Screening for Osteoporosis in General Practice

NCT ID: NCT02220699

Last Updated: 2016-07-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 367 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2015-05-31

Brief Summary

All Danish general practices have a data capture system that collects selected data from the electronic patient record. These data are used for various quality assurance purposes. The aim of the study is to evaluate the quality assurance system/program that identifies patients having an increased risk of osteoporosis.

Detailed Description

Background/Method

General practitioners (GPs) have the Sentinel data capture program as an integrated part of their medical record system. The program identifies if a patient has one or more of the following risk factors registered with an ICPC code (International Classification of Primary Care - 2, Wonca International Classification Committee (WICC)):

Alcohol abuse (P15), chronic obstructive pulmonary disease (COPD) (R95), hyperthyroidism (T85), rheumatoid arthritis (L88), fracture (L72, L73, L74, L75 and L76 (age > 50))*, anorexia (P86), glomerulonephritis/ nephropathy (U88), early menopause (ages 40 to 45 and X05), smoker (current/former P17), corticosteroid treatment (at least two prescriptions), body mass index (BMI) (between 10-19).

*L72: radius/ulna fracture, L73: tibia/fibula fracture, L74: hand/foot fracture, L75: femur fracture, L76: NEC (not elsewhere classified) fracture.

The GP can generate a list of his own patients that have an increased risk of osteoporosis with name, personal identification number, age, address, eGFR (estimated glomerular filtration rate), BMI, an indication of which of the above mentioned diagnoses the patient has, and whether the patient had been instructed in calcium and vitamin D intake. In order to generate a list, the GP must have been using ICPC coding for at least 6 months with a minimum of 70% of patient contacts.

The GP can afterwards invite these high-risk individuals for a consultation focussing on osteoporosis prevention.

The Study

The study has initiated in January 2014 including two general practices (Clinic A & B) from the Aalborg Municipality that volunteered to participate. Based on the investigators pilot study the investigators aimed at clinics with approximately 200 patients at risk in each.

Clinic A (www.laegernesloejfen.dk) is located in eastern Aalborg, Denmark. Clinic B (www.lægerneiskalborg.dk) is located in southwest Aalborg, Denmark.

Clinic A and B's lists of patients at an increased risk of osteoporosis is printed and downloaded, along with their ICPC coded diagnoses and data.

The patients' medical records are screened for exclusion criteria. Eligible patients are contacted and asked to come for a consultation regarding the risk of developing osteoporosis. The patients are contacted directly if they visit the clinic anyway; otherwise they are contacted by e-mail or letter.

Patients coming for a consultation are given a questionnaire regarding osteoporosis risk factors in relation to lifestyle, diet, diseases predisposing osteoporosis, fall prophylaxis, and medication. The questionnaire also evaluate the patient's attitude towards being offered preventive examination and treatment by his/hers general practitioner. Patients wanting a consultation, but not wishing to participate in the scientific study are examined and offered treatment equal to the consenting patient according to national standards.

The patients then have a consultation regarding osteoporosis prevention (typically by a nurse). During the consultation the patient's different risk factors are discussed and advice is given regarding fall prophylaxis, diet, calcium and vitamin D. The patient's medication is examined as specified by national guidelines. All patients are then offered referral to a DXA-scan.

Patients that are scanned and classified as having osteoporosis are offered a new consultation regarding osteoporosis treatment and blood tests for secondary osteoporosis screening purposes.

Patients with osteopenia and normal bone mineral density are informed about their test result and if necessary advised to have a new DXA-scan in a few years.

The study is based on the routine identification of patients at risk of osteoporosis found by using the Sentinel data capture program. Intervention is not used in the study, however the patients at risk are offered regular preventive examination according to their risk (DXA-scan). The study analyses data based on the quality assurance work regarding osteoporosis of the general practices.

Patients are informed that participation is completely voluntary and they can withdraw from the study at any time and it will have no bearing on present or future treatment. All participating patients give oral and written informed consent.

Patients not wanting to participate will not be part of the study and only their sex, age, risk factors and reason for exclusion will be registered anonymously in order to evaluate the selection of patients.

Lack of participation in the study will have no consequences on the examination and treatment offered to patients at risk.

Conditions

Osteoporosis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

Inclusion Criteria

• Patient identified as being at an increased risk of osteoporosis by the data capture system

Exclusion Criteria

• Known osteoporosis.
• Patients treated with alendronate.
• Patients below 25 years of age.
• Bone metastasis.
• Terminal disease.
• Severe dementia or other disease or condition that is incompatible with participation.
• Bone mineral density scan within the past 3 years.
• Errors in their ICPC coding that leads to the patient being misclassified as having an increased risk of osteoporosis.
• Patients not wanting to participate.

• Minimum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aalborg University Hospital

OTHER

Sponsor Role: collaborator

Aalborg University

OTHER

Sponsor Role: lead

Responsible Party

Martin Bach Jensen

GP, Ph.D, Professor at Department of Clinical Medicin, Aalborg University and head of the Research Unit of General Practice in Aalborg

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Lægerne Sløjfen (a family medicine clinic)

Aalborg, North Denmark, Denmark

Countries

Denmark

Other Identifiers

FEA-RN-2014-1

Identifier Type: -

Identifier Source: org_study_id