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Coordinating Teams in Primary Health Care.

Primary Purpose

Musculoskeletal Diseases

Status

Completed

Phase

Not Applicable

Locations

Norway

Study Type

Interventional

Intervention

coordinating primary health care

usual primary health care

About this trial

This is an interventional health services research trial for Musculoskeletal Diseases focused on measuring primary health care, Physical Therapy Specialty, General Practitioners, General Practice

Eligibility Criteria

21 Years - 58 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

patient in one of the participating general practices
musculoskeletal complaints in 3 years before start of this study
informed consent

Exclusion Criteria:

Sites / Locations

Stjørdal Legesenter
Persaunet Legesenter
Rosten Legesenter
Sjøsiden Legesenter

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

coordinating primary health care 1

usual primary health care 1

coordinating primary health care 2

usual primary health care 2

Arm Description

musculoskeletal pain care by a coordinating team of one general practitioner and two physical therapists

usual care of musculoskeletal pain in general practice

musculoskeletal pain care by a coordinating team of one general practitioner and two physical therapists

usual care of musculoskeletal pain in general practice

Outcomes

Primary Outcome Measures

change in sick leave

average number of days sick leave during 3 years pre-intervention and during the first, second and third year of the study

referrals to specialist care

number of referrals to specialist care including private rehabilitation centers

Secondary Outcome Measures

Full Information

NCT ID

NCT02020772

First Posted

December 19, 2013

Last Updated

October 19, 2021

Sponsor

Norwegian University of Science and Technology

1. Study Identification

Unique Protocol Identification Number

NCT02020772

Brief Title

Coordinating Teams in Primary Health Care.

Official Title

Coordination Between General Practitioners and Physical Therapists in Primary Health Care for Musculoskeletal Pain: Effect on Sick Leave and Referral to Specialist Care.

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Completed

Study Start Date

December 2013 (Actual)

Primary Completion Date

August 1, 2018 (Actual)

Study Completion Date

August 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Norwegian University of Science and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Patients who suffer from musculoskeletal pain often have more than one diagnosis. These patients mostly have to wait a long time for the doctor's examination and treatment, and they also often have a sick leave for a long period of time. The investigators expect that treatment and follow-up by an coordinating interdisciplinary team can improve these patients opportunity to function, increase their quality of life, and decrease their pain. The purpose of this study is to investigate if use of a coordinating interdisciplinary team in primary health care will result in reduced sick leave compared with practice as usual, and give fewer referrals to specialized health services and private rehabilitation centers. Research data will be obtained from the patients journals, questionnaires, and clinical examinations..

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Musculoskeletal Diseases

Keywords

primary health care, Physical Therapy Specialty, General Practitioners, General Practice

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

969 (Actual)

8. Arms, Groups, and Interventions

Arm Title

coordinating primary health care 1

Arm Type

Experimental

Arm Description

musculoskeletal pain care by a coordinating team of one general practitioner and two physical therapists

Arm Title

usual primary health care 1

Arm Type

Active Comparator

Arm Description

usual care of musculoskeletal pain in general practice

Arm Title

coordinating primary health care 2

Arm Type

Experimental

Arm Description

musculoskeletal pain care by a coordinating team of one general practitioner and two physical therapists

Arm Title

usual primary health care 2

Arm Type

Active Comparator

Arm Description

usual care of musculoskeletal pain in general practice

Intervention Type

Other

Intervention Name(s)

coordinating primary health care

Intervention Type

Other

Intervention Name(s)

usual primary health care

Primary Outcome Measure Information:

Title

change in sick leave

Description

average number of days sick leave during 3 years pre-intervention and during the first, second and third year of the study

Time Frame

3 years

Title

referrals to specialist care

Description

number of referrals to specialist care including private rehabilitation centers

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

58 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: patient in one of the participating general practices musculoskeletal complaints in 3 years before start of this study informed consent Exclusion Criteria: -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Siv Mørkved, prof phd

Organizational Affiliation

Norwegian University of Science and Technology

Official's Role

Study Director

Facility Information:

Facility Name

Stjørdal Legesenter

City

Stjørdal

Country

Norway

Facility Name

Persaunet Legesenter

City

Trondheim

Country

Norway

Facility Name

Rosten Legesenter

City

Trondheim

Country

Norway

Facility Name

Sjøsiden Legesenter

City

Trondheim

Country

Norway

12. IPD Sharing Statement

Citations:

PubMed Identifier

33482782

Citation

Garnaes KK, Morkved S, Salvesen O, Tonne T, Furan L, Gronhaug G, Vasseljen O, Johannessen HH. What factors are associated with health-related quality of life among patients with chronic musculoskeletal pain? A cross-sectional study in primary health care. BMC Musculoskelet Disord. 2021 Jan 22;22(1):102. doi: 10.1186/s12891-020-03914-x.

Results Reference

result

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Coordinating Teams in Primary Health Care.

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