Multimorbidity Management Supported by a Digital Platform
NCT ID: NCT05593835
Last Updated: 2023-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
1380 participants
INTERVENTIONAL
2025-06-01
2027-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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METHIS Intervention
The METHIS intervention will consist of two components. The first component is a Goal-Oriented Care (GOC) Training Program for health professionals. The training program will include the concept of personalised care, methods of goal elation, implications of GOC in healthcare practice, and how METHIS platform can be used to support the application of GOC. The training will be implemented through a blended-learning, continuous education program that will be credited by Nova University of Lisbon. The second component is a GOC information system. This will be the digital platform METHIS, which will be designed to nudge clinicians to adopt a GOC and to encourage patients and caregivers to take an active role in healthcare. The investigators will adapt an existing platform that was developed for a pilot study during the COVID-19 pandemic, that promotes care coordination, optimises disease prioritisation, and patient self-management.
METHIS Platform
The METHIS platform is a digital healthcare platform, supported by three databases using PostreSQL (based in relational SQL). One of the databases allows adequate internal testing before production. Another database of production (secured with unique access codes) will be created to retrieve data from the practices' and the last database for the research data, where pseudonymised production data can be analysed for research purposes. The platform is integrated (via FCCN Scientific Computation Unit of the Portuguese Fundação para a Ciência e a Tecnologia) with the Software Zoom® to allow encrypted teleconsultations, with a guarantee that each patient connection is unique. The digital platform is web-based, and it can be used in multiple devices.
Goal-Oriented Care Training Program
The training program will have three stages: initial face-to-face training, which will happen before the data collection, followed by remote, asynchronous training during a 12-month period, and a final seminar to discuss the results and inquire about the usability of the GOC model and the METHIS platform. The course will be offered to the intervention group one month before the start of patient recruitment, and for the control group at least one month after the end of data collection.
Control
The control group in this trial will be the best usual care, using the standard Electronic Health Records available to the practice. Our understanding of what "best usual care" is for people with multimorbidity is informed by qualitative research in an earlier stage of this project. Our results suggest that healthcare professionals often provide disease-driven care. When faced with multiple healthcare problems, they prioritise based on 1) patient complaints; 2) which condition is less well controlled; or 3) which condition is more likely to adversely impact on patient Health Related-Quality of life. General practitioners and primary care nurses are often not familiar with the Goal-Oriented Care model. However, they already try to implement some of its principles such as identifying patient goals and supporting shared decision making.
No interventions assigned to this group
Interventions
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METHIS Platform
The METHIS platform is a digital healthcare platform, supported by three databases using PostreSQL (based in relational SQL). One of the databases allows adequate internal testing before production. Another database of production (secured with unique access codes) will be created to retrieve data from the practices' and the last database for the research data, where pseudonymised production data can be analysed for research purposes. The platform is integrated (via FCCN Scientific Computation Unit of the Portuguese Fundação para a Ciência e a Tecnologia) with the Software Zoom® to allow encrypted teleconsultations, with a guarantee that each patient connection is unique. The digital platform is web-based, and it can be used in multiple devices.
Goal-Oriented Care Training Program
The training program will have three stages: initial face-to-face training, which will happen before the data collection, followed by remote, asynchronous training during a 12-month period, and a final seminar to discuss the results and inquire about the usability of the GOC model and the METHIS platform. The course will be offered to the intervention group one month before the start of patient recruitment, and for the control group at least one month after the end of data collection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* aged 50 or older
* with complex multimorbidity (co-occurrence of three or more chronic conditions affecting three or more different body systems)
* with access to an Internet connection and a communication technology device
Exclusion Criteria
50 Years
ALL
No
Sponsors
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Administração Regional de Saúde de Lisboa e Vale do Tejo, Portugal
UNKNOWN
Universidade Lusófona de Humanidades e Tecnologias
OTHER
NOVA Medical School
OTHER
NOVA School of Science and Technology ı FCT NOVA
OTHER
University Hospital, Geneva
OTHER
Universidade Nova de Lisboa
OTHER
Responsible Party
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Principal Investigators
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Luís V. Lapão, PhD
Role: PRINCIPAL_INVESTIGATOR
Universidade Nova de Lisboa
Central Contacts
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References
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Onder G, Palmer K, Navickas R, Jureviciene E, Mammarella F, Strandzheva M, Mannucci P, Pecorelli S, Marengoni A; Joint Action on Chronic Diseases and Promoting Healthy Ageing across the Life Cycle (JA-CHRODIS). Time to face the challenge of multimorbidity. A European perspective from the joint action on chronic diseases and promoting healthy ageing across the life cycle (JA-CHRODIS). Eur J Intern Med. 2015 Apr;26(3):157-9. doi: 10.1016/j.ejim.2015.02.020. Epub 2015 Mar 18.
