NCT05756478

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. 1.To assess the implementation outcomes: Appropriateness, Penetration/Reach, Acceptability, Feasibility, Sustainability (primary)
  2. 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. 3.To conduct cost analysis of the intervention (secondary).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 6, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 16, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 16, 2023

Completed
Last Updated

February 9, 2024

Status Verified

February 1, 2024

Enrollment Period

9 months

First QC Date

January 30, 2023

Last Update Submit

February 8, 2024

Conditions

Potentially Inappropriate MedicationsMultimorbidityPolypharmacy

Keywords

Inappropriate prescribingFeasibility study

Outcome Measures

Primary Outcomes (6)

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

    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.

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

  • Implementers' attitudes towards the appropriateness of the intervention

    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.

    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.

  • Implementers' attitudes towards the acceptability of the intervention

    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.

    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.

  • Implementers' attitudes towards the feasibility of the intervention.

    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.

    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.

  • Implementers' attitudes towards the sustainability of the intervention.

    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.

    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.

  • Implementers' views on the fidelity of the intervention.

    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.

    :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.

Secondary Outcomes (5)

  • 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

  • Effectiveness of the intervention: Percentage of patients with other medication issues identified before and after intervention.

    6 months during implementation period

  • Manpower cost to conduct medication review

    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 Arms (1)

Medication Review

OTHER

This is a feasibility study of implementing a pharmacist-led medication review using prescribing tools (e.g. STOPP/START, Beers Criteria) .

Other: Medication review

Interventions

Medication reviewOTHER

This is a feasibility study of implementing a pharmacist-led medication review using prescribing tools (e.g. STOPP/START, Beers Criteria)

Medication Review

Eligibility Criteria

Age21 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Older adults age 65 and above
  • Currently attending Geriatric Medicine Clinic
  • on at least 5 medications.

You may not qualify if:

  • Those younger than 65
  • Not a Geriatric Medicine outpatient clinic patient
  • On fewer than 5 medications
  • Currently receiving other pharmacist-related services such as medication therapy management.
  • Non-English, non-Chinese, and non-Malay speaking patients.
  • Patient or caregiver who declines any of the study procedure required within the intervention framework.
  • Doctors and pharmacists
  • who are involved in the delivery or support of the intervention during the implementation period.
  • Those who are not involved in the implementation of the study.
  • Those who are not involved in the delivery of the intervention.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Changi General Hospital

Singapore, Sinagpore, 529889, Singapore

Location

Tan Tock Seng Hospital

Singapore, 308440, Singapore

Location

Related Publications (1)

  • Tang JY, Teng PHJ, Chen CY, Tan KT, Ang W, Lau S, Ang AGC, Kyaw KK, Tay XY, Lim WMS, Espeleta WDV, Lin H, Ding YY, Lun P. Appropriate Prescribing for older adults with Multimorbidity (Pro-M): protocol for a feasibility study. Arch Public Health. 2024 Mar 18;82(1):37. doi: 10.1186/s13690-024-01264-x.

    PMID: 38500190DERIVED

MeSH Terms

Interventions

Medication Review

Intervention Hierarchy (Ancestors)

Medication SystemsOrganization and AdministrationHealth Services AdministrationPatient Care Management

Study Officials

  • Penny Lun, M.A.

    Geriatric Education and Research Institute, Singapore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: In order to investigate if implementing routine pharmacist-led medication reviews in the outpatient clinics of public hospitals for older adults with multi-morbidity, we are conducting a single-arm study at 2 sites to understand how the implementation strategies could be best carried out to facilitate the aim to reduce inappropriate prescribing. Pre- and post-medication review data on potentially inappropriate medications and other issues flagged will also be collected for a future scale up study. Each site is expected to recruit 30 patients. An evaluation will also be conducted with the doctors and pharmacists delivering and implementing the study.
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2023

First Posted

March 6, 2023

Study Start

February 1, 2023

Primary Completion

October 16, 2023

Study Completion

October 16, 2023

Last Updated

February 9, 2024

Record last verified: 2024-02

Locations

SG(2)