Standard Telephone Consultation for Pain | NCT01923324

Studies
Standard Telephone Consultation for Pain

NCT01923324

Sponsor

University of Calgary

Status

Completed

Last Update Posted

Aug 15, 2013Estimated

Enrollment

80Actual

Phase

Not Applicable

Conditions

Chronic Pain

Interventions

Physician telephone consultation
Usual family physician care

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2005

Primary Completion Date

Dec 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

Aug 13, 2013

First Submission Date that Met QC Criteria

Aug 13, 2013

First Posted Date

Aug 15, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 13, 2013

Last Update Posted Date

Aug 15, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to investigate whether pain control for patients with chronic pain is improved by the availability of structured telephone consultations between the patients' family physicians and pain physicians, compared to pain control for patients receiving usual care.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Physician telephone consultation	Experimental	Received direct telephone consultation with pain physician about index patient	Behavioral: Physician telephone consultation
Usual family physician care	Active Comparator	Usual family physician care (without direct telephone consultation with pain physician)	Behavioral: Usual family physician care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Physician telephone consultation	Behavioral	Pain physician support for family physician treating patient	Physician telephone consultation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Numerical Rating Scale for pain intensity (NRS)	11 point scale (from zero to 10), zero equals no pain, 10 worst possible pain.	6 months

Secondary Outcomes

Measure	Description	Time Frame
Pain Disability Index (PDI)	7 item self-report scale assessing pain disability	6 months
Patient Global Impression of Change Scale (PGIC)	7 point scale

Other Outcomes

Measure	Description	Time Frame
Pain treatment satisfaction scale (patient)		6 months
Family physician satisfaction questionnaire		6 months
Family physician knowledge transfer questionnaire

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients referred to Alberta Health Services chronic pain center in Calgary with neurological or muscular skeletal pain

Exclusion Criteria:

increased risk for suicide, very complex patients, family physician could not reliably identify patient's pain problem, or condition warranted expedited consultation with pain physician, case represented a new presentation of chronic regional pain syndrome, or low back pain with radicular symptoms or sciatica

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Neil Drummond, PhD	University of Calgary	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Alberta Health Services Chronic Pain Centre		Calgary	Alberta	T2S 3C3	Canada

Condition Browse Module

MeSH Terms

ID	Term
D059350	Chronic Pain

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided