Akademiskt Primärvårdscentrum, Solnavägen 1D
Stockholm, 113 65, Sweden
NCT Number: NCT05577026
Opioid analgesics are commonly prescribed addictive narcotics intended for the treatment of pain. Inappropriate prescription of opioids in quantities and for conditions which lack clinical evidence contributes to the risk of misuse and addiction. The majority of opioid prescriptions are written by physicians (general practitioners) in primary health care (PHC). PHC is thus an important setting for efforts to encourage the safe and appropriate prescription of opioids. Increasing knowledge of pain treatment recommendations, risks of opioids, and guidelines for the prescription of opioids may decrease inappropriate prescription, and thereby risk of tolerance, dependence, and addiction.
This study is active but is not currently recruiting participants.
18 year and older
All sexes
Interventional
Not applicable
Stockholm, 113 65, Sweden
Opioids are a class of addictive narcotic drugs which can be obtained by prescription for the treatment of pain. There is clinical evidence for the use of opioids for acute, post-operative, and cancer related pain, although guidelines recommend the lowest effective dose and duration be prescribed. There is less evidence for the long-term benefits of opioid therapy for chronic non-cancer pain and the risk for harm and addiction is increased with prolonged use. Patients with long-term treatment may experience only marginal pain reduction and a risk of long-term consequences including tolerance, dependence, and adverse effects such as cognitive disturbance and decline, behavioral problems, emergency visits, accidents, suicide, and drug-related mortality. As the majority of opioids are prescribed by physicians in primary health care, this is an important setting for promoting the safe and appropriate use of prescription opioids.
This trial evaluates whether a brief educational intervention in primary health care (PHC) followed by 12 months of feedback on prescription data changes the prescription of opioids in primary care.
PHC centers in Stockholm County will be invited to participate in the study. Centers that express interest in participating, meet the inclusion criteria, and do not meet the exclusion criteria will be randomized to the intervention or control group. Personnel at the intervention centers will participate in a brief educational intervention followed by 12 months of regular feedback on opioid prescriptions, with benchmarking to other local PHC centers. Centers randomized to the active control group will receive written information on treatment guidelines but will not receive the onsite educational intervention or prescription feedback.
The primary outcome, change in opioid prescription, will be measured at 12 months after intervention start. Data on outcomes and characteristics of participating primary health care centers including prescription before, during and after the intervention will be extracted from regional health care registers and databases and analyzed statistically.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Eligibility criteria apply to primary health care centers.
Inclusion criteria
Exclusion criteria
Brief educational intervention and patient and provider materials regarding prescription of opioids. Subsequent feedback on clinic prescription of opioids over 12 months.
Written information on guidelines and recommendations regarding prescription of opioids.
Time frame: 12 months
Change in prescription of opioids as measured by defined daily dose (DDD) and morphine milligram equivalents (MME)
Time frame: 12 months
Change in type of opioids prescribed by drug class (ATC code)
Time frame: 24 months
Change in prescriptions of opioids as measured by defined daily dose (DDD) and morphine milligram equivalents (MME)
Time frame: 12 months
Change in number of patients prescribed opioids (new or continued prescription)
Time frame: 12 months
Change in number of patients with initial (new) opioid prescriptions among opioid-naïve patients
Region Stockholm
Other Gov
Safe and Appropriate Prescribing of Opioids in Primary Care: a Randomized Control Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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