Team Approach to Polypharmacy Evaluation and Reduction

Medication Therapy Management Clinical Trial

— TAPER  

Official title:

Team Approach to Polypharmacy Evaluation and Reduction: Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02562352
• Other study ID #: TAPER-001-19-Aug-15
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: November 2019

Study information

• Verified date: September 2020
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In an aging population, most seniors suffer from multiple chronic conditions. When the number of medications taken is ≥5 (polypharmacy), the burden of taking so many together can do more harm than good. This study will test a program focused on medication reduction involving patient, pharmacist and physician using current technology aimed at reducing the harms of polypharmacy. Reducing the risk of adverse effects from drugs or the interactions between them involves prioritizing the most important ones according to the patient's preference and stopping those which may no longer be necessary. Reducing the dose also reduces the risk of drug side effects. Patients, aged over 69 years taking ≥5 medications, will randomly receive the program immediately or at 6 months. The program involves information gathering from the patient, medication review with the pharmacist and then a consultation with the family doctor focused on discontinuing/reducing the dose of medications where possible using a 'pause and monitor' framework to assess the need for restart. An electronic program that detects drug adverse effects and flags potentially inappropriate medications will be integrated into a clinical pathway incorporating monitoring and follow up systems. This study will examine effects on patient and health relevant outcome measures as well as patients' and clinicians' experiences of the program. The results will be used to determine whether this system can be implemented as part of routine preventative care in older adults.

Description:

Patients will be randomized 1:1 to receive the intervention at study start or delayed appointment 6 months later. The intervention includes initial baseline data collection from the patient including data on demographics, medications, and illness characteristics. The patient will then attend an appointment with a pharmacist to review medications appropriate for discontinuation/dose reduction, after which the patient will meet with his/her family physician to discuss patient preferences for discontinuation/dose reduction. Follow up appointments will take place at one week, 3 months and 6 months (study end). Questionnaires and a semi-structured interview will take place at the 6 month appointment. After six months, the control group will be offered the intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: November 2019
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

Inclusion Criteria:

• Aged 70 years of age or older

• Participating family doctor as most responsible provider

• Patient of McMaster Family Health Team

• Currently taking 5 or more medications

• Have not had a recent comprehensive medication review

• Patient consents

Exclusion Criteria:

• English language or cognitive skills inadequate to understand and respond to rating scales

• Terminal illness or other circumstance precluding 13 month study period

Related Conditions & MeSH terms

• Comorbidity
• Medication Therapy Management

Intervention

Other:
• TAPER program
Patients will be randomized to receive the TAPER program at study start or delayed intervention at 6 months.

Locations

Country	Name	City	State
Canada	McMaster University	Hamilton	Ontario

Sponsors (5)

Lead Sponsor	Collaborator
McMaster University	David Braley and Nancy Gordon Chair in Family Medicine, Health Canada, RxISK, The Labarge Optimal Aging Initiative

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful discontinuation (Difference in mean number of medications)	Difference in mean number of medications per patient.	6 months
Secondary	Quality of Life (EQ-5D)	EQ-5D	6 months
Secondary	Nutritional Status (Mini Nutritional Assessment Short-Form)	Mini Nutritional Assessment Short-Form;	6 months
Secondary	Patient experience of deprescribing (Thematic analysis of semi structured interviews)	Thematic analysis of semi structured interviews	6 months
Secondary	Physical Functional Capacity (Manty structured validated interview)	Manty structured validated interview	6 months
Secondary	Falls (self report number of falls)	self report number of falls	6 months
Secondary	Adverse Events (patient self report or clinician report)	patient self report or clinician report	6 months
Secondary	Health Resource Utilization (Number of hospital admissions and emergency dept visits)	Number of hospital admissions and emergency dept visits	6 months
Secondary	Cognition (The Mini Mental Status Examination)	The Mini Mental Status Examination	6 months
Secondary	Fatigue (Avlund Mob-T Scale)	Avlund Mob-T Scale	6 months
Secondary	Patient Enablement (Patient Enablement Index)	Patient Enablement Index	6 months
Secondary	Self-Efficacy (Stanford Self-Efficacy Scale)	Stanford Self-Efficacy Scale	6 months
Secondary	Patient self report of change in quality of life/morbidity (Global Impression Scale)	Global Impression Scale	6 months