EMMACE-4

Tags: LCBRU Study Category

A prospective longitudinal observational study of routine clinical care.

​http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=14493

A 6,000 patient multi-centre study.

In Leicester, the EMMACE-4 study will use CiviCRM to track completion of data collection instruments.

All other study data will be recorded in tools and applications supplied by Leeds Teaching Hospital.

Contact for this study is Velina Jordan, PI for Leicester is Ian Hudson.

Civi object model:

New group for patients: EMMACE-4

New study: EMMACE-4

• Standard Timeline
  • Consent
  • Receive Questionnaire (subject = 'inpatient medication list') (same day)
  • Check study questionnaire (subject = 'inpatient medication list')
  • Input Study Data (subject = 'inpatient medication list')
  • Receive Questionnaire (subject = 'inpatient EQ-5D') (same day)
  • Check study questionnaire (subject = 'inpatient EQ-5D')
  • Input Study Data (subject = 'inpatient EQ-5D')
  • Receive Questionnaire (subject = 'inpatient IPQ') (same day)
  • Check study questionnaire (subject = 'inpatient IPQ')
  • Input Study Data (subject = 'inpatient IPQ')
  • Patient discharged (needed so subsequent events can be timed from this event)
  • Receive Questionnaire (subject = '30-day medications list') (overdue at 44 days)
  • Check study questionnaire (subject = '30-day medications list') (overdue at 44 days)
  • Send data to lead site (subject = '30-day medications list') (overdue at 44 days)
  • Receive Questionnaire (subject = '30-day EQ-5D') (overdue at 44 days)
  • Check study questionnaire (subject = '30-day EQ-5D') (overdue at 44 days)
  • Send data to lead site (subject = '30-day EQ-5D') (overdue at 44 days)
  • Receive Questionnaire (subject = '30-day IPQ') (Illness Perception Questionnaire) (overdue at 44 days)
  • Check study questionnaire (subject = '30-day IPQ') (overdue at 44 days)
  • Send data to lead site (subject = '30-day IPQ') (overdue at 44 days)
  • Receive Questionnaire (subject = '30-day PROM') (overdue at 44 days)
  • Check study questionnaire (subject = '30-day PROM') (overdue at 44 days)
  • Send data to lead site (subject = '30-day PROM') (overdue at 44 days)
  • Receive Questionnaire (subject = '30-day SIMS') (Satisfaction with Information about Medicines Scale (overdue at 44 days)
  • Check study questionnaire (subject = '30-day SIMS') (overdue at 44 days)
  • Send data to lead site (subject = '30-day SIMS') (overdue at 44 days)
  • Send data to lead site (subject = 'Send MINAP data to LEEDS') (overdue at 120 days)
  • Receive Questionnaire (subject = '180-day medications list') (overdue at 194 days)
  • Check study questionnaire (subject = '180-day medications list') (overdue at 194 days)
  • Send data to lead site (subject = '180-day medications list') (overdue at 194 days)
  • Receive Questionnaire (subject = '180-day EQ-5D') (overdue at 194 days)
  • Check study questionnaire (subject = '180-day EQ-5D') (overdue at 194 days)
  • Send data to lead site (subject = '180-day EQ-5D') (overdue at 194 days)
  • Receive Questionnaire (subject = '180-day IPQ') (Illness Perception Questionnaire) (overdue at 194 days)
  • Check study questionnaire (subject = '180-day IPQ') (overdue at 194 days)
  • Send data to lead site (subject = '180-day IPQ') (overdue at 194 days)
  • Receive Questionnaire (subject = '180-day SIMS') (Satisfaction with Information about Medicines Scale (overdue at 194 days)
  • Check study questionnaire (subject = '180-day SIMS') (overdue at 194 days)
  • Send data to lead site (subject = '180-day SIMS') (overdue at 194 days)
  • Receive Questionnaire (subject = '365-day medications list') ( overdue at 379 days)
  • Check study questionnaire (subject = '365-day medications list') (overdue at 379 days)
  • Send data to lead site (subject = '365-day medications list') (overdue at 379 days)
  • Receive Questionnaire (subject = '365-day EQ-5D') ( overdue at 379 days)
  • Check study questionnaire (subject = '365-day EQ-5D') (overdue at 379 days)
  • Send data to lead site (subject = '365-day EQ-5D') (overdue at 379 days)
  • Receive Questionnaire (subject = '365-day IPQ') (Illness Perception Questionnaire) ( overdue at 379 days)
  • Check study questionnaire (subject = '365-day IPQ') (overdue at 379 days)
  • Send data to lead site (subject = '365-day IPQ') (overdue at 379 days)

Study documentation implies online data entry by patients, but for the foreseeable future this will not be happening.

Probably do need additional activity for "MINAP data submitted to LEEDS", at around 120 days post-discharge.

Each q'aire also has an activity of 'check completeness', and a further activity for 'copy sent to Leeds'.

Additional activities available for 'send out a copy' in cases where patient hasn't completed it.

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