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Collaborative Care for Opioid and Alcohol Use Disorders in Primary Care: The SUMMIT Randomized Clinical Trial.

ABSTRACT: Importance:Primary care offers an important and underutilized setting to deliver treatment for opioid and/or alcohol use disorders (OAUD). Collaborative care (CC) is effective but has not been tested for OAUD. Objective:To determine whether CC for OAUD improves delivery of evidence-based treatments for OAUD and increases self-reported abstinence compared with usual primary care. Design, Setting, and Participants:A randomized clinical trial of 377 primary care patients with OAUD was conducted in 2 clinics in a federally qualified health center. Participants were recruited from June 3, 2014, to January 15, 2016, and followed for 6 months. Interventions:Of the 377 participants, 187 were randomized to CC and 190 were randomized to usual care; 77 (20.4%) of the participants were female, of whom 39 (20.9%) were randomized to CC and 38 (20.0%) were randomized to UC. The mean (SD) age of all respondents at baseline was 42 (12.0) years, 41(11.7) years for the CC group, and 43 (12.2) yearsfor the UC group. Collaborative care was a system-level intervention, designed to increase the delivery of either a 6-session brief psychotherapy treatment and/or medication-assisted treatment with either sublingual buprenorphine/naloxone for opioid use disorders or long-acting injectable naltrexone for alcohol use disorders. Usual care participants were told that the clinic provided OAUD treatment and given a number for appointment scheduling and list of community referrals. Main Outcomes and Measures:The primary outcomes were use of any evidence-based treatment for OAUD and self-reported abstinence from opioids or alcohol at 6 months. The secondary outcomes included the Healthcare Effectiveness Data and Information Set (HEDIS) initiation and engagement measures, abstinence from other substances, heavy drinking, health-related quality of life, and consequences from OAUD. Results:At 6 months, the proportion of participants who received any OAUD treatment was higher in the CC group compared with usual care (73 [39.0%] vs 32 [16.8%]; logistic model adjusted OR, 3.97; 95% CI, 2.32-6.79; P?

SUBMITTER: Watkins KE

PROVIDER: S-EPMC5710213 | biostudies-literature | 2017 Oct

REPOSITORIES: biostudies-literature

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Collaborative Care for Opioid and Alcohol Use Disorders in Primary Care: The SUMMIT Randomized Clinical Trial.

Watkins Katherine E KE Ober Allison J AJ Lamp Karen K Lind Mimi M Setodji Claude C Osilla Karen Chan KC Hunter Sarah B SB McCullough Colleen M CM Becker Kirsten K Iyiewuare Praise O PO Diamant Allison A Heinzerling Keith K Pincus Harold Alan HA

JAMA internal medicine 20171001 10

<h4>Importance</h4>Primary care offers an important and underutilized setting to deliver treatment for opioid and/or alcohol use disorders (OAUD). Collaborative care (CC) is effective but has not been tested for OAUD.<h4>Objective</h4>To determine whether CC for OAUD improves delivery of evidence-based treatments for OAUD and increases self-reported abstinence compared with usual primary care.<h4>Design, setting, and participants</h4>A randomized clinical trial of 377 primary care patients with ...[more]

