandiera

Lam

Locatelli

et al. 2022

Diabetol Metab Syndr

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Background An interprofessional medication adherence intervention led by pharmacists, combining motivational interviews and feedback with electronic monitor (EM) drug assessment, was offered to all consecutive patients with diabetic kidney disease (DKD) (estimated glomerular filtration rate < 60 mL/min/1.73 m2) visiting their nephrologist or endocrinologist. Approximately 73% (202/275) of eligible patients declined to participate, and the factors and reasons for refusal were investigated. Methods Sociodemographic and clinical data of included patients and those who refused were collected retrospectively for those who had previously signed the general consent form. Multivariate logistic regression analysis was performed to identify independent variables associated with non-participation. Patients who refused or accepted the adherence study were invited to participate in semi-structured interviews. Verbatim transcription, thematic analysis, and inductive coding were performed. Results Patients who refused to participate were older (n = 123, mean age 67.7 years, SD:10.4) than those who accepted (n = 57, mean age 64.0 years, SD:10.0, p = 0.027) and the proportion of women was higher among them than among patients who accepted it (30.9% vs 12.3%, p = 0.007). The time from diabetes diagnosis was longer in patients who refused than in those who accepted (median 14.2 years IQR 6.9–22.7 vs. 8.6 years, IQR 4.5–15.9, p = 0.003). Factors associated with an increased risk of non-participation were female sex (OR 3.8, 95% CI 1.4–10.0, p = 0.007) and the time from diabetes diagnosis (OR 1.05, 95% CI 1.01–1.09, p = 0.019). The included patients who were interviewed (n = 14) found the interprofessional intervention useful to improve their medication management, support medication literacy, and motivation. Patients who refused to participate and who were interviewed (n = 16) explained no perceived need, did not agree to use EM, and perceived the study as a burden and shared that the study would have been beneficial if introduced earlier in their therapeutic journey. Other barriers emerged as difficult relationships with healthcare providers, lack of awareness of the pharmacist’s role, and negative perception of clinical research. Conclusions Investigating the factors and reasons for participation and non-participation in a study helps tailor intervention designs to the needs of polypharmacy patients. Patients who refused the adherence intervention may not be aware of the benefits of medication management and medication literacy. There is an urgent need to advocate for interprofessional outpatient collaborations to support medication adherence in patients with DKD. Trial registration Clinicaltrials.gov NCT04190251_PANDIA IRIS.

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“…During the lockdown, the IMAP organization was adapted to avoid patients coming to the pharmacy (eg, medications were mailed, interventions were delivered by phone or in person to patients known to have adherence issues). 14 The following IMAP participants were included in the CovADH database: patients with diabetic kidney disease (DKD) from the PANDIA-IRIS study, 15 patients with solid cancer from the OpTAT study, 16 participants of the SHCS and patients with miscellaneous long-term diseases (MLTD) (eg, hypertension, diabetes, heart diseases, renal failure). To be eligible for inclusion, participants had to use one or more EMs during the lockdown (the minimum monitored period was 47 days).…”

Section: Methodsmentioning

confidence: 99%

Medication Adherence Evaluated Through Electronic Monitors During the 2020 COVID-19 Pandemic Lockdown in Switzerland: A Longitudinal Analysis

Bandiera¹,

Pasquier²,

Locatelli³

et al. 2022

PPA

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Background: During the 2020 COVID-19 lockdown, patients included in the Interprofessional Medication Adherence Program (IMAP) in Switzerland continued to use electronic monitors (EMs) that registered daily drug-dose intake. We aimed to understand to what extent patients' medication implementation (ie, the extent to which the patient took the prescribed medicine), measured with EMs, was impacted by the lockdown. Methods: Patients participating in the IMAP were diagnosed with diabetic kidney disease (DKD), solid cancer, human immunodeficiency virus (HIV) and miscellaneous long-term diseases (MLTD). Patient implementation was defined through a proxy: if all patient EMs were opened at least once daily, implementation was considered active (=1), and no implementation was considered (=0) otherwise. Implementation before (from December 2019 to March 2020), during (March to June 2020) and after (June to September 2020) the lockdown was compared. Subanalyses were performed according to the patients' diseases. Subanalyses were performed in patients who used at least one EM in 2018-2019 during the same periods (defined as winter, spring and summer). The logistic regression models used to estimate medication implementation according to the period were fitted using generalized estimating equations. Results: In 2020, patient implementation (n = 118) did not differ significantly before versus during (OR = 0.98, 95% CI: 0.84-1.15, p = 0.789) and before versus after (OR = 0.91, 95% CI: 0.79-1.06, p = 0.217) the lockdown. These findings remained stable when separately analyzing the implementation of patients with HIV (n = 61), DKD (n = 25) or MLTD (n = 22). Too few patients with cancer were included (n = 10) to interpret the results. In 2019, the implementation of 61/118 (51.7%) patients was significantly lower during summertime versus wintertime (OR = 0.73, 95% CI: 0.60-0.89, p = 0.002). Conclusion: Medication implementation remained steady before, during and after the lockdown in 2020. The IMAP before, during and after the lockdown may have supported the adherence of most patients, by ensuring continuity of care during periods of routine disturbances.

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Interprofessional Medication Adherence Program for Patients With Diabetic Kidney Disease: Protocol for a Randomized Controlled and Qualitative Study (PANDIA-IRIS)

Cited by 6 publications

References 27 publications

Estimation of adherence to medication treatment in presence of censoring

Estimation of adherence to medication treatment in presence of censoring

Understanding reasons and factors for participation and non-participation to a medication adherence program for patients with diabetic kidney disease in Switzerland: a mixed methods study

Medication Adherence Evaluated Through Electronic Monitors During the 2020 COVID-19 Pandemic Lockdown in Switzerland: A Longitudinal Analysis

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