The Supporting Patient Activation in Transition to Home Intervention ([sPATH])

• ClinicalTrials.gov Identifier: NCT02823795
• Recruitment Status: Completed
• First Posted: July 6, 2016
• Last Update Posted: September 23, 2020
• Sponsor: Karolinska Institutet
• Collaborators: Vårdalstiftelsen; Forte
• Information provided by (Responsible Party): Mirjam Ekstedt, Karolinska Institutet

Study Description

Brief Summary:

This study evaluates if motivational interviewing sessions aiming to motivate recently discharged patients with either chronic obstructive pulmonary disease or congestive heart failure to be active in post-discharge self-management can reduce re-hospitalization rates.

Condition or disease	Intervention/treatment	Phase
Medication Adherence; Self-care; Heart Failure; Chronic Obstructive Pulmonary Disease	Behavioral: Motivational Interviewing	Not Applicable

Detailed Description:

Included patients transition to home will be bridged through a telephone-call from a patient activation coach two days post-discharge. The patients will thereafter get motivational interviewing sessions by the same patient activation coach with the the goal that the patients are motivated to the knowledge, skills and confidence needed to manage the four main activity areas: 1) medication management; 2) adhere to care plan/ follow-up visits according to the discharge plan; 3) recognize indications (symptoms/signs) that the condition is worsening and how to respond; and 4) contact and manage relations/encounters with health care providers. Patients in control group will receive standard care, i.e. discharge and follow-up as in normal procedures. The investigators will use a randomization in permuted blocks of 10 intervention patients and 10 control patients included. To test the hypothesis that the re-hospitalizations rate is 15 % lower in the intervention group compared to the control group 242 patients (121 per group) are needed for power of 80% with the level of significance set to 5 % using two-sided chi-square.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 118 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: The Supporting Patient Activation in Transition to Home (sPATH) Intervention - a Study Protocol of Randomized Controlled Trial
• Actual Study Start Date: September 2016
• Actual Primary Completion Date: June 30, 2018
• Actual Study Completion Date: September 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: sPATH; Motivational Interviewing in five sessions post hospital discharge	Behavioral: Motivational Interviewing; Patients will get motivational interviewing sessions by a patient activation coach (medical social workers and/or nurses trained in motivational interviewing and in the intervention) in five post hospital discharge sessions (whereof one face-to-face, four by phone) aiming to increase patient motivation to become active in self-management (medication management, care plan/follow-up, symptoms/signs of worsening condition, contacts with health care provider).
No Intervention: Control; Care as usual

Outcome Measures

Primary Outcome Measures :

1. Re-hospitalization [ Time Frame: 90 days ]
   Registry data from the Swedish Register for Health Care Encounters

Secondary Outcome Measures :

1. Healthcare usage [ Time Frame: 30, 90 and 180 days ]
   Registry data from the Swedish Register for Health Care Encounters: re-hospitalization at 30 and 180 days. Emergency room and primary care visits at 30, 90 and 180 days
2. Medication adherence [ Time Frame: 30, 90 and 180 days ]
   Patient reported data using the Morisky Medication Adherence Scale, 8 items, and registry data using medicine data from the Swedish Prescribed Drug Registry
3. Patient activation [ Time Frame: 30, 90 and 180 days ]
   Patient reported data using the Patient Activation Measure, 13 item
4. Health related quality of life [ Time Frame: 30, 90 and 180 days ]
   Patient reported data using the EQ-5D-5L
5. Basic Psychological Needs [ Time Frame: 30, 90 and 180 days ]
   Patient reported data using the the Basic Psychological Need Satisfaction & Frustration Scale, 18 items
6. Depression [ Time Frame: 30, 90 and 180 days ]
   Patient reported data using PHQ-9 (Patient Health Questionnaire)

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Patients aged 18 years or older with chronic obstructive pulmonary disease or congestive heart failure admitted at a short-term medical ward and who are living in their private home.

Exclusion Criteria:

• Diagnoses of dementia or cognitive impairment, and need of interpreter to participate in conversations.

The exclusion criteria are related to the patients' possibilities to participate in the motivational interviewing sessions by phone.

Contacts and Locations

Locations

Sweden

Akutkliniken, Karolinska University Hospital

Huddinge, Sweden

Karolinska Universitetssjukhuset, Lung- Allergikliniken

Huddinge, Sweden

Sponsors and Collaborators

Karolinska Institutet

Vårdalstiftelsen

Forte

Investigators

• Principal Investigator: Mirjam Ekstedt, Professor; LIME, Karolinska Institutet

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Brandberg C, Ekstedt M, Flink M. Self-management challenges following hospital discharge for patients with multimorbidity: a longitudinal qualitative study of a motivational interviewing intervention. BMJ Open. 2021 Jul 30;11(7):e046896. doi: 10.1136/bmjopen-2020-046896.

Flink M, Brandberg C, Ekstedt M. Why patients decline participation in an intervention to reduce re-hospitalization through patient activation: whom are we missing? Trials. 2019 Jan 25;20(1):82. doi: 10.1186/s13063-019-3187-9.

Flink M, Lindblad M, Frykholm O, Kneck A, Nilsen P, Arestedt K, Ekstedt M. The Supporting Patient Activation in Transition to Home (sPATH) intervention: a study protocol of a randomised controlled trial using motivational interviewing to decrease re-hospitalisation for patients with COPD or heart failure. BMJ Open. 2017 Jul 10;7(7):e014178. doi: 10.1136/bmjopen-2016-014178.

• Responsible Party: Mirjam Ekstedt, Professor, Karolinska Institutet
• ClinicalTrials.gov Identifier: NCT02823795
• Other Study ID Numbers: C751231003; Dnr 2014-0026 ( Other Grant/Funding Number: Vårdalsstiftelsen ); Dnr 2014-4948 ( Other Grant/Funding Number: Forte )
• First Posted: July 6, 2016
• Last Update Posted: September 23, 2020
• Last Verified: September 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

Keywords provided by Mirjam Ekstedt, Karolinska Institutet:

Patient participation; Empowerment; Medication management; Symptom management; Self determination theory; Motivational Interviewing

Additional relevant MeSH terms:

Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes