Transplant regimen adherence for kidney recipients by engaging information technologies (TAKE IT): Rationale and methods for a randomized controlled trial of a strategy to promote medication adherence among transplant recipients

Marina Serper; Daniela P. Ladner; Laura M. Curtis; Sumi S. Nair; Scott I. Hur; Mary J. Kwasny; Bing Ho; John Friedewald; Peter P. Reese; Michael M.I. Abecassis; Michael S. Wolf

doi:10.1016/j.cct.2021.106294

Transplant regimen adherence for kidney recipients by engaging information technologies (TAKE IT): Rationale and methods for a randomized controlled trial of a strategy to promote medication adherence among transplant recipients

Marina Serper, Daniela P. Ladner, Laura M. Curtis, Sumi S. Nair, Scott I. Hur, Mary J. Kwasny, Bing Ho, John Friedewald, Peter P. Reese, Michael M.I. Abecassis, Michael S. Wolf

Research output: Contribution to journal › Article › peer-review

14 Scopus citations

Abstract

Background: Several studies report a high prevalence of non-adherence to prescribed immunosuppressive (IS) medications among kidney transplant recipients (KTRs), yet few interventions have been effective for helping patients sustain appropriate post-transplant adherence. We describe a multifaceted, evidence-based, medication adherence monitoring strategy (‘TAKE IT’) that leverages available transplant center resources to identify potential medication non-adherence and other concerns earlier to prevent complications that could result from inadequate IS adherence. Methods: The TAKE IT strategy includes: 1) medication adherence mobile application; 2) routine, online patient self-reported adherence assessments; 3) care alert notifications via the electronic health record (EHR) directed to transplant coordinators; 4) quarterly adherence reports to monitor IS values and summarize adherence trends; 5) deployment of adherence support tools tailored to specific adherence concerns. To test the TAKE IT intervention, we will conduct a two-arm, patient-randomized controlled trial at two large, diverse transplant centers (Northwestern University, Mayo Clinic, AZ) with planned recruitment of 450 KTRs (n = 225 per site) within 2 years of transplantation and 2 years of follow-up. Study assessments will take place at baseline, 6 weeks, 6, 12, 18 and 24 months. The primary effectiveness outcome is medication adherence via pill count, secondary outcomes include self-reported adherence and clinical outcomes. Process outcomes and cost-effectiveness will also be examined. Conclusion: The TAKE IT trial presents an innovative approach to monitoring and optimizing medication adherence among a population taking complex medication regimens. This trial seeks to evaluate the effectiveness and feasibility of this strategy compared to usual care.

Original language	English (US)
Article number	106294
Journal	Contemporary Clinical Trials
Volume	103
DOIs	https://doi.org/10.1016/j.cct.2021.106294
State	Published - Apr 2021
Externally published	Yes

Keywords

Immunosuppression
Medication safety
e-Health
mHealth

ASJC Scopus subject areas

Pharmacology (medical)

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10.1016/j.cct.2021.106294

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Serper, M., Ladner, D. P., Curtis, L. M., Nair, S. S., Hur, S. I., Kwasny, M. J., Ho, B., Friedewald, J., Reese, P. P., Abecassis, M. M. I., & Wolf, M. S. (2021). Transplant regimen adherence for kidney recipients by engaging information technologies (TAKE IT): Rationale and methods for a randomized controlled trial of a strategy to promote medication adherence among transplant recipients. Contemporary Clinical Trials, 103, Article 106294. https://doi.org/10.1016/j.cct.2021.106294

Transplant regimen adherence for kidney recipients by engaging information technologies (TAKE IT): Rationale and methods for a randomized controlled trial of a strategy to promote medication adherence among transplant recipients. / Serper, Marina; Ladner, Daniela P.; Curtis, Laura M. et al.
In: Contemporary Clinical Trials, Vol. 103, 106294, 04.2021.

Research output: Contribution to journal › Article › peer-review

Serper, M, Ladner, DP, Curtis, LM, Nair, SS, Hur, SI, Kwasny, MJ, Ho, B, Friedewald, J, Reese, PP, Abecassis, MMI & Wolf, MS 2021, 'Transplant regimen adherence for kidney recipients by engaging information technologies (TAKE IT): Rationale and methods for a randomized controlled trial of a strategy to promote medication adherence among transplant recipients', Contemporary Clinical Trials, vol. 103, 106294. https://doi.org/10.1016/j.cct.2021.106294

Serper M, Ladner DP, Curtis LM, Nair SS, Hur SI, Kwasny MJ et al. Transplant regimen adherence for kidney recipients by engaging information technologies (TAKE IT): Rationale and methods for a randomized controlled trial of a strategy to promote medication adherence among transplant recipients. Contemporary Clinical Trials. 2021 Apr;103:106294. doi: 10.1016/j.cct.2021.106294

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title = "Transplant regimen adherence for kidney recipients by engaging information technologies (TAKE IT): Rationale and methods for a randomized controlled trial of a strategy to promote medication adherence among transplant recipients",

abstract = "Background: Several studies report a high prevalence of non-adherence to prescribed immunosuppressive (IS) medications among kidney transplant recipients (KTRs), yet few interventions have been effective for helping patients sustain appropriate post-transplant adherence. We describe a multifaceted, evidence-based, medication adherence monitoring strategy ({\textquoteleft}TAKE IT{\textquoteright}) that leverages available transplant center resources to identify potential medication non-adherence and other concerns earlier to prevent complications that could result from inadequate IS adherence. Methods: The TAKE IT strategy includes: 1) medication adherence mobile application; 2) routine, online patient self-reported adherence assessments; 3) care alert notifications via the electronic health record (EHR) directed to transplant coordinators; 4) quarterly adherence reports to monitor IS values and summarize adherence trends; 5) deployment of adherence support tools tailored to specific adherence concerns. To test the TAKE IT intervention, we will conduct a two-arm, patient-randomized controlled trial at two large, diverse transplant centers (Northwestern University, Mayo Clinic, AZ) with planned recruitment of 450 KTRs (n = 225 per site) within 2 years of transplantation and 2 years of follow-up. Study assessments will take place at baseline, 6 weeks, 6, 12, 18 and 24 months. The primary effectiveness outcome is medication adherence via pill count, secondary outcomes include self-reported adherence and clinical outcomes. Process outcomes and cost-effectiveness will also be examined. Conclusion: The TAKE IT trial presents an innovative approach to monitoring and optimizing medication adherence among a population taking complex medication regimens. This trial seeks to evaluate the effectiveness and feasibility of this strategy compared to usual care.",

keywords = "Immunosuppression, Medication safety, e-Health, mHealth",

author = "Marina Serper and Ladner, {Daniela P.} and Curtis, {Laura M.} and Nair, {Sumi S.} and Hur, {Scott I.} and Kwasny, {Mary J.} and Bing Ho and John Friedewald and Reese, {Peter P.} and Abecassis, {Michael M.I.} and Wolf, {Michael S.}",

note = "Publisher Copyright: {\textcopyright} 2021 Elsevier Inc.",

year = "2021",

month = apr,

doi = "10.1016/j.cct.2021.106294",

language = "English (US)",

volume = "103",

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T1 - Transplant regimen adherence for kidney recipients by engaging information technologies (TAKE IT)

T2 - Rationale and methods for a randomized controlled trial of a strategy to promote medication adherence among transplant recipients

AU - Serper, Marina

AU - Ladner, Daniela P.

AU - Curtis, Laura M.

AU - Nair, Sumi S.

AU - Hur, Scott I.

AU - Kwasny, Mary J.

AU - Ho, Bing

AU - Friedewald, John

AU - Reese, Peter P.

AU - Abecassis, Michael M.I.

AU - Wolf, Michael S.

PY - 2021/4

Y1 - 2021/4

N2 - Background: Several studies report a high prevalence of non-adherence to prescribed immunosuppressive (IS) medications among kidney transplant recipients (KTRs), yet few interventions have been effective for helping patients sustain appropriate post-transplant adherence. We describe a multifaceted, evidence-based, medication adherence monitoring strategy (‘TAKE IT’) that leverages available transplant center resources to identify potential medication non-adherence and other concerns earlier to prevent complications that could result from inadequate IS adherence. Methods: The TAKE IT strategy includes: 1) medication adherence mobile application; 2) routine, online patient self-reported adherence assessments; 3) care alert notifications via the electronic health record (EHR) directed to transplant coordinators; 4) quarterly adherence reports to monitor IS values and summarize adherence trends; 5) deployment of adherence support tools tailored to specific adherence concerns. To test the TAKE IT intervention, we will conduct a two-arm, patient-randomized controlled trial at two large, diverse transplant centers (Northwestern University, Mayo Clinic, AZ) with planned recruitment of 450 KTRs (n = 225 per site) within 2 years of transplantation and 2 years of follow-up. Study assessments will take place at baseline, 6 weeks, 6, 12, 18 and 24 months. The primary effectiveness outcome is medication adherence via pill count, secondary outcomes include self-reported adherence and clinical outcomes. Process outcomes and cost-effectiveness will also be examined. Conclusion: The TAKE IT trial presents an innovative approach to monitoring and optimizing medication adherence among a population taking complex medication regimens. This trial seeks to evaluate the effectiveness and feasibility of this strategy compared to usual care.

AB - Background: Several studies report a high prevalence of non-adherence to prescribed immunosuppressive (IS) medications among kidney transplant recipients (KTRs), yet few interventions have been effective for helping patients sustain appropriate post-transplant adherence. We describe a multifaceted, evidence-based, medication adherence monitoring strategy (‘TAKE IT’) that leverages available transplant center resources to identify potential medication non-adherence and other concerns earlier to prevent complications that could result from inadequate IS adherence. Methods: The TAKE IT strategy includes: 1) medication adherence mobile application; 2) routine, online patient self-reported adherence assessments; 3) care alert notifications via the electronic health record (EHR) directed to transplant coordinators; 4) quarterly adherence reports to monitor IS values and summarize adherence trends; 5) deployment of adherence support tools tailored to specific adherence concerns. To test the TAKE IT intervention, we will conduct a two-arm, patient-randomized controlled trial at two large, diverse transplant centers (Northwestern University, Mayo Clinic, AZ) with planned recruitment of 450 KTRs (n = 225 per site) within 2 years of transplantation and 2 years of follow-up. Study assessments will take place at baseline, 6 weeks, 6, 12, 18 and 24 months. The primary effectiveness outcome is medication adherence via pill count, secondary outcomes include self-reported adherence and clinical outcomes. Process outcomes and cost-effectiveness will also be examined. Conclusion: The TAKE IT trial presents an innovative approach to monitoring and optimizing medication adherence among a population taking complex medication regimens. This trial seeks to evaluate the effectiveness and feasibility of this strategy compared to usual care.

KW - Immunosuppression

KW - Medication safety

KW - e-Health

KW - mHealth

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DO - 10.1016/j.cct.2021.106294

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SN - 1551-7144

VL - 103

JO - Contemporary Clinical Trials

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ER -

Transplant regimen adherence for kidney recipients by engaging information technologies (TAKE IT): Rationale and methods for a randomized controlled trial of a strategy to promote medication adherence among transplant recipients

Abstract

Keywords

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