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

November 12, 2024 updated by: HES-SO Valais-Wallis

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Other: 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.
Other Names:
  • Preventive intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Target population is recruited
Time Frame: 6 months
Number screened per month; number enrolled per month; average time delay from screening to enrolment
6 months
Study participants are retained
Time Frame: 6 months
Treatment-specific retention rates (%) for study measurements (eligible / recruted / completed); reasons for drop-outs
6 months
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
6 months
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
6 months
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)
6 months
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)
6 months
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
6 months
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)
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Study displays clinical relevance
Time Frame: 6 months
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%).
6 months
Cognitive function
Time Frame: 6 months
Unit of measure: score from 0 to 28 Score from 0 to 28 of the Six-item Cognitive Impairment Test (6-CIT)
6 months
Multidimensional frailty
Time Frame: 6 months
Score from 0 to 15 of the Tilburg Frailty Indicator (TFI)
6 months
Medication-related problems risk
Time Frame: 6 months
Score from 0 to 17 of the domestic risk tool
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HES-SO Valais-Wallis

Collaborators

Polytechnic of Leiria
Institute for Primary Health Care BIHAM, University of Bern

Investigators

  • Principal Investigator: Henk Verloo, PhD, HES-SO Valais-Wallis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 6, 2021

Primary Completion (Actual)

December 6, 2022

Study Completion (Actual)

June 30, 2023

Study Registration Dates

First Submitted

November 19, 2021

First Submitted That Met QC Criteria

November 12, 2024

First Posted (Estimated)

November 14, 2024

Study Record Updates

Last Update Posted (Estimated)

November 14, 2024

Last Update Submitted That Met QC Criteria

November 12, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 105 995

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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