Effects of two guideline implementation strategies on patient outcomes in primary care: a cluster randomized controlled trial.
METHODS
Cluster randomized controlled trial.


OBJECTIVE
To improve quality of care for patients with low back pain (LBP) a multifaceted general practitioner education alone and in combination with motivational counseling by practice nurses has been implemented in German general practices. We studied effects on functional capacity (main outcome), days in pain, physical activity, quality of life, or days of sick leave (secondary outcomes) compared with no intervention.


BACKGROUND
International research has lead to the development of the German LBP guideline for general practitioners. However, there is still doubt about the most effective implementation strategy. Although effects on process of care have been observed frequently, changes in patient outcomes are rarely seen.


METHODS
We recruited 1378 patients with LBP in 118 general practices, which were randomized to 1 of 3 study arms: a multifaceted guideline implementation (GI), GI plus training of practice nurses in motivational counseling (MC), and the postal dissemination of the guideline (controls, C). Data were collected (questionnaires and patient interviews) at baseline and after 6 and 12 months. Multilevel mixed effects modeling was used to adjust for clustering of data and potential confounders.


RESULTS
After 6 months, functional capacity was higher in the intervention groups with a cluster adjusted mean difference of 3.650 between the MC group and controls (95% CI = 0.320-6.979, P = 0.032) and 2.652 between the GI group and controls (95% CI = -0.704 to 6.007, P = 0.120). Intervention effects were more pronounced regarding days in pain per year with an average reduction of 16 (GI) to 17 days (MC) after 6 months (12 and 9 days after 12 months) compared with controls.


CONCLUSIONS
Active implementation of the German LBP guideline results in slightly better outcomes during 6 months follow-up than its postal dissemination. Results are more distinct when practice nurses are trained in motivational counseling.
Becker
Annette
A
Department of General Practice, Preventive and Rehabilitation Medicine, University of Marburg, Marburg, Germany. Annette.Becker@med.uni-marburg.de
Leonhardt
Corinna
C
Kochen
Michael M
MM
Keller
Stefan
S
Wegscheider
Karl
K
Baum
Erika
E
Donner-Banzhoff
Norbert
N
Pfingsten
Michael
M
Hildebrandt
Jan
J
Basler
Heinz-Dieter
HD
Chenot
Jean F
JF
D000328:Adult; D002908:Chronic Disease; D003376:Counseling; D005260:Female; D005500:Follow-Up Studies; D019983:Guideline Adherence; D006284:Health Plan Implementation; D006801:Humans; D017116:Low Back Pain / Q000451:nursing / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009042:Motivation; D010821:Physicians, Family; D011320:Primary Health Care / Q000379:methods* / Q000592:standards*; D011787:Quality of Health Care; D011788:Quality of Life; D016896:Treatment Outcome