Clinical trial NCT05756478: Appropriate Prescribing for Older Adults With Multimorbidity (Pro-M)
Official title: Appropriate Prescribing for Older Adults With Multimorbidity (Pro-M): A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Potentially Inappropriate Medications
Multimorbidity
Polypharmacy
Keywords: Inappropriate prescribing
Feasibility study
Lead sponsor: Geriatric Education and Research Institute
Sponsor class: OTHER_GOV
Collaborators: name: Tan Tock Seng Hospital
name: Changi General Hospital
First posted: 2023-03-06
Enrollment: 36
Sex: ALL
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria for patients:

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

Exclusion Criteria for patients:

* 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.

Inclusion Criteria for implementer:

* Doctors and pharmacists
* who are involved in the delivery or support of the intervention during the implementation period.

Exclusion criteria for implementer:

* Those who are not involved in the implementation of the study.
* Those who are not involved in the delivery of the intervention.

Primary outcomes:
measure: Patients' attitudes towards acceptance of the intervention (Penetration/Reach)
timeFrame: A single-time-point survey to be administered immediately after the intervention
measure: Implementers' attitudes towards the appropriateness of the intervention
timeFrame: 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.
measure: Implementers' attitudes towards the acceptability of the intervention
timeFrame: 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.
measure: Implementers' attitudes towards the feasibility of the intervention.
timeFrame: 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.
measure: Implementers' attitudes towards the sustainability of the intervention.
timeFrame: 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.
measure: Implementers' views on the fidelity of the intervention.
timeFrame: :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:
measure: Recruitment rate
timeFrame: 6 months during implementation period
measure: Effectiveness of the intervention: Percentage of patients with at least one PIM before and after intervention.
timeFrame: 6 months during implementation period
measure: Effectiveness of the intervention: Percentage of patients with other medication issues identified before and after intervention.
timeFrame: 6 months during implementation period
measure: Manpower cost to conduct medication review
timeFrame: 6 months during implementation period
measure: Cost of PIM and other medications with issues identified before and after medication review.
timeFrame: 6 months during implementation period
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Changi General Hospital
state: Sinagpore
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
Study officials:
affiliation: Geriatric Education and Research Institute, Singapore
name: Penny Lun, M.A.
role: PRINCIPAL_INVESTIGATOR
References: