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Trial record 1 of 1 for:    NCT02379455
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Cooperation for Improved Pharmacotherapy in Home-dwelling Elderly People Receiving Polypharmacy - The COOP Study (COOP)

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

Tracking Information
First Submitted Date  ICMJE February 27, 2015
First Posted Date  ICMJE March 5, 2015
Last Update Posted Date January 26, 2018
Actual Study Start Date  ICMJE March 2015
Actual Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 4, 2015)
Health-related quality of life as measured with 15D [ Time Frame: 16 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 4, 2015)
  • Short Physical Performance Battery (SPPB) [ Time Frame: 16 weeks ]
  • Short Physical Performance Battery (SPPB) [ Time Frame: 24 weeks ]
  • Gait speed [ Time Frame: 16 weeks ]
  • Gait speed [ Time Frame: 24 weeks ]
  • Hand grip strength [ Time Frame: 16 weeks ]
  • Hand grip strength [ Time Frame: 24 weeks ]
  • Functional Independence Measure (FIM) [ Time Frame: 16 weeks ]
  • Functional Independence Measure (FIM) [ Time Frame: 24 weeks ]
  • Trail making test A and B [ Time Frame: 16 weeks ]
  • Trail making test A and B [ Time Frame: 24 weeks ]
  • Digit Span [ Time Frame: 16 weeks ]
  • Digit Span [ Time Frame: 24 weeks ]
  • Five Digits Test [ Time Frame: 16 weeks ]
  • Five Digits Test [ Time Frame: 24 weeks ]
  • Medication Appropriateness Index (MAI) [ Time Frame: 16 weeks ]
  • Medication Appropriateness Index (MAI) [ Time Frame: 24 weeks ]
  • Assessment of Underutilization (AOU) [ Time Frame: 16 weeks ]
  • Assessment of Underutilization (AOU) [ Time Frame: 24 weeks ]
  • Number of falls [ Time Frame: During the first 16 weeks after baseline ]
    Recorded with the aid of diaries kept by patients/caregivers
  • Number of falls [ Time Frame: During the first 24 weeks after baseline ]
    Recorded with the aid of diaries kept by patients/caregivers
  • Orthostatic blood pressure [ Time Frame: 16 weeks ]
  • Orthostatic blood pressure [ Time Frame: 24 weeks ]
  • Changes in body weight [ Time Frame: 16 weeks ]
  • Changes in body weight [ Time Frame: 24 weeks ]
  • Relative Stress Scale [ Time Frame: 16 weeks ]
  • Relative Stress Scale [ Time Frame: 24 weeks ]
  • Number of hospital admissions (with reasons) [ Time Frame: During the first 16 weeks from baseline ]
  • Number of hospital admissions (with reasons) [ Time Frame: During the first 24 weeks from baseline ]
  • Number of days in own home (in contrast to being in hospital or nursing home) [ Time Frame: During the first 16 weeks from baseline ]
  • Number of days in own home (in contrast to being in hospital or nursing home) [ Time Frame: During the first 24 weeks from baseline ]
  • Admission to permanent institutional care [ Time Frame: 16 weeks ]
  • Admission to permanent institutional care [ Time Frame: 24 weeks ]
  • Current use of home nursing service [ Time Frame: 16 weeks ]
  • Current use of home nursing service [ Time Frame: 24 weeks ]
  • Mortality [ Time Frame: 16 weeks ]
  • Mortality [ Time Frame: 24 weeks ]
  • Health-related quality of life as measured with 15D [ Time Frame: 24 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cooperation for Improved Pharmacotherapy in Home-dwelling Elderly People Receiving Polypharmacy - The COOP Study
Official Title  ICMJE Cooperation for Improved Pharmacotherapy in Home-dwelling Elderly People Receiving Polypharmacy - The COOP Study
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Condition  ICMJE Drug Usage
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Comprehensive drug review
    Intervention: Other: Comprehensive drug review
  • No Intervention: Control group
    Follow-up by family physician "as usual".
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 24, 2018)
192
Original Estimated Enrollment  ICMJE
 (submitted: March 4, 2015)
200
Actual Study Completion Date  ICMJE September 22, 2017
Actual Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 70 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02379455
Other Study ID Numbers  ICMJE 222033/H10
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Torgeir Bruun Wyller, Oslo University Hospital
Study Sponsor  ICMJE Oslo University Hospital
Collaborators  ICMJE
  • The Research Council of Norway
  • University of Oslo
Investigators  ICMJE
Principal Investigator: Torgeir B Wyller, MD PhD Oslo University Hospital
PRS Account Oslo University Hospital
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP