PMID- 35396305 OWN - NLM STAT- MEDLINE DCOM- 20220412 LR - 20220531 IS - 2044-6055 (Electronic) IS - 2044-6055 (Linking) VI - 12 IP - 4 DP - 2022 Apr 8 TI - Cost-effectiveness of multicomponent interventions in type 2 diabetes mellitus in a cluster randomised controlled trial: the INDICA study. PG - e058049 LID - 10.1136/bmjopen-2021-058049 [doi] LID - e058049 AB - OBJECTIVE: To analyse the cost-effectiveness of multicomponent interventions designed to improve outcomes in type 2 diabetes mellitus (T2DM) in primary care in the Canary Islands, Spain, within the INDICA randomised clinical trial, from the public health system perspective. DESIGN: An economic evaluation was conducted for the within-trial period (2 years) comparing the four arms of the INDICA study. SETTING: Primary care in the Canary Islands, Spain. PARTICIPANTS: 2334 patients with T2DM without complications were included. INTERVENTIONS: Interventions for patients (PTI), for primary care professionals (PFI), for both (combined intervention arm for patients and professionals, CBI) and usual care (UC) as a control group. OUTCOMES: The main outcome was the incremental cost per quality-adjusted life-years (QALY). Only the intervention and the healthcare costs were included. ANALYSIS: Multilevel models were used to estimate results, and to measure the size and significance of incremental changes. Missed values were treated by means of multiple imputations procedure. RESULTS: There were no differences between arms in terms of costs (p=0.093), while some differences were observed in terms of QALYs after 2 years of follow-up (p=0.028). PFI and CBI arms were dominated by the other two arms, PTI and UC. The differences between the PTI and the UC arms were very small in terms of QALYs, but significant in terms of healthcare costs (p=0.045). The total cost of the PTI arm (euro2571, 95% CI euro2317 to euro2826) was lower than the cost in the UC arm (euro2750, 95% CI euro2506 to euro2995), but this difference did not reach statistical significance. Base case estimates of the incremental cost per QALY indicate that the PTI strategy was the cost-effective option. CONCLUSIONS: The INDICA intervention designed for patients with T2DM and families is likely to be cost-effective from the public healthcare perspective. A cost-effectiveness model should explore this in the long term. TRIAL REGISTRATION NUMBER: NCT01657227. CI - (c) Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. FAU - Garcia-Perez, Lidia AU - Garcia-Perez L AUID- ORCID: 0000-0002-5626-8116 AD - Canary Islands Health Research Institute Foundation (FIISC), Tenerife, Spain lidia.garciaperez@sescs.es. AD - Research Network on Health Services in Chronic Diseases (REDISSEC), Tenerife, Spain. AD - Network for Research on Chronicity, Primary Care, and Health Promotion (RICAPPS), Tenerife, Spain. FAU - Ramallo-Farina, Yolanda AU - Ramallo-Farina Y AUID- ORCID: 0000-0002-1541-3989 AD - Canary Islands Health Research Institute Foundation (FIISC), Tenerife, Spain. AD - Research Network on Health Services in Chronic Diseases (REDISSEC), Tenerife, Spain. AD - Network for Research on Chronicity, Primary Care, and Health Promotion (RICAPPS), Tenerife, Spain. FAU - Vallejo-Torres, Laura AU - Vallejo-Torres L AUID- ORCID: 0000-0001-5833-6066 AD - Canary Islands Health Research Institute Foundation (FIISC), Tenerife, Spain. AD - Research Network on Health Services in Chronic Diseases (REDISSEC), Tenerife, Spain. FAU - Rodriguez-Rodriguez, Leticia AU - Rodriguez-Rodriguez L AD - Canary Islands Health Research Institute Foundation (FIISC), Tenerife, Spain. AD - Network for Research on Chronicity, Primary Care, and Health Promotion (RICAPPS), Tenerife, Spain. FAU - Gonzalez-Pacheco, Himar AU - Gonzalez-Pacheco H AD - Canary Islands Health Research Institute Foundation (FIISC), Tenerife, Spain. FAU - Santos-Hernandez, Beatriz AU - Santos-Hernandez B AD - Canary Islands Health Research Institute Foundation (FIISC), Tenerife, Spain. FAU - Garcia-Bello, Miguel Angel AU - Garcia-Bello MA AD - Canary Islands Health Research Institute Foundation (FIISC), Tenerife, Spain. FAU - Wagner, Ana Maria AU - Wagner AM AD - Department of Endocrinology and Nutrition, Insular University Hospital of Gran Canaria, Las Palmas de Gran Canaria, Spain. AD - University Institute for Biomedical and Health Research (iUIBS), University of Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, Spain. FAU - Carmona, Montserrat AU - Carmona M AD - Research Network on Health Services in Chronic Diseases (REDISSEC), Tenerife, Spain. AD - Network for Research on Chronicity, Primary Care, and Health Promotion (RICAPPS), Tenerife, Spain. AD - Health Technology Assessment Agency, Instituto de Salud Carlos III, Madrid, Spain. FAU - Serrano-Aguilar, Pedro G AU - Serrano-Aguilar PG AD - Research Network on Health Services in Chronic Diseases (REDISSEC), Tenerife, Spain. AD - Network for Research on Chronicity, Primary Care, and Health Promotion (RICAPPS), Tenerife, Spain. AD - Evaluation Unit (SESCS), Canary Islands Health Service (SCS), Santa Cruz de Tenerife, Spain. CN - INDICA team LA - eng SI - ClinicalTrials.gov/NCT01657227 PT - Journal Article PT - Randomized Controlled Trial DEP - 20220408 PL - England TA - BMJ Open JT - BMJ open JID - 101552874 SB - IM MH - Cluster Analysis MH - Cost-Benefit Analysis MH - Diabetes Mellitus, Type 2/*economics/*therapy MH - Humans MH - Primary Health Care MH - Quality of Life MH - Quality-Adjusted Life Years MH - Spain PMC - PMC8995956 OTO - NOTNLM OT - diabetes & endocrinology OT - health economics OT - health informatics OT - primary care OT - quality in health care COIS- Competing interests: None declared. FIR - Rosa, Abraham Perez de la IR - Rosa AP FIR - Rios, Alicia Pareja IR - Rios AP FIR - Perello, Andres Sifre IR - Perello AS FIR - Perez, Angela Trinidad Gutierrez IR - Perez ATG FIR - Leon, Antonio Cabrera de IR - Leon AC FIR - Quintana, Antonio Garcia IR - Quintana AG FIR - Dominguez, Armando Carrillo IR - Dominguez AC FIR - Dominguez, Bernardo Eusebio Herrera IR - Dominguez BEH FIR - Perez, Carlos Sedeno IR - Perez CS FIR - Alamo, Carlos Ramirez IR - Alamo CR FIR - Aguilar, Carmen Daranas IR - Aguilar CD FIR - Marrero, Carolina Guerra IR - Marrero CG FIR - Soto, Cecilia Lobos IR - Soto CL FIR - Perez, Cristina Padron IR - Perez CP FIR - Martel, Dacil Alvarado IR - Martel DA FIR - Obregon, Daniel Hernandez IR - Obregon DH FIR - Correa, Dulce N Hernandez IR - Correa DNH FIR - Pozuelo, Elsa Espinosa IR - Pozuelo EE FIR - Mayor, Elsa Florido IR - Mayor EF FIR - Dominguez, Engracia Pinilla IR - Dominguez EP FIR - Garcia, Fatima Herrera IR - Garcia FH FIR - Aguiar, Felix Bonilla IR - Aguiar FB FIR - Alvarez, Fernando Monton IR - Alvarez FM FIR - Lopez, Francisco Cabrera IR - Lopez FC FIR - Torre, Gloria Guerra de la IR - Torre GG FIR - Martin, Gregorio Muelas IR - Martin GM FIR - Monzon, Guillermo IR - Monzon G FIR - Merino, Hector de la Rosa IR - Merino HR FIR - Puente, Ignacio Garcia IR - Puente IG FIR - Segura, Ignacio Llorente Gomez de IR - Segura ILG FIR - Calcerrada, Isabel Garcia IR - Calcerrada IG FIR - Rodriguez, Ivan Castilla IR - Rodriguez IC FIR - Perez, Jacqueline Alvarez IR - Perez JA FIR - Page, Jorge Federico Aldunate IR - Page JFA FIR - Dopico, Jose Antonio Garcia IR - Dopico JAG FIR - Hernandez, Juan Andres Baez IR - Hernandez JAB FIR - Valencia, Juan Jose Perez IR - Valencia JJP FIR - Wiebe, Julia Charlotte IR - Wiebe JC FIR - Perez, Lilisbeth Perestelo IR - Perez LP FIR - Martin, Leopoldo IR - Martin L FIR - Majem, Lluis Serra IR - Majem LS FIR - Herrera, Luis Morcillo IR - Herrera LM FIR - Ramirez, Marcos Estupinan IR - Ramirez ME FIR - Ruano, Margarita Roldan IR - Ruano MR FIR - Fernandez, Maria Del Mar Romero IR - Fernandez MDMR FIR - Perez, Maria Inmaculada Gonzalez IR - Perez MIG FIR - Morales, Maria Isabel Visuerte IR - Morales MIV FIR - Medina, Maria Pino Afonso IR - Medina MPA FIR - Ruiz, Marta Riano IR - Ruiz MR FIR - Santana, Marta Tejera IR - Santana MT FIR - Cortes, Mauro Boronat IR - Cortes MB FIR - Medina, Mercedes Lorenzo IR - Medina ML FIR - Garcia, Miguel JuanMora IR - Garcia MJ FIR - Delgado, Nayra Perez IR - Delgado NP FIR - Martin, Pablo Pedrianez IR - Martin PP FIR - Velasco, Pedro de Pablos IR - Velasco PP FIR - Alba, Pilar Pelaez IR - Alba PP FIR - Valcarcel, Rafael IR - Valcarcel R FIR - Sanchez, Remedios Castro IR - Sanchez RC FIR - Gonzalez, Rodrigo Abreu IR - Gonzalez RA FIR - Trujillo, Rosa Borges IR - Trujillo RB FIR - Gonzalez, Salvador Acosta IR - Gonzalez SA FIR - Girardot, Sybille Kaiser IR - Girardot SK FIR - Sellares, Victor Lorenzo IR - Sellares VL EDAT- 2022/04/10 06:00 MHDA- 2022/04/13 06:00 PMCR- 2022/04/08 CRDT- 2022/04/09 05:18 PHST- 2022/04/09 05:18 [entrez] PHST- 2022/04/10 06:00 [pubmed] PHST- 2022/04/13 06:00 [medline] PHST- 2022/04/08 00:00 [pmc-release] AID - bmjopen-2021-058049 [pii] AID - 10.1136/bmjopen-2021-058049 [doi] PST - epublish SO - BMJ Open. 2022 Apr 8;12(4):e058049. doi: 10.1136/bmjopen-2021-058049.