PMID: 28846769

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Project description:BackgroundMost people with opioid use disorder (OUD) never receive treatment. Medication treatment of OUD in primary care is recommended as an approach to increase access to care. The PRimary Care Opioid Use Disorders treatment (PROUD) trial tests whether implementation of a collaborative care model (Massachusetts Model) using a nurse care manager (NCM) to support medication treatment of OUD in primary care increases OUD treatment and improves outcomes. Specifically, it tests whether implementation of collaborative care, compared to usual primary care, increases the number of days of medication for OUD (implementation objective) and reduces acute health care utilization (effectiveness objective). The protocol for the PROUD trial is presented here.MethodsPROUD is a hybrid type III cluster-randomized implementation trial in six health care systems. The intervention consists of three implementation strategies: salary for a full-time NCM, training and technical assistance for the NCM, and requiring that three primary care providers have DEA waivers to prescribe buprenorphine. Within each health system, two primary care clinics are randomized: one to the intervention and one to Usual Primary Care. The sample includes all patients age 16-90 who visited the randomized primary care clinics from 3 years before to 2 years after randomization (anticipated to be > 170,000). Quantitative data are derived from existing health system administrative data, electronic medical records, and/or health insurance claims ("electronic health records," [EHRs]). Anonymous staff surveys, stakeholder debriefs, and observations from site visits, trainings and technical assistance provide qualitative data to assess barriers and facilitators to implementation. The outcome for the implementation objective (primary outcome) is a clinic-level measure of the number of patient days of medication treatment of OUD over the 2 years post-randomization. The patient-level outcome for the effectiveness objective (secondary outcome) is days of acute care utilization [e.g. urgent care, emergency department (ED) and/or hospitalizations] over 2 years post-randomization among patients with documented OUD prior to randomization.DiscussionThe PROUD trial provides information for clinical leaders and policy makers regarding potential benefits for patients and health systems of a collaborative care model for management of OUD in primary care, tested in real-world diverse primary care settings. Trial registration # NCT03407638 (February 28, 2018); CTN-0074 https://clinicaltrials.gov/ct2/show/NCT03407638?term=CTN-0074&draw=2&rank=1.

Project description:ImportanceCollaborative care for depression and anxiety is superior to usual care from primary care physicians for these conditions; however, challenges limit its provision in routine practice and at scale. Advances in technology may overcome these barriers but have yet to be tested.ObjectiveTo examine the effectiveness of combining an internet support group (ISG) with an online computerized cognitive behavioral therapy (CCBT) provided via a collaborative care program for treating depression and anxiety vs CCBT alone and whether providing CCBT in this manner is more effective than usual care.Design, setting, and participantsIn this 3-arm randomized clinical trial with blinded outcome assessments, primary care physicians from 26 primary care practices in Pittsburgh, Pennsylvania, referred 2884 patients aged 18 to 75 years in response to an electronic medical record prompt from August 2012 to September 2014. Overall, 704 patients (24.4%) met all eligibility criteria and were randomized to CCBT alone (n = 301), CCBT+ISG (n = 302), or usual care (n = 101). Intent-to-treat analyses were conducted November 2015 to January 2017.InterventionsSix months of guided access to an 8-session CCBT program provided by care managers who informed primary care physicians of their patients' progress and promoted patient engagement with our online programs.Main outcomes and measuresMental health-related quality of life (12-Item Short-Form Health Survey Mental Health Composite Scale) and depression and anxiety symptoms (Patient-Reported Outcomes Measurement Information System) at 6-month follow-up, with treatment durability assessed 6 months later.ResultsOf the 704 randomized patients, 562 patients (79.8%) were female, and the mean (SD) age was 42.7 (14.3) years. A total of 604 patients (85.8%) completed our primary 6-month outcome assessment. At 6-month assessment, 254 of 301 patients (84.4%) receiving CCBT alone started the program (mean [SD] sessions completed, 5.4 [2.8]), and 228 of 302 patients (75.5%) in the CCBT+ISG cohort logged into the ISG at least once, of whom 141 (61.8%) provided 1 or more comments or posts (mean, 10.5; median [range], 3 [1-306]). Patients receiving CCBT+ISG reported similar 6-month improvements in mental health-related quality of life, mood, and anxiety symptoms compared with patients receiving CCBT alone. However, compared with patients receiving usual care, patients in the CCBT alone cohort reported significant 6-month effect size improvements in mood (effect size, 0.31; 95% CI, 0.09-0.53) and anxiety (effect size, 0.26; 95% CI, 0.05-0.48) that persisted 6 months later, and completing more CCBT sessions produced greater effect size improvements in mental health-related quality of life and symptoms.Conclusions and relevanceWhile providing moderated access to an ISG provided no additional benefit over guided CCBT at improving mental health-related quality of life, mood, and anxiety symptoms, guided CCBT alone is more effective than usual care for these conditions.Trial registrationclinicaltrials.gov Identifier: NCT01482806.

Project description:To test a collaborative care model for interfacing sleep specialists with primary care providers to enhance patients' sleep disorders management.This study used a randomized, parallel group, clinical intervention trial design. A total of 137 adult (29 women) VA outpatients with sleep complaints were enrolled and randomly assigned to (1) an intervention (INT) consisting of a one-time consultation with a sleep specialist who provided diagnostic feedback and treatment recommendations to the patient and the patient's primary care provider; or (2) a control condition consisting of their usual primary care (UPC). Provider-focused outcomes included rates of adherence to recommended diagnostic procedures and sleep-focused interventions. Patient-focused outcomes included measures taken from sleep diaries and actigraphy; Pittsburgh Sleep Quality Index (PSQI) scores; and self-report measures of sleepiness, fatigue, mood, quality of life, and satisfaction with health care.The proportions of provider-initiated sleep-focused interventions were significantly higher in the INT group than in the UPC group for polysomnography referrals (49% versus 6%; P < 0.001) and mental health clinic referrals (19% versus 6%; P = 0.02). At the 10-mo follow up, INT recipients showed greater estimated mean reductions in diary total wake time (-17.0 min; 95% confidence interval [CI]: -30.9, -3.1; P = 0.02) and greater increases in sleep efficiency (+3.7%; 95% CI: 0.8, 6.5; P = 0.01) than did UPC participants. A greater proportion of the INT group showed ? 1 standard deviation decline on the PSQI from baseline to the 10-mo follow-up (41% versus 21%; P = 0.02). Moreover, 69% of the INT group had normal (? 10) Epworth Sleepiness Scale scores at the 10-mo follow-up, whereas only 50% of the UPC group fell below this clinical cutoff (P = 0.03).A one-time sleep consultation significantly increased healthcare providers' attention to sleep problems and resulted in benefits to patients' sleep/wake symptoms.This study is registered with clinicaltrials.gov with identifier # NCT00390572.

Project description:BackgroundHarmful alcohol use is a leading cause of global disability and death. However, increased detection and brief intervention capacity of more severe alcohol use disorders has not been accompanied by increased availability of treatment services. Incorporating treatment for such disorders into primary care is of paramount importance for improving access and health outcomes. This study aims to estimate the effectiveness of a Brief Motivational Treatment (BMT) applied in primary care for treatment of these disorders.MethodsA parallel-group, single-blinded, severity-stratified, randomized clinical trial will test the superiority of BMT over enhanced usual care. Eligible participants will be those seeking treatment and who fulfill DSM-V criteria for alcohol use disorder and criteria for harmful alcohol use. With an estimated a loss to follow-up of 20%, a total of 182 participants will be recruited and equally randomized to each treatment group. The intervention group will receive an adaptation of the motivational enhancement therapy, as manualized in Project MATCH. This treatment consists of four 45-min sessions provided by a general psychologist with at least 3 years of primary care experience. The primary outcome is the change from baseline in the drinks per drinking day during the last 90 days, which will be captured using the Timeline Follow Back method. Secondary outcomes will describe the changes in alcohol use pattern, motivational status, and severity of the disorder. All participants will be analyzed according to the group they were allocated, regardless of the treatment actually received. Mean differences (MD) will be computed for continuous outcomes and relative risks (RR) and RR reductions (RRR) for dichotomous results. Linear models will deliver the subgroup analyses. Missingness is assumed to be associated with the baseline alcohol use pattern and severity, so a multiple imputation method will be used to handle missing data.DiscussionThis trial aims to test the superiority of BMT over enhanced usual care with a reasonable superiority margin, over which the BMT could be further considered for incorporation into PC in Chile. Its pragmatic approach ultimately aims to inform policymakers about the benefit of including a brief psychosocial treatment into PC.Trial registrationClinicalTrials.gov NCT04345302 . Registered on 28 April 2020.

