Condition category
Musculoskeletal Diseases
Date applied
21/06/2011
Date assigned
21/06/2011
Last edited
24/06/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Jacqueline Gray

ORCID ID

Contact details

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

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

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 measures

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

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

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

Sponsor information

Organisation

Keele University (United Kingdom)

Sponsor details

Keele
Newcastle under Lyme
ST5 5BG
United Kingdom

Sponsor type

University/education

Website

http://www.keele.ac.uk/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes