Primary care Osteoarthritis Screening Trial (POST): a cluster randomised trial of an electronic prompt for comorbidity screening in clinical osteoarthritis consultations in primary care. | Not Recruiting
Primary care Osteoarthritis Screening Trial (POST): a cluster randomised trial of an electronic prompt for comorbidity screening in clinical osteoarthritis consultations in primary care.
POST
Trial Source

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Health Conditions
  • Osteoarthritis
Ms Jacqueline Gray
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Primary Contact Details
Not Recruiting
Recruitment Status
ISRCTN40721988
Primary Trial ID Number
Summary
Not provided at time of registration
Research Details
  • 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
Phase
Not Applicable
Study Design
Randomised; Interventional; Design type: Screening
Study Type
Interventional
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 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
Publication(s)
Sorry, this information is not available
Result Reports
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Gender
Both
Age Range
Adult
Who Can Participate
Patient
Number of Participants
Planned Sample Size: 1309; UK Sample Size: 1309
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 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
Trial Location(s)
Newcastle under Lyme
ST5 5BG
Trial Contact(s)
Primary Trial Contact
Ms Jacqueline Gray
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
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.
EudraCT Number
Sorry, this information is not available
Funder(s)
  • National Institute for Health Research, ref: RP-PG-0407-10386 (United Kingdom)
Other Study ID Numbers
10334
Sponsor(s)
Keele University (United Kingdom)
Key Dates

Recruitment Start Date

29 Jul 2011

Recruitment End Date

30 Sep 2012

Trial Start Date

29 Jul 2011

Trial End Date

30 Sep 2012

Date Assigned

21 Jun 2011

Last Updated

24 Jun 2015