Mercer S, Furler J, Moffat K, Fischbacher-Smith D, Sanci LA, World Health Organization, et al. Multimorbidity: Technical Series on Safer Primary Care. Geneva, Switzerland: World Health Organization; 2016
Quinaz Romana G, Kislaya I, Salvador MR, Cunha Goncalves S, Nunes B, Dias C. [Multimorbidity in Portugal: Results from The First National Health Examination Survey]. Acta Med Port. 2019 Feb 1;32(1):30-37. doi: 10.20344/amp.11227. Epub 2019 Feb 1. Portuguese.
Amer Nordin A, Mohd Hairi F, Choo WY, Hairi NN. Care Recipient Multimorbidity and Health Impacts on Informal Caregivers: A Systematic Review. Gerontologist. 2019 Sep 17;59(5):e611-e628. doi: 10.1093/geront/gny072.
van der Aa MJ, van den Broeke JR, Stronks K, Plochg T. Patients with multimorbidity and their experiences with the healthcare process: a scoping review. J Comorb. 2017 Jan 27;7(1):11-21. doi: 10.15256/joc.2017.7.97. eCollection 2017.
Fortin M, Lapointe L, Hudon C, Vanasse A, Ntetu AL, Maltais D. Multimorbidity and quality of life in primary care: a systematic review. Health Qual Life Outcomes. 2004 Sep 20;2:51. doi: 10.1186/1477-7525-2-51.
Makovski TT, Schmitz S, Zeegers MP, Stranges S, van den Akker M. Multimorbidity and quality of life: Systematic literature review and meta-analysis. Ageing Res Rev. 2019 Aug;53:100903. doi: 10.1016/j.arr.2019.04.005. Epub 2019 Apr 30.
Marengoni A, von Strauss E, Rizzuto D, Winblad B, Fratiglioni L. The impact of chronic multimorbidity and disability on functional decline and survival in elderly persons. A community-based, longitudinal study. J Intern Med. 2009 Feb;265(2):288-95. doi: 10.1111/j.1365-2796.2008.02017.x.
Boyd CM, Darer J, Boult C, Fried LP, Boult L, Wu AW. Clinical practice guidelines and quality of care for older patients with multiple comorbid diseases: implications for pay for performance. JAMA. 2005 Aug 10;294(6):716-24. doi: 10.1001/jama.294.6.716.
Cairo Notari S, Sader J, Caire Fon N, Sommer JM, Pereira Miozzari AC, Janjic D, Nendaz M, Audetat MC. Understanding GPs' clinical reasoning processes involved in managing patients suffering from multimorbidity: A systematic review of qualitative and quantitative research. Int J Clin Pract. 2021 Sep;75(9):e14187. doi: 10.1111/ijcp.14187. Epub 2021 May 5.
Damarell RA, Morgan DD, Tieman JJ. General practitioner strategies for managing patients with multimorbidity: a systematic review and thematic synthesis of qualitative research. BMC Fam Pract. 2020 Jul 1;21(1):131. doi: 10.1186/s12875-020-01197-8.
Spencer-Bonilla G, Quinones AR, Montori VM; International Minimally Disruptive Medicine Workgroup. Assessing the Burden of Treatment. J Gen Intern Med. 2017 Oct;32(10):1141-1145. doi: 10.1007/s11606-017-4117-8. Epub 2017 Jul 11.
Whitehead L, Palamara P, Allen J, Boak J, Quinn R, George C. Nurses' perceptions and beliefs related to the care of adults living with multimorbidity: A systematic qualitative review. J Clin Nurs. 2022 Oct;31(19-20):2716-2736. doi: 10.1111/jocn.16146. Epub 2021 Dec 6.
Muth C, Blom JW, Smith SM, Johnell K, Gonzalez-Gonzalez AI, Nguyen TS, Brueckle MS, Cesari M, Tinetti ME, Valderas JM. Evidence supporting the best clinical management of patients with multimorbidity and polypharmacy: a systematic guideline review and expert consensus. J Intern Med. 2019 Mar;285(3):272-288. doi: 10.1111/joim.12842. Epub 2018 Dec 10.
Kernick D, Chew-Graham CA, O'Flynn N. Clinical assessment and management of multimorbidity: NICE guideline. Br J Gen Pract. 2017 May;67(658):235-236. doi: 10.3399/bjgp17X690857. No abstract available.
De Maeseneer J, Boeckxstaens P. James Mackenzie Lecture 2011: multimorbidity, goal-oriented care, and equity. Br J Gen Pract. 2012 Jul;62(600):e522-4. doi: 10.3399/bjgp12X652553. No abstract available.
Gonzalez AI GONZALEZ, Schmucker C, Nothacker J, Motschall E, Nguyen TS, Brueckle MS, Blom J, van den Akker M, Rottger K, Wegwarth O, Hoffmann T, Straus SE, Gerlach FM, Meerpohl JJ, Muth C. Health-related preferences of older patients with multimorbidity: an evidence map. BMJ Open. 2019 Dec 15;9(12):e034485. doi: 10.1136/bmjopen-2019-034485.
Mold JW, Blake GH, Becker LA. Goal-oriented medical care. Fam Med. 1991 Jan;23(1):46-51.
Steele Gray C, Grudniewicz A, Armas A, Mold J, Im J, Boeckxstaens P. Goal-Oriented Care: A Catalyst for Person-Centred System Integration. Int J Integr Care. 2020 Nov 4;20(4):8. doi: 10.5334/ijic.5520.
Goncalves-Bradley DC, J Maria AR, Ricci-Cabello I, Villanueva G, Fonhus MS, Glenton C, Lewin S, Henschke N, Buckley BS, Mehl GL, Tamrat T, Shepperd S. Mobile technologies to support healthcare provider to healthcare provider communication and management of care. Cochrane Database Syst Rev. 2020 Aug 18;8(8):CD012927. doi: 10.1002/14651858.CD012927.pub2.
Gagnon MP, Godin G, Gagne C, Fortin JP, Lamothe L, Reinharz D, Cloutier A. An adaptation of the theory of interpersonal behaviour to the study of telemedicine adoption by physicians. Int J Med Inform. 2003 Sep;71(2-3):103-15. doi: 10.1016/s1386-5056(03)00094-7.
Shojania KG, Jennings A, Mayhew A, Ramsay CR, Eccles MP, Grimshaw J. The effects of on-screen, point of care computer reminders on processes and outcomes of care. Cochrane Database Syst Rev. 2009 Jul 8;2009(3):CD001096. doi: 10.1002/14651858.CD001096.pub2.
Lamprell K, Tran Y, Arnolda G, Braithwaite J. Nudging clinicians: A systematic scoping review of the literature. J Eval Clin Pract. 2021 Feb;27(1):175-192. doi: 10.1111/jep.13401. Epub 2020 Apr 27.
Kraef C, van der Meirschen M, Free C. Digital telemedicine interventions for patients with multimorbidity: a systematic review and meta-analysis. BMJ Open. 2020 Oct 13;10(10):e036904. doi: 10.1136/bmjopen-2020-036904.
Pascual-de la Pisa B, Palou-Lobato M, Marquez Calzada C, Garcia-Lozano MJ. [Effectiveness of interventions based on telemedicine on health outcomes in patients with multimorbidity in Primary Care: A systematic review]. Aten Primaria. 2020 Dec;52(10):759-769. doi: 10.1016/j.aprim.2019.08.004. Epub 2019 Dec 5. Spanish.
Berntsen G, Strisland F, Malm-Nicolaisen K, Smaradottir B, Fensli R, Rohne M. The Evidence Base for an Ideal Care Pathway for Frail Multimorbid Elderly: Combined Scoping and Systematic Intervention Review. J Med Internet Res. 2019 Apr 22;21(4):e12517. doi: 10.2196/12517.
Lapao LV, Peyroteo M, Maia M, Seixas J, Gregorio J, Mira da Silva M, Heleno B, Correia JC. Implementation of Digital Monitoring Services During the COVID-19 Pandemic for Patients With Chronic Diseases: Design Science Approach. J Med Internet Res. 2021 Aug 26;23(8):e24181. doi: 10.2196/24181.
Kastner M, Hayden L, Wong G, Lai Y, Makarski J, Treister V, Chan J, Lee JH, Ivers NM, Holroyd-Leduc J, Straus SE. Underlying mechanisms of complex interventions addressing the care of older adults with multimorbidity: a realist review. BMJ Open. 2019 Apr 3;9(4):e025009. doi: 10.1136/bmjopen-2018-025009.
Quinaz Romana G, Kislaya I, Cunha Goncalves S, Salvador MR, Nunes B, Matias Dias C. Healthcare use in patients with multimorbidity. Eur J Public Health. 2020 Feb 1;30(1):16-22. doi: 10.1093/eurpub/ckz118.
Broeiro, P. (2015). Multimorbilidade e comorbilidade: duas perspectivas da mesma realidade. Revista Portuguesa De Medicina Geral E Familiar, 31(3), 150-60.
Peyroteo M. O sistema de informação e o modelo de orientação na prestação de cuidados de saúde em pacientes com multimorbilidade numa unidade de saúde familiar em Lisboa: uma perspetiva dos profissionais de saúde Instituto de Higiene Tropical, Universidade NOVA de Lisboa; 2020. Available from: https://run.unl.pt/handle/10362/116922
Smith SM, Wallace E, Salisbury C, Sasseville M, Bayliss E, Fortin M. A Core Outcome Set for Multimorbidity Research (COSmm). Ann Fam Med. 2018 Mar;16(2):132-138. doi: 10.1370/afm.2178.
Cheung AS, de Rooy C, Hoermann R, Lim Joon D, Zajac JD, Grossmann M. Quality of life decrements in men with prostate cancer undergoing androgen deprivation therapy. Clin Endocrinol (Oxf). 2017 Mar;86(3):388-394. doi: 10.1111/cen.13249. Epub 2016 Nov 2.
Gonzalez-Ortega M, Gene-Badia J, Kostov B, Garcia-Valdecasas V, Perez-Martin C. Randomized trial to reduce emergency visits or hospital admissions using telephone coaching to complex patients. Fam Pract. 2017 Apr 1;34(2):219-226. doi: 10.1093/fampra/cmw119.
Bunevicius A, Peceliuniene J, Mickuviene N, Valius L, Bunevicius R. Screening for depression and anxiety disorders in primary care patients. Depress Anxiety. 2007;24(7):455-60. doi: 10.1002/da.20274.
Puhan MA, Frey M, Buchi S, Schunemann HJ. The minimal important difference of the hospital anxiety and depression scale in patients with chronic obstructive pulmonary disease. Health Qual Life Outcomes. 2008 Jul 2;6:46. doi: 10.1186/1477-7525-6-46.
Corder K, Brage S, Ekelund U. Accelerometers and pedometers: methodology and clinical application. Curr Opin Clin Nutr Metab Care. 2007 Sep;10(5):597-603. doi: 10.1097/MCO.0b013e328285d883.
Tudor-Locke C, Craig CL, Aoyagi Y, Bell RC, Croteau KA, De Bourdeaudhuij I, Ewald B, Gardner AW, Hatano Y, Lutes LD, Matsudo SM, Ramirez-Marrero FA, Rogers LQ, Rowe DA, Schmidt MD, Tully MA, Blair SN. How many steps/day are enough? For older adults and special populations. Int J Behav Nutr Phys Act. 2011 Jul 28;8:80. doi: 10.1186/1479-5868-8-80.
Arvidsson D, Fridolfsson J, Borjesson M. Measurement of physical activity in clinical practice using accelerometers. J Intern Med. 2019 Aug;286(2):137-153. doi: 10.1111/joim.12908. Epub 2019 Apr 16.
Richardson, S. and D. Mackinnon. (2017). Left to their own Devices? Privacy Implications of Wearable Technology in Canadian Workplaces. Surveillance Studies Centre. Available at: https://www.surveillance-studies.ca/sites/sscqueens.org/files/left_to_their_own_devices.pdf
Evenson KR, Goto MM, Furberg RD. Systematic review of the validity and reliability of consumer-wearable activity trackers. Int J Behav Nutr Phys Act. 2015 Dec 18;12:159. doi: 10.1186/s12966-015-0314-1.
Johnson EJ, Goldstein D. Medicine. Do defaults save lives? Science. 2003 Nov 21;302(5649):1338-9. doi: 10.1126/science.1091721. No abstract available.
Gil Conde M, Peyroteo M, Maria A, Maia MR, Gregorio J, Paulo MS, Alves M, Papoila AL, Lapao LV, Heleno B. Protocol for a cluster randomised trial of a goal-oriented care approach for multimorbidity patients supported by a digital platform. BMJ Open. 2023 Nov 17;13(11):e070044. doi: 10.1136/bmjopen-2022-070044.
Other Identifiers
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METHIS_CRTMB2022
Identifier Type: -
Identifier Source: org_study_id