Project description:ImportanceUp to 20% of adolescents experience an episode of major depression by age 18 years yet few receive evidence-based treatments for their depression.ObjectiveTo determine whether a collaborative care intervention for adolescents with depression improves depressive outcomes compared with usual care.DesignRandomized trial with blinded outcome assessment conducted between April 2010 and April 2013.SettingNine primary care clinics in the Group Health system in Washington State.ParticipantsAdolescents (aged 13-17 years) who screened positive for depression (Patient Health Questionnaire 9-item [PHQ-9] score ≥10) on 2 occasions or who screened positive and met criteria for major depression, spoke English, and had telephone access were recruited. Exclusions included alcohol/drug misuse, suicidal plan or recent attempt, bipolar disorder, developmental delay, and seeing a psychiatrist.InterventionsTwelve-month collaborative care intervention including an initial in-person engagement session and regular follow-up by master's-level clinicians. Usual care control youth received depression screening results and could access mental health services through Group Health.Main outcomes and measuresThe primary outcome was change in depressive symptoms on a modified version of the Child Depression Rating Scale-Revised (CDRS-R; score range, 14-94) from baseline to 12 months. Secondary outcomes included change in Columbia Impairment Scale score (CIS), depression response (≥50% decrease on the CDRS-R), and remission (PHQ-9 score <5).ResultsIntervention youth (n = 50), compared with those randomized to receive usual care (n = 51), had greater decreases in CDRS-R scores such that by 12 months intervention youth had a mean score of 27.5 (95% CI, 23.8-31.1) compared with 34.6 (95% CI, 30.6-38.6) in control youth (overall intervention effect: F2,747.3 = 7.24, P < .001). Both intervention and control youth experienced improvement on the CIS with no significant differences between groups. At 12 months, intervention youth were more likely than control youth to achieve depression response (67.6% vs 38.6%, OR = 3.3, 95% CI, 1.4-8.2; P = .009) and remission (50.4% vs 20.7%, OR = 3.9, 95% CI, 1.5-10.6; P = .007).Conclusions and relevanceAmong adolescents with depression seen in primary care, a collaborative care intervention resulted in greater improvement in depressive symptoms at 12 months than usual care. These findings suggest that mental health services for adolescents with depression can be integrated into primary care.Trial registrationclinicaltrials.gov Identifier: NCT01140464.

Project description:ImportanceUnhealthy alcohol use (UAU) is the fourth most preventable cause of death in the US. The US Preventive Services Task Force recommends that primary care clinicians routinely screen all adults 18 years and older for UAU; however, this preventive service is poorly implemented.ObjectiveTo determine if practice facilitation improved delivery of the recommended care for UAU compared to usual care.Design, setting, and participantsThis practice-level cluster randomized clinical trial was conducted across diverse and representative primary care practices throughout Virginia. A total of 76 primary care practices enrolled between October 2019 and January 2023.InterventionPractices received immediate (intervention) or 6-month delayed (control) practice facilitation, which included tailored educational sessions, workflow management, and tools for addressing UAU.Main outcomes and measuresOutcomes included the increase in recommended screening for UAU, brief interventions, referral for counseling, and medication treatment. Data were collected via medical record review (structured and free text data) and transcripts of practice facilitator sessions and exits interviews.ResultsOf the 76 primary care practices enrolled, 32 were randomized to intervention and 35 to control; 11 789 patients (mean [SD] age, 50.1 [16.3] years; 61.1% women) were randomly selected for analysis, with patient demographics similar to Virginia at large. From baseline to 6 months after intervention, screening with a validated instrument increased from 2.1% (95% CI, 0.5%-8.4%) to 35.5% (95% CI, 11.5%-69.9%) in the intervention group compared to 0.4% (95% CI, 0.1%-1.8%) to 1.4% (95% CI, 0.3%-5.8%) in the control group (P < .001). Brief office-based interventions for the intervention group increased from 26.2% (95% CI, 14.2%-45.8%) to 62.6% (95% CI, 43.6%-78.3%) vs 45.5% (95% CI, 28.0%-64.1%) to 55.1% (95% CI, 36.5%-72.3%) in the control group (P = .008). Identification of UAU, referral for counseling, and medication treatment had similar changes for both groups. Qualitative analyses of transcripts revealed that few clinicians understood the preventive service prior to practice facilitation, but at the end most felt much more competent and confident with screening and brief intervention for UAU.Conclusions and relevanceThis cluster randomized clinical trial demonstrated that practice facilitation can help primary care practices to better implement screening and counseling for UAU into their routine workflow. Effective primary care practice implementation interventions such as this can have a profound effect on the health of communities. Given the number of people that the participating practices care for, this intervention resulted in an additional 114 604 patients being screened annually for UAU who would not have been otherwise.Trial registrationClinicalTrials.gov Identifier: NCT04248023.

Project description:ImportanceExperts recommend that alcohol use disorders (AUDs) be managed in primary care, but effective approaches are unclear.ObjectiveTo test whether 12 months of alcohol care management, compared with usual care, improved drinking outcomes among patients with or at high risk for AUDs.Design, setting, and participantsThis randomized clinical trial was conducted at 3 Veterans Affairs (VA) primary care clinics. Between October 11, 2011, and September 30, 2014, the study enrolled 304 outpatients who reported heavy drinking (≥4 drinks per day for women and ≥5 drinks per day for men).InterventionsNurse care managers offered outreach and engagement, repeated brief counseling using motivational interviewing and shared decision making about treatment options, and nurse practitioner-prescribed AUD medications (if desired), supported by an interdisciplinary team (CHOICE intervention). The comparison was usual primary care.Main outcomes and measuresPrimary outcomes, assessed by blinded telephone interviewers at 12 months, were percentage of heavy drinking days in the prior 28 days measured by timeline follow-back interviews and a binary good drinking outcome, defined as abstinence or drinking below recommended limits in the prior 28 days (according to timeline follow-back interviews) and no alcohol-related symptoms in the past 3 months as measured by the Short Inventory of Problems.ResultsOf 304 participants, 275 (90%) were male, 206 (68%) were white, and the mean (SD) age was 51.4 (13.8) years. At baseline, both the CHOICE intervention (n = 150) and usual care (n = 154) groups reported heavy drinking on 61% of days (95% CI, 56%-66%). During the 12-month intervention, 137 of 150 patients in the intervention group (91%) had at least 1 nurse visit, and 77 of 150 (51%) had at least 6 nurse visits. A greater proportion of patients in the intervention group than in the usual care group received alcohol-related care: 42% (95% CI, 35%-49%; 63 of 150 patients) vs 26% (95% CI, 19%-35%; 40 of 154 patients). Alcohol-related care included more AUD medication use: 32% (95% CI, 26%-39%; 48 of 150 patients in the intervention group) vs 8% (95% CI, 5%-13%; 13 of 154 patients in the usual care group). No significant differences in primary outcomes were observed at 12 months between patients in both groups. The percentages of heavy drinking days were 39% (95% CI, 32%-47%) and 35% (95% CI, 28%-42%), and the percentages of patients with a good drinking outcome were 15% (95% CI, 9%-22%; 18 of 124 patients) and 20% (95 % CI, 14%-28%; 27 of 134 patients), in the intervention and usual care groups, respectively (P = .32-.44). Findings at 3 months were similar.Conclusions and relevanceThe CHOICE intervention did not decrease heavy drinking or related problems despite increased engagement in alcohol-related care.Trial registrationclinicaltrials.gov Identifier: NCT01400581.

Dataset Information

Collaborative Care for Opioid and Alcohol Use Disorders in Primary Care: The SUMMIT Randomized Clinical Trial.

Publications

Collaborative Care for Opioid and Alcohol Use Disorders in Primary Care: The SUMMIT Randomized Clinical Trial.

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