Primary care Osteoarthritis Screening Trial (POST): a cluster randomised trial of an electronic prompt for comorbidity screening in clinical osteoarthritis consultations in primary care

ISRCTN	ISRCTN40721988
DOI	https://doi.org/10.1186/ISRCTN40721988
Secondary identifying numbers	10334

Submission date: 21/06/2011
Registration date: 21/06/2011
Last edited: 23/07/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Ms Jacqueline Gray
Scientific

Arthritis Research UK Primary Care Centre
Primary Care Sciences
Keele University
Newcastle under Lyme
ST5 5BG
United Kingdom

Study information

Study design	Randomised; Interventional; Design type: Screening
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Screening
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
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
Study acronym	POST
Study objectives	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(s)	11/WM/0093; First MREC approval date 04/04/2011
Health condition(s) or problem(s) studied	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
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 study start date	29/07/2011
Completion date	30/09/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	Planned Sample Size: 1309; UK Sample Size: 1309
Key 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
Key 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
Date of first enrolment	29/07/2011
Date of final enrolment	30/09/2012

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Keele University

Newcastle under Lyme
ST5 5BG
United Kingdom

Sponsor information

Keele University
University/education

Keele
Newcastle under Lyme
ST5 5BG
England
United Kingdom

Website	http://www.keele.ac.uk/
"ROR"	https://ror.org/00340yn33

Funders

Funder type

Government

National Institute for Health Research, ref: RP-PG-0407-10386 (United Kingdom)
Government organisation / National government

Alternative name(s): National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	11/04/2017		Yes	No
Results article	results	01/07/2018		Yes	No
Other publications	cost-utility analysis	01/12/2018	23/07/2019	Yes	No

Editorial Notes

23/07/2019: Publication reference added.
27/07/2018: Publication reference added.
12/04/2017: Publication reference added.