Condition category
Nutritional, Metabolic, Endocrine
Date applied
26/02/2007
Date assigned
26/02/2007
Last edited
25/04/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr R Dijkstra

ORCID ID

Contact details

Centre for Quality of Care Research (117-WOK)
Radboud University Medical Centre
P.O. Box 9101
Nijmegen
6500 HB
Netherlands
r.dijkstra@kwazo.umcn.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

DIHS

Study hypothesis

A patient centred or a professional directed intervention to improve adherence to diabetes guidelines in hospitals are more (cost) effective compared to usual care.

More details can be found at:
1. http://www.ncbi.nlm.nih.gov/pubmed/12191541
2. http://www.ncbi.nlm.nih.gov/pubmed/15860240

Ethics approval

The ethics committee of St Radboud Medical Centre approved the trial on 30/11/1998, ref: CWOM-nr: 9810-0208

Study design

Randomised, active controlled, parallel group, multicentre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Diabetes, empowerment, guideline adherence, guidelines, physician-patient interaction

Intervention

At hospitals in the professional-directed group (n = 4), the health professionals received aggregated feedback on baseline data on their patient population. During an educational meeting for internists, Diabetes Specialist Nurses (DSNs) and dieticians, the guidelines were discussed, promoted and distributed by a national opinion leader in diabetic care. Also desktop reminder cards of key guidelines were distributed, including a nomogram to easily calculate the Body Mass Index (BMI).

Internists and DSNs preferred these reminder cards to locally adapted written protocols. After six months the internists received personal benchmarked feedback on their clinical performance.

At the hospitals in the patient centred group (n = 4) intervention activities were addressed to the health care professionals and to the patients. As in the other intervention group feedback was given to the professionals on baseline data. During an educational meeting with a national opinion leader, guidelines as well as the diabetes passports were introduced. Barriers and facilitators to implement the diabetes passports in the clinic were discussed.

Like in the other intervention group after six months personal feedback was given to the internists only, but this time on clinical performance as well as on the use of the diabetes passport. For the patients in the patient centred group, additional educational meetings were organised in collaboration with the local patient organisations. Furthermore 4,500 diabetes passports were made available at the four hospitals and waiting room posters, reminders for the patients to bring their passports and leaflets explaining how to use the passport were distributed. The passports were introduced and given to the patients by internists or DSNs during the clinic hours.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The mean HbA1c level (mmol/l) of the patients in the different intervention groups.

Secondary outcome measures

Clinical outcomes at the patient level:
1. Quality of Life (Short Form Health Survey [SF-20]) locus of control
2. Patient satisfaction

Overall trial start date

01/12/2000

Overall trial end date

18/03/2004

Reason abandoned

Eligibility

Participant inclusion criteria

In 13 hospitals, the first 150 patients with diabetes that came for a check-up at their internists were included.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

1950

Participant exclusion criteria

1. Patients with a short (less than one year) life expectancy
2. Pregnant patients

Recruitment start date

01/12/2000

Recruitment end date

18/03/2004

Locations

Countries of recruitment

Netherlands

Trial participating centre

Centre for Quality of Care Research (117-WOK)
Nijmegen
6500 HB
Netherlands

Sponsor information

Organisation

University Medical Centre St. Radboud (The Netherlands)

Sponsor details

Center for Quality of Care Research (WOK)
117 KWAZO
P.O. Box 9101
Nijmegen
6500 HB
Netherlands

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

The Netherlands Ministry of Health, Welfare and Sport (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2006 results in: http://www.ncbi.nlm.nih.gov/pubmed/16433714
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/23949558

Publication citations

  1. Results

    Dijkstra RF, Niessen LW, Braspenning JC, Adang E, Grol RT, Patient-centred and professional-directed implementation strategies for diabetes guidelines: a cluster-randomized trial-based cost-effectiveness analysis., Diabet. Med., 2006, 23, 2, 164-170, doi: 10.1111/j.1464-5491.2005.01751.x.

  2. Results

    Slingerland AS, Herman WH, Redekop WK, Dijkstra RF, Jukema JW, Niessen LW, Stratified patient-centered care in type 2 diabetes: a cluster-randomized, controlled clinical trial of effectiveness and cost-effectiveness., Diabetes Care, 2013, 36, 10, 3054-3061, doi: 10.2337/dc12-1865.

Additional files

Editorial Notes