Ignite Creation Date:
2024-05-06 @ 3:14 PM
Last Modification Date:
2024-10-26 @ 1:45 PM
Study NCT ID:
NCT04565743
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-11
First Post:
2020-09-17
Brief Title:
Stop At One Stockholm SAOS- Secondary Fracture Prevention Through Active Patient Identification and Staff Education
Sponsor:
Helena Salminen
Organization:
Karolinska Institutet
Study Overview
Official Title:
Stop At One Stockholm Co-operation Between Health Care Providers and Medical Education in Primary Health Care to Prevent Falls and Fractures in the Elderly
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SAOS
Brief Summary:
This is a study on the effects of education on secondary fracture prevention in primary health care centers PHCC and referral from hospitals to these PHCC of patients with recent fragility fractures
The design is Cluster-randomized controlled study with two arms 40 primary health care centers PHCC are included each PHCC constitutes a cluster The intervention group contains 20 PHCCs and the control group of the remaining 20 PHCCs The educational part of the intervention is divided into three sessions one web based course succeeded by two multiprofessional seminars with six months interval During the intervention period patients enlisted at the intervention PHCCs aged 60 or more who are diagnosed on a fragility fracture are referred to their respective PHCC The primary outcome are the proportions of patients who receive bone specific treatment after their fracture in the intervention group compared to the control group
The design is Cluster-randomized controlled study with two arms 40 primary health care centers PHCC are included each PHCC constitutes a cluster The intervention group contains 20 PHCCs and the control group of the remaining 20 PHCCs The educational part of the intervention is divided into three sessions one web based course succeeded by two multiprofessional seminars with six months interval During the intervention period patients enlisted at the intervention PHCCs aged 60 or more who are diagnosed on a fragility fracture are referred to their respective PHCC The primary outcome are the proportions of patients who receive bone specific treatment after their fracture in the intervention group compared to the control group
Detailed Description:
Fragility fractures are in this study defined as a fracture of the spine hip pelvis proximal humerus och distal radius caused by low energy trauma A trauma not exceeding the force implied on the body from a fall from standing height on a flat surface is regarded to be a low energy trauma
The educational intervention targets general practitioners and nurses from the PHCC as well as physiotherapists occupational therapists and dietitians from a nearby rehabilitation centre
All professions go through the same web course before educational session 1 which is held at the PHCC The web course includes basic knowledge about risk factors for fragility fractures
At session 1 all professions first participate in a common seminar of 45 minutes After that physicians nurses and rehabilitation related professions each have an additional seminar of 45 minutes that means three separate seminars Three teachers lead the seminars a specialist in family medicine a nurse specialized in primary care and a physiotherapist They are all present during all of the seminars at each PHCC and the same three individuals leads the seminars at all PHCCs The seminars focus on identification of persons at high risk of fracture and different methods to lower that risk The importance of multiprofessional care for these patients is stressed The participants are given opportunity to discuss how they might facilitate cooperation between the different health vare professions Development of local routines for multiprofessional care is encouraged
Educational session 2 is held approximally 6 months after session 1 Session 2 invites the same health care professionals as session 1 There are three parts A first part of 45 minutes for the physicians and nurses A second part of 45 minutes where personnel from the rehabilitation center joins The third part of 45 minutes includes just the rehabilitation personnel
At session 2 includes a short review of the contents discussed in session 1 The focus however is on the development of new local routines to secure the ability for patients with a high risk of fracture to be offered multiprofessional care What needs to be done and who does what at your PHCCrehabilitation center The participants also get feedback on the number of patients being treated with bone-specific drugs before and after the start of the intervention
Inclusion of patients stops at december 1 2020 Referrals to the PHCC of the patients included last will be conducted during January 2021
Primary outcome data is gathered at each PHCC from the medical journals of the enlisted patients aged 60 with fragility fractures Data includes the time frame one year before start of study until two years after the last patient was included
Secondary outcomes fractures and fall related injuries will be collected from National health care registers three and five years after the last patient was included
The educational intervention targets general practitioners and nurses from the PHCC as well as physiotherapists occupational therapists and dietitians from a nearby rehabilitation centre
All professions go through the same web course before educational session 1 which is held at the PHCC The web course includes basic knowledge about risk factors for fragility fractures
At session 1 all professions first participate in a common seminar of 45 minutes After that physicians nurses and rehabilitation related professions each have an additional seminar of 45 minutes that means three separate seminars Three teachers lead the seminars a specialist in family medicine a nurse specialized in primary care and a physiotherapist They are all present during all of the seminars at each PHCC and the same three individuals leads the seminars at all PHCCs The seminars focus on identification of persons at high risk of fracture and different methods to lower that risk The importance of multiprofessional care for these patients is stressed The participants are given opportunity to discuss how they might facilitate cooperation between the different health vare professions Development of local routines for multiprofessional care is encouraged
Educational session 2 is held approximally 6 months after session 1 Session 2 invites the same health care professionals as session 1 There are three parts A first part of 45 minutes for the physicians and nurses A second part of 45 minutes where personnel from the rehabilitation center joins The third part of 45 minutes includes just the rehabilitation personnel
At session 2 includes a short review of the contents discussed in session 1 The focus however is on the development of new local routines to secure the ability for patients with a high risk of fracture to be offered multiprofessional care What needs to be done and who does what at your PHCCrehabilitation center The participants also get feedback on the number of patients being treated with bone-specific drugs before and after the start of the intervention
Inclusion of patients stops at december 1 2020 Referrals to the PHCC of the patients included last will be conducted during January 2021
Primary outcome data is gathered at each PHCC from the medical journals of the enlisted patients aged 60 with fragility fractures Data includes the time frame one year before start of study until two years after the last patient was included
Secondary outcomes fractures and fall related injuries will be collected from National health care registers three and five years after the last patient was included
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None