Protocol for a Multi-site Pilot Study of the OptiMed Clinical Trial
NCT ID: NCT06688591
Last Updated: 2024-11-14
Study Results
Results pending
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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Recruitment Status
WITHDRAWN
Clinical Phase
NA
Study Classification
INTERVENTIONAL
Study Start Date
2021-12-06
Study Completion Date
2023-06-30
Brief Summary
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Background: Optimal medication management is one of the essential preconditions for polymedicated home-dwelling older adults with multiple chronic conditions to remain at home and preserve their quality of life and autonomy. This study aims to explore the feasibility and acceptability of an evidence-based, multi-component, interprofessional intervention programme supported by informal caregivers to decrease medication related problems (MRPs) among polymedicated, home-dwelling older adults with multiple chronic conditions.
Methods: The pragmatic multi-site OptiMed pilot study will use an open-label design, where participants know what they are signing up for and will take place in primary healthcare settings in Portugal and Switzerland. The research population will comprise polymedicated home-dwelling adults aged 65 years old or more, at risk of MRPs and receiving community-based healthcare.
Discussion: This pilot study will focus on the recruitment and collaboration of study participants and piloting the feasibility of the evidence-based, multi-component, interprofessional intervention programme. The full-scale study, following on from the OptiMed pilot study, will support the development of a standardised, evidence-based, multi-component, interprofessional intervention programme to reduce MRPs. It will also be an essential part of follow-up research programmes on the multiple roles of informal caregivers, as it will put their coordination tasks into perspective with their own needs.
Methods: The pragmatic multi-site OptiMed pilot study will use an open-label design, where participants know what they are signing up for and will take place in primary healthcare settings in Portugal and Switzerland. The research population will comprise polymedicated home-dwelling adults aged 65 years old or more, at risk of MRPs and receiving community-based healthcare.
Discussion: This pilot study will focus on the recruitment and collaboration of study participants and piloting the feasibility of the evidence-based, multi-component, interprofessional intervention programme. The full-scale study, following on from the OptiMed pilot study, will support the development of a standardised, evidence-based, multi-component, interprofessional intervention programme to reduce MRPs. It will also be an essential part of follow-up research programmes on the multiple roles of informal caregivers, as it will put their coordination tasks into perspective with their own needs.
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Detailed Description
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The pilot study's primary objective is to explore the feasibility and acceptability of an evidence-based, multi-component, interprofessional intervention programme, supported by informal caregivers, to decrease MRPs among polymedicated, home-dwelling older adults with multiple chronic conditions. The pilot study will gather information about the feasibility and acceptability of recruitment, participant retention, adherence, fidelity, acceptability and satisfaction, intervention dose, and the intervention programme's overall credibility. The secondary objective is to test the different data collection tools planned for use in the full study.
After the older participant has been recruited via their nurse primary-care manager, working for their primary healthcare centre (PHC), the intervention's first component (t0) involves a baseline assessment of them at a meeting conducted by a research nurse. The research is explained to the older participant in detail, both orally and in writing, and the consent form is signed. Following this, the older participant is asked to answer some sociodemographic and health-related questions and provide a complete list of their current medication prescription. The research nurse completes a questionnaire on the risk of MRPs-doMESTIC risk. A first meeting also takes place individually with the family caregiver (who will also answer some sociodemographic and health-related questions and describe their role in medication management). The older participant is asked to identify the healthcare professional(s) (GP or specialist, nurse primary-care manager and/or community pharmacist) most involved in their medication management.
The second component (t1) involves a review of the prescribed medications in week 1, including a medication reconciliation and a structured medication analysis by the pharmacist study partner, to identify drugs with a high risk of MRPs among older adults. This will use the STOPP/START criteria, and undertreated indications or missed therapies will use the START criteria. The older adult's physician will be invited to participate in the review of prescribed medications in collaboration with the pharmacist study partner. They will discuss validated, evidence-based, internationally recognised guidelines to reconsider beneficial or non-beneficial therapies or to simplify and focus on specific care goals and adjust medications to be consistent with guidelines. If the older adult's physician adopts no changes despite the medication review (t1) highlighting their relevance, the research team will inform the older adult of their physician's decision and will invite them to proceed with the study.
Based on the baseline assessment (t0), the research nurse will use a joint consultation in week 2 to explore the needs and care goals of the older participant and their informal caregiver so as to reduce the risk of MRPs (t2). The research nurse will then design a target education plan-in collaboration with the designated healthcare professional(s)-to empower the older adult's medication management and reduce the risk of MRPs (t2). This is based on a four-step patient empowerment process: 1) the patient understands their role; 2) the patient acquires sufficient knowledge to be able to engage with their healthcare professionals; 3) the patient improves their skills; and 4) there is a facilitating environment. Each older adult participant's plan will be unique and consider their preferences, medication literacy and treatment adherence.
