PolypharmacyOptiMedNCT06688591
Protocol for a Multi-site Pilot Study of the OptiMed Clinical Trial
A study testing Intervention programme to optimise medication management and prevent MRPs in people with Polypharmacy and Multiple Chronic Conditions, run by HES-SO Valais-Wallis.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Polypharmacy, Multiple Chronic Conditions
- What is being tested?
- Intervention programme to optimise medication management and prevent MRPs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 6 Dec 2021to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Effectiveness of an Evidence-based Multi-component Intervention Programme to Reduce Medication-related Problems Among Polymedicated Home-dwelling Older Adults: Protocol for a Multi-site Pilot Study of the OptiMed Clinical Trial
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.
Read the detailed description
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.
- Conditions
- Polypharmacy, Multiple Chronic Conditions
- Being tested
- Intervention programme to optimise medication management and prevent MRPs
- Keywords
- protocol, pilot study, feasibility, informal caregivers, interprofessional collaboration, patient-centred care, medication management, home-dwelling older adults, medication safety, medication-related problems
- Medical subject headings
- Multiple Chronic Conditions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention programme to optimise medication management and prevent MRPsOther
Also called Preventive intervention
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.
| Study group | Role | What they receive |
|---|---|---|
| Medication-management intervention programme to reduce the risks of MRPs | Experimental | 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 Receives: Other: Intervention programme to optimise medication management and prevent MRPs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target population is recruited
Number screened per month; number enrolled per month; average time delay from screening to enrolment
Measured: 6 months
Study participants are retained
Treatment-specific retention rates (%) for study measurements (eligible / recruted / completed); reasons for drop-outs
Measured: 6 months
Study participants adhere to their instructions
Treatment-specific rates (%) of adherence to study protocol (in-person session attendance, homework, home sessions, etc.); treatment-specific measurements of competencies
Measured: 6 months
Medication review is successful
Treatment-specific fidelity rates in %; time invested in hours; number of discrepancies between professional sources; number of discrepancies between patient-reported medication use and professional sources n= or %; number of questions; number of items needing clarification; number of recommendations made by the pharmacist; number of pharmacist's recommendations adopted by the physician
Measured: 6 months
Assessments are not considered too burdensome
Proportion of planned assessments that are completed (%); duration of assessment visits (minutes); reasons for drop-outs (listing); ease of use of doMESTIC RISK tool (self-reporting closed questionnaire); ease of use of structured medication review template (self-reporting closed questionnaire)
Measured: 6 months
All interventions are rated as > 70% acceptable
Acceptability ratings (%); qualitative assessments; reasons for drop-outs; treatment-specific preference ratings (pre-and post-intervention)
Measured: 6 months
Credibility of each component of the interprofessional intervention programme is assessed as >70% positive
Ratings (%) for treatment-specific expectations of benefit
Measured: 6 months
Relationship between dose of nursing and response to the programme is measured
Amount (number), frequency ( x/day/week, intensity (+/++/+++) and duration (minutes)
Measured: 6 months
Secondary outcomes (4)
Study displays clinical relevance
How participants perceive the intervention programme (patient-reported outcomes), PROMS (51) (self-reporting closed questionnaire). Identify what is relevant for participants (such as quality of life or remaining at home) (=open question in PRO). Enables a choice of which final outcomes from the pilot study will go into the intervention (> 70%).
Measured: 6 months
Cognitive function
Unit of measure: score from 0 to 28 Score from 0 to 28 of the Six-item Cognitive Impairment Test (6-CIT)
Measured: 6 months
Multidimensional frailty
Score from 0 to 15 of the Tilburg Frailty Indicator (TFI)
Measured: 6 months
Medication-related problems risk
Score from 0 to 17 of the domestic risk tool
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2024
- Study start6 Dec 2021
- Primary completion6 Dec 2022
- Study completion30 Jun 2023
Why it stopped: difficulty in finding participants for the various stages of the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for PolypharmacyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- HES-SO Valais-Wallis
- Sponsor type
- University, hospital or other
- Collaborators
- Polytechnic of Leiria, Institute for Primary Health Care BIHAM, University of Bern
- Responsible party
- Sponsor
- Investigators
- Henk Verloo, PhD, Principal investigator, HES-SO Valais-Wallis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06688591
- Sponsor's protocol ID
- 105 995
- Acronym
- OptiMed
- Status last verified
- Nov 2024
- First submitted
- 19 Nov 2021
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
Publications
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.
PubMed 6846631Pellegrin 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.
PubMed 28823545Mekonnen 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.
PubMed 26908524Beuscart 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.
PubMed 33583002O'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.
PubMed 25324330American 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.
PubMed 22376048Pereira 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.
PubMed 31908421Verloo 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.
PubMed 28510645Knight 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.
PubMed 21838834Thabane 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.
PubMed 20053272Weldring 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.
PubMed 25114561Kwan 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.
PubMed 33034566Beuscart 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.
PubMed 29433501O'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.
PubMed 27537241Gobbens 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.
PubMed 32110005
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Evidence-based Multi-component Intervention Programme to Reduce Medication-related Problems Among Polymedicated Home-dwelling Older Adults: Protocol for a Multi-site Pilot Study of the OptiMed Clinical Trial
- ClinicalTrials.gov ID
- NCT06688591
- Acronym / sponsor ID
- OptiMed / 105 995
- Conditions
- Polypharmacy, Multiple Chronic Conditions
- Keywords
- protocol, pilot study, feasibility, informal caregivers, interprofessional collaboration, patient-centred care, medication management, home-dwelling older adults
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: difficulty in finding participants for the various stages of the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- HES-SO Valais-WallisUniversity, hospital or other
- Collaborators
- Polytechnic of Leiria, Institute for Primary Health Care BIHAM, University of Bern
- Study start
- 6 Dec 2021 (actual)
- Primary completion
- 6 Dec 2022 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 14 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Medication-management intervention programme to reduce the risks of MRPs | Experimental | Other: Intervention programme to optimise medication management and prevent MRPsThe 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 |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention programme to optimise medication management and prevent MRPsAlso: Preventive interventionThe 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. | Other | Medication-management intervention programme to reduce the risks of MRPs |
Primary outcome
Target population is recruited
Time frame: 6 months
Number screened per month; number enrolled per month; average time delay from screening to enrolment
Study participants are retained
Time frame: 6 months
Treatment-specific retention rates (%) for study measurements (eligible / recruted / completed); reasons for drop-outs
Study participants adhere to their instructions
Time frame: 6 months
Treatment-specific rates (%) of adherence to study protocol (in-person session attendance, homework, home sessions, etc.); treatment-specific measurements of competencies
Medication review is successful
Time frame: 6 months
Treatment-specific fidelity rates in %; time invested in hours; number of discrepancies between professional sources; number of discrepancies between patient-reported medication use and professional sources n= or %; number of questions; number of items needing clarification; number of recommendations made by the pharmacist; number of pharmacist's recommendations adopted by the physician
Assessments are not considered too burdensome
Time frame: 6 months
Proportion of planned assessments that are completed (%); duration of assessment visits (minutes); reasons for drop-outs (listing); ease of use of doMESTIC RISK tool (self-reporting closed questionnaire); ease of use of structured medication review template (self-reporting closed questionnaire)
All interventions are rated as > 70% acceptable
Time frame: 6 months
Acceptability ratings (%); qualitative assessments; reasons for drop-outs; treatment-specific preference ratings (pre-and post-intervention)
Credibility of each component of the interprofessional intervention programme is assessed as >70% positive
Time frame: 6 months
Ratings (%) for treatment-specific expectations of benefit
Relationship between dose of nursing and response to the programme is measured
Time frame: 6 months
Amount (number), frequency ( x/day/week, intensity (+/++/+++) and duration (minutes)
4 secondary outcomes
Study displays clinical relevance
Time frame: 6 months
Cognitive function
Time frame: 6 months
Multidimensional frailty
Time frame: 6 months
Medication-related problems risk
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
- Background: PubMed 6846631Katzman 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.
- Results publication: PubMed 28823545Pellegrin 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.
- Results publication: PubMed 26908524Mekonnen 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.
- Results publication: PubMed 33583002Beuscart 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.
- Results publication: PubMed 25324330O'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.
- Results publication: PubMed 22376048American 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.
- Results publication: PubMed 31908421Pereira 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.
- Results publication: PubMed 28510645Verloo 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.
- Results publication: PubMed 21838834Knight 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.
- Results publication: PubMed 20053272Thabane 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.
- Results publication: PubMed 25114561Weldring 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.
- Results publication: PubMed 33034566Kwan 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.
- Individual participant dataSharing planned: No. The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henk Verloo, PhD principal investigator
HES-SO Valais-Wallis
Questions about this trial
What is this clinical trial studying?
A study testing Intervention programme to optimise medication management and prevent MRPs in people with Polypharmacy and Multiple Chronic Conditions, run by HES-SO Valais-Wallis.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target population is recruited (time frame: 6 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06688591, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2024.