Trial document




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  DRKS00012554

Trial Description

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Title

Healthcare provision, functional ability and quality of life after proximal femoral fracture (ProFem)

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Trial Acronym

ProFem

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URL of the Trial

https://innovationsfonds.g-ba.de/projekte/versorgungsforschung/profem-versorgung-funktionsfaehigkeit-und-lebensqualitaet-nach-proximaler-femurfraktur.42

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Brief Summary in Lay Language

Among older people, falls often lead to a fracture of the hip, also known as a fracture of the femoral neck. Experts speak of proximal femoral fractures. A major worry for affected people is to not fully recover from the fracture and being in need for care. However, more than half of those affected by a proximal femoral fracture do not receive any further treatment beyond hospital care. Special follow-up care programs should provide opportunities to reach the highest possible level of independence for older people. A crucial healthcare gap is opening up.
The objective of the ProFem project is, on the one hand, to describe the current situation of healthcare provision (use of health services and their costs) and clinical events such as hospital admissions or the occurrence of need for care. On the other hand, the data reported by those affected on quality of life, functional ability and social participation will be analysed during the course of the project.
The aim is to identify people who are potentially in need of more intensive healthcare. Therefore, existing health insurance data for persons affected by a proximal femoral fracture are linked with data generated within the project by patients or a caring relative / related person (person of trust) or a legally prescribed guardian (primary data). Health insurance data are usually generated by the statutory health insurance companies in the course of treatment (secondary data) and will be provided for the year before and after the proximal femoral fracture. The primary data collection will take place at 3, 6 and 12 months after discharge from the hospital.
The project is funded for 3 years with a total of approximately 1.3 million EUR.
The project results should help to identify possible deficits in care for people with hip fractures, and identify those with special care needs.

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Brief Summary in Scientific Language

Background:
Proximal femoral fractures (PFFs) are one of the most frequent fracture types in older people. However, knowledge is scarce regarding the situation of those affected after a PFF. Studies indicate poor outcomes following a PFF, e.g. 50% of those affected retained functional limitations, 15% were newly admitted to a nursing home and around 20% died within 1 year. Specific aspects of healthcare provision, such as treatment in geriatric trauma centers or rehabilitation, have hardly been investigated. It is not yet clear for which patients specific care models are of particular benefit. In addition to healthcare processes, patient-reported outcomes such as quality of life, functional ability and social participation among older people following PFF have been little researched. Subgroups characterized by particularly poor clinical and patient-reported outcomes, that may need more intensive care, have not yet been identified.

The research questions are:
1. What is the status of healthcare provision after PFF in the older population? How are specific treatment measures (e.g. geriatric rehabilitation, pain treatment) implemented at the interfaces of care?
2. How do clinical (hospitalization, need of care) and patient-reported outcomes (quality of life, functional ability, esp. social participation) after PFF present themselves in the course of time? What are the clinical and sociodemographic predictors (comorbidity, social situation, esp. social support) for this?
3. Which subgroups have poor outcomes (e. g. people living at home with low social support,
comorbidity and high utilization levels)? Are they identifiable with an algorithm according to a 'case finding'?
The project is funded by the Innovation Fund (Grant number: 01VSF16043). The project started on May 1, 2017.

Methods:
This is a population-based prospective observational study based on statutory health insurance (SHI) data which are individually linked to questionnaire survey data collected from persons insured with the AOK Rheinland/Hamburg. From the Rheinland region we will consecutively include all people aged minimum 60 years, who are at least constantly insured with the AOK Rheinland/Hamburg ≥ 12 months and sustain a PFF (S72.0, S72.1 and S72.2 according to ICD-10). In a period of 1 year we expect that this will be approximately 4000 people. Out of these, 700 persons will be randomly selected and will be consecutively included in the survey over a period of 12 months and followed up for 1 year. Primary data collection is planned 3 and 12 months after hospital discharge during home visits, and 6 months after discharge by postal survey. The primary data collection of patient-relevant outcomes includes health-related quality of life, functional ability and social participation. Sociodemographic characteristics and socio-economic status, social relations and social support are surveyed as influencing factors and adjustment variables, as well as questions about lifestyle, intake/use of medication, use of medical aids, restrictions and special events. SHI data are also used to record healthcare provision and utilization (inpatient and outpatient medical care, rehabilitation, medication, remedies and medical aids, nursing services), patient-relevant outcomes (inpatient stays, nursing home admission, costs, death) as well as influencing factors and adjustment variables (demographic data, comorbidity) 12 months after PFF, influencing factors also 12 months before PFF. If the insured person is not in a position to provide information, an attempt will be made to establish contact with a caring relative / related person (person of trust) or a legally prescribed guardian and to conduct a proxy interview.
A comprehensive SHI data analysis is planned for all identified insured persons (approx. n=4.000) with PFF (observation period: 12 months before and 12 months after the fracture event). For the randomly selected persons (approx. n=700) who participate in the questionnaire survey and have given their consent, the SHI data collected 12 month before and 12 month after the event will be linked to the patient-reported data.
The baseline variables are described by descriptive statistics. Possible associations between influencing factors and outcomes are examined using multiple linear or logistic regression models. Adjustments for the multiple measurements per Person are made by adaptation of the corresponding mixed models (covariance pattern models). Mortality analyses are calculated using Kaplan-Meier curves and Cox regression. The development of an algorithm according to a 'case finding' is done by adaptation of the mixed logistic regression models (deriving a score). To avoid bias, the score is developed on one half of the population and tested on the other half.
Discussion and practical implications:
The results of the project should help to identify possible deficits in healthcare for people with PFF, and detect people with special needs.

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

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00012554
  •   2018/02/23
  •   [---]*
  •   yes
  •   Approved
  •   6128R, Ethik-Kommission an der Medizinischen Fakultät der Heinrich-Heine-Universität Düsseldorf
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Secondary IDs

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Health Condition or Problem studied

  •   S72.0 -  Fracture of neck of femur
  •   S72.2 -  Subtrochanteric fracture
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Interventions/Observational Groups

  •   Persons with PFF will be interviewed with a questionnaire on their health-related quality of life (EQ-5D, SF-12), functional ability (Mobility Parker Score, Oxford Hip Score, Barthel Index) and social participation (IMET) at three points in time (3 and 12 months after hospital discharge during home visits and 6 month after discharge by postal survey). In addition, socio-economic and sociodemographic questions will be asked (3 months after discharge) as well as questions on social relations/social support, lifestyle, intake/use of medication, use of medical aids, and special events (each 3 and 12 months after discharge). Restrictions (e.g. pain, fear of falling) will also be recorded (3, 6 and 12 months after discharge). The collected primary data will be linked to the SHI data.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

The Healthcare situation (SHI data) will be assessed 12 months before and after PFF.
Quality of life (SF-12, EQ-5D), functional ability (Mobility Parker Score, Oxford Hip Score, Barthel Index) and social participation (IMET) will be assessed by a questionnaire at three points in time (3, 6 and 12 months after the event).

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Secondary Outcome

None

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2018/06/13
  •   700
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Persons from the Rhineland region aged 60 years and older with surgical PFF who have been insured with the AOK Rheinland/Hamburg for at least 12 months will be consecutively identified over 1 year on the basis of the diagnosis 'proximal femoral fracture' (S72.0, S72.1 and S72.2) according to the 10th edition of the International Classification of Diseases (ICD-10) as well as by selected surgical and procedural keys for: closed reduction and osteosynthesis with intramedullary nail, plate or dynamic hip screw (5-790.0e, 5-790.3e, 5-790.3f, 5-790.4e, 5-790.4f, 5-790.5e, 5-790.5f, 5-790.7e, 5-790.7f, 5-790.8e, 5-790.8f), open reduction of a simple fracture on the proximal femur and osteosynthesis with intramedullary nail, plate or dynamic hip screw (5-793.2e, 5-793.2f, 5-793.4e, 5-793.4f, 5-793.5e, 5-793.5f, 5-793.ae, 5-793.af, 5-793.be, 5-793.bf), open reduction of a multifragmentary fracture on the proximal femur and osteosynthesis with intramedullary nail, plate or dynamic hip screw (5-794.1e, 5-794.1f, 5-794.3f, 5-794.3e, 5-794.4f, 5-794.4e, 5-794.ae, 5-794.af, 5-794.be, 5-794.bf) and implantation of hip endoprosthesis (5-820).

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Exclusion Criteria

Lack of or limited German language skills;
People with dementia/heavy cognitive impairment who are no longer able to conduct the interviews themselves and for whom no suitable caring relative / related person (person of trust) or legally prescribed guardian is willing to participate

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Addresses

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Sources of Monetary or Material Support

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    • Gemeinsamer Bundesausschuss
    • Wegelystr. 8
    • 10623  Berlin
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.