NCT02762240

Brief Summary

Accreditation is used increasingly in health systems worldwide. However, there is a lack of evidence of the effectiveness of accreditation. The overall aim of this study is to evaluate the effectiveness of a mandatory accreditation in general practice.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,900

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2014

Longer than P75 for not_applicable

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

Study Start

First participant enrolled

June 1, 2014

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

March 29, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 4, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

May 26, 2016

Status Verified

May 1, 2016

Enrollment Period

3.1 years

First QC Date

March 29, 2016

Last Update Submit

May 24, 2016

Conditions

Quality Control

Keywords

AccreditationCertificationGeneral PracticeFamily MedicineRandomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

  • Changes in number of prescribed drugs in patients above 65 years in the observation periods.

    Data regarding Prescription medication is retrieved from Nationwide Medication Database (MD)

    6 months periods

Secondary Outcomes (9)

  • • Changes in the proportion of polypharmacy patients above 65 years (>5 prescribed drugs) between periods.

    6 months periods

  • • Changes in Daily Drug Dose of NSAID without Proton-pump inhibitor in period between periods.

    6 months periods

  • • Changes in Daily Drug Dose of sleeping medicine between periods.

    6 month periods

  • Changes in the proportion of elderly above 75 receiving a preventive home visit between periods.

    6 month periods

  • Changes in the number of annual controls for chronic diseases between periods.

    6 month periods

  • +4 more secondary outcomes

Study Arms (2)

DHQP 2016

ACTIVE COMPARATOR

This group consists of general practices allocated to undergo accreditation scheme in 2016.

Other: DHQP 2016

DHQP 2018

PLACEBO COMPARATOR

This group consists of general practices allocated to undergo accreditation scheme in 2018.

Other: DHQP 2018

Interventions

DHQP 2016OTHER

DHQP for general practice consists of 16 standards with associated indicators within the following areas: 1. Quality and patient safety, 2. Patient safety critical standards, 3. Good patient continuity of care, 4. Management and organisation.

Also known as: Early Intervention
DHQP 2016
DHQP 2018OTHER

DHQP for general practice consists of 16 standards with associated indicators within the following areas: 1. Quality and patient safety, 2. Patient safety critical standards, 3. Good patient continuity of care, 4. Management and organisation.

Also known as: Late Intervention
DHQP 2018

Eligibility Criteria

AgeUp to 120 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • General practices working under the Danish Health Insurance at June 2014

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Kirstine Andersen M, Pedersen LB, Waldorff FB. Retirement, job satisfaction and attitudes towards mandatory accreditation: a Danish survey study in general practice. BMJ Open. 2018 Aug 13;8(8):e020419. doi: 10.1136/bmjopen-2017-020419.

    PMID: 30104311DERIVED

  • Andersen MK, Pedersen LB, Siersma V, Bro F, Reventlow S, Sondergaard J, Kousgaard MB, Waldorff FB. Accreditation in general practice in Denmark: study protocol for a cluster-randomized controlled trial. Trials. 2017 Feb 13;18(1):69. doi: 10.1186/s13063-017-1818-6.

    PMID: 28193288DERIVED

Related Links

MeSH Terms

Interventions

Early Intervention, Educational

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 29, 2016

First Posted

May 4, 2016

Study Start

June 1, 2014

Primary Completion

July 1, 2017

Study Completion

December 1, 2020

Last Updated

May 26, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share