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Clinical Trials/NCT05756478
NCT05756478
Completed
Not Applicable

Appropriate Prescribing for Older Adults With Multimorbidity (Pro-M): A Feasibility Study

Geriatric Education and Research Institute2 sites in 1 country36 target enrollmentFebruary 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Potentially Inappropriate Medications
Sponsor
Geriatric Education and Research Institute
Enrollment
36
Locations
2
Primary Endpoint
Implementers' attitudes towards the feasibility of the intervention.
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

This is a two-site feasibility study to test implementation of an intervention that aims to reduce inappropriate prescribing for older adults with multimorbidity in geriatric medicine specialist clinics at public hospitals in Singapore. The specific aims are:

  1. To assess the implementation outcomes: Appropriateness, Penetration/Reach, Acceptability, Feasibility, Sustainability (primary)
  2. To collect data on recruitment and pre-post data on prevalence of potentially inappropriate prescribing (PIP) for the purpose of determining sample size for a scale up next phase study (secondary).
  3. To conduct cost analysis of the intervention (secondary).

Detailed Description

The Appropriate prescribing for older adults with multi-morbidity (Pro-M) study aims to assess the feasibility of implementing routine medication review using prescribing criteria for older adults with multi-morbidity at the Geriatric Medicine outpatient clinics at 2 public hospitals in Singapore. The study will consist of a recruitment and implementation period and an evaluation period at the end. Flow of the intervention (6 months): 1. Eligible patients with multimorbidity and are taking at least 5 medications daily will be identified and invited by the doctor to undergo medication review (MR). 2. Patients will undergo medication reviews with a pharmacist, involving the use of specific prescribing criteria and tools (e.g. STOPP/START, Beers Criteria), as determined by the sites. 3. Medication review findings will be documented in the electronic medical records and shared with the doctor, who will review the findings and make necessary changes to patients' prescriptions during consultations with the patients. 4. The Doctors will document the review outcome and prescribing decisions in the electronic medical records and communicate the changes (if any) to other relevant prescribers. 5. Patients will be invited to do a short survey on their experiences of the intervention at the end to assess implementation outcomes. The intervention will be compared to 'usual care', where medication review is only done in an ad-hoc and informal basis. Patients' last consultation prior to the intervention period would be used as the point to measure 'usual care'. Evaluation(3 months): Doctors and pharmacists who implemented the study (delivery or support) will be invited to a survey and selected in-depth interviews to assess implementation outcomes.

Registry
clinicaltrials.gov
Start Date
February 1, 2023
End Date
October 16, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Geriatric Education and Research Institute
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Implementers' attitudes towards the feasibility of the intervention.

Time Frame: 3-month Evaluation period: A single-time-point survey to be conducted immediately after the 6-month implementation period. Selected in-depth interviews will follow to provide a qualitative context to the survey results.

The survey consists of 25 items, and each item is measured on a 5-point Likert (level of agreement). This is a mixed method implementation study that is focused on investigating the feasibility of implementing medication reviews as routine care for older adults with multimorbidity in the outpatient clinics. The first 6 months will be the implementation period, followed by a 3-month evaluation period that consists of a survey of the implementers (doctors and pharmacists), then an in-depth interview with selected implementers.

Patients' attitudes towards acceptance of the intervention (Penetration/Reach)

Time Frame: A single-time-point survey to be administered immediately after the intervention

The survey consists of 11 items, and each item is on a 5-point Likert scale (level of agreement). This is a mixed method implementation study that is focused on investigating the feasibility of implementing medication reviews as routine care for older adults with multimorbidity in the outpatient clinics. The first 6 months will be the implementation period, followed by a 3-month evaluation period that consists of a first survey of the implementers (doctors and pharmacists), then an in-depth interview with selected implementers.

Implementers' attitudes towards the sustainability of the intervention.

Time Frame: 3-month Evaluation period: A single-time-point survey to be conducted immediately after the 6-month implementation period. Selected in-depth interviews will follow to provide a qualitative context to the survey results.

The survey consists of 25 items, and each item is measured on a 5-point Likert (level of agreement). This is a mixed method implementation study that is focused on investigating the feasibility of implementing medication reviews as routine care for older adults with multimorbidity in the outpatient clinics. The first 6 months will be the implementation period, followed by a 3-month evaluation period that consists of a survey of the implementers (doctors and pharmacists), then an in-depth interview with selected implementers.

Implementers' attitudes towards the appropriateness of the intervention

Time Frame: 3-month Evaluation period: A single-time-point survey to be conducted immediately after the 6-month implementation period. Selected in-depth interviews will follow to provide a qualitative context to the survey results.

The survey consists of 25 items, and each item is measured on a 5-point Likert (level of agreement). This is a mixed method implementation study that is focused on investigating the feasibility of implementing medication reviews as routine care for older adults with multimorbidity in the outpatient clinics. The first 6 months will be the implementation period, followed by a 3-month evaluation period that consists of a survey of the implementers (doctors and pharmacists), then an in-depth interview with selected implementers.

Implementers' attitudes towards the acceptability of the intervention

Time Frame: 3-month Evaluation period: A single-time-point survey to be conducted immediately after the 6-month implementation period. Selected in-depth interviews will follow to provide a qualitative context to the survey results.

The survey consists of 25 items, and each item is measured on a 5-point Likert (level of agreement). This is a mixed method implementation study that is focused on investigating the feasibility of implementing medication reviews as routine care for older adults with multimorbidity in the outpatient clinics. The first 6 months will be the implementation period, followed by a 3-month evaluation period that consists of a survey of the implementers (doctors and pharmacists), then an in-depth interview with selected implementers.

Implementers' views on the fidelity of the intervention.

Time Frame: :3-month Evaluation period: A single-time-point survey to be conducted immediately after the 6-month implementation period. Selected in-depth interviews will follow to provide a qualitative context to the survey results.

The survey consists of 25 items, and each item is measured on a 5-point Likert (level of agreement). This is a mixed method implementation study that is focused on investigating the feasibility of implementing medication reviews as routine care for older adults with multimorbidity in the outpatient clinics. The first 6 months will be the implementation period, followed by a 3-month evaluation period that consists of a survey of the implementers (doctors and pharmacists), then an in-depth interview with selected implementers.

Secondary Outcomes

  • Recruitment rate(6 months during implementation period)
  • Effectiveness of the intervention: Percentage of patients with at least one PIM before and after intervention.(6 months during implementation period)
  • Manpower cost to conduct medication review(6 months during implementation period)
  • Effectiveness of the intervention: Percentage of patients with other medication issues identified before and after intervention.(6 months during implementation period)
  • Cost of PIM and other medications with issues identified before and after medication review.(6 months during implementation period)

Study Sites (2)

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