NCT01004276

Brief Summary

This pilot study will determine the feasibility of studying a new smoking cessation management module in an existing chronic disease management system. The new module is intended to help healthcare providers deliver more smoking cessation counselling to their patients.

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
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 29, 2009

Completed
3 days until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

October 29, 2009

Status Verified

October 1, 2009

Enrollment Period

5 months

First QC Date

October 28, 2009

Last Update Submit

October 28, 2009

Conditions

Keywords

primary health caredelivery of health caresmoking cessationchronic diseasedisease managementpilot projects

Outcome Measures

Primary Outcomes (2)

  • Smoker Identifying Cards

    3 months post-intervention

  • Chronic disease management system's activity log

    monthly post-intervention

Secondary Outcomes (1)

  • Smoking cessation counselling billing codes from physician's remittance advice files

    monthly post-intervention

Study Arms (2)

Improved module

EXPERIMENTAL
Other: New, improved smoking cessation management module

Standard module

NO INTERVENTION

Interventions

The intervention that will be tested is an improved smoking cessation management module in an existing chronic disease management system, P-PROMPT CDMS. This module includes the following components: a) the Patient Care Status and Update Form, b) the smoking registry and c) patient prompts.

Improved module

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Physician subscribers to P-PROMPT CDMS

You may not qualify if:

  • Paper users
  • Physicians expected to retire during the course of the study
  • Physicians whose billing files are not set-up with DataSynch

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

McMaster University

Hamilton, Ontario, L8S 4L8, Canada

Location

Centre for Addiction and Mental Health

Toronto, Ontario, M5S 2S1, Canada

Location

MeSH Terms

Conditions

Smoking CessationChronic Disease

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Natalie T. MacLeod, M.Sc. Candidate

    McMaster University

    PRINCIPAL INVESTIGATOR
  • Rolf J. Sebaldt, MD

    McMaster University

    PRINCIPAL INVESTIGATOR
  • Peter Selby, MD

    Centre for Addiction and Mental Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 28, 2009

First Posted

October 29, 2009

Study Start

November 1, 2009

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

October 29, 2009

Record last verified: 2009-10

Locations