Protocol for a Multi-site Pilot Study of the OptiMed Clinical Trial

NCT06688591 | Withdrawn DMC

• 1 other identifier: 105 995
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Polypharmacy; Multiple Chronic Conditions

Keywords

protocol; pilot study; feasibility; informal caregivers; interprofessional collaboration; patient-centred care; medication management; home-dwelling older adults; medication safety; medication-related problems

Outcome Measures

Primary Outcomes (8)

• Target population is recruited

  Number screened per month; number enrolled per month; average time delay from screening to enrolment

  6 months

• Study participants are retained

  Treatment-specific retention rates (%) for study measurements (eligible / recruted / completed); reasons for drop-outs

  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

  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

  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)

  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)

  6 months

• Credibility of each component of the interprofessional intervention programme is assessed as >70% positive

  Ratings (%) for treatment-specific expectations of benefit

  6 months

• Relationship between dose of nursing and response to the programme is measured

  Amount (number), frequency ( x/day/week, intensity (+/++/+++) and duration (minutes)

  6 months

Secondary Outcomes (4)

• Study displays clinical relevance

  6 months

• Cognitive function

  6 months

• Multidimensional frailty

  6 months

• Medication-related problems risk

  6 months

Study Arms (1)

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

Other: Intervention programme to optimise medication management and prevent MRPs

Interventions

Intervention programme to optimise medication management and prevent MRPs 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.

Also known as: Preventive intervention

Medication-management intervention programme to reduce the risks of MRPs

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• HES-SO Valais-Wallis: lead
• Polytechnic of Leiria: collaborator
• Institute for Primary Health Care BIHAM, University of Bern: collaborator

Related Publications (18)

• 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.

  PMID: 28823545 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.

  PMID: 26908524 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.

  PMID: 33583002 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.

  PMID: 25324330 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.

  PMID: 22376048 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.

  PMID: 31908421 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.

  PMID: 28510645 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.

  PMID: 21838834 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.

  PMID: 20053272 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.

  PMID: 25114561 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.

  PMID: 33034566 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.

  PMID: 29433501 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.

  PMID: 27537241 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.

  PMID: 32110005 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.

  PMID: 6846631 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.

  PMID: 20511102 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.

  PMID: 22145124 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.

  PMID: 28339923 BACKGROUND

MeSH Terms

Conditions

Multiple Chronic Conditions

Condition Hierarchy (Ancestors)

Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Henk Verloo, PhD

  HES-SO Valais-Wallis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 19, 2021
• First Posted: November 14, 2024
• Study Start: December 6, 2021
• Primary Completion: December 6, 2022
• Study Completion: June 30, 2023
• Last Updated: November 14, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share