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Trial registered on ANZCTR


Registration number
ACTRN12617000665336
Ethics application status
Approved
Date submitted
30/03/2017
Date registered
8/05/2017
Date last updated
19/04/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Impact of clinical pharmacist medication review on appropriate prescribing in elderly patients: A randomized, controlled trial
Scientific title
Impact of clinical pharmacist medication review on appropriate prescribing as measured by Medication Appropriateness Index in elderly patients: A randomized, controlled trial
Secondary ID [1] 291588 0
nil
Universal Trial Number (UTN)
U1111-1194-9579
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
inappropriate prescribing 302702 0
Condition category
Condition code
Public Health 302217 302217 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients with chronic disease have regular visit to their physician in the Specialist Out-patient Clinic (SOPC) for follow-up.
For the intervention group, clinical pharmacist with 5 years of clinical experience will perform medication chart review prior to the next SOPC follow-up, The review includes assessing the appropriateness of each of the regular medications based on laboratory findings, medication lists, consultation and discharge notes, procedures and test results. Face-to-face interview (lasts for around 30-45 mins) will then be conducted with patients on the day prior to the SOPC follow-up. Clinical pharmacists will assess drug use history, identify drug-related problems and provide drug therapy interventions through written pharmacist note to physicians during the SOPC follow-up, based on the medication chart review and the above pharmaceutical assessments. Immediately after the SOPC follow up, clinical pharmacist will provide education (which lasts about 15 minutes) on drug-related problem identified before the visit, reinforce physician’s instruction, and encourage drug compliance using written patient educational leaflets. Phone follow follow-up will be conducted 1 month after the pharmacist intervention.
Written patient education leaflets were published by the Central Pharmacy Office, Hong Kong Hospital Authority.
Intervention code [1] 297656 0
Treatment: Other
Comparator / control treatment
For patient randomzied to control group, they will attend the medical follow-up as usual and receive usual care, in which patients would have visit their physicians during the Specalist Out-patient Clinic (SOPC) and with their medication dispensed in the Out-patient pharmacy as usual. No pharmacist medication review will be performed, and no pharmacist interview with patients for the contro group.
Control group
Active

Outcomes
Primary outcome [1] 301630 0
Medication Appropriateness Index (MAI)
Timepoint [1] 301630 0
measured at baseline and at 1 month post intervention
Secondary outcome [1] 333347 0
Change in number of drugs prescribed to each participant
assessed by review of medical record
Timepoint [1] 333347 0
baseline and 1 month post intervention
Secondary outcome [2] 333573 0
Potentially Inappropriate Medications (PIMs) identified by Screening Tool of Older Persons’ Prescription (STOPP)
by review of medical record
Timepoint [2] 333573 0
Baseline and 1 month post intervention
Secondary outcome [3] 333574 0
Potential Prescription Omission (PPOs) identified by the Screening Tool to Alert Doctors to the Right Treatment (START)
by review of medical record
Timepoint [3] 333574 0
baseline and 1 month post intervention
Secondary outcome [4] 333575 0
Changes in total number of drug related problems
by review of medical record
Timepoint [4] 333575 0
baseline and 1 month post intervention
Secondary outcome [5] 333576 0
Number of pharmacist intervention made
assessed by review of medical record
Timepoint [5] 333576 0
1 month post intervention
Secondary outcome [6] 333577 0
30 day-unplanned hospital admission
by review of medical record
Timepoint [6] 333577 0
1 month post intervention
Secondary outcome [7] 333578 0
30 day- AED visit
by review of medical record
Timepoint [7] 333578 0
1 month post intervention
Secondary outcome [8] 333579 0
Medication adherence measured by Morisky Score (MMAS-4)
by interview with patient
Timepoint [8] 333579 0
baseline and 1 month post intervention
Secondary outcome [9] 333580 0
Patient satisfaction will be assessed by four questions from the Health Care Attitude Questionnaire at the end of study, which will be rated by a 5-point Likert scales
by interview with patient
Timepoint [9] 333580 0
1 month post intervention
Secondary outcome [10] 333842 0
Percentage of pharmacist intervention that is followed by physician
by review of medical record
Timepoint [10] 333842 0
1 month post intervention

Eligibility
Key inclusion criteria
Patients are eligible for the study if they 1) attend medical follow up in Specialized Out-patient Clinic (SOPC) of the Department of Medicine, 2) are 65 years or older, 3) have hyper-polypharmacy (defined as 10 or more regular drugs and 4) agree to provide oral informed consent
Minimum age
65 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) patients who are cognitively impaired (defined as a clinical diagnosis of dementia or mild cognitive impairment and/or not communicable and do not have care-givers, 2)patients who had received pharmacist medication review within six months prior to randomization.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomization by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
randomized using computer generated number
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
The sample size calculation is based on previous study showing clinical pharmacist significantly reduced inappropriate prescribing. A sample size of 100 per arm is required to provide a 80% power using a two sided alpha-level of 0.05 to detect a mean difference in MAI of 0.4 between the intervention group and control group. Sample size is made up to 120 per arm to account for drop out.
For baseline characteristic, Wilcoxon rank sum test will be used for ordinal variables, and chi-square test will be used for categorical variables. Difference in MAI between the intervention group and control group will be compared by Student’s t-test.For other secondary outcome measurement with ordinal variables, Wilcoxon rank sum test will be used, and chi-square test for categorical variables. In all cases, 2-tailed P values of <0.05 will be considered statistically significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 8771 0
Hong Kong
State/province [1] 8771 0

Funding & Sponsors
Funding source category [1] 296076 0
Hospital
Name [1] 296076 0
Pamela Youde Nethersole Eastern Hospital
Address [1] 296076 0
Pamela Youde Nethersole Eastern Hospital
3 Lok Man Road, Chai Wan, HK
Country [1] 296076 0
Hong Kong
Primary sponsor type
Hospital
Name
Pamela Youde Nethersole Eastern Hospital
Address
Pamela Youde Nethersole Eastern Hospital
3 Lok Man Road, Chai Wan, HK
Country
Hong Kong
Secondary sponsor category [1] 294969 0
None
Name [1] 294969 0
Address [1] 294969 0
Country [1] 294969 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297334 0
HKEC Ethics Comittee
Ethics committee address [1] 297334 0
Pamela Youde Nethersole Eastern Hospital
3 Lok Man Road, Chai Wan, HK
Ethics committee country [1] 297334 0
Hong Kong
Date submitted for ethics approval [1] 297334 0
13/04/2017
Approval date [1] 297334 0
29/04/2017
Ethics approval number [1] 297334 0

Summary
Brief summary
The study aims to evaluate the impact of clinical pharmacist medication review to improve appropriate prescribing as demonstrated by Medication Appropriateness Index (MAI) in comparison to standard care.
This is a prospective randomized controlled trial, which will be conducted in Specialized Out-patient Clinic (SOPC) of the Department of Medicine in Pamela Youde Nethersole Eastern Hospital.
For the intervention group, medication chart review and corresponding written recommendation will be performed by clinical pharmacists for all randomized patients. Medication chart review includes assessing the appropriateness of each of the regular medications based on laboratory findings, medication lists, consultation and discharge notes, procedures and test results. Face-to-face interview will be conducted with patients prior to the SOPC follow-up. Clinical pharmacists will assess drug use history, identify drug-related problems and provide drug therapy interventions through written pharmacist note to physicians during the SOPC follow-up, based on the medication chart review and the above pharmaceutical assessments. After the SOPC follow up, clinical pharmacist will provide education on drug-related problem identified before the visit, reinforce physician’s instruction, and encourage drug compliance using written patient educational leaflets. Phone follow follow-up will be conducted 1months after the SOPC visit.
For patients randomized to the SOC group, they will attend the medical follow-up as usual and receive usual care
All patients will be followed up for 1 months post-SOPC visit. Data collection will be conducted at baseline and1monthafter the SOPC visit.
Primary outcome of the study is Medication Appropriateness Index (MAI)5, which will be measured at baseline (prior to physician visit), and at 1 month post SOPD follow-up.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1612 1612 0 0

Contacts
Principal investigator
Name 73738 0
Miss Heidi Chan
Address 73738 0
Pharmacy, Pamela Youde Nethersole Eastern Hospital
3Lok Man Road, Chai Wan, HK
Country 73738 0
Hong Kong
Phone 73738 0
+852-64601008
Fax 73738 0
Email 73738 0
cyh123@ha.org.hk
Contact person for public queries
Name 73739 0
Miss Heidi Chan
Address 73739 0
Pharmacy, Pamela Youde Nethersole Eastern Hospital
3Lok Man Road, Chai Wan, HK
Country 73739 0
Hong Kong
Phone 73739 0
+852-64601008
Fax 73739 0
Email 73739 0
cyh123@ha.org.hk
Contact person for scientific queries
Name 73740 0
Miss Heidi Chan
Address 73740 0
Pharmacy, Pamela Youde Nethersole Eastern Hospital
3Lok Man Road, Chai Wan, HK
Country 73740 0
Hong Kong
Phone 73740 0
+852-64601008
Fax 73740 0
Email 73740 0
cyh123@ha.org.hk

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary