Clinician-patient Interaction During Addiction Consultation (CLiPID)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2013 by University of St Andrews
Sponsor:
Collaborator:
NHS Fife
Information provided by (Responsible Party):
Prof G Humphris, University of St Andrews
ClinicalTrials.gov Identifier:
NCT01769651
First received: January 10, 2013
Last updated: January 14, 2013
Last verified: January 2013
  Purpose

Accurately predicting the risk factors of patients' suffering a drug overdose plays a crucial role in effective prevention of drug overdose. In order to investigate possible risk factors for drug overdose, the NHS Fife Research & Development Office funded this project to be carried out by a group of researchers based in the University of St Andrews, in collaboration with the NHS Fife Addiction Services.

To improve our understanding of drug misusers' risk of suffering a drug overdose, the investigators focus on the factors that are associated with the aspects of the addiction consultation process (e.g. verbal and non-verbal behaviours of clinicians and patients). The investigators are particularly interested in how clinicians recognize and manage patients' emotional concerns during consultations. Based on the empirical evidence in the area of patient-centred consultation, the investigators hypothesize that successful management of patient emotional distress is positively correlated with improved healthcare outcomes including patient's feeling more emotionally valued and satisfied with the consultation. The investigators also hypothesize, according to the research findings on the relationship between facial expressions and suicidal reattempt, that some non-verbal behaviours during consultation (e.g. patient's 'looking down' activity) are related to patient's risk of suffering a drug overdose.

After obtaining informed consent from clinicians and patients, the investigators will video record a patient's first consultation session with a key worker within the NHS Fife Addition Services. The investigators expect to collect a minimum of 16 consultations (about eight clinicians with two patients per staff member) for this one-year pilot study. A validated coding scheme will be modified to code patients' expressions of emotional distress and clinicians' responses. Additional survey method will be also employed to collect demographic information and patient satisfaction. The investigators hope the findings of the study will improve our understanding of drug overdose risk factors and contribute to the development of drug overdose prevention programmes.


Condition Intervention
Drug Dependency
Other: methadone replacement therapy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Clinician-patient Interaction During Addiction Consultation and Drug Overdose Risk

Resource links provided by NLM:


Further study details as provided by University of St Andrews:

Primary Outcome Measures:
  • Number of days patients injected non-prescribed drugs [ Time Frame: one month after the video recorded consultation ] [ Designated as safety issue: No ]
    The primary outcome measure of the study is patient risk of suffering a drug overdose, measured by the number of days patients injected non-prescribed drugs, recorded on the Treatment Outcomes Profile Questionnaire, one month after the recorded consultation.


Secondary Outcome Measures:
  • Patient Satisfaction [ Time Frame: an expected average of 30 minutes after recorded consultation ] [ Designated as safety issue: No ]
    Patient satisfaction is the secondary outcome, measured by the Patient Satisfaction Survey completed by patients, an expected average of 30 minutes after the recorded consultation.


Estimated Enrollment: 16
Study Start Date: February 2013
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Drug service users
Those patients who receive Methadone replacement therapy as part of their treatment plan. In addition, those drug user patients who have a first consultation session with their Addiction Nurses.
Other: methadone replacement therapy
Patients are prescribed Methadone as part of their treatment plan, having been assessed as having opioid dependence syndrome and requiring pharmacological substitution therapy. A bio-psychosocial approach is taken in the treatment management of individuals.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

All drug user patients refered to the NHS Fife Addiction Services by a Fife wide triage contact point, patient GPs or Consultant, who are to have a first session with their Addiction Nurses, are identified as potential patient participants.

Criteria

Inclusion Criteria:

  • Drug service users in NHS Fife Addiction Services
  • Have a first session with their Addiction Nurses
  • English is first language

Exclusion Criteria:

  • Mental health problems
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01769651

Contacts
Contact: Yuefang Zhou, PhD 00441334461866 yz10@st-andrews.ac.uk

Locations
United Kingdom
School of Medicine, University of St Andrews
St Andrews, Fife, Scotland, United Kingdom, KY16 9TF
Sponsors and Collaborators
University of St Andrews
NHS Fife
Investigators
Principal Investigator: Gerry M Humphris, PhD University of St Andrews
  More Information

Publications:
Zimmermann, C., Del Piccolo, L., Bensing, J., Bergvik, S., De Haes, H. & Eide, H. et al. (2011). Coding patient emotional cues and concerns in medical consultations: The Verona coding definitions of emotional sequences (VR-CoDES). Patient Education and Counseling, 82, 141-148.

Responsible Party: Prof G Humphris, Chair of Health Psychology, University of St Andrews
ClinicalTrials.gov Identifier: NCT01769651     History of Changes
Other Study ID Numbers: CLiPID01
Study First Received: January 10, 2013
Last Updated: January 14, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of St Andrews:
drug user patients
addiction nurses
overdose risk

Additional relevant MeSH terms:
Methadone
Analgesics
Analgesics, Opioid
Antitussive Agents
Central Nervous System Agents
Central Nervous System Depressants
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014