During weeks 3 and 4 (t3), the research nurse will help the older participant and their informal caregiver to implement their target education plan (t2) aimed at empowering their medication management and promoting their active engagement in reducing the risks of MRPs. Two joint consultations will be organised between the older adult, their informal caregiver and the research nurse (once each week). During planned home visits, the nurse will periodically evaluate older adults' medication status (primary and secondary outcomes) and promote communication between the different professional and non-professional actors involved in medication management.
The research nurse will carry out a final assessment (t4) of each older adult's risks of MRPs in week 5 (35-40 days after t0) in collaboration with the study partner pharmacist. The occurrence of MRPs and medication-related hospital admissions will be investigated. Finally, the acceptability of the interprofessional intervention programme to reduce MRPs will be assessed by the healthcare professionals designated by the older adult in a final questionnaire.
As already described, the medication-management intervention programme guiding OptiMed's pilot study comprises four components based on concurrent interacting processes previously identified by Boult and Wieland. The pilot study will explore possible biases so that they can be correctly addressed in the full study.
After the older participant has been recruited via their nurse primary-care manager, working for their primary healthcare centre (PHC), the intervention's first component (t0) involves a baseline assessment of them at a meeting conducted by a research nurse. The research is explained to the older participant in detail, both orally and in writing, and the consent form is signed. Following this, the older participant is asked to answer some sociodemographic and health-related questions and provide a complete list of their current medication prescription. The research nurse completes a questionnaire on the risk of MRPs-doMESTIC risk. A first meeting also takes place individually with the family caregiver (who will also answer some sociodemographic and health-related questions and describe their role in medication management). The older participant is asked to identify the healthcare professional(s) (GP or specialist, nurse primary-care manager and/or community pharmacist) most involved in their medication management.
The second component (t1) involves a review of the prescribed medications in week 1, including a medication reconciliation and a structured medication analysis by the pharmacist study partner, to identify drugs with a high risk of MRPs among older adults. This will use the STOPP/START criteria, and undertreated indications or missed therapies will use the START criteria. The older adult's physician will be invited to participate in the review of prescribed medications in collaboration with the pharmacist study partner. They will discuss validated, evidence-based, internationally recognised guidelines to reconsider beneficial or non-beneficial therapies or to simplify and focus on specific care goals and adjust medications to be consistent with guidelines. If the older adult's physician adopts no changes despite the medication review (t1) highlighting their relevance, the research team will inform the older adult of their physician's decision and will invite them to proceed with the study.
Based on the baseline assessment (t0), the research nurse will use a joint consultation in week 2 to explore the needs and care goals of the older participant and their informal caregiver so as to reduce the risk of MRPs (t2). The research nurse will then design a target education plan-in collaboration with the designated healthcare professional(s)-to empower the older adult's medication management and reduce the risk of MRPs (t2). This is based on a four-step patient empowerment process: 1) the patient understands their role; 2) the patient acquires sufficient knowledge to be able to engage with their healthcare professionals; 3) the patient improves their skills; and 4) there is a facilitating environment. Each older adult participant's plan will be unique and consider their preferences, medication literacy and treatment adherence.
During weeks 3 and 4 (t3), the research nurse will help the older participant and their informal caregiver to implement their target education plan (t2) aimed at empowering their medication management and promoting their active engagement in reducing the risks of MRPs. Two joint consultations will be organised between the older adult, their informal caregiver and the research nurse (once each week). During planned home visits, the nurse will periodically evaluate older adults' medication status (primary and secondary outcomes) and promote communication between the different professional and non-professional actors involved in medication management.
The research nurse will carry out a final assessment (t4) of each older adult's risks of MRPs in week 5 (35-40 days after t0) in collaboration with the study partner pharmacist. The occurrence of MRPs and medication-related hospital admissions will be investigated. Finally, the acceptability of the interprofessional intervention programme to reduce MRPs will be assessed by the healthcare professionals designated by the older adult in a final questionnaire.
As already described, the medication-management intervention programme guiding OptiMed's pilot study comprises four components based on concurrent interacting processes previously identified by Boult and Wieland. The pilot study will explore possible biases so that they can be correctly addressed in the full study.
Conditions
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Polypharmacy
Multiple Chronic Conditions
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
The pilot OptiMed randomised pragmatic trial will focus on the feasibility components using an open-label design where participants know what they are signing up for. It will support the development of a standardised, evidence-based, multi-component, interprofessional intervention programme to reduce MRPs.
