NCT01769651

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 17, 2013

Completed
2.1 years until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

February 18, 2015

Status Verified

February 1, 2015

Enrollment Period

6 months

First QC Date

January 10, 2013

Last Update Submit

February 16, 2015

Conditions

Keywords

drug user patientsaddiction nursesoverdose risk

Outcome Measures

Primary Outcomes (1)

  • Number of days patients injected non-prescribed drugs

    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.

    one month after the video recorded consultation

Secondary Outcomes (1)

  • Patient Satisfaction

    an expected average of 30 minutes after recorded consultation

Study Arms (1)

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

Interventions

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.

Drug service users

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • Mental health problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Medicine, University of St Andrews

St Andrews, Fife, Scotland, KY16 9TF, United Kingdom

Location

Related Publications (3)

  • Archinard M, Haynal-Reymond V, Heller M. Doctor's and patients' facial expressions and suicide reattempt risk assessment. J Psychiatr Res. 2000 May-Jun;34(3):261-2. doi: 10.1016/s0022-3956(00)00011-x. No abstract available.

    PMID: 10960300BACKGROUND
  • Stewart MA. Effective physician-patient communication and health outcomes: a review. CMAJ. 1995 May 1;152(9):1423-33.

    PMID: 7728691BACKGROUND
  • Zimmermann C, Del Piccolo L, Bensing J, Bergvik S, De Haes H, Eide H, Fletcher I, Goss C, Heaven C, Humphris G, Kim YM, Langewitz W, Meeuwesen L, Nuebling M, Rimondini M, Salmon P, van Dulmen S, Wissow L, Zandbelt L, Finset A. Coding patient emotional cues and concerns in medical consultations: the Verona coding definitions of emotional sequences (VR-CoDES). Patient Educ Couns. 2011 Feb;82(2):141-8. doi: 10.1016/j.pec.2010.03.017. Epub 2010 Apr 28.

    PMID: 20430562BACKGROUND

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Gerry M Humphris, PhD

    University of St Andrews

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuefang Zhou, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair of Health Psychology

Study Record Dates

First Submitted

January 10, 2013

First Posted

January 17, 2013

Study Start

March 1, 2015

Primary Completion

September 1, 2015

Study Completion

December 1, 2015

Last Updated

February 18, 2015

Record last verified: 2015-02

Locations