Trial document




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  DRKS00015055

Trial Description

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Title

Family conferences and shared prioritization to improve patient safety in the frail elderly

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Trial Acronym

COFRAIL

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URL of the Trial

https://www.cofrail.com/

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Brief Summary in Lay Language

Frailty in elderly is a distinctive health state characterized by an increase in an individual’s vulnerability for developing increased dependency and/or mortality when exposed to a stressor. Frailty is a key issue in primary care and home care because it is associated with an increased risk of poor health outcomes including falls, delirium, malnutrition, hospitalization, and mortality. Medical decision making in frail patients is often characterized by complexity due to multi-morbidity, polypharmacy, and lack of evidence. Since polypharmacy is recognized as an important contributing factor for the pathogenesis of frailty, reducing inappropriate medication use is a promising approach to prevent frail patients from adverse effects, to preserve independency and improve quality of life.

The aim of this trial is to improve primary care outcomes in frail patients living at home. Family conferences with patients, relatives, and general practitioners should facilitate shared prioritization of medical treatment and the process deprescribing by means of shared decision making on medication use.

136 GPs and 670 patients will be enrolled into the study. In the intervention group the GPs receive three consecutive educational trainings followed by three family conferences, at the beginning of the study and after 3 and 9 months, for 30 - 45 minutes each with GPs, patients and their family carers. Clinical and socioeconomic data will be collected from GPs and patients to assess changes in hospitalization rates, drug use, grade of frailty, and further patient relevant outcomes like quality of life. A positive evaluation of the intervention will facilitate the implementation of family conferences as a tool for shared decision making in frail elderly patients into routine care.

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Brief Summary in Scientific Language

Rationale and Objectives: Frailty in the elderly is a key issue in primary care and home care because it coincides with increased stress vulnerability and a higher risk of developing dependency and multi-morbidity. Since polypharmacy is a contributing factor for frailty, reducing inappropriate medication is a promising approach to prevent frail elderly patients from adverse effects and to improve their quality of life. Our study aims to evaluate the potential benefit of de-prescribing polypharmacy in frail elderly patients utilizing family conferences as a tool for shared decision making between patients, family carers, and general practitioners (GPs).

Intervention: Complex intervention in two steps: 1) three consecutive educational trainings for GPs, 2) three family conferences, at the beginning of the study and after 6 and 12 months, for 30 - 45 minutes each with GPs, patients and their family carers. In the control group care as usual will be delivered.

Methods: Prospective cluster-randomized controlled trial with 136 GPs and 676 frail elderly patients (≥ 70 years) with polypharmacy (≥ 5 drugs per day). Data collection during study nurse home visits at baseline and after 6 and 12 months. Due to the COVID-19 pandemic from March 1st, 2020, all patient data will be collected through telephone calls. Primary patient-relevant endpoint is the hospitalization rate. Secondary outcomes are Total number of medications, geriatric assessments including weakness measured by grip strength, cognition, psychological status, health related quality of life, activities in daily living, mobility, weight, rate of self-reported falls, and health economic parameters.

Expected Results/Benefits: A positive evaluation of the intervention will facilitate the implementation of family conferences as a tool for shared decision making for de-prescribing polypharmacy in frail elderly patients into routine care.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00015055
  •   2019/02/06
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  •   yes
  •   Approved
  •   A 2018-0151, Ethik-Kommission an der Medizinischen Fakultät der Universität Rostock
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Secondary IDs

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Health Condition or Problem studied

  •   R54 -  Senility
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Interventions/Observational Groups

  •   Family conferences with GPs (general practitioners), patients and relatives to enhance shared prioritisation on pharmacotherapy
  •   care as usual
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Control group receives no treatment
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Hospitalisation rate reported by patients, collected by study nurses during home visits (from March 1st, 2020 by telephone calls) at baseline (t0), after 6 months (t1) and after 12 months (t2).

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Secondary Outcome

1) Total number of medications (collected by study nurses during home visits)
2) Drug Burden Index (DBI) defined as the number of anticholinergic and sedative medications
3) prevalence of PIM
4) Weakness measured by grip strength using a dynamometer
5) Cognition: Two short cognitive subtests from the CERAD neuropsychological test battery: Episodic memory, Executive function
6) Psychological status measured by the Geriatric Depression Scale (GDS)
7) Mobility measured by the Timed Up & Go - Test (fom March 1st, 2020 no longer be carried out due to conversion to telephone data collection)
8) Health related quality of life (EQ-5D)
9) Activities in daily living (Barthel-Index)
10) Weight (self-reported)
11) Rate of self-reported falls
All of these data will be collected at baseline (t0), after 6 months (t1) and after 12 months (t2).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2019/03/31
  •   670
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   70   Years
  •   no maximum age
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Additional Inclusion Criteria

1) Positive screening of frailty in a short screening questionnaire answered by the GP utilising the CSHA Clinical Frailty Scale. Patients at the levels 5-7 are eligible for participating in this trial.
2) Regular intake of five or more different drugs per day (Polypharmacy)
3) Care dependency (Pflegestufe / level if care 1 or higher) or comparable status
4) Either nursing care at home by informal family carers alone or supported by professional carers.

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Exclusion Criteria

1) moderate or high dementia
2) not under legal guardianship
3) reduced life expectancy of less than 6 months (palliative care)
4) living in a nursing home
5) no fluent German language skills of patients and family carer OR no availability of a translator

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Addresses

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    • Heinrich-Heine-Universität Düsseldorf, Medizinische Fakultät
    • Moorenstr. 5
    • 40225  Düsseldorf
    • Germany
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    • Heinrich-Heine-Universität Düsseldorf, Medizinische Fakultät, Institut für Allgemeinmedizin
    • Mr.  Prof Dr. med.  Stefan  Wilm 
    • Werdener Str. 4
    • 40227  Düsseldorf
    • Germany
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    • Heinrich-Heine-Universität Düsseldorf, Medizinische Fakultät, Institut für Allgemeinmedizin
    • Mr.  Prof Dr. med.  Achim  Mortsiefer 
    • Werdener Str. 4
    • 40227  Düsseldorf
    • Germany
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Sources of Monetary or Material Support

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    • Innovationsausschuss beim Gemeinsamen Bundesausschuss
    • Postfach 12 06 06
    • 10623  Berlin
    • Germany
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Status

  •   Recruiting complete, follow-up complete
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  •   2021/06/30
  •   623
  •   623
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Trial Publications, Results and other Documents

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