Primary Study Purpose
PREVENTION
Blinding Strategy
NONE
Study Groups
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Medication-management intervention programme to reduce the risks of MRPs
The research nurse will help the older participant and their informal caregiver to implement their target education plan (t2) aimed at empowering their medication management and promoting their active engagement in reducing the risks of MRPs
Group Type
EXPERIMENTAL
Intervention programme to optimise medication management and prevent MRPs
Intervention Type
OTHER
The intervention is based on a four-step patient empowerment process: 1) the patient understands their role; 2) the patient acquires sufficient knowledge to be able to engage with their healthcare professionals; 3) the patient improves their skills; and 4) there is a facilitating environment (30). Each older adult participant's plan will be unique and consider their preferences, medication literacy and treatment adherence.
Interventions
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Intervention programme to optimise medication management and prevent MRPs
The intervention is based on a four-step patient empowerment process: 1) the patient understands their role; 2) the patient acquires sufficient knowledge to be able to engage with their healthcare professionals; 3) the patient improves their skills; and 4) there is a facilitating environment (30). Each older adult participant's plan will be unique and consider their preferences, medication literacy and treatment adherence.
Intervention Type
OTHER
Other Intervention Names
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Preventive intervention
Eligibility Criteria
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Inclusion Criteria
* Aged 65 or older for both men and women
* Suffering from multiple chronic conditions (two or more)
* Managing at least four prescribed medications daily for more than 90 days (2) (explored during recruitment)
* At risk of MRPs identified using the doMESTIC RISK tool
* Living alone or with a partner, in a rural or urban area
* Supported by a Primary Healthcare Centre
* An informal caregiver is involved in medication management
* Gives written informed consent
* Suffering from multiple chronic conditions (two or more)
* Managing at least four prescribed medications daily for more than 90 days (2) (explored during recruitment)
* At risk of MRPs identified using the doMESTIC RISK tool
* Living alone or with a partner, in a rural or urban area
* Supported by a Primary Healthcare Centre
* An informal caregiver is involved in medication management
* Gives written informed consent
Exclusion Criteria
* Unable to speak and understand French
* Moderate or severe dementia criteria (≥ 10 on the Six-item Cognitive Impairment Test, 6-CIT)
* No risk of MRPs (doMESTIC RISK tool score \< 5)
* No informal caregiver
* Moderate or severe dementia criteria (≥ 10 on the Six-item Cognitive Impairment Test, 6-CIT)
* No risk of MRPs (doMESTIC RISK tool score \< 5)
* No informal caregiver
Minimum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Polytechnic of Leiria
UNKNOWN
Sponsor Role
collaborator
Institute for Primary Health Care BIHAM, University of Bern
UNKNOWN
Sponsor Role
collaborator
HES-SO Valais-Wallis
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Henk Verloo, PhD
Role: PRINCIPAL_INVESTIGATOR
HES-SO Valais-Wallis
References
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Pellegrin KL, Lee E, Uyeno R, Ayson C, Goo R. Potentially preventable medication-related hospitalizations: A clinical pharmacist approach to assessment, categorization, and quality improvement. J Am Pharm Assoc (2003). 2017 Nov-Dec;57(6):711-716. doi: 10.1016/j.japh.2017.06.019. Epub 2017 Aug 16.
Reference Type
BACKGROUND
Mekonnen AB, McLachlan AJ, Brien JA. Effectiveness of pharmacist-led medication reconciliation programmes on clinical outcomes at hospital transitions: a systematic review and meta-analysis. BMJ Open. 2016 Feb 23;6(2):e010003. doi: 10.1136/bmjopen-2015-010003.
Reference Type
BACKGROUND
Beuscart JB, Pelayo S, Robert L, Thevelin S, Marien S, Dalleur O. Medication review and reconciliation in older adults. Eur Geriatr Med. 2021 Jun;12(3):499-507. doi: 10.1007/s41999-021-00449-9. Epub 2021 Feb 13.
Reference Type
BACKGROUND
O'Mahony D, O'Sullivan D, Byrne S, O'Connor MN, Ryan C, Gallagher P. STOPP/START criteria for potentially inappropriate prescribing in older people: version 2. Age Ageing. 2015 Mar;44(2):213-8. doi: 10.1093/ageing/afu145. Epub 2014 Oct 16.
Reference Type
BACKGROUND
American Geriatrics Society 2012 Beers Criteria Update Expert Panel. American Geriatrics Society updated Beers Criteria for potentially inappropriate medication use in older adults. J Am Geriatr Soc. 2012 Apr;60(4):616-31. doi: 10.1111/j.1532-5415.2012.03923.x. Epub 2012 Feb 29.
Reference Type
BACKGROUND
Pereira F, von Gunten A, Rosselet Amoussou J, De Giorgi Salamun I, Martins MM, Verloo H. Polypharmacy Among Home-Dwelling Older Adults: The Urgent Need for an Evidence-Based Medication Management Model. Patient Prefer Adherence. 2019 Dec 16;13:2137-2143. doi: 10.2147/PPA.S232575. eCollection 2019.
Reference Type
BACKGROUND
Verloo H, Chiolero A, Kiszio B, Kampel T, Santschi V. Nurse interventions to improve medication adherence among discharged older adults: a systematic review. Age Ageing. 2017 Sep 1;46(5):747-754. doi: 10.1093/ageing/afx076.
Reference Type
BACKGROUND
Knight DA, Thompson D, Mathie E, Dickinson A. 'Seamless care? Just a list would have helped!' Older people and their carer's experiences of support with medication on discharge home from hospital. Health Expect. 2013 Sep;16(3):277-91. doi: 10.1111/j.1369-7625.2011.00714.x. Epub 2011 Aug 12.
Reference Type
BACKGROUND
Thabane L, Ma J, Chu R, Cheng J, Ismaila A, Rios LP, Robson R, Thabane M, Giangregorio L, Goldsmith CH. A tutorial on pilot studies: the what, why and how. BMC Med Res Methodol. 2010 Jan 6;10:1. doi: 10.1186/1471-2288-10-1.
Reference Type
BACKGROUND
Weldring T, Smith SM. Patient-Reported Outcomes (PROs) and Patient-Reported Outcome Measures (PROMs). Health Serv Insights. 2013 Aug 4;6:61-8. doi: 10.4137/HSI.S11093. eCollection 2013.
Reference Type
BACKGROUND
Kwan YH, Weng SD, Loh DHF, Phang JK, Oo LJY, Blalock DV, Chew EH, Yap KZ, Tan CYK, Yoon S, Fong W, Ostbye T, Low LL, Bosworth HB, Thumboo J. Measurement Properties of Existing Patient-Reported Outcome Measures on Medication Adherence: Systematic Review. J Med Internet Res. 2020 Oct 9;22(10):e19179. doi: 10.2196/19179.
Reference Type
BACKGROUND
Beuscart JB, Knol W, Cullinan S, Schneider C, Dalleur O, Boland B, Thevelin S, Jansen PAF, O'Mahony D, Rodondi N, Spinewine A. International core outcome set for clinical trials of medication review in multi-morbid older patients with polypharmacy. BMC Med. 2018 Feb 13;16(1):21. doi: 10.1186/s12916-018-1007-9.
Reference Type
BACKGROUND
O'Sullivan D, O'Regan NA, Timmons S. Validity and Reliability of the 6-Item Cognitive Impairment Test for Screening Cognitive Impairment: A Review. Dement Geriatr Cogn Disord. 2016;42(1-2):42-9. doi: 10.1159/000448241. Epub 2016 Aug 19.
Reference Type
BACKGROUND
Gobbens RJ, Boersma P, Uchmanowicz I, Santiago LM. The Tilburg Frailty Indicator (TFI): New Evidence for Its Validity. Clin Interv Aging. 2020 Feb 21;15:265-274. doi: 10.2147/CIA.S243233. eCollection 2020.
Reference Type
BACKGROUND
Katzman R, Brown T, Fuld P, Peck A, Schechter R, Schimmel H. Validation of a short Orientation-Memory-Concentration Test of cognitive impairment. Am J Psychiatry. 1983 Jun;140(6):734-9. doi: 10.1176/ajp.140.6.734.
Reference Type
BACKGROUND
Gobbens RJ, van Assen MA, Luijkx KG, Wijnen-Sponselee MT, Schols JM. The Tilburg Frailty Indicator: psychometric properties. J Am Med Dir Assoc. 2010 Jun;11(5):344-55. doi: 10.1016/j.jamda.2009.11.003. Epub 2010 May 8.
Reference Type
BACKGROUND
Deshpande PR, Rajan S, Sudeepthi BL, Abdul Nazir CP. Patient-reported outcomes: A new era in clinical research. Perspect Clin Res. 2011 Oct;2(4):137-44. doi: 10.4103/2229-3485.86879.
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BACKGROUND
Male L, Noble A, Atkinson J, Marson T. Measuring patient experience: a systematic review to evaluate psychometric properties of patient reported experience measures (PREMs) for emergency care service provision. Int J Qual Health Care. 2017 Jun 1;29(3):314-326. doi: 10.1093/intqhc/mzx027.
Reference Type
BACKGROUND
Other Identifiers
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105 995
Identifier Type: -
Identifier Source: org_study_id
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