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

Health Conditions
  • Osteoarthritis
Not Recruiting
Recruitment Status
ISRCTN40721988
Primary Trial ID Number
Summary
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
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
Research Question
  • 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
Design Type
Sorry, this information is not available
Ethics Approval
11/WM/0093; First MREC approval date 04/04/2011
Publications
Sorry, this information is not available
Countries of Recruitment
United Kingdom
Participant Sex
Both
Participant Age Range
Adult
Participant Type
Patient
Trial 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
Interventions
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
Design Details
Sorry, this information is not available
Study Design
Randomised; Interventional; Design type: Screening
Results Reporting
Sorry, this information is not available
Acronym
POST
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.
Secondary Trial Identifying Number
10334
Website
Sorry, this information is not available
Study Funded By
National Institute for Health Research, ref: RP-PG-0407-10386 (United Kingdom)
Funder Type
Sorry, this information is not available
Study Sponsored By
Keele University (United Kingdom)
Study Also Sponsored By
Sorry, this information is not available
Primary Sponsor Type
Sorry, this information is not available
Secondary Sponsor Type
Sorry, this information is not available
Key Dates

Date of First Enrollment

29 Jul 2011

Recruitment End Date

30 Sep 2012

Trial End Date

30 Sep 2012

Date added to Registry

21 Jun 2011

Last Updated

24 Jun 2015