Stop At One Stockholm (SAOS)- Secondary Fracture Prevention Through Active Patient Identification and Staff Education.

NCT04565743 | Active Not Recruiting

• 1 other identifier: 2018/927-31/2
• Study Type: interventional
• Target: 3,600
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporotic Fractures; Osteoporosis; Osteoporosis Risk

Keywords

Organization & administration; Secondary prevention; Bone Density Conservation Agents

Outcome Measures

Primary Outcomes (1)

• Proportion of participants treated with bone specific drugs after first fragility fracture at different points in time up to three years after inclusion.

  Participants are included in the study at the date of their first fragility fracture within the study period. The proportion of participants treated with bone-specific drugs any time since the fracture date, will be measured every 6 months during the study period.

  Three years after inclusion of study participant

Secondary Outcomes (1)

• Proportion of participants treated with calcium and vitamin D but not bone specific drugs after first fragility fracture at different points in time after inclusion up to three years after inclusion.

  Three years

Other Outcomes (1)

• Incidence of new fractures and fall related injuries after index fracture.

  Three and sive years after last participant was included,

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Multiprofessional education for health professionals in primary care on secondary prevention of osteoporotic fractures. Identification and referral of patients with recent osteoporotic fracture.

Behavioral: Support on dentification and treatment of patients with high risk of osteoporotic fractures

Control

NO INTERVENTION

No intervention from study. No restrictions regarding education or the local organization of care for the prevention of osteoporotic fractures.

Interventions

Support on dentification and treatment of patients with high risk of osteoporotic fractures BEHAVIORAL

Education for primary care health care professionals and referral of patients with recent osteoporotic fracture.

Intervention

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient has a diagnose at a medical care unit within Stockholm county on a low energy fracture of hip, pelvis, spine, proximal humerus och distal radius between three months before study start an end of study.
• Patient is enlisted at one of the PHCCs in the interventional arm of the study
• Patent is aged 60 years or older

You may not qualify if:

• The patient has after the index fracture, already been referred to the correct primary health care center for secondary fracture prevention.

Sponsors & Collaborators

• Helena Salminen: lead
• Region Stockholm: collaborator

Study Sites (1)

Karolinska Instititet

Huddinge, Stockholm County, 14183, Sweden

Location

MeSH Terms

Conditions

Osteoporotic Fractures; Osteoporosis

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Helena Salminen, MD, Ass Prof

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate professor

Model Details: Cluster randomized controlled study. 40 clusters with an estimated cluster size of 90 participating individuals in each cluster.

Study Record Dates

• First Submitted: September 17, 2020
• First Posted: September 25, 2020
• Study Start: February 1, 2018
• Primary Completion: June 1, 2025
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 10, 2025

Record last verified: 2024-04

Locations

SE (1)