Cooperation for Improved Pharmacotherapy in Home-dwelling Elderly People Receiving Polypharmacy - The COOP Study

Drug Usage Clinical Trial

— COOP  

Official title:

Cooperation for Improved Pharmacotherapy in Home-dwelling Elderly People Receiving Polypharmacy - The COOP Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02379455
• Other study ID #: 222033/H10
• Status: Completed
• Phase: N/A
• First received: February 27, 2015
• Last updated: January 24, 2018
• Start date: March 2015
• Est. completion date: September 22, 2017

Study information

• Verified date: January 2018
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Polypharmacy increases the risk of adverse drug effects, interactions and other drug-related problems, and several studies indicate that inappropriate drug use is a major reason for poor health and impaired function in the elderly. A majority of interventions for improvement of drug treatment in the elderly have been evaluated by the use of surrogate outcomes such as drug-related problems, number of prescribed drugs or prevalence of potentially inappropriate prescriptions - and it is so far unclear whether such interventions can result in clinical significant improvements. The primary objective of this trial is therefore to evaluate the effect upon patients, relatives and local health care service of a structured cooperation between a hospital-based geriatrician and family physicians on complex drug regimens in home-dwelling frail elderly patients.

Description:

This is a 24 weeks cluster randomized, single-blinded, controlled trial. Family physicians will be invited to participate in the project with patients from their lists, and can participate with 1-5 patients each. The investigators will carry out cluster randomization on physician level instead of individual randomization on patient level.

The investigators suppose that such a comprehensive clinical evaluation and drug review that they will test, is most relevant for patients with relatively pronounced polypharmacy. It has previously been shown that conventionally used limits for polypharmacy, e.g. five drugs used regularly, identifies many patients without particular complex health states and without drug related problems. The investigators will therefore limit this project to patients using seven regular drugs or more, in order to increase the likelihood that they may benefit from a drug review.

A major challenge when studying complex interventions is to describe the intervention with sufficient precision as to facilitate replication. Our main strategy for this will be to compensate for the necessary degree of pragmatism in the interventional approach with a detailed description of the interventions that were in fact carried out, in particular changes in the drug regimens of the individual patients.

The intervention will consist of three main parts:

1. Geriatric assessment: The patients will be seen by a physician trained in geriatric medicine. The physician will carry out a medical history and a physical examination, and relevant blood analyses and other supplementary test will be ordered if not already available. The geriatric work-up will be aimed at evaluating whether current medications are indicated, whether the relevant conditions are satisfactorily compensated, whether the dosages are appropriate, whether the patient has symptoms that may in reality be adverse drug effects, and whether drug-drug interactions or drug-disease interactions are likely to occur. Published tools like the START (Screening Tool of Older Persons' Prescriptions) criteria, Screening Tool to Alert doctors to Right Treatment (STOPP) criteria and The Norwegian General Practice (NORGEP) criteria will be used.

2. Conference with common drug review: The main purpose of this conference is to combine the competence of the geriatrician and that of the family physician in a focused drug review. The two physicians will discuss the patient's drug list systematically. The geriatrician may suggest changes in the drug regimen, but the family physician retains the medical responsibility for the patient and is in charge of all ordinations and medication changes.

3. Clinical follow-up: Depending on medication changes that have been done, the two physicians will arrange the necessary follow-up within the project period.

The investigators will assess the outcomes at 16 and 24 weeks, counted from baseline, and will also assess baseline values for the outcomes in order to adjust for potential inequalities.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: September 22, 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

Inclusion Criteria:

• The patient must be on the list of one of the family physicians participating in the study

• Home dwelling (not permanently institutionalised)

• Medications administered by the home nursing service

• Polypharmacy defined as the use of at least seven different systemic medications taken regularly

• Informed consent by the patient or a close relative

Exclusion Criteria:

• Patient or relative denies inclusion

• The family physician does not want the particular patient to participate

• Moderate/severe dementia (Clinical Dementia Rating Scale score > 1) and contact with the closest proxy less than once every other week.

• The patient does not speak/understand Norwegian

• Expected to become permanently institutionalised within six months

• Life expectancy < six months

Related Conditions & MeSH terms

• Drug Usage

Intervention

Other:
• Comprehensive drug review
1) Geriatric assessment including medical history, physical examination, supplementary tests. The geriatric work-up will be aimed at evaluating whether current medications are indicated, whether the relevant conditions are satisfactorily compensated, whether the dosages are appropriate, whether the patient has symptoms that may in reality be adverse drug effects, and whether drug-drug interactions or drug-disease interactions are likely to occur. 2) Conference with common drug review. The project physician and the family physician will discuss the patient's drug list systematically. 3) Individualized clinical follow-up depending on the medication changes that have been done.

Locations

Country	Name	City	State
Norway	Dept. of Geriatric Medicine, Oslo University Hospital	Oslo

Sponsors (3)

Lead Sponsor	Collaborator
Oslo University Hospital	The Research Council of Norway, University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health-related quality of life as measured with 15D		16 weeks
Secondary	Short Physical Performance Battery (SPPB)		16 weeks
Secondary	Short Physical Performance Battery (SPPB)		24 weeks
Secondary	Gait speed		16 weeks
Secondary	Gait speed		24 weeks
Secondary	Hand grip strength		16 weeks
Secondary	Hand grip strength		24 weeks
Secondary	Functional Independence Measure (FIM)		16 weeks
Secondary	Functional Independence Measure (FIM)		24 weeks
Secondary	Trail making test A and B		16 weeks
Secondary	Trail making test A and B		24 weeks
Secondary	Digit Span		16 weeks
Secondary	Digit Span		24 weeks
Secondary	Five Digits Test		16 weeks
Secondary	Five Digits Test		24 weeks
Secondary	Medication Appropriateness Index (MAI)		16 weeks
Secondary	Medication Appropriateness Index (MAI)		24 weeks
Secondary	Assessment of Underutilization (AOU)		16 weeks
Secondary	Assessment of Underutilization (AOU)		24 weeks
Secondary	Number of falls	Recorded with the aid of diaries kept by patients/caregivers	During the first 16 weeks after baseline
Secondary	Number of falls	Recorded with the aid of diaries kept by patients/caregivers	During the first 24 weeks after baseline
Secondary	Orthostatic blood pressure		16 weeks
Secondary	Orthostatic blood pressure		24 weeks
Secondary	Changes in body weight		16 weeks
Secondary	Changes in body weight		24 weeks
Secondary	Relative Stress Scale		16 weeks
Secondary	Relative Stress Scale		24 weeks
Secondary	Number of hospital admissions (with reasons)		During the first 16 weeks from baseline
Secondary	Number of hospital admissions (with reasons)		During the first 24 weeks from baseline
Secondary	Number of days in own home (in contrast to being in hospital or nursing home)		During the first 16 weeks from baseline
Secondary	Number of days in own home (in contrast to being in hospital or nursing home)		During the first 24 weeks from baseline
Secondary	Admission to permanent institutional care		16 weeks
Secondary	Admission to permanent institutional care		24 weeks
Secondary	Current use of home nursing service		16 weeks
Secondary	Current use of home nursing service		24 weeks
Secondary	Mortality		16 weeks
Secondary	Mortality		24 weeks
Secondary	Health-related quality of life as measured with 15D		24 weeks