Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
10334
Study information
Scientific title
Primary care Osteoarthritis Screening Trial (POST): a cluster randomised trial of an electronic prompt for comorbidity screening in clinical osteoarthritis consultations in primary care
Acronym
POST
Study hypothesis
POST is a cluster randomised clinical trial that will compare pain intensity and interference outcomes over a 12-month period in osteoarthritis (OA)/joint pain patients screened for depression and anxiety (intervention arm) to those who receive usual care (control arm; screened only for pain intensity).
As a cluster randomised trial the GP practices will be randomised (to one of the 2 arms) rather than the patients. We aim to recruit 44 GP practices in total in order to screen and contact 1745 patients. Recruitment of patients from GP practices will take place over 12 months. It is anticipated that patients will be contacted within 1-2 weeks of their index consultation with a baseline questionnaire and those who consent will be followed-up with further postal questionnaires 3, 6 and 12 months following their baseline. These questionnaires contain detailed questions on pain intensity and interference (our primary outcomes) and further questions on anxiety, depression, pain catastrophising, health economics and demographics. A medical record review of treatments, diagnoses and referrals will be conducted for patients who consent
Ethics approval
11/WM/0093; First MREC approval date 04/04/2011
Study design
Randomised; Interventional; Design type: Screening
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Osteoarthritis
Intervention
Generalised Anxiety Disorder-2 (GAD-2)
1. Eligible patients in the intervention arm consulting their GP for osteoarthritis or joint pain will be asked these 4 questions on depressive and anxiety symptoms during their consultation:
1.1. Modified Patient Hlth Quest
1.2. Modified Patient Health Questionnaire (PHQ-2)
2. Eligible patients in the intervention arm consulting their GP for osteoarthritis or joint pain will be asked these 4 questions on depressive and anxiety symptoms during their consultation
3. Follow-up length: 12 months
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. Self report measure of current pain intensity measured at baseline, 3 months, 6 months and 12 months
Secondary outcome measures
1. Anxiety (GAD-7 (5)) at baseline, 3 months, 6 months and 12 months
2. Body mass index (from self reported height and weight) at baseline, 3 months, 6 months and 12 months
3. Characteristic Pain Intensity and Disability Score at baseline, 3 months, 6 months and 12 months
4. Demographics (marital status and occupation/employment details) at baseline, 3 months, 6 months and 12 months
5. Depression (PHQ-8 (4)) at baseline, 3 months, 6 months and 12 months
6. Detailed questions about pain at baseline, 3 months, 6 months and 12 months
7. Medication and health care use at baseline, 3 months, 6 months and 12 months
8. Overall quality of life (EQ5D (2) and SF-36 (3)) at baseline, 3 months, 6 months and 12 months
9. Pain Catastrophising Scale (6) at baseline, 3 months, 6 months and 12 months
10. Pain interference with daily activities at baseline, 3 months, 6 months and 12 months
11. Social support (questions taken from previous postal surveys) at baseline, 3 months, 6 months and 12 months
Overall trial start date
29/07/2011
Overall trial end date
30/09/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged 45 years and over
2. Registered with the participating GP practices during the specified study period of that practice
3. Read-coded peripheral joint pain or OA consultation within the specified study period (termed the index consultation)
4. May be first, new episode, or ongoing consultation)
5. Provided full written informed consent to study participation and to further contact
6. Male & female
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 1309; UK Sample Size: 1309
Participant exclusion criteria
1. Patients who are under active care for or who have a diagnosis of depression and/or an anxiety disorder in the past 12 months
2. Vulnerable patients, including any patients on the Quality and Outcomes Framework mental health register, or those who have a diagnosis of dementia or a terminal illness
3. Patients who reside in a nursing home
4. Red flag pathology
5. Recent trauma associated with significant injury
6. Acute, red, hot swollen joint
7. Inflammatory arthropathy, crystal disease, spondyloarthropathy and polymyalgia rheumatic
Recruitment start date
29/07/2011
Recruitment end date
30/09/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Keele University
Newcastle under Lyme
ST5 5BG
United Kingdom
Sponsor information
Organisation
Keele University
Sponsor details
Keele
Newcastle under Lyme
ST5 5BG
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research, ref: RP-PG-0407-10386 (United Kingdom)
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28399129
2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30048076