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

• ClinicalTrials.gov Identifier: NCT02379455
• Recruitment Status: Completed
• First Posted: March 5, 2015
• Last Update Posted: January 26, 2018
• Sponsor: Oslo University Hospital
• Collaborators: The Research Council of Norway; University of Oslo
• Information provided by (Responsible Party): Torgeir Bruun Wyller, Oslo University Hospital

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Drug Usage	Other: Comprehensive drug review	Not Applicable

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 192 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Health Services Research
• Official Title: Cooperation for Improved Pharmacotherapy in Home-dwelling Elderly People Receiving Polypharmacy - The COOP Study
• Actual Study Start Date: March 2015
• Actual Primary Completion Date: August 2017
• Actual Study Completion Date: September 22, 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: Comprehensive drug review	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.
No Intervention: Control group; Follow-up by family physician "as usual".

Outcome Measures

Primary Outcome Measures :

1. Health-related quality of life as measured with 15D [ Time Frame: 16 weeks ]

Secondary Outcome Measures :

1. Short Physical Performance Battery (SPPB) [ Time Frame: 16 weeks ]
2. Short Physical Performance Battery (SPPB) [ Time Frame: 24 weeks ]
3. Gait speed [ Time Frame: 16 weeks ]
4. Gait speed [ Time Frame: 24 weeks ]
5. Hand grip strength [ Time Frame: 16 weeks ]
6. Hand grip strength [ Time Frame: 24 weeks ]
7. Functional Independence Measure (FIM) [ Time Frame: 16 weeks ]
8. Functional Independence Measure (FIM) [ Time Frame: 24 weeks ]
9. Trail making test A and B [ Time Frame: 16 weeks ]
10. Trail making test A and B [ Time Frame: 24 weeks ]
11. Digit Span [ Time Frame: 16 weeks ]
12. Digit Span [ Time Frame: 24 weeks ]
13. Five Digits Test [ Time Frame: 16 weeks ]
14. Five Digits Test [ Time Frame: 24 weeks ]
15. Medication Appropriateness Index (MAI) [ Time Frame: 16 weeks ]
16. Medication Appropriateness Index (MAI) [ Time Frame: 24 weeks ]
17. Assessment of Underutilization (AOU) [ Time Frame: 16 weeks ]
18. Assessment of Underutilization (AOU) [ Time Frame: 24 weeks ]
19. Number of falls [ Time Frame: During the first 16 weeks after baseline ]
    Recorded with the aid of diaries kept by patients/caregivers
20. Number of falls [ Time Frame: During the first 24 weeks after baseline ]
    Recorded with the aid of diaries kept by patients/caregivers
21. Orthostatic blood pressure [ Time Frame: 16 weeks ]
22. Orthostatic blood pressure [ Time Frame: 24 weeks ]
23. Changes in body weight [ Time Frame: 16 weeks ]
24. Changes in body weight [ Time Frame: 24 weeks ]
25. Relative Stress Scale [ Time Frame: 16 weeks ]
26. Relative Stress Scale [ Time Frame: 24 weeks ]
27. Number of hospital admissions (with reasons) [ Time Frame: During the first 16 weeks from baseline ]
28. Number of hospital admissions (with reasons) [ Time Frame: During the first 24 weeks from baseline ]
29. Number of days in own home (in contrast to being in hospital or nursing home) [ Time Frame: During the first 16 weeks from baseline ]
30. Number of days in own home (in contrast to being in hospital or nursing home) [ Time Frame: During the first 24 weeks from baseline ]
31. Admission to permanent institutional care [ Time Frame: 16 weeks ]
32. Admission to permanent institutional care [ Time Frame: 24 weeks ]
33. Current use of home nursing service [ Time Frame: 16 weeks ]
34. Current use of home nursing service [ Time Frame: 24 weeks ]
35. Mortality [ Time Frame: 16 weeks ]
36. Mortality [ Time Frame: 24 weeks ]
37. Health-related quality of life as measured with 15D [ Time Frame: 24 weeks ]

Eligibility Criteria

• Ages Eligible for Study: 70 Years and older (Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Norway

Dept. of Geriatric Medicine, Oslo University Hospital

Oslo, Norway, 0424

Sponsors and Collaborators

Oslo University Hospital

The Research Council of Norway

University of Oslo

Investigators

• Principal Investigator: Torgeir B Wyller, MD PhD; Oslo University Hospital

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Romskaug R, Skovlund E, Straand J, Molden E, Kersten H, Pitkala KH, Lundqvist C, Wyller TB. Effect of Clinical Geriatric Assessments and Collaborative Medication Reviews by Geriatrician and Family Physician for Improving Health-Related Quality of Life in Home-Dwelling Older Patients Receiving Polypharmacy: A Cluster Randomized Clinical Trial. JAMA Intern Med. 2019 Oct 16. doi: 10.1001/jamainternmed.2019.5096. [Epub ahead of print]

Romskaug R, Molden E, Straand J, Kersten H, Skovlund E, Pitkala KH, Wyller TB. Cooperation between geriatricians and general practitioners for improved pharmacotherapy in home-dwelling elderly people receiving polypharmacy - the COOP Study: study protocol for a cluster randomised controlled trial. Trials. 2017 Apr 4;18(1):158. doi: 10.1186/s13063-017-1900-0.

• Responsible Party: Torgeir Bruun Wyller, MD, PhD, Oslo University Hospital
• ClinicalTrials.gov Identifier: NCT02379455
• Other Study ID Numbers: 222033/H10
• First Posted: March 5, 2015
• Last Update Posted: January 26, 2018
• Last Verified: January 2018

Keywords provided by Torgeir Bruun Wyller, Oslo University Hospital:

Polypharmacy; Geriatrics; Elderly